john hopkins type 2 diabetes research

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Diabetes Medications for Adults With Type 2 Diabetes: An Update

Comparative Effectiveness Reviews, No. 173

Investigators: Shari Bolen , MD, MPH, Eva Tseng , MD, MPH, Susan Hutfless , PhD, Jodi B Segal , MD, MPH, Catalina Suarez-Cuervo , MD, Zackary Berger , MD, PhD, Lisa M Wilson , ScM, Yue Chu , MSPH, Emmanuel Iyoha , MBChB, MPH, and Nisa M Maruthur , MD, MHS.

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Structured Abstract

Objectives:.

To evaluate the comparative effectiveness and safety of monotherapy and metformin-based combination therapy for type 2 diabetes.

Data sources:

We searched MEDLINE ® , Embase ® , and the Cochrane Central Register of Controlled Trials (CENTRAL) for English-language articles using the search developed for the prior review (2011), with date restrictions of April 2009 through April 2015. We searched Drugs@FDA and ClinicalTrials.gov for unpublished data.

Review methods:

Two reviewers independently reviewed titles, abstracts, and full-text articles to identify studies that assessed intermediate and clinical outcomes or safety for monotherapy (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 [DPP-4] inhibitors, glucagon-like peptide-1 [GLP-1] agonists, and sodium glucose cotransporter-2 [SGLT-2] inhibitors) or metformin-based combination therapy (metformin plus one of these monotherapy drugs or insulin) comparisons. Two reviewers extracted data from included articles sequentially using standardized protocols; risk of bias was assessed independently. Two reviewers graded the strength of the evidence sequentially using a protocol adapted from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria.

We included 216 studies and found moderate- or high-strength evidence for the following. Hemoglobin A1c (HbA1c) reduction was similar across all monotherapy comparisons and across metformin-based combination comparisons except DPP-4 inhibitors, which yielded smaller reductions than metformin. Metformin, DPP-4 inhibitors, GLP-1 agonists, and SGLT-2 inhibitors reduced or maintained body weight, while sulfonylureas, thiazolidinediones, and insulin increased weight; between-group differences ranged from 1 to 5 kilograms. SGLT-2 inhibitors and GLP-1 agonists plus metformin reduced systolic blood pressure by 3 to 5 mmHg compared with metformin. Cardiovascular mortality in studies over 2 years in duration was 50 to 70 percent higher for sulfonylureas than metformin (risk difference, 0.1% to 2.9% in randomized controlled trials). Sulfonylurea-based therapy increased the risk of total and severe hypoglycemia versus most comparisons. Gastrointestinal adverse events were higher with metformin than other drugs except GLP-1 agonists, which increased nausea/vomiting 1.5 times compared with metformin. SGLT-2 inhibitors increased the risk of genital mycotic infections over other drugs. The evidence did not support substantive conclusions for microvascular outcomes, congestive heart failure, cancer, pancreatitis, or other safety outcomes.

Conclusions:

Evidence from this updated systematic review supports metformin as firstline therapy, given its beneficial effects on HbA1c, weight, and cardiovascular mortality (relative to sulfonylureas) and its relative safety profile. In addition, evidence on comparative outcomes associated with different medication classes can be used to facilitate personalized treatment choices by patients and clinicians, guideline development, and decisionmaking by payers and regulators.

• Collapse All
• Addendum and Errata
• Acknowledgments
• Technical Expert Panel
• Peer Reviewers
• Executive Summary
• Rationale for Update of Review on Comparative Effectiveness of Diabetes Medications
• Analytic Framework
• Key Questions
• Topic Refinement and Review Protocol
• Literature Search Strategy
• Data Extraction
• Risk of Bias Assessment of Individual Studies
• Data Synthesis
• Strength of the Body of Evidence
• Applicability
• Peer Review and Public Commentary
• Results of Literature Searches
• Study Duration of RCTs for All Key Questions (KQ1–KQ4)
• Key Questions 1a and 1b. Intermediate Outcomes
• Key Questions 2a and 2b. All-Cause Mortality and Macrovascular and Microvascular Outcomes
• Key Questions 3a and 3b. Safety
• Key Question 4. Subgroups
• Key Findings in Context
• Implications for Clinical and Policy Decisionmaking
• Limitations of the Comparative Effectiveness Review Process
• Limitations of the Evidence Base
• Research Gaps and Future Research Needs
• Conclusions
• Abbreviations
• Appendix A. Detailed Electronic Database Search Strategies
• Appendix B. Forms
• Appendix C. List of Excluded Studies
• Appendix D. Evidence Tables
• Appendix E. Gray Literature
• Appendix F. Key Points and Evidence Grades
• Appendix G. References

Suggested citation:

Bolen S, Tseng E, Hutfless S, Segal JB, Suarez-Cuervo C, Berger Z, Wilson LM, Chu Y, Iyoha E, Maruthur NM. Diabetes Medications for Adults With Type 2 Diabetes: An Update. Comparative Effectiveness Review No. 173. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2012-00007-I.) AHRQ Publication No. 16-EHC013-EF. Rockville, MD: Agency for Healthcare Research and Quality; April 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm .

This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00007-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov . Search on the title of the report.

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• Cite this Page Bolen S, Tseng E, Hutfless S, et al. Diabetes Medications for Adults With Type 2 Diabetes: An Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Apr. (Comparative Effectiveness Reviews, No. 173.)
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• Review Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes: A Systematic Review and Meta-analysis. [Ann Intern Med. 2016] Review Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes: A Systematic Review and Meta-analysis. Maruthur NM, Tseng E, Hutfless S, Wilson LM, Suarez-Cuervo C, Berger Z, Chu Y, Iyoha E, Segal JB, Bolen S. Ann Intern Med. 2016 Jun 7; 164(11):740-51. Epub 2016 Apr 19.
• Review Oral Diabetes Medications for Adults With Type 2 Diabetes: An Update [ 2011] Review Oral Diabetes Medications for Adults With Type 2 Diabetes: An Update Bennett WL, Wilson LM, Bolen S, Maruthur N, Singh S, Chatterjee R, Marinopoulos SS, Puhan MA, Ranasinghe P, Nicholson WK, et al. 2011 Mar
• Review Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. [Ann Intern Med. 2011] Review Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Bennett WL, Maruthur NM, Singh S, Segal JB, Wilson LM, Chatterjee R, Marinopoulos SS, Puhan MA, Ranasinghe P, Block L, et al. Ann Intern Med. 2011 May 3; 154(9):602-13. Epub 2011 Mar 14.
• Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials. [BMJ. 2021] Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials. Palmer SC, Tendal B, Mustafa RA, Vandvik PO, Li S, Hao Q, Tunnicliffe D, Ruospo M, Natale P, Saglimbene V, et al. BMJ. 2021 Jan 13; 372:m4573. Epub 2021 Jan 13.
• Review Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report [ 2011] Review Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report Jonas D, Van Scoyoc E, Gerrald K, Wines R, Amick H, Triplette M, Runge T. 2011 Feb

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Type 2 Diabetes: Sequencing Therapies

• Treatment of hyperglycemia in diabetes should be progressively intensified as necessary to control blood glucose to target ranges.
• Modification of cardiovascular risk factors and reduction in cardiovascular risk is equally important to reduce future cardiovascular events.
• This requires, first, establishing goals, especially for hemoglobin A1c and determining baseline cardiovascular disease status and risk. Patients without overt CVD, with shorter duration of disease, and lower baseline HbA1c may benefit from more intensive strategies. It then requires adjusting therapy to reach those targets.
• Recommendations should be considered in the context of the needs, preferences, and tolerances of each patient.
• Patient-centered care should be an organizing principle. It is defined as an approach to "providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions." [6]
• Ultimately it is the patient that makes the final decisions regarding lifestyle choices.

EPIDEMIOLOGY

• The risk of microvascular complications of diabetes ( retinopathy , nephropathy , neuropathy ) is closely related to control of blood glucose.
• Microvascular complications are a major cause of morbidity and mortality (see specific complications).
• Most people with diabetes do not have optimal glycemic control (average U.S. HbA1c >7%), indicating the need to advance therapy more quickly.
• Prevention of macrovascular complications (cardiovascular disease) has been historically linked to control of traditional risk factors (e.g. blood pressure, lipids, smoking), which should also be aggressively managed in people with diabetes.
• Since 2008, the Food and Drug Administration (FDA) set a requirement for new diabetes treatments to undergo additional trials focused on cardiovascular disease outcomes to demonstrate safety. Outcomes of these studies demonstrated superiority of specific agents compared to placebo, and led to some agents receiving FDA approval for cardiovascular risk reduction.

CLINICAL TREATMENT

• Dietary modification and increased physical activity are always the basis of good care and have been shown in clinical studies to be more effective than medication in prevention of diabetes [15] .
• It is important to individualize treatment goals. Shared decision making with the patient may help in selection of therapeutic options.
• Elements that can guide choosing an HbA1c target for a specific patient include: patient attitude and expected treatment benefits, risk potentially associated with adverse events (i.e. hypoglycemia), disease duration, life expectancy, comorbidities, functional status, established vascular complications, and psychosocial resources (i.e. support system ).
• Metformin is generally the first-line oral agent (along with lifestyle recommendations) used in treating type 2 diabetes on diagnosis, unless contraindicated or not tolerated. Initially 500 mg one to two times daily (often started as once daily for 2-4 weeks to reduce gastrointestinal side effects) then titrated quickly. Maximize metformin dose to glycemic goals (unless GI side effects limit tolerated dose).
• Consider dual therapy if A1c is ≥1.5% above glycemic target. Should also initiate a second agent if glycemic control is inadequate on maximal doses of therapy (after 3 months).
• Current American Diabetes Association (ADA) and American Academy of Clinical Endocrinology (AACE) guidelines provide multiple options for additional therapy after metformin initiation.
• Approved to reduce the risk of major adverse cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors (primary or secondary CVD prevention).
• REWIND trial [1] showed dulaglutide group had a 12% reduction in risk of MACE vs. the placebo group.
• Approved to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease
• LEADER trial [4] showed a 13% reduction in composite death, nonfatal myocardial infarction, and nonfatal stroke versus placebo.
• Approved to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease
• SUSTAIN 6 trial [5] showed weekly semaglutide group had a 26% reduction in risk of major adverse cardiovascular event vs. placebo. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction (including silent), or nonfatal stroke.
• Approved to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease
• CANVAS trial [3] showed a 14% reduction in a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke versus placebo.
• Approved to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease
• EMPA-REG trial [7] showed a 14% reduction in MACE and 38% relative risk reduction in death from cardiovascular causes versus placebo.
• Approved to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
• DECLARE trial [2] showed dapagliflozin group had a 17% reduction in risk of cardiovascular death or hospitalization for heart failure than placebo. It should be noted that primary outcome in trial was driven by heart failure hospitalization as there was no difference in the rate of cardiovascular death.
• Sulfonylureas (high glucose-lowering ability, risk of hypoglycemia, weight gain, low cost)
• Thiazolidinediones (high glucose-lowering ability, weight gain, potential risk of HF, ASCVD-risk benefit, low cost)
• DPP-IV inhibitors (less likely to cause hypoglycemia and weight neutral)
• GLP-1 analogs (high glucose-lowering ability, weight loss, less likely to cause hypoglycemia, injectable)
• Early use of basal insulin (if A1c>8% on optimal therapy).
• Sodium-glucose cotransporter 2 inhibitor (less likely to cause hypoglycemia, promotes weight loss)
• Other approved agents to consider but less frequently used as additional oral agents include bromocriptine , colesevelam, alpha glucosidase inhibitors, and meglitinides.
• Review side effects and contraindications prior to initiating additional medications. Combination oral pills may be available.
• If patient is already on 2-3 oral agents and still not optimally controlled, consider adding a GLP-1 analog as the recommended initial injectable agent prior to initiation of insulin therapy in type 2 diabetes (T2DM) due to lower risk of hypoglycemia and potential weight loss. However, these agents may be more costly.
• Patients with high baseline HbA1c ( i.e. ≥10%) have a low probability of achieving a near-normal target with oral monotherapy. Insulin therapy may be initially considered on diagnosis. Once initial symptoms are resolved and metabolic state stabilized upon diagnosis, it may be possible to taper insulin partially or completely to non-insulin antihyperglycemic agents.
• In patients with new-onset diabetes, lifestyle therapy alone may be considered as initial therapy in a select group of patients with HbA1c close to goal (i.e. < 7.5%). [6]
• Table Table 1 summarizes the relative efficacy of non-insulin glucose lowering agents available for the treatment of type 2 diabetes:

*Ranges are approximate and rounded to nearest half digit

• Changing treatment regimen may require follow-up more frequently than usual (i.e. review of weekly glucose logs), depending on the circumstance.
• At a minimum, patients with recent dose changes in therapy should be seen within 3 months in clinic; those on a stable regimen at goal may be seen at 6-month intervals.
• Consider dietary patterns and physical activity level when determining treatment regimen.

EXPERT COMMENTS

• Goals of care are to achieve glycemic targets but also avoid unacceptable hypoglycemia, improve quality-of-life, and also to reduce risk of cardiovascular disease .
• Many agents now have demonstrated cardiovascular benefit (i.e. a label indication from the FDA for reducing cardiovascular events) in patients with established cardiovascular disease, and in some instances, among those at high-risk for CVD ; in patients with heart failure with reduced ejection fraction or CKD, specific SGLT2 inhibitors have also been found to have cardiovascular or renal benefit and are preferred in these patients.
• The most common error in blood glucose management is advancing treatment regimen too slowly, allowing prolonged poor glycemic control.
• Beware of "clinical inertia": the tendency of clinicians not to change a medical regimen even when it is not working after some time [9] .
• The progressive nature of type 2 diabetes and need for intensification of therapies should be explained to patients.
• Avoid using insulin as a threat or describing it as a failure of treatment.
• When initiating insulin, consider continuation of another agent if appropriate (e.g. metformin ) to potentially reduce insulin requirement and weight gain.
• T2DM often requires multiple oral agents and/or relatively high-dose insulin therapy.
• Wide differences exist among clinicians’ exact sequencing of oral agents; evidence favoring one sequence over others is virtually nonexistent especially after initiation of metformin among those without history of cardiovascular disease, heart failure, or CKD.
• A patient-centered approach be used to guide the choice of pharmacological agents.
• Considerations in choosing therapies include efficacy, cost, potential side effects, effects on weight, cormobidities, hypoglycemia risk, and patient preferences.
• Alpha glucosidase inhibitors may also be beneficial for dumping syndrome in patients after gastric bypass surgery
• Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet . 2019;394(10193):121-130.   [PMID:31189511]
• Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med . 2019;380(4):347-357.   [PMID:30415602]
• Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med . 2017;377(7):644-657.   [PMID:28605608]
• Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med . 2016;375(4):311-22.   [PMID:27295427]
• Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med . 2016;375(19):1834-1844.   [PMID:27633186]
• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care . 2015;38(1):140-9.   [PMID:25538310]
• Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med . 2015;373(22):2117-28.   [PMID:26378978]

Comment: A concensus committee's recommendation on sequencing of treatment of type 2 diabetes. Quite non-specific after initiation of metformin.

Comment: An interesting study of factors that contribute to "clinical inertia", the tendency not to adjust treatment even when it is not working.

Comment: A useful review of available insulins and a practical consideration of how to start and then intensify insulin regimens

Comment: Open label comparison of exenatide (an incretin mimetic) vs. insulin glargine in type 2 diabetics who had failed oral agents. Exenatide had similar glycemic efficacy, but more weight reduction, and higher incidence of gastrointestinal side effects.

Comment: An important review of the mechanisms of action, side effects and clinical use of thiazolidinediones.

Comment: An expert committee statement of the rationale and approaches to weight control.

Comment: A relatively small randomized trial in which patients were given nutrition education or not. Those educated in a sound nutrition plan showed better glycemic control.

Comment: The Diabetes Prevention Program demonstrated that Intensive Lifestyle reduced incidence of diabetes by 58%, metformin by 31% in subjects with impaired glucose tolerance

Comment: AACE Clinical Guidelines for managing diabetes, describing in detail the available medications available, important characteristics, and a general statement of choices for sequencing.

Comment: AACE statement of recommended sequencing on treatments.

• American Diabetes Association: Standards of medical care in diabetes--2017. Diabetes Care Vol 40 Suppl 1. https://professional.diabetes.org/sites/professional.diabetes.org/files/me ...

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Study Finds Undiagnosed Diabetes in U.S. Less Than Half of Current Estimates

Analysis, based on two screening tests instead of one, suggests undiagnosed diabetes is more prevalent in older and obese adults, racial/ethnic minorities, and those without health care access  

A new study from researchers at the Johns Hopkins Bloomberg School of Public Health estimates that the overall number of undiagnosed diabetes cases in the U.S. is significantly lower than current government estimates suggest.

The findings, published online July 11 in Diabetes Care , suggest that public health efforts to improve diabetes awareness and screening over the past three decades have translated into better detection of type 2 diabetes in the U.S. At the same time, the study showed major disparities in the burden of undiagnosed diabetes in certain population subgroups.

For their analysis, the researchers used government health survey data covering thousands of people over more than 30 years, 1988 to 2020. Instead of estimating undiagnosed diabetes from single blood test results, as the Centers for Disease Control and Prevention does, the researchers used the two-test criterion that doctors use when screening for diabetes. The researchers found that about 9.5 percent of the total diabetes burden in the U.S. is undiagnosed, versus estimates in the 20-to-30 percent range.

“Our findings suggest that the true figure is much lower and that providers in the U.S. are doing a good job overall with diabetes screening and diagnosis,” says study senior author Elizabeth Selvin, PhD, professor in the Bloomberg School’s Department of Epidemiology. “Nonetheless, undiagnosed diabetes remains high in some subgroups, indicating that there’s still a long way to go.”

The analysis found that undiagnosed diabetes is more prevalent in older and obese adults, racial/ethnic minorities, notably Mexican Americans and Asian Americans, and those without health care access. Individuals who reported an interval of more than one year since their last health care visit also had a high estimated prevalence of confirmed undiagnosed diabetes.

“It’s a real concern that certain populations are being missed by the health care system. This is likely a major reason why undiagnosed diabetes remains high in these groups,” says Michael Fang, PhD, assistant professor in the Department of Epidemiology at the Bloomberg School and the paper’s first author.

Diabetes is considered one of the world’s top public health burdens. A condition featuring chronic elevated glucose in the bloodstream, diabetes affects approximately 14 percent of the U.S. adult population, and more than one-quarter of adults over 65. The prevalence of diabetes has been increasing in recent decades, in part due to the epidemic of obesity. Chronically elevated glucose levels in diabetes can weaken immunity, promote inflammation, harm blood vessels, raise the risk of heart attacks and strokes and can also cause retinopathy (eye disease), kidney disease, and damage to the nerves.

Researchers have been endeavoring to understand the true burden of undiagnosed diabetes, with the aim of identifying those patients who need treatment. The Centers for Disease Control and Prevention, in its 2020 National Diabetes Statistics Report, estimated that about 2.8 percent of the 18-and-over population, or roughly seven million Americans, have undiagnosed diabetes. That figure would represent about 22 percent of the total diabetes burden. The report’s estimates were based on national survey data and using any single blood test result indicating elevated glucose. Doctors typically diagnose diabetes only after confirming an elevated test result—this approach reduces the possibility of giving patients a false positive diagnosis of diabetes. For example, clinical guidelines recommend that an initial elevated result on the standard fasting glucose test be confirmed with a glycated hemoglobin test, also known as the HbA1c test, or a second fasting glucose test a few weeks later.

In their new study, Selvin, Fang, and colleagues applied a similar two-test criterion to blood test results in the CDC’s National Health and Nutrition Examination Surveys. These surveys combine interviews and checkups of nationally representative samples of U.S. adults and have been conducted for the past several decades. The research team drew from survey results covering 30,492 people from the period 1988–2020, ending just before the start of the COVID-19 pandemic.

The researchers considered individuals in the survey as having “confirmed undiagnosed diabetes” if they had no diabetes diagnosis, yet their test results included elevated results on both a fasting glucose and an HbA1c test.

The researchers found that the number of individuals in this category suggested a national prevalence, for the latest dataset (2017–2020), of only 1.23 percent—less than half the CDC’s most recent estimate based on single test results—and only about 9.5 percent of the total diabetes prevalence. This more conservative readout of undiagnosed diabetes prevalence was also basically unchanged since 1988.

In contrast, the results suggest that diagnosed diabetes prevalence in the U.S. rose sharply, from 4.6 percent of the population in the 1988–1994 survey period to 11.7 percent in 2017–2020—representing 90.5 percent of all diabetes prevalence in the country. Thus, the increase in the diabetes burden in the U.S. in recent decades essentially has been due to more diagnosed cases.

The demographic groups with the highest prevalence of undiagnosed diabetes include Mexican Americans, with a confirmed undiagnosed diabetes prevalence of 3.31 percent, nearly three times the national average, and nearly four times the figure (0.86 percent) for non-Hispanic white Americans. Asian Americans had a confirmed undiagnosed diabetes prevalence of 2.59 percent, triple the figure for whites.

"Traditional methods seem to have captured the large majority of adults with undiagnosed diabetes,” says Fang. “The populations with undiagnosed diabetes may be more difficult to reach. Screening interventions targeting these groups may be needed."

“Undiagnosed Diabetes in U.S. Adults: Prevalence and Trends” was co-authored by Michael Fang, Dan Wang, Josef Coresh and Elizabeth Selvin.

Funding was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (K24 DK106414).

# # # Media contacts:  Jonathan Eichberger at  [email protected]  and  Carly Kempler at  [email protected] .

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Together on Diabetes

Focus Area: Diabetes & Obesity Prevention

American Indian youth are affected by obesity and type 2 diabetes at disproportionate rates. These chronic health issues are complex; prevention and treatment requires a comprehensive and holistic approach. Utilizing concepts and program structure from previous evidence-based diabetes prevention programs, four American Indian communities and the Center for American Indian Health developed the Together on Diabetes Program, a family-based, home-visiting diabetes prevention/management program for American Indian youth and their families.

About the Together on Diabetes Program

In 2011, the Center for American Indian Health received a grant from the Bristol Meyers Squibb Foundation to develop and implement Together on Diabetes. Between 2012 and 2015, Family Health Coaches, local paraprofessionals trained in the curriculum and program procedures, delivered Together on Diabetes to 250 youth and their families in four tribal communities.

Together on Diabetes Impacts Multiple System Levels:

Individual Impact : Providing one-on-one, home-based healthy living education and social support to youth with or at-risk of type 2 diabetes. Family Impact : Educating caregivers of young people to create a healthy home environment through lessons delivered in the home. Health Care Impact : Providing youth with transportation to clinic appointments and working with a care team to ensure comprehensive and consistent care. Community Impact : Working with local organizations to provide healthy living opportunities to families. Results

Preliminary results indicate improvements in youth knowledge, quality of life and emotional health, as well as stabilized BMI among participants in the program. Learn more .

This project has been supported by the Bristol-Myers Squibb Foundation. Additional support was provided by the Notah Begay III Foundation.

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Who? Sulfonylureas and meglitinides are recommended for persons with type 2 diabetes who have poorly controlled blood glucose levels. On average, most patients find that their Hb A1c levels drop by up to 1.5% on these medications. What? Oral tablets - sulfonylureas ...

DPP-IV Inhibitors

Who? DPP-IV inhibitors are recommended for patients with type 2 diabetes who have poorly controlled blood glucose and high Hb A1c levels. On average, most patients find that their A1c levels drop by 0.5-1.0% on these medications.What? Oral tabletsA few types of DPP-IV ...

GLP-1 Receptor Agonists

Who? GLP-1 agonists , also known as incretin mimetics , are recommended for persons with type 2 diabetes who have poorly controlled blood glucose and high Hb A1c levels. On average, most patients find that their HbA1c levels drop by as much as 0.5-1.5% on these...

Alpha Glucosidase Inhibitors

Who? Alpha glucosidase inhibitors are recommended for persons with type 2 diabetes who have poorly controlled blood glucose despite using other diabetic medications. These are typically not first-line, but can be used in special situations. On average, most patients...

Thiazolidinediones

Who? Thiazolidinediones are recommended for persons with type 2 diabetes who have poorly controlled blood glucose and high Hb A1c levels.   What? Oral tablet - There are two types of thiazolidinediones that are currently available: Pioglitazone (marketed as...

Insulin Treatment in Type 2 Diabetes

The decision to take insulin is never an easy one. For many patients, it comes after years of having type 2 diabetes and trying multiple weight-loss regimens, diets, and oral medications. For other patients, the decision to take insulin is made...

Basal Insulins (Intermediate and Long-Acting)

Who?Intermediate- and long-acting (basal) insulins are recommended for patients with type 1, type 2, or gestational diabetes . They may also be used in other types of diabetes (i.e. steroid-induced).Persons with type 1 diabetes generally use...

Bolus Insulins (Short-Acting and Rapid-Acting)

Who? Short-acting (Regular) and rapid-acting insulins ( Aspart , Lispro , Glulisine ) are recommended for patients with type 1, type 2, or gestational diabetes . They may also be used in other types of diabetes. Persons with type 1 diabetes often use insulin regular or...

SGLT2 Inhibitors

 Who? Sodium glucose co-transporter 2 ( SGLT2 ) inhibitors are a relatively new class of drugs recommended for persons with type 2 diabetes who have poorly controlled blood glucose and high HbA1c levels.What? Taken as an oral tablet.There are three types of SGLT2 ...

New Research Sheds Light on Cause of Type 2 Diabetes

Newswise — St. Petersburg, Fla. – September 12, 2023 – Scientists at Johns Hopkins All Children’s Hospital, along with an international team of researchers, are shedding new light on the causes of Type 2 diabetes. The new research, published in the journal Nature Communications, offers a potential strategy for developing new therapies that could restore dysfunctional pancreatic beta-cells or, perhaps, even prevent Type 2 diabetes from developing.

The new study shows that the beta-cells of Type 2 diabetes patients are deficient in a cell trafficking protein called “phosphatidylinositol transfer protein alpha” (or PITPNA), which can promote the formation of “little packages,” or intracellular granules containing insulin. These structures facilitate processing and maturation of insulin “cargo.” By restoring PITPNA in the Type 2 deficient beta-cells, production of insulin granule is restored and this reverses many of the deficiencies associated with beta-cell failure and Type 2 diabetes.

Researchers say it’s important to understand how specific genes regulate pancreatic beta-cell function, including those that mediate insulin granule production and maturation like PITPNA to provide therapeutic options for people.

Matthew Poy, Ph.D.,  an associate professor of Medicine and Biological Chemistry in the Johns Hopkins University School of Medicine and leader of the Johns Hopkins All Children’s team within the  Institute for Fundamental Biomedical Research , was lead researcher on the study. He adds that follow-up work is now focused on whether PITPNA can enhance the functionality of stem-cell-derived pancreatic beta-cells. Since stem cell-based therapies are still in their relatively early stages of clinical development, it appears a great deal of the potential of this approach remains untapped. Poy believes that increasing levels of PITPNA in stem cell-derived beta-cells is an approach that could enhance the ability to produce and release mature insulin prior to transplantation in diabetic subjects.

“Our dream is that increasing PITPNA could improve the efficacy and potency of beta-like stem cells,” Poy says. “This is where our research is heading, but we have to discover whether the capacity of these undifferentiated stem cells that can be converted into many different cell types can be optimized — and to what level — to be converted into healthy insulin producing beta-cells. The goal would be to find a cure for type 2 diabetes.”

Read more about this groundbreaking research.

This study was funded through grants from the  Johns Hopkins All Children’s Foundation , the  National Institute of Health , the Robert A. Welch Foundation, the  Helmholtz Gemeinschaft , the  European Foundation for the Study of Diabetes , the  Swedish Science Council , the  NovoNordisk Foundation  and the  Deutsche Forschungsgemeinschaft .

About Johns Hopkins All Children’s Hospital

Johns Hopkins All Children’s Hospital in St. Petersburg is a leader in children’s health care, combining a legacy of compassionate care focused solely on children since 1926 with the innovation and experience of one of the world’s leading health care systems. The 259-bed teaching hospital, stands at the forefront of discovery, leading innovative research to cure and prevent childhood diseases while training the next generation of pediatric experts. With a network of Johns Hopkins All Children’s Outpatient Care centers and collaborative care provided by All Children’s Specialty Physicians at regional hospitals, Johns Hopkins All Children’s brings care closer to home. Johns Hopkins All Children’s Hospital consistently keeps the patient and family at the center of care while continuing to expand its mission in treatment, research, education and advocacy. For more information, visit HopkinsAllChildrens.org .

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Introduction

Research design and methods, conclusions, article information, a national physician survey of deintensifying diabetes medications for older adults with type 2 diabetes.

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Scott J. Pilla , Rabia Jalalzai , Olive Tang , Nancy L. Schoenborn , Cynthia M. Boyd , Sherita H. Golden , Nestoras N. Mathioudakis , Nisa M. Maruthur; A National Physician Survey of Deintensifying Diabetes Medications for Older Adults With Type 2 Diabetes. Diabetes Care 1 June 2023; 46 (6): 1164–1168. https://doi.org/10.2337/dc22-2146

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To determine physicians’ approach to deintensifying (reducing/stopping) or switching hypoglycemia-causing medications for older adults with type 2 diabetes.

In this national survey, U.S. physicians in general medicine, geriatrics, or endocrinology reported changes they would make to hypoglycemia-causing medications for older adults in three scenarios: good health, HbA 1c of 6.3%; complex health, HbA 1c of 7.3%; and poor health, HbA 1c of 7.7%.

There were 445 eligible respondents (response rate 37.5%). In patient scenarios, 48%, 4%, and 20% of physicians deintensified hypoglycemia-causing medications for patients with good, complex, and poor health, respectively. Overall, 17% of physicians switched medications without significant differences by patient health. One-half of physicians selected HbA 1c targets below guideline recommendations for older adults with complex or poor health.

Most U.S. physicians would not deintensify or switch hypoglycemia-causing medications within guideline-recommended HbA 1c targets. Physician preference for lower HbA 1c targets than guidelines needs to be addressed to optimize deintensification decisions.

Graphical Abstract

The benefits of glycemic control to prevent diabetes complications take years to accrue and diminish with limited life expectancy ( 1 ). Therefore, guidelines from the American Diabetes Association (ADA) and others recommend selecting higher hemoglobin A 1c (HbA 1c ) targets for older adults with worse health status defined by multiple comorbidities, functional or cognitive limitations, and limited life expectancy ( 2 ). Accordingly, diabetes guidelines recommend deintensifying therapy (i.e., reducing or stopping a diabetes medication) when it can prevent medication-related harms and be achieved within the individualized glycemic target ( 2 ). However, deintensification rarely occurs in practice, and glycemic control does not vary by the patient’s health status ( 3 – 5 ). Therefore, we conducted a national survey of U.S. physicians to understand their decisions to deintensify diabetes therapy and select glycemic targets for older adults.

We surveyed 1,950 physicians in general medicine ( n = 525), geriatrics ( n = 525), and endocrinology ( n = 900) identified using the American Medical Association Physician Masterfile ( 6 ). Endocrinologists were oversampled because medical specialists had lower response rates in prior surveys ( 7 – 10 ). Trainees and physicians not routinely providing outpatient care to older adults with type 2 diabetes were excluded. The survey was distributed in three mailing waves with a $10 gift card in the first wave and follow-up e-mails and phone calls to nonrespondents ( Supplementary Survey Methods ). Responses were received between June 2021 and March 2022.

The survey instrument was developed through a participatory action research process ( 11 ) involving patients, caregivers, and multidisciplinary physicians. The final survey ( Supplementary Material ) included three scenarios representing older adults with type 2 diabetes in different states of health (good, complex, and poor) who were taking an intermediate dose of a hypoglycemia-causing medication with HbA 1c below their individualized target ( 2 ). Scenario 1 was a healthy 79-year-old woman taking glimepiride with an HbA 1c of 6.3%. Scenario 2 was a 77-year-old man with multiple chronic conditions taking insulin glargine with an HbA 1c of 7.3%. Scenario 3 was a 78-year-old woman with advanced dementia taking glipizide with an HbA 1c of 7.7%. Each scenario started with a base case in which the patient reported no recent hypoglycemia or medication concerns, followed by nine variations with different patient characteristics and preferences. For each variation, physicians were asked the identical question of what change they would make, if any, to the diabetes medication. The survey also asked physicians to select the HbA 1c target they would recommend for older adults in good, complex, and poor health as described using the language in the ADA Standards of Medical Care in Diabetes—2022 ( 2 ).

Characteristics were compared across specialties using χ 2 or Kruskal-Wallis test. We used multinomial logistic regression models ( Supplementary Table 1 ) to determine the association between predictors of interest and physicians’ actions in clinical scenarios, adjusted for physician specialty and accounting for clustering of responses within physicians. Analyses were conducted using Stata 14 statistical software (StataCorp LP, College Station, TX).

Survey Response and Population

There were 445 eligible respondents ( Table 1 ). The response rate was 37.5%, with 38.3%, 30.0%, and 40.8% response rates from physicians in general medicine, geriatrics, and endocrinology, respectively ( Supplementary Fig. 1 ). The most common reason for ineligibility was not providing outpatient diabetes care ( Supplementary Table 2 ). There were no significant differences between the characteristics of respondents and nonrespondents, except specialty ( Supplementary Table 3 ). Physicians of different specialties had similar demographic, but different practice characteristics ( Supplementary Table 4 ). On average, respondents completed 98% of the survey questions.

Characteristics of included physicians

Data are n (%) unless otherwise indicated.

There were 7.4% missing data for insurance type and no missing data for age and years in practice, which used data from the AMA Physician Masterfile if not reported by survey respondents.

Deintensifying or Switching Hypoglycemia-Causing Medications in Clinical Scenarios

In the base case of clinical scenarios (patient had no hypoglycemia or medication concerns), physicians predominantly made no change to the hypoglycemia-causing medication ( Fig. 1 ). Physicians deintensified more often for the healthy patient with an HbA 1c of 6.3% than for patients with more complex health with an HbA 1c of 7.3–7.7% ( P < 0.001). Physicians switched medications 17% of the time overall, with no significant difference across scenarios. There were statistically significant differences in deintensification and switching by primary specialty ( Supplementary Table 5 ), although the overall pattern of responses was consistent.

Physicians’ modifications to sulfonylureas or insulin therapy for patients who reported no hypoglycemia or medication concerns in three clinical scenarios. Scenarios described older adults with type 2 diabetes taking a hypoglycemia-causing medication with HbA 1c below guideline-recommended targets. Scenario 1 was a healthy patient with an HbA 1c of 6.3% taking glimepiride. Scenario 2 was a patient with complex health and an HbA 1c of 7.3% taking insulin glargine. Scenario 3 was a patient with poor health and an HbA 1c of 7.7% taking glipizide.

In scenario variations ( Fig. 2 ), a history of recent hypoglycemia had the strongest effect on physicians’ actions. Even mild hypoglycemia caused >99% of physicians to modify therapy, predominantly by deintensifying. In variations where the patient had a major hypoglycemia risk factor, physicians were more likely to deintensify medications compared with the base case and less likely to switch. Notably, a substantial minority of physicians (12–27% depending on the scenario) made no medication change for a significant decline in health ( Supplementary Fig. 2 ). Physicians were modestly responsive to patient preferences for less medication or tighter glycemic control ( Fig. 2 ). There were significant differences in physicians’ responses to scenario variations by specialty such that geriatricians were the most likely to stop medications and endocrinologists the most likely to switch ( Supplementary Table 6 ).

Effect of patient characteristics and preference on physicians’ modifications to sulfonylureas or insulin therapy in clinical scenarios. Shown is the percentage of physicians deintensifying (reducing or stopping), switching, or making no change or increasing the medication in all three clinical scenarios combined. The first bar shows the base case where the patient reported no recent hypoglycemia or medication concerns, followed by each listed variation. Increasing the medication was uncommon (<3%) except where the patient desired tight control (12% increased). Physicians’ actions for mild hypoglycemia (three episodes within the past month of mild symptoms and blood glucose 55–65 mg/dL) and severe hypoglycemia (confusion requiring family assistance) were similar to hypoglycemia causing somnolence resulting in an emergency department visit (data not shown).

Selection of Glycemic Targets and Their Association With Deintensification

Most physicians selected guideline-concordant HbA 1c targets for patients in good health ( Fig. 3 ). An HbA 1c of 7.0% was the most common target, selected by 60% of physicians ( Supplementary Table 7 ). The majority of physicians (90%) selected a higher target for patients with complex health than they did for patients with good health, and 81% selected a higher target for patients with poor health than they did for complex health. However, for patients with complex and poor health, more physicians selected HbA 1c targets below guidelines than selected guideline-concordant targets. Generalists and endocrinologists selected similar HbA 1c targets, while geriatricians were more likely to select higher targets, especially for patients with poor health ( Supplementary Table 7 ).

Physicians’ selection of HbA 1c target for older adults with type 2 diabetes in relation to ADA guidelines. Patients in good, complex, and poor health were described using the language in the ADA Standards of Medical Care in Diabetes—2022 section on older adults ( 2 ). Guideline-concordant HbA 1c targets were <7.0 to 7.5% (good health), <8.0% (complex health), and <8.5% or no specific target (poor health).

Physicians who selected HbA 1c targets below ADA guidelines deintensified hypoglycemia-causing medications infrequently in all clinical scenarios ( Supplementary Table 8 ). One-half of physicians who selected a guideline-concordant HbA 1c target for patients with good health deintensified in clinical scenario 1, whereas 23% of physicians who selected a target below guidelines deintensified in this scenario ( P < 0.001). For patients with complex health, 7% of physicians who selected a guideline-concordant HbA 1c target deintensified in clinical scenario 2, whereas 2% of physicians who selected a target below guidelines deintensified in this scenario ( P = 0.06). For patients with poor health, 27% of physicians who selected a guideline-concordant HbA 1c target deintensified in clinical scenario 3, whereas 9% of physicians who selected a target below guidelines deintensified in this scenario ( P < 0.001). Physicians’ HbA 1c targets were not significantly associated with switching diabetes medications ( Supplementary Table 9 ).

In this national survey, we found that most U.S. physicians would not deintensify or switch sulfonylureas or insulin for older adults with complex or poor health and higher HbA 1c levels (7.3–7.7%). This approach does not align with ADA guidelines that recommend deintensification within individualized HbA 1c targets for patients at increased hypoglycemia risk ( 2 ). Furthermore, most physicians selected lower HbA 1c targets than guidelines for older adults with complex and poor health, and selecting a lower target was strongly associated with not deintensifying. Therefore, optimizing deintensification decisions will require increasing physicians’ comfort with higher HbA 1c targets for older adults with complex health and limited life expectancy for whom the harms of hypoglycemia-causing medications may outweigh the benefits ( 5 ).

The reasons physicians prefer lower HbA 1c targets than recommended in guidelines are unclear and require further study. Medical training may play a role, given our findings that geriatricians were more likely to deintensify medications than other specialties and that endocrinologists were more likely to switch. It was surprising that so few physicians chose to switch hypoglycemia-causing medications given the availability of newer medication classes with low hypoglycemia risk. Physicians’ reluctance to switch may be related to limited insurance coverage for newer medications, which is a significant barrier to their use in clinical practice ( 12 ).

Nearly all respondents appropriately deintensified or switched therapy where the patient reported a history of recent hypoglycemia, suggesting that physicians view hypoglycemia history as the most important factor in considering a patient’s hypoglycemia risk. While all clinical scenarios in this survey provided the patients’ hypoglycemia history, in practice, patients often do not report hypoglycemic events to their provider, and many events may be missed ( 13 ). Therefore, routine assessment of hypoglycemia history may be critical for promoting appropriate medication change to prevent hypoglycemia.

We found that most physicians deintensified hypoglycemia-causing medications where patients had additional major hypoglycemia risk factors. However, deintensification was not universal, including where patients experienced a serious decline in health, such as initiating hospice. Physicians’ inertia in these cases likely contributes to patient harm, as exemplified by the large number of patients who experience hypoglycemia while receiving hospice care ( 14 ).

Strengths of this study include that the survey was designed through collaboration between clinical and community stakeholders and that we surveyed a national sample of the physicians providing the majority of outpatient diabetes care ( 15 ). This study also has several limitations. The clinical scenarios included relatively simple diabetes medication regimens and, thus, did not address simplification of complex regimens ( 2 , 16 ). Response rates were <50%, which may have introduced response bias. Geriatricians had a lower response rate than other specialties, although the interpretation of the main findings is the same across specialties.

In conclusion, from this national survey, we found that physicians’ approach to deintensifying and switching hypoglycemia-causing medications did not align with diabetes guidelines because of inertia against modifying therapy and selecting lower HbA 1c targets for patients with complex and poor health. There is a need to change physicians’ practices to promote individualized treatment decisions that can improve the safety of diabetes care for many older adults.

See accompanying article, p. 1137 .

This article contains supplementary material online at https://doi.org/10.2337/figshare.21965912 .

Funding. This study was funded by the U.S. Deprescribing Research Network, which is funded by the National Institute on Aging (NIA) (R24AG064025). S.J.P. was supported by the Johns Hopkins KL2 Clinical Research Scholars Program (KL2TR003099) and the National Institute of Diabetes and Digestive and Kidney Diseases (K23DK128572). N.L.S. was supported by the NIA (K76AG059984). C.M.B. was also supported by the U.S. Deprescribing Research Network (NIA grant R24AG064025) and by NIA grant K24AG056578. N.N.M. was supported by the NIDDK (R01DK125780).

Duality of Interest. C.M.B. received honoraria for writing a chapter on multiple chronic conditions for UpToDate and a chapter on falls in older adults for DynaMed. No other potential conflicts of interest relevant to this article were reported.

Author Contributions. S.J.P. contributed to the study design, data acquisition, analysis, and discussion and wrote the manuscript. R.J. contributed to the data acquisition and background research and reviewed and edited the manuscript. O.T. contributed to the analysis and discussion and reviewed and edited the manuscript. N.L.S., C.M.B., S.H.G., N.N.M., and N.M.M. contributed to the study design, analysis, and discussion and reviewed and edited the manuscript. All authors approved the final version of the manuscript. S.J.P. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Prior Presentation. Parts of this article were presented in poster form at the Society of General Internal Medicine Annual Meeting, Orlando, FL, 6–9 April 2022, and the 82nd Scientific Sessions of the American Diabetes Association, New Orleans, LA, 3–7 June 2022.

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AI could change the way we measure brain pressure in neurocritical patients

by Catherine Graham, Johns Hopkins University

A Johns Hopkins University research team has developed an algorithm to non-invasively measure intracranial pressure (ICP) using vital sign data routinely checked in the ICU.

The new method leverages deep learning techniques to generate ICP measurements with an accuracy comparable to the current gold-standard approach, which requires drilling through the skull.

"Non-invasive ICP measurement is something of a holy grail in intensive care medicine . This new method could be a game changer because we could potentially offer the ability to obtain ICP measurements without performing this extremely invasive procedure ," said senior author Robert Stevens, an associate professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine.

The research team—which includes biomedical engineering students and faculty, anesthesiologists, and neurosurgeons— published their findings in the July issue of Computers in Biology and Medicine .

Learning to innovate with artificial intelligence

As an intensive care physician, Stevens treats patients with acute brain trauma, a condition that can lead to brain swelling and a potentially fatal increase in pressure inside the patient's skull.

Currently, the most effective way to monitor ICP is to drill a hole in the skull and advance a catheter into the brain tissue to collect waveform information—a high-risk procedure that requires a surgical team and can only be performed in an intensive care unit, operating room, or emergency department. There are other non-invasive methods for measuring ICP, but few have demonstrated reliability, and most can't generate continuous ICP measurements.

Three years ago, Stevens challenged students in the Department of Biomedical Engineering's Undergraduate Design Team program to use AI to help clinicians accurately and continuously monitor ICP without surgery.

"Our team brought a wide variety of experience to the project, from strong data science and programming skills to prototyping expertise," said Shiker Nair, Engr '22, the study's first author and leader of the Design Team ICPredict. "But our biggest challenge was balancing technical feasibility with clinical impact. In the scope of just one year, what could we possibly do that would make a definitive change in the current landscape of ICP monitoring?"

The students shadowed clinicians and neurologists in the Neuro-ICU at Johns Hopkins Hospital, getting a first-hand look at the importance of ICP monitoring and the major limitations they needed to address. Nair said that while they explored many possible solutions addressing various aspects of the problem, the process of integrating these solutions was challenging.

Eventually, under the guidance of Stevens and Nicholas Durr, an associate professor of biomedical engineering, the students developed an AI algorithm designed to indirectly calculate ICP by analyzing the waveform patterns of physiologic variables which are more readily accessible, such as arterial blood pressure.

Testing the algorithm

To build and test their approach's predictive abilities, the team studied three sources of waveform data that are continuously collected from ICU patients: arterial blood pressure (ABP), electrocardiogram (ECG), and photoplethysmography (the signal used for pulse oximetry recordings).

They started with a dataset of patients who had simultaneous measurements taken of these variables and invasive ICP measurements obtained via catheters in the brain. Next, they used ABP, ECG, and PPG waveforms to train six different deep-learning algorithms to see if they could generate ICP waveforms that were accurate when compared to the "ground truth" ICP measured using invasive methods.

It worked. The ICP values estimated using the new algorithm closely matched those measured using invasive methods. What's more, the Hopkins algorithm was as accurate as, or even more accurate than, other non-invasive methods for evaluating ICP.

These results are quite significant, according to Stevens, who points out that a method that allows for continuous, real-time non-invasive ICP monitoring could spare patients from a risky surgery and let physicians know when they must intervene to decrease ICP.

"If further studies confirm that this is reliable and accurate, maybe we can do away with the invasive ICP monitoring altogether," Stevens said. "What's also exciting is that this would mean ICP could be monitored in various care settings, and not just in an intensive care unit."

The team plans to validate these findings using a much larger dataset before moving on to enrolling a cohort of patients for a prospective trial. Many of the students, including Nair, have continued to work on the project even after moving on to other institutions or industry positions.

"It's been remarkable to see how something that started as a class project ended up here. It's a testament to the motivation and engagement of our students that we've arrived at a result that is, in many ways, a great success," Stevens said.

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Association Between Accelerometer-Measured Irregular Sleep Duration and Type 2 Diabetes Risk: A Prospective Cohort Study in the UK Biobank

Affiliations.

• 1 Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
• 2 Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
• 3 Broad Institute of MIT and Harvard, Cambridge, MA.
• 4 Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.
• 5 Department of Internal Medicine, Section of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.
• 6 Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Victoria, Australia.
• 7 Flinders Health and Medical Research Institute (Sleep Health), Flinders University, Bedford Park, SA, Australia.
• 8 Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, University of Manchester, Manchester, U.K.
• 9 Diabetes, Endocrinology and Metabolism Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Manchester, U.K.
• 10 Division of Sleep Medicine, Harvard Medical School, Boston, MA.
• PMID: 39017683
• DOI: 10.2337/dc24-0213

Objective: To evaluate the association between irregular sleep duration and incident diabetes in a U.K. population over 7 years of follow-up.

Research design and methods: Among 84,421 UK Biobank participants (mean age: 62 years) who were free of diabetes at the time of providing accelerometer data in 2013-2015 and prospectively followed until May 2022, sleep duration variability was quantified by the within-person SD of 7-night accelerometer-measured sleep duration. We used Cox proportional hazard models to estimate hazard ratios (HRs) for incident diabetes (identified from medical records, death register, and/or self-reported diagnosis) according to categories of sleep duration SD.

Results: There were 2,058 incident diabetes cases over 622,080 person-years of follow-up. Compared with sleep duration SD ≤ 30 min, the HR (95% CI) was 1.15 (0.99, 1.33) for 31-45 min, 1.28 (1.10, 1.48) for 46-60 min, 1.54 (1.32, 1.80) for 61-90 min, and 1.59 (1.33, 1.90) for ≥91 min, after adjusting for age, sex, and race. We found a nonlinear relationship (p nonlinearity 0.0002), with individuals with a sleep duration SD of >60 vs. ≤60 min having 34% higher diabetes risk (95% CI 1.22, 1.47). Further adjustment for lifestyle, comorbidities, environmental factors, and adiposity attenuated the association (HR comparing sleep duration SD of >60 vs. ≤60 min: 1.11; 95% CI 1.01, 1.22). The association was stronger among individuals with lower diabetes polygenic risk score (PRS; P interaction ≤ 0.0264) and longer sleep duration (P interaction ≤ 0.0009).

Conclusions: Irregular sleep duration was associated with higher diabetes risk, particularly in individuals with a lower diabetes PRS and longer sleep duration.

© 2024 by the American Diabetes Association.

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Two Decades of Research Shows Where Multivitamins Fall Short

Grace Cary / Getty Images

Key Takeaways

• A new study by the National Cancer Institute found that multivitamins do not help you live longer.
• The study showed no reduction in death from cancer, heart disease, or cerebrovascular diseases due to multivitamin use.
• Multivitamins may still be beneficial for people with nutritional deficiencies or specific health conditions affecting nutrient absorption.

A new study by researchers at the National Cancer Institute (NCI) found that taking multivitamins does not help you live longer.

“Many adults in the United States take multivitamins with the hope of improving their health,” lead study author Erikka Loftfield, PhD , said in a statement . “However, the benefits and harms of regular multivitamin use remain unclear.”

Billions of dollars are spent in the U.S. on multivitamins each year despite a lack of evidence for their benefits. Loftfield said that previous studies of multivitamin use and mortality yielded mixed results and have been limited by short follow-up times.

For the new study, Loftfield and her team analyzed data from nearly 400,000 U.S. adults who agreed to be tracked for over 20 years. The study was published in JAMA Network Open.

The data for the study came from three large, geographically diverse prospective studies involving 390,124 people in the U.S. The participants were generally healthy, with no history of cancer or other chronic diseases.

In addition to no lowered risk of overall death, the study also showed that multivitamin use did not affect death from cancer, heart disease, or cerebrovascular diseases. The results were adjusted for race and ethnicity, education, and diet quality.  

Should You Ditch Your Multivitamin?

You probably didn’t expect multivitamins to help you live forever, and the fact that they can’t isn’t necessarily a reason to stop taking them. Loftfield said that despite finding multivitamins don’t reduce mortality risk in healthy adults, they may still be worthwhile for some groups, like people with nutritional deficiencies.

On average, adults under-consume vegetables, fruits, whole grains, and calcium-rich foods, said Vanessa King, MS, RDN , a registered dietitian in Oahu, Hawaii, and a spokesperson for the American Academy of Nutrition and Dietetics. That means they lack vitamins like A, C, D, and E, as well as minerals like magnesium and potassium.

While whole foods are the best sources of these vitamins and nutrients, prenatal multivitamins are important for people who are pregnant and breastfeeding, King said. In addition, people may benefit from a multivitamin if they’re living with health conditions that impact nutrient absorption:

• Chronic health conditions such as cancer and chronic kidney disease can increase the demand for certain nutrients while reducing the need for others.
• Gastrointestinal illnesses such as irritable bowel syndrome (IBS) and inflammatory bowel disease can impair nutrient absorption.
• Some medications can lead to nutrient loss. For example, diabetes medication metformin can contribute to B12 deficiencies.

If you fall into one of these groups, King suggests asking your doctor about whether or not a multivitamin can benefit you and your specific health needs. The same goes if you’re 60 and older, since a 2023 study suggests multivitamins can protect memory as you age.

If you don’t fall into any of these groups, start by taking a good look at your diet.

“If you are thinking about taking a multivitamin, first think about what else you are putting into your body,” Michael Crupain, MD, MPH , a regent at large for the American College of Preventive Medicine and a faculty member at the Johns Hopkins Bloomberg School of Public Health, told Verywell. Are you eating vitamin-rich foods like fruits, vegetables, fish, whole grains, nuts, and seeds? “Think about how can you eat more of the foods that have consistently been associated with living a longer, healthier life in study after study.”

What This Means For You

Talk to your doctor or a registered dietitian about whether and how you can try to get the bulk of your daily nutrients from foods such as fruits, vegetables, nuts, seeds, whole grains, and fish. For many people, a multivitamin isn’t necessary.

Loftfield E, O’Connell CP, Abnet CC, et al. Multivitamin use and mortality risk in 3 prospective US cohorts . JAMA Netw Open. 2024;7(6):e2418729. doi:10.1001/jamanetworkopen.2024.18729

Reist E. Navigating a chronic kidney disease diet for individuals with cancer . J Ren Nutr . 2021;31(3):e1-e2. doi:10.1053/j.jrn.2020.11.003

Balestrieri P, Ribolsi M, Guarino MPL, Emerenziani S, Altomare A, Cicala M. Nutritional aspects in inflammatory bowel diseases . Nutrients . 2020;12(2):372. doi:10.3390/nu12020372

Kim J, Ahn CW, Fang S, Lee HS, Park JS. Association between metformin dose and vitamin B12 deficiency in patients with type 2 diabetes . Medicine (Baltimore) . 2019;98(46):e17918. doi:10.1097/MD.0000000000017918

Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial . Am J Clin Nutr . 2023;118(1):273-282. doi:10.1016/j.ajcnut.2023.05.011

By Fran Kritz Kritz is a healthcare reporter with a focus on health policy. She is a former staff writer for Forbes Magazine and U.S. News and World Report.

Masks Strongly Recommended but Not Required in Maryland, Starting Immediately

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While there is currently no cure for diabetes, it can be controlled, allowing people to have full, productive lives. By integrating diet, oral medication or insulin, and patient education, the Diabetes Center works to achieve the best possible outcomes, helping people with diabetes to live long and healthy lives.

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With access to additional Hopkins resources and top specialists including the Wilmer Eye Institute, Hopkins Cardiology, Hopkins GYN/OB, and much more, Diabetes Center patients have available the full-range of treatment options. Focusing on teamwork, the Diabetes Center will communicate with your primary care-givers and will work with your insurance company.

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Assistant director, research finance compliance.

In collaboration with the Executive Director of Research Finance for the Johns Hopkins University School of Medicine (JHU SOM) we are seeking a  Assistant Director, Research Finance Compliance  who will be responsible for developing SOM-wide policies, procedures and guidelines for the financial and compliance monitoring and oversight of SOM sponsored projects, service centers and non-sponsored research related funds which encompass roles, responsibilities, and expectations of department personnel. In this role, the Assistant Director, Research Finance Compliance will assess research compliance needs for the SOM (admin, clinical, basic science), develop innovative reporting, influence and deploy IT applications/solutions, monitor progress and make recommendations for improvements through policies and standardized processes while promoting transparency and ensuring compliance. The Assistant Director will lead and manage multiple sponsored finance projects requiring strong analytical skills with the ability to proactively communicate information impacting strategic fiscal planning. Strong leadership, organization and communication skills are imperative.

Critical to this role is the responsibility to work collaboratively with School and University stakeholders supporting sponsored compliance activities including, but not limited to: Sponsored Projects Shared Services (SPSS), Financial Research Compliance (FRC), Office of Internal Audits (OIA), Office of Research Administration (ORA), SOM Institutional Review Board (IRB) and Financial Systems Administration.

Scope of Responsibility

The Assistant Director, Research Finance Compliance will oversee the administrative and financial monitoring of sponsored research accounts across the School of Medicine, encompassing 39 clinical, basic science and other academic departments totaling over $1B in annual sponsored expenditures, optimize operating margins, direct proper financial stewardship, mitigate risk and enhance operational performance and efficiencies in the sponsored space. The Assistant Director will develop and distribute innovative reports and technology-based reporting solutions to be for use by SOM department administration, research administration & finance teams, to drive compliance and financial monitoring for sponsored and non-sponsored research funds.

The Assistant Director oversees and guides the financial activities of all SOM service centers, coordinates the rate and budget development activities for the research finance vertical, and meets regularly with departmental points of contact to ensure two-way communication for advocacy, knowledge transfer, and a shared understanding of financial activities of SOM service centers. The Assistant Director demonstrates an understanding of SOM service centers operations to align operations and implement best practices across service centers.

Specific Duties & Responsibilities

• The primary focus of this position is to enhance sponsored research and operational compliance within the SOM with a strong emphasis on areas with high regulatory and financial risk.
• Collaborates with and directs IT programmer(s) in the building of Enterprise-wide IT applications by leveraging a deep knowledge of hierarchal structures, SAP/Analysis, logic and regulatory requirements. Leads the testing, training, deployment, and enhancement of these IT applications.
• Through strategic collaborations, identifies, recommends and influences operational and reporting changes at the Enterprise level based on School and Departmental operational impacts (PI Dashboard, JHU-Enterprise Research Compliance Dashboard and JHU Internal Audits Dashboard). Identifies trends and advocates for business process improvement at the Enterprise level to prevent, detect and respond appropriately to compliance risks.
• Serves as a resident expert on central school developed systems, SAP/Analysis and research administration activities by leveraging institutional knowledge to provide at the elbow advice and training to departmental personnel in areas of sponsored research accounting and compliance. Serve as SOM Boot Camp Instructor and host training sessions on SOM developed systems.
• Identifies data blind spots and works with School and University Stakeholders to implement process improvements with a focus on utilizing technology to provide transparency and departmental accountability.
• Design, develop, and analyze School-wide comprehensive reports by leveraging automated systems and delivery portals where possible on a monthly basis including, but not limited to: Control Salary, Undistributed Budget, Deficit Balance, Surplus Balance, Clinical Trial Start-Up Billing, Deferred Revenue, Goods Receipt/Invoice Receipt (GR/IR) Discrepancies. Manage and monitor the monthly distribution of compliance reports ensuring accuracy & consistency.
• Analyze on a monthly basis reports distributed in order to determine and identify trends for non-compliance and implement effective tools in order to mitigate risk including: policies, process documentation, and training materials. Implement corrective action plans including training and policy development.
• Analyze the Sponsored Compliance Dashboard monthly to determine areas of risk surrounding: Financial Status Reports (FSR’s), Deficit Balances, Transfers over 90+ Days, Effort, Unbilled Revenue, Account Reconciliation and Open Receivables.
• Assist SOM leadership with the coordination, implementation and close-out of current and future internal audits findings impacting the SOM. Collaborate by providing insight, guidance and recommendations to the Process Business Owner (PBO), as required.
• Participate in strategic planning sessions with the Executive Director of Research Finance and Associate Director of Research Operations by offering subject matter expertise coupled with strong institutional & industry knowledge for optimizing operational outcomes and mitigating risk within the SOM.
• Manages the creation of vertical-wide budgets and rates in conjunction with discussions with other Research Finance staff. Oversees the preparation of budgets, scenario planning, long-range planning, financial modeling, variances, forecasting, projections, financial plans and reports, and other types of complex analysis, involving the review of significant amounts of data.
• Meets regularly with departments to ensure two-way communication to create advocacy for the department, knowledge transfer, and a shared understanding of financial activities.

Special Knowledge, Skills, & Abilities

• Demonstrated subject matter expertise and knowledge of pre-award and post-award sponsored activities involving sponsored projects. Demonstrated knowledge of financial reporting to include All Funds and sponsored funding impacts.
• Demonstrated skills in quantitative financial analyses, thorough working knowledge of Generally Accepted Accounting Principles (GAAP) and practices with an emphasis on university financial accounting (Johns Hopkins University SAP accounting and financial systems preferred).
• Demonstrated skills in formulating and implementing financial policies and standards to ensure accountability and compliance with policies and procedures.
• Demonstrated ability to make independent judgments and to act on decisions on a daily basis.
• Self-starter as an independent thinker, self-governing to organize, complete and deliver projects and deliverables with little to no direction by prioritizing work with flexibility to act and or change direction as needed while working on multiple tasks simultaneously with concurrent deadlines.
• Demonstrated ability to improve the quality and outcomes of administrative functions within the SOM.
• Demonstrated knowledge and skill in using MS Excel, PowerPoint, Word and other software applications as required.
• Provide strong leadership in the Research Finance Compliance unit with the ability to maintain confidentiality.
• Bachelor's Degree in Finance, Accounting, Business, or a related field.
• Seven years of progressively responsible experience in financial and business operations, preferably in a large and complex organization.
• Related experience in a medical school or academic medical center.
• Additional education (Master's in a related field) may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

Classified Title: Assistant Director Finance  Job Posting Title (Working Title): Assistant Director, Research Finance Compliance    Role/Level/Range: ATP/04/PF   Starting Salary Range: $85,500 - $149,800 Annually (Commensurate with experience)  Employee group: Full Time  Schedule: Mon-Fri 8.30am - 5.00pm  Exempt Status: Exempt  Location: Hybrid/School of Medicine Campus  Department name: ​​​​​​​SOM Admin Finance Research Operations  Personnel area: School of Medicine 

Total Rewards The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/ .

Education and Experience Equivalency Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion .

Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at [email protected] . For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/ .

Vaccine Requirements Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine . Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.  This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/  and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/ .

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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Drug expiration dates a problem for any mission to Mars

How many drugs in your bathroom medicine cabinet have expired?

Now imagine you have no way of refilling them, because you're millions of miles from home. Advertisement

That's the dilemma that will face astronauts on a Mars mission, a new study warns.

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These include staples like pain relievers, antibiotics, allergy medicines and sleep aids.

Astronauts on their way back from Mars could end up relying on drugs that have become either ineffective or even harmful over time, researchers reported Tuesday in the journal Microgravity.

"It doesn't necessarily mean the medicines won't work, but in the same way you shouldn't take expired medications you have lying around at home, space exploration agencies will need to plan on expired medications being less effective," said senior researcher Dr. Daniel Buckland , an assistant professor of emergency medicine at Duke University School of Medicine in Durham, N.C.

For the study, researchers reviewed the formulary of medications kept on the International Space Station (ISS), assuming NASA would stock similar drugs on a Mars mission. Advertisement

"Prior experience and research show astronauts do get ill on the International Space Station, but there is real-time communication with the ground and a well-stocked pharmacy that is regularly resupplied, which prevents small injuries or minor illnesses from turning into issues that affect the mission," Buckland said in a Duke news release.

About 54 of the 91 medications kept on the ISS had a shelf life of three years or less, researchers found.

About three of five of these drugs would expire before a Mars mission could return home, under the most optimistic estimates, researchers said. Under more conservative estimates, as many as 98% of the drugs would expire, they added.

What's more, the study didn't consider the likelihood that drugs stored in space might lose their potency more quickly, researchers added.

Earthbound medications can lose a little to a lot of their strength as they age past their expiration date, researchers said.

But the stability and potency of medications in space remains largely unknown, researchers said. Weightlessness, radiation and other factors could reduce drugs' effectiveness even more over time.

"Those responsible for the health of space flight crews will have to find ways to extend the expiration of medications to complete a Mars mission duration of three years, select medications with longer shelf lives or accept the elevated risk associated with administering expired medication," said researcher Thomas Diaz , a pharmacy resident at the Johns Hopkins Hospital in Baltimore. Advertisement

More information

The Pharmaceutical Journal has more about drugs in space .

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