Category Archives: Diabetes News

Fractyl Health Announces New Results From Its Rejuva® Platform Demonstrating Potent and Durable Effects of a Single Dose of a Human GLP-1 Pancreatic Gene Therapy Transgene Compared to Semaglutide in the db/db Mouse Model of Diabetes and Obesity

Diabetes News


Fractyl Health, Inc.

Fractyl Health, Inc.

Data provides first demonstration of glucose lowering and weight loss potency from pancreas-produced native human GLP-1, highlighting the capacity of pancreatic GLP-1 to provide metabolic control.

The human GLP-1 transgene sequence used in RJVA-001 was administered to eight-week-old db/db mice with established disease and resulted in up to 50% blood sugar lowering and 11% weight loss vs vehicle at four weeks after a single administration, compared to 32% glucose lowering and 2% weight loss vs vehicle with chronic semaglutide.

These results with a native, short half-life human GLP-1 sequence to be used in RJVA-001 build upon earlier results with a prototype transgene GLP-1 analogue.

BURLINGTON, Mass., March 12, 2024 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced promising new preclinical findings for the first clinical candidate in its Rejuva® pancreatic gene therapy platform. RJVA-001 is the Company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D.

“As we advance our Rejuva program through preclinical development, we now observe that a single-dose administration of a human GLP-1 transgene (as in RJVA-001) can achieve durable lowering of blood sugar and body weight compared to vehicle or chronic semaglutide administration in the well-validated db/db mouse model of diabetes,” said Dr. Timothy Kieffer, Fractyl Health Chief Scientific Officer. “With these data, we are one step closer to IND enablement for RJVA-001 as part of our broader preclinical development package.”

These results show that the human GLP-1 coding sequence of RJVA-001 demonstrates potency on both glucose lowering and weight loss in db/db mice, the standard rodent T2D efficacy model used for clinical development. The Company has reached alignment with European regulators on the use of this efficacy model to support the submission of a Clinical Trial Application (CTA) in Europe.

“While there are clear benefits of GLP-1 for weight loss, glucose control, and metabolic health in general, there remains a need for advances in care that can offer a major step forward in GLP-1 therapy,” said Dr. Harith Rajagopalan, CEO of Fractyl Health. “Our goal with RJVA-001 is to change the trajectory of both obesity and T2D with a single administration therapy that offers the potential for the durable remission of metabolic disease.”

Fractyl Health anticipates progressing RJVA-001 through IND-enabling toxicity studies in 2024 and initiating First-in-Human clinical studies in 2025.

About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including T2D and obesity. Despite advances in treatment over the last 50 years, T2D and obesity continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit www.fractyl.com or www.twitter.com/FractylHealth.

About Rejuva
Fractyl Health’s Rejuva® platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of T2D and obesity. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company’s need for substantial additional financing; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; additional time may be required to develop and obtain regulatory approval or certification for the Company’s Rejuva gene therapy candidates; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the Company’s reliance on third parties for the manufacture of the materials for its Rejuva gene therapy platform for preclinical studies and its ongoing clinical studies; changes in methods of the Company’s Rejuva gene therapy candidate manufacturing or formulation; and any contamination or interruption in the Company’s Rejuva gene therapy candidates’ manufacturing process, shortages of raw materials or failure of the Company’s suppliers of plasmids and viruses to deliver necessary components could result in delays in the Company’s Rejuva gene therapy candidates’ preclinical and clinical development or marketing schedules. These and other important factors discussed under the caption “Risk Factors” in the Company’s prospectus filed with the Securities and Exchange Commission (the “SEC”) on February 2, 2024, and its other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.

Contacts
Corporate Contact
Lisa Davidson, Chief Financial Officer
ir@fractyl.com, 781.902.8800

Media Contact
Beth Brett, Corporate Communications
Bbrett@fractyl.com, 720.656.6544

Investor Contact
Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com, 619.949.3681





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Certain people with Type 2 diabetes can now donate a kidney. A Mayo Clinic nephrologist explains – Post Bulletin

Diabetes News


ROCHESTER — A change in federal guidelines for living organ donation opens the door for people with well-controlled Type 2 diabetes to become kidney donors.

“I think this is a very significant shift in the eligibility criteria for living kidney donation in the U.S.,” said Dr. Naim Issa, a transplant nephrologist at Mayo Clinic in Rochester, the county’s second-largest living organ donor center. “In Europe, actually, diabetes was not completely (a) contraindication to donate a kidney.”

Before the Organ Procurement and Transplantation Network updated its policies in 2022, a potential living kidney donor would be disqualified if they were diagnosed with either Type 1 or Type 2 diabetes.

“Diabetes, especially if it’s poorly controlled, can lead to complications affecting our vital organs, especially the kidneys, the eyes, the heart,” Issa said. “And diabetes, in fact, is the leading cause of kidney disease in the U.S.”

But now, people with Type 2 diabetes could become kidney donors if they meet certain critera. (Type 1 diabetes is still excluded.)

Through Mayo Clinic, a potential kidney donor would be eligible if they don’t use insulin, are not overweight, don’t have a family history of kidney disease and go through a health assessment. Right now, those donors would also need to be at least 60 years old, Issa said.

“If you’re young with Type 2 diabetes … (you’ll) have another 20, 30 years to live, and we don’t know what will happen to their kidney function and to their vital organs,” Issa said.

Additionally, potential donors between the ages of 60 and 64 would need to not be on any medications for their diabetes. But, at age 65 and older, they can be taking up to two oral medications and still be eligible, according to the Mayo Clinic guidelines.

While Issa said he only expects a “handful” of living kidney donations per year from donors who meet the Type 2 diabetes critera, he said this type of donation can be helpful in certain situations, such as when a person wants to donate a kidney to their spouse.

naim-issa-14325870.png

Dr. Naim Issa, a transplant nephrologist at Mayo Clinic in Rochester.

Contributed / Mayo Clinic

“If a wife needs a kidney, they don’t have any potential donors, instead of staying on the waiting list for five to seven years,” Issa said, “Let’s say the husband is diabetic, but very well-controlled. (He’s) lean, maybe takes one medication, older than 65 and the diabetes did not affect any of the vital organs, the heart, the kidneys or the eyes.”

The expanded critera for living kidney donation comes at a time when, Issa said, the need for kidney transplants is increasing and the wait time for kidneys from deceased donors can last years for some patients.

“People are getting older, more diabetes and more obesity causing more and more kidney disease in this country — we have more than 90,000 people waiting for a kidney transplant,” Issa said. “This is mainly to address the increasing demand fo rkidneys and provide some people with a better chance for successful transplant and, of course, improve quality of life.”

Deceased donors with diabetes have been able to donate kidneys, Issa said, if their organs weren’t substantially harmed by their diabetes.





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Analysis of Hematological Parameters in Type 1 and Type 2 Diabetes Patients

Diabetes News


The following is a summary of “Changes in selected hematological parameters in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis,” published in the February 2024 issue of Hematology by Bambo et al.


Researchers conducted a retrospective study to uncover pooled mean differences in white and red blood cell parameters among diabetic patients, aiming to shed light on potential hematological imbalances in type 1 and type 2 diabetes mellitus.

Using appropriate entry terms, they extensively searched articles in various bibliographic databases, including PubMed, Cochrane Library, Scopus, Web of Science, PsycINFO, Embase, online archives, and university repositories. Relevant studies were identified based on eligibility criteria. Data, including author details, study characteristics, diabetes type, sample size, and hematological parameter means with SD, were extracted in Excel and analyzed in Stata 11. Pooled standardized mean difference (SMD) was determined with a random effects model, assessing heterogeneity using Higgins’ I2 statistics. Egger’s test and funnel plot analysis evaluated bias. A sensitivity analysis assessed the impact of small studies.

The results showed 39,222 articles following methodology screening, 22 articles with 14,041 participants (6,146 T2DM, 416 T1DM patients, and 7,479 HCs). Pooled SMD in TLC were 0.66, 109 for T2DM and -0.21 for T1DM. Absolute differential WBC counts in T2DM showed differences of 0.84 (neutrophils), -1.59 (eosinophils), 3.20 (basophils), 0.36 (lymphocytes), and 0.26 (monocytes). Relative differential counts in T2DM were neutrophils (1.31%), eosinophils (-0.99%), basophils (0.34%), lymphocytes (-0.19%), and monocytes (-0.64%). In T1DM, SMD of WBC  109 parameters were neutrophils (-0.10), lymphocytes (-0.69), monocytes (0.19), and basophils (-0.32). Pooled SMD in RBC parameters for T2DM were: RBC (-0.57, 106/μL), Hb (-0.73 g/dL), and HCT (-1.22%). In T1DM, RBC, Hb, and HCT were -1.23 (106/μL), -0.80 g/dL, and -0.29%, respectively.

They concluded that T2DM showed elevated white & specific cell types, while T1DM had decreased white & red blood cell parameters, highlighting diabetes’ impact on blood composition.

Source: frontiersin.org/articles/10.3389/fmed.2024.1294290/full



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Convicted murderer and rapist Thabo Bester wants diabetes-friendly food, own clothes

Diabetes News
Thabo Bester appeared at the Free State High Court in Bloemfontein on Wednesday.


Thabo Bester appeared at the Free State High Court in Bloemfontein on Wednesday.

Thabo Bester appeared at the Free State High Court in Bloemfontein on Wednesday.

Convicted rapist and murderer Thabo Bester refused to eat before his court appearance and, as a result, could not take his diabetes medication, the Free State High Court in Bloemfontein heard on Wednesday.

But, along with several complaints, his lawyer told the court Bester refused to eat because the food was not appropriate for a diabetic person.

Bester and his lover, Dr Nandipha Magudumana, her father, Zolile Sekeleni; their gardener, Zanda Moyo; as well as Frans Makhotsa, Senohe Matsoara, Buti Masukela, Teboho Lipholo and Joel Maketha appeared for what was meant to be a pre-trial conference.

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‘I’m a diabetes doctor – these five exercises could keep blood sugar levels in check’

Diabetes News


Diabetes raises the spectre of dangerous complications posed by high levels of sugar in your blood.

Fortunately, lifestyle changes, including exercise, are some of the best weapons you can add to your arsenal of protection against dangerously high blood sugar levels.

Physical activity not only lowers your blood glucose levels, but it also boosts your body’s sensitivity to insulin, countering insulin resistance.

Insulin resistance occurs when your body’s cells don’t respond properly to insulin, leading to high blood sugar levels. However, exercise could make you more insulin sensitive, helping to manage high blood sugar levels more effectively.

Fortunately, a diabetes doctor has outlined the five best exercises for diabetics.

1.Walking

One of the most common exercises in the world, walking can be easily done anywhere you go.

An endocrine specialist, known on TikTok as The Voice of Diabetes, said: “What I recommend is about 30 minutes of brisk walking five times a week.”

2.Tai Chi

This Chinese martial arts practice is surprisingly good for lowering blood sugar levels, according to the diabetes specialist. She added: “It also helps your mental health. It helps people calm down. It involves a lot of slow different movements so Tai Chi is a great option.”

3.Yoga

This popular exercise has been proven to lower blood sugar levels, making a “great option” for diabetics.

4.Dancing

You might not associate dancing with exercise, but this fun physical movement could also benefit diabetics. The expert said: “Dancing is also good to lower blood sugar levels. And believe it or not, it actually helps your mental health.

“It can also reduce anxiety and depression. So I mean we could all benefit from some dancing.

5.Swimming

Swimming is another “wonderful option” for diabetics. The expert shared it can also stretch your muscles and joints.

The expert said: “It puts no strain on your joint muscles, so you don’t have to worry about knee replacement with swimming.”



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Diabetes risk is noticeable in young Samoan children

Diabetes News
Measuring Blood sugar


Obesity is a serious problem worldwide, with over 4 million deaths yearly due to being overweight or obese. Even children are affected, with rates increasing dramatically since 1975. Nicola Hawley, from Yale, studies how obesity affects maternal and child health. She and her colleague, Courtney Choy, have been studying obesity in Samoa for almost ten years, focusing on child health in the Pacific.

A new study by Choy and Hawley revealed a significant rise in overweight or obese Samoan children, doubling from 16% to 36% between 2015 and 2020. In their latest research, published in Pediatric Obesity, they found alarming rates of diabetes and high blood pressure in children as young as 6 to 9 years old. About one in ten children showed signs of prediabetes. However, specific early growth patterns could predict these health issues, aiding clinicians in identifying children who may require intervention.

Choy, the study’s lead author, said, “Those worrisome levels in and of themselves motivate us to continue our work and better understand the state of obesity, diabetes, and hypertension in Samoa.”

Obesity is one part of malnutrition, with underweight and micronutrient deficiencies being the other, says WHO. Factors like imported, low-nutrient foods, and rising costs of local produce contribute to obesity in Samoa. Modernization has led to less active lifestyles and poorer diets.

Only a tiny percentage of women maintain a healthy weight in Samoa. Hawley and Choy’s study is the first to assess childhood heart and metabolic risks in a nation with high adult obesity rates. Their long-term study could help pinpoint the best times and methods for interventions against adult diseases.

The study began nine years ago with Samoa’s Ministry of Health, the Bureau of Statistics, and the Ministry of Women, Community, and Social Development. Choy, initially a YSPH student, recruited participants during her summer MPH internship with Samoa’s Ministry of Health. She continued the project with a Fulbright fellowship and later as a PhD at Brown University, funded by the NIH. An NIH K99 grant now supports Choy’s research. Her focus on Pacific health stems from her upbringing in Hawai’i.

Choy and Hawley, both at Yale, met early on. Hawley admires Choy’s determination and transition from student to independent investigator. They share a passion for improving health in Samoa.

Hawley and Choy’s study in Samoa examines how social and cultural factors affect children’s well-being. They aim to develop interventions by understanding what works best at different ages and how to prevent adult diseases.

After collecting data, Choy shares findings with village participants and engages children by involving them in the process. Next, they plan to gather participants’ input to address risk factors related to obesity, diabetes, and other health issues, ensuring children can achieve their aspirations.

Hawley and Choy’s study gives valuable insights into childhood well-being in Samoa. By understanding the social and cultural context, they aim to develop effective interventions to promote health and prevent diseases in children, thus enabling them to realize their dreams.

Journal reference:

  1. Avery A. Thompson, Rachel L. Duckham et al., Sex differences in the associations of physical activity and macronutrient intake with child body composition: A cross-sectional study of 3- to 7-year-olds in Samoa. Pediatric Obesity. DOI: 10.1111/ijpo.12603.



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Milk May Lower T2D Risk in Patients With Lactose Intolerance

Diabetes News


Patients with lactose intolerance are usually advised to avoid milk. However, many still consume dairy products despite experiencing gastrointestinal symptoms. Surprisingly, this “unreasonable” strategy may have the benefit of reducing the risk for type 2 diabetes, as shown in a recent American study.

“At first glance, the statement of the study seems counterintuitive,” said Robert Wagner, MD, head of the Clinical Studies Center at the German Diabetes Center-Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany. “However, lactose intolerance has different manifestations.” Less severely affected individuals often consume milk and tolerate discomfort such as bloating or abdominal pain. “It is precisely these individuals that the study clearly shows have a lower incidence of diabetes associated with milk consumption,” said Wagner.

Milk’s Heterogeneous Effect

The effect of milk consumption on diabetes, among other factors, has been repeatedly studied in nutritional studies, with sometimes heterogeneous results in different countries. The reason for this is presumed to be that in Asia, most people — 60%-100% — are lactose intolerant, whereas in Europe, only as much as 40% of the population has lactose intolerance.

The authors, led by Kai Luo, PhD, research fellow in the Department of Epidemiology and Population Health at Albert Einstein College of Medicine in Bronx, New York, did not mention lactose tolerance and intolerance in their paper in Nature Metabolism. Instead, they divided the study population into lactase-persistent and non-lactase-persistent participants.

“Not being lactase-persistent does not necessarily exclude the ability to consume a certain amount of lactose,” said Lonneke Janssen Duijghuijsen, PhD, a nutrition scientist at Wageningen University, Wageningen, the Netherlands. “Studies have shown that many individuals who lack lactase can still consume up to 12 g of lactose per day — equivalent to the amount in a large glass of milk — without experiencing intolerance symptoms.”

Gut Microbiome and Metabolites

Luo and his colleagues analyzed data from 12,653 participants in the Hispanic Community Health Study/Study of Latinos, an ongoing prospective cohort study involving adults with Hispanic backgrounds. It collects detailed information on nutrition and the occurrence of diseases.

The authors examined whether the study participants were lactase-persistent or non-lactase-persistent and how frequently they consumed milk. They also analyzed the gut microbiome and various metabolites in the blood over a median follow-up period of 6 years.

The data analysis showed that higher milk consumption in non-lactase-persistent participants — but not in lactase-persistent participants — is associated with about a 30% reduced risk for type 2 diabetes when socioeconomic, demographic, and behavioral factors are accounted for. Comparable results were obtained by Luo and his colleagues with data from the UK Biobank, which served as validation.

A higher milk consumption was associated not only with a lower diabetes risk in non-lactase-persistent individuals but also with a lower body mass index. “This could be one of the factors behind the diabetes protection,” said Wagner. “However, no formal mediation analyses were conducted in the study.”

Luo’s team primarily attributed the cause of the observed association between milk consumption and diabetes risk to the gut. Increased milk intake was also associated with changes in the gut microbiome. For example, there was an enrichment of Bifidobacterium, while Prevotella decreased. Changes were also observed in the circulating metabolites in the blood, such as an increase in indole-3-propionate and a decrease in branched-chain amino acids.

These metabolites, speculated the authors, could be more intensely produced by milk-associated bacteria and might be causally related to the association between milk consumption and reduced risk for type 2 diabetes in non-lactase-persistent individuals. “The authors have not been able to provide precise evidence of these mediators, but one possible mediator of these effects could be short-chain fatty acids, which can directly or indirectly influence appetite, insulin action, or liver fat beneficially,” said Wagner.

Bacteria in the Colon

For Janssen Duijghuijsen, the conclusion that milk consumption can influence the composition of the microbiome and thus the metabolic profile, especially in individuals without lactase persistence, is plausible.

“Individuals with lactase persistence efficiently digest lactose and absorb the resulting galactose and glucose molecules in the small intestine. In contrast, in non-lactase-persistent individuals, lactase is not expressed in the brush border of the small intestine. As a result, lactose remains undigested in the colon and can serve as an energy source for gut bacteria. This can influence the composition of the microbiome, which in turn can alter the concentration of circulating metabolites,” she said.

Janssen Duijghuijsen has investigated the effect of lactose intake on the microbiome. In a recently published study, she also showed that increasing lactose intake by non-lactase-persistent individuals leads to changes in the microbiome, including an increase in Bifidobacteria.

“In line with the current study, we also found a significant increase in fecal β-galactosidase activity. Given the close relationship between the composition of the gut microbiome and the metabolite profile, it is likely that changes in one can affect the other,” said Janssen Duijghuijsen.

Nutritional Recommendations

The nutrition scientist warned against concluding that milk consumption can protect against type 2 diabetes in non-lactase-persistent individuals, however. “The study suggests a statistical association between milk consumption, certain metabolites, and the frequency of type 2 diabetes. These associations do not provide definitive evidence of a causal relationship,” she said. Any dietary recommendations cannot be derived from the study; much more research is needed for that.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.



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Two-Step Screening Uncovers Heart Failure Risk in Diabetes

Diabetes News


TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

  • Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
  • They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
  • Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
  • They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
  • The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

  • Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
  • Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
  • The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
  • Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study led by Kershaw Patel of the Houston Methodist Academic Institute, Houston, Texas, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.



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