This means that even more people living with the disease will be able to use this life-changing app. For the first time, the FDA authorised the use of the artificial pancreas system in pregnancy.

CamAPS FX, produced by Cambridge spinout company CamDiab (www.camdiab.com), is an Android app that can be used to help manage glucose levels in people with type 1 diabetes, including during pregnancy.

The app allows a compatible insulin pump and a compatible continuous glucose monitor to talk to each other, creating an artificial pancreas.

The CamAPS FX closed loop algorithm was given FDA authorisation on Thursday 23 May. It had already been CE-marked for use in the UK and the EU.

CamAPS FX creator Roman Hovorka is Professor of Metabolic Technology at the Institute of Metabolic Science and Department of Paediatrics at the University of Cambridge, where the technology was developed.

He said: "We set out to help people with type 1 diabetes and their families live better lives and were delighted that the FDA has reviewed the safety and effectiveness of CamAPS FX and has given the technology its approval."

"It has been extensively tested and were proud that it is considered by many to be the best algorithm out there."

CamAPS FX is already used by more than 27,000 people in 15 countries across Europe and Australia. Artificial pancreas systems such as CamAPS FX have been granted approval for wide use by the NHS in November 2023 by the National Institute for Health and Care Excellence (NICE).

Read more about the device here

Excerpt from:
US Food and Drug Administration approves Cambridge-developed artificial pancreas - University of Cambridge news

Novo Nordisks Ozempic cut the risk of death in a trial of patients with type 2 diabetes and chronic kidney disease, suggesting it may offer some added benefits over other classes of drugs approved to treat this population.

Specifically, the diabetes drug cut the risk of cardiovascular-related deaths by 29% and all-cause deaths by 20%. Given the study parameters, this implies that over three years, 39 people would need to be treated to prevent one death from any cause, according to new results presented Friday at a meeting of the European Renal Association and published in the New England Journal of Medicine.

Ozempic also lowered the risk of major heart complications including cardiovascular-related death, heart attack, or stroke by 18%, driven primarily by the reduced rate of heart-linked death.

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Ozempic cut risk of death in diabetes patients with chronic kidney disease - STAT

After years of anticipation, the FLOW trial has brought forth a conclusion many had expected but had no clinical trial data to prove: semaglutide 1.0 mg provides renoprotective benefit in patients with type 2 diabetes and chronic kidney disease (CKD).

With topline data announced in March 2024, the medical community waited with bated breath to learn about the full results of the trial, which were presented at the 61st European Renal Association Congress and offered insight into the effects beyond the trials primary composite endpoint by detailing the impact of semaglutide 1.0 mg across a myriad of kidney-specific and cardiovascular-based outcomes from the trial.

Aninternational, double-blind, randomized, placebo-controlled trial, FLOW randomized 3533 patients in a 1:1 ratio to semaglutide 1.0 mg or placebo therapy. For inclusion in the trial, patients were required to have type 2 diabetes and chronic kidney disease, which was defined as an eGFR of 50 to 75 ml/min/1.73m2of body-surface area and a UACR greater than 300 andless than5000 or an eGFR of 25 to less than 50 ml/min/1.73m2and a UACR greater than 100 and less than 5000.

The trials primary outcome of interest was a composite of major kidney disease events, which included dialysis, transplantation, or an eGFR of less than15 ml/min/1.73m2, at least a 50% reduction in the eGFR from baseline, or death from kidney-related or cardiovascular causes.

Results suggested use of semaglutide was associated with a 24% relative risk reduction for the trials primary outcome of major kidney disease events compared to placebo therapy (Hazard Ratio [HR], 0.76; 95% Confidence Interval [CI], 0.66 to 0.88;P= .0003). Analysis of kidney-specific components of the primary outcome indicated semaglutide use was associated with a 21% reduction in risk relative to placebo therapy (HR, 0.79; 95% CI, 0.66 to 0.94). Further analysis demonstrated risk of death from cardiovascular causes was reduced by 29% relative to placebo therapy (HR, 0.71; 95% CI, 0.56 to 0.89).

To celebrate the trial and break down what it means for people with type 2 diabetes and CKD, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, recorded a special edition episode ofDiabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives.Check out the episode to learn more about the clinical application of this trial, unmet need in CKD management, the future of incretin therapies, and more!

Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care, MannKind, Sanofi, and others.

References:

Perkovic V, Tuttle K, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.New England Journal of Medicine. Published online May 24, 2024. doi:10.1056/NEJMoa2403347

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Diabetes Dialogue: FLOW Trial and Semaglutide's Benefit in Chronic Kidney Disease - MD Magazine

Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States and theyre all closely connected.

Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who dont have diabetes. People with diabetes Type 1 and Type 2 are also at risk of developing kidney disease. And when the kidneys dont work well, a persons heart has to work even harder to pump blood to them, which can then lead to heart disease.

The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new study suggests that nearly 90 percent of American adults already show some early signs of these connected conditions.

While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still astronomically higher than expected, said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Womens Hospital in Boston and co-author of the study.

The research suggests that people should pay attention to shared risk factors for these diseases early on including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.

Your kidneys, heart and metabolic system (which helps process the food you eat into energy and maintains your blood sugar levels) work closely together. If something goes awry with one, it can lead to problems with the others.

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What to Know About CKM, the Link Between Heart Health, Diabetes and Kidney Disease - The New York Times

New research published in The New England Journal of Medicine announced that semaglutide (Wegovy: Novo Nordisk) could reduce the risk of clinically important kidney outcomes and death caused by cardiovascular issues among individuals with type 2 diabetes and chronic kidney disease (CKD). The results were found in the international, double-blind, randomized, place-controlled FLOW trial, which assessed the safety and efficacy of a 1.0 mg dose of semaglutide weekly.1

Image credit: nazif | stock.adobe.com

The study authors noted that more than half a billion individuals are affected by CKD and are at high risk for kidney failure, cardiovascular events, and death with type 2 diabetes as the main cause. Treatment options like Reninangiotensin system (RAS) inhibitors, sodiumglucose cotransporter 2 (SGLT2) inhibitors, and finerenonehave been reported to protect kidneys and reduce the risk of cardiovascular outcomes. However, despite these therapies, numerous individuals continue to lose kidney function, experience kidney failure, or die.1

Semaglutide, as a glucagon-like peptide-1 (GLP-1) receptor antagonist, could offer further treatment options to improve patient outcomes.2 The FDA recently approved a new indication for the use of semaglutide to reduce the risk of cardiovascular death, heart attack, and stroke among individuals with cardiovascular disease.2

The use of GLP-1 receptor agonists in broader populations with type 2 diabetes has previously been shown to improve glycemic control, decrease body weight, and reduce cardiovascular events. However, previous dedicated trials addressing clinically important kidney outcomes, such as kidney failure or a substantial decline in the eGFR, have been lacking, said study authors in a news release.1

The FLOW trial included 3533 individuals with type 2 diabetes who were eligible for inclusion if they experienced high-risk CKD and were receiving a maximal dose of RAS inhibitors, according to study authors.1 The individuals were randomly assigned to receive semaglutide or placebo. The study authors noted that an 8-week dose escalation regimen was used, increasing from 0.25 mg per week for 4 weeks to 0.5 mg per week for 4 weeks, then continuing with a 1.0 mg maintenance dose until the end of the study. The median follow-up was 3.4 years.1

The results showed that the primary outcome of major kidney disease events, a composite of onset of kidney failure,was 24% lower among individuals treated with semaglutide compared with the placebo group(331 vs. 410 first events; HR 0.76; 95% CI, 0.66 to 0.88; P=0.0003). Additionally, semaglutide displayed favorable results over the placebo group among kidney-specific components and death from cardiovascular causes, according to study authors.1

Furthermore, confirmatory secondary outcomes were also greater among individuals in the semaglutide group with a slower decrease in the mean annual eGFR slope by 1.16 ml per minute per 1.73 m2, and a 18% lower risk of major cardiovascular events.1

Serious adverse events were reported to be fewer among individuals in the semaglutide group compared with individuals in the placebo group (877 [49.6%] vs. 950 [53.8%]).1 However, the study authors noted that this could be due to less infections or serious cardiovascular disorders in the semaglutide group.2

However, limitations in the study included limited ability of the effects of combination therapy and a lack of detecting differences between important subgroups.1

Our trial has important strengths. This trial of a GLP-1 receptor agonist in a population of patients with chronic kidney disease and type 2 diabetes assessed clinically important outcomes, and significant benefits were shown for kidney and cardiovascular outcomes and death from any cause, said study authors in the news release.1

Continued here:
Study Finds Semaglutide Improves Chronic Kidney Disease in Patients With Type 2 Diabetes - Pharmacy Times

Photo Credit: Panuwat Dangsungnoen

People with both T2D and sarcopenia appear to be at increased risk for CVD, and they may develop CVD earlier in life than people with T2D alone.

People with both type 2 diabetes (T2D) and sarcopenia appear to be at increased risk for cardiovascular disease (CVD), and they may develop CVD earlier in life than people with T2D alone, according to research published in Diabetes, Obesity and Metabolism.

Sarcopenia in people with type 2 diabetes was associated with a higher risk of developing CVD, stroke, HF [heart failure] and MI [myocardial infarction]. Incident CVD events possibly occurred 14.5 years earlier among those with sarcopenia than those without, wrote lead author Jirapitcha Boonpor, MSc, and coauthors. Sarcopenia screening in patients with T2D may be useful to reduce the complications of CVD.

Boonpor and colleagues studied 11,974 people aged 40-70 who had T2D and enrolled in the UK Biobank prospective cohort study in England, Wales, and Scotland from 2006-2010. Because the criteria to define sarcopenia vary by ethnicity and the UK Biobank contains data from relatively few non-White participants, the researchers restricted their analyses to White Europeans.

At baseline, all participants completed touch-screen questionnaires, underwent physical measurements, and provided biological samples. The researchers used Cox proportional hazard models to adjust for sociodemographic and lifestyle factors (including age, sex, education, socioeconomic status, BMI, processed meat intake, smoking status, alcohol intake, physical activity level, and T2D duration) to analyze the links between sarcopenia (assessed by grip strength, muscle mass, and gait speed) and CVD incidence. They used the rate advancement period to estimate the time it took for patients CVD to advance due to sarcopenia.

Over a median follow-up of 10.7 years, 1,957 participants developed CVD (742 HF, 373 stroke, and 307 MI). Compared with patients with T2D without sarcopenia, those with sarcopenia had higher risks for CVD (HR, 1.89; 95% CI, 1.61-2.21), HF (HR, 2.59; 95% CI, 2.12-3.18), stroke (HR, 1.90; 95% CI, 1.38-2.63), and MI (HR, 1.56; 95% CI, 1.04-2.33) after adjusting for all covariates.

CVD, heart failure, stroke, and MI incidence rates among participants with sarcopenia matched the rates of those without sarcopenia who were 14.5, 13.7, 13.7, and 12.8 years older, respectively.

The findings intrigue Preethika Ekanayake, MD, who was not involved in the study.

Most international working groups for sarcopenia, such as the European Working Group on Sarcopenia in Older People (EWGSOP) and the Asian Working Group for Sarcopenia (AWGS), predominantly define sarcopenia as an age-related muscle mass loss and recommend screening in older adults, she says.

Although we spend a lot of time evaluating, screening, and emphasizing prevention of microvascular complications like nephropathy, neuropathy, and retinopathy in patients with diabetes, we do not place much emphasis on evaluating sarcopenia, Dr. Ekanayake notes. These findings may encourage doctors to screen their patients for sarcopenia and to counsel them on undertaking weight-bearing and resistance exercises and physical therapy to improve muscle mass and help stave off CVD onset.

As the authors state, while the large sample size, long follow-up, and wide age range are strengths of the study, the lack of non-White participants limits the generalizability of the findings to other populations; UK Biobank participants having been invited, not selected, may introduce selection bias; and self-reported activity levels and diabetes duration may not be reliable.

There is no mention of the degree of diabetes control, Dr. Ekanayake adds. For example, hemoglobin A1C [HbA1C] was not mentioned. I would be curious whether the patients with sarcopenia and higher CVD risk also had higher HbA1C values, which could have confounded the results. Moreover, low muscle mass did not impart higher CVD risk in the models that were minimally and maximally adjusted for confounders, which is also curious because sarcopenia is the loss of muscle mass.

Dr. Ekanayake joins the researchers in recommending further related research. Randomized controlled trials are needed to corroborate the findings, she advises.

Link:
Sarcopenia Screening May Reduce CVD Risk in Patients With Type 2 Diabetes - Physician's Weekly