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

Everyone deserves a fair, healthy future. But today, for many Canadians, our provincial and territorial health care systems are under strain.

One of the biggest pressures right now is affordable medication. The medications many Canadians need are often too expensive, leading to fewer visits to pharmacies, less treatment, and more frequent health scares. The cost of contraceptives, and medications for those who are diabetic, is one of the largest barriers to access.

Were making sure Canadians get the medication that they need, when they need it.

The Prime Minister, Justin Trudeau, today highlighted measures in Budget2024 to make two key forms of prescription medication free, as well as the federal governments work to make health care fairer for every generation.

Heres what were doing:

Universal coverage for a range of contraception and diabetes medications. With $1.5billion in federal investments, we are launching the first phase of a national pharmacare plan.

The Prime Minister also highlighted the federal governments work to improve dental and health care, such as:

Making dental care more affordable:

Helping provinces and territories train more doctors and nurses, reduce hospital wait times, clear backlogs, and improve primary care, with:

Affordable health care, including prescription medication, is about fairness. This means every woman will have the ability to choose a contraceptive that is best for her, regardless of cost. And it means Canadians with diabetes will have access to the life-saving medication they need.

This is part of our work to improve the health of Canadians, strengthen the social safety net, and help every generation get ahead. Thats what were investing in through Budget2024. Right alongside this, were building more homes, creating more jobs, investing in our economy, and delivering fairness for every generation.

Medications like contraceptives and insulin are too expensive. Thats why were covering the cost. By launching the first phase of universal pharmacare, were making sure Canadians get the care they need, when they need it, and without worrying about the bill. Thats what fairness is all about.

Women should have the autonomy to make their own choices about their health and their bodies. Our plan to make common contraceptives free like birth control pills, IUDs, and even emergency contraception mean that, for nine million Canadian women, freedom of choice will be truly free. And it means more Canadian women will have freedom of choice over their bodies and their lives.

Were taking steps each day to build a stronger health care system, so everyone in Canada gets the care they need. From our pharmacare plan that will help millions of people receive free contraceptives and diabetes medication to the Canadian Dental Care Plan that is making dental care more accessible right across the country, we are focused on getting Canadians better public health care.

See the original post here:
Making contraception and diabetes medications free for Canadians - Prime Minister of Canada

In patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), semaglutide reduced the risk of clinically important kidney outcomes, major cardiovascular events, and death from any cause by 24%, according to a study published in The New England Journal of Medicine.1

To come to these findings, researchers randomly assigned 3533 patients with T2D and CKD to receive either 1.0 mg of subcutaneous semaglutide weekly (n = 1767) or placebo (n = 1766). CKD was defined by an estimated glomerular filtration rate (eGFR) of 50 to 75 mL/min/1.73 m2 with a urinary albumin-to-creatinine ratio of 300 to 5000 mg/g, or an eGFR of 25 to less than 50 mL/min/1.73 m2 with a urinary albumin-to-creatinine ratio of 100 to 5000 mg/g.

The primary outcome measured was major kidney disease events, including the onset of kidney failuredefined as dialysis, transplantation, or an eGFR of less than 15 mL/min/1.73 m2a reduction of eGFR by at least 50% from baseline, or death from kidney-related or cardiovascular causes. Hierarchical testing was used for prespecified confirmatory secondary outcomes. The median follow-up was 3.4 years, translating to about 177 weeks of semaglutide for the treatment group.

Semaglutide injections | Image credit: Patrick Bay Damsted stock.adobe.com

Compared with placebo, patients who took the weekly glucagon-like peptide 1 (GLP-1) receptor agonist experienced a 24% lower risk of primary outcome events, with 331 events in the treatment group and 410 in the placebo group (HR, 0.76; 95% CI, 0.66-0.88; P = .0003).

Specifically, these patients were 21% less likely to experience the kidney-related primary outcomes (HR, 0.79; 95% CI, 0.66-0.94) and 29% less likely to die due to cardiovascular causes (HR, 0.71; 95% CI, 0.56-0.89).

All confirmatory secondary outcomes also favored semaglutide. The mean annual eGFR slope decline was slower by 1.16 mL/min/1.73 m2 (P < .001), the risk of major cardiovascular events was 18% lower (HR, 0.82; 95% CI, 0.68-0.98; P = .029), and the risk of death from any cause was 20% lower (HR, 0.80; 95% CI, 0.67-0.95; P = .01) in the treatment arm.

These benefits reflect important clinical effects on kidney, cardiovascular, and survival outcomes among high-risk patients, particularly given the reassuring safety findings, and support a therapeutic role for semaglutide in this population, the researchers said.

Additionally, fewer participants in the semaglutide arm (49.6%) experienced serious adverse events compared with the placebo group (53.8%), although the researchers noted this was mainly because fewer participants in the semaglutide group were reported to have serious infections or infestations (17.9% vs 21.3%) or serious cardiovascular disorders (15.4% vs 18.1%). Serious eye disorders were more frequent in the semaglutide group compared with the placebo group (3.0% vs 1.7%), while the occurrence of diabetic retinopathy events was similar between the groups (22.8% vs 22.5%). Adverse events leading to the permanent discontinuation of treatment were more common with semaglutide (13.2%) than with placebo (11.9%), primarily due to gastrointestinal disorders (4.5% vs 1.1%).

Given the benefits of renin-angiotensin system (RAS) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and mineralocorticoid-receptor antagonism with finerenone for patients with T2D and CKD, clinicians and patients must carefully prioritize the use of semaglutide and other GLP-1 receptor agonists once studied, according to the researchers. While SGLT2 inhibitors have shown significant benefits for kidney outcomes, their effects on major cardiovascular events and mortality in this population have been mixed in prior research. With a favorable safety profile, the benefits demonstrated in the new study support the consideration of semaglutide as an initial therapeutic option alongside other proven therapies for patients with T2D and CKD.

Combination therapy is likely to be important in the future, and we found no clear heterogeneity of effect among patients receiving SGLT2 inhibitors at baseline as compared with those who were not, although the statistical power of this analysis was limited, the researchers added. Further analyses of these data are planned, and studies assessing approaches to combination therapy should be a priority.

This study was funded by Novo Nordisk, a manufacturer of Wegovy (semaglutide).

This news comes a few months after the FDA added another indication for semaglutide, expanding its use to reduce the risk of cardiovascular death, heart attack, or stroke in adults who have cardiovascular disease and overweight or obesity.2 Also, recent research showed that semaglutide led to significant improvements in exercise capacity, weight loss, and a number of secondary end points in patients with heart failure with preserved ejection fraction and obesity.3 In that study, patients taking the GLP-1 receptor agonist for a year lost 2.9% more body weight compared with patients taking placebo.

Reference

View post:
Semaglutide Lowers Risk of Major Kidney Outcomes, Cardiovascular Events, Death in Patients With Diabetes and CKD - AJMC.com Managed Markets Network

The trial, conducted between June 2019 and May 2021, used a lower dose of semaglutide than generally used for diabetes or weight loss treatment, with patients receiving 1.0 mg per week or a placebo. The trial was funded by pharmaceutical company Novo Nordisk, the supplier of Ozempic.

Semaglutide also slowed down loss of kidney function, lowered systolic blood pressure, and reduced body weight among participants.

Serious adverse effects were also less common, compared to those experienced by the placebo group, but were still experienced by almost 50 per cent of those on semaglutide, which Prof. Perkovic said was a function of the poor health of those involved in the trial people with high-risk chronic kidney disease.

The proven benefits prompted the trial to be cut short, based on a recommendation by an Independent Data Monitoring Committee.

Its the same chemical compound but we used a lower dose ... we did that deliberately because people with kidney disease tend to be more sensitive to the effects and side effects of drugs, Prof. Perkovic said.

Thats helpful in terms of being able to perhaps have the drug more widely used than might have otherwise been the case given the current supply limitations.

Its hoped the findings could soon help the growing number of people with kidney disease, which now affects about 850 million people worldwide, Prof. Perkovic said.

One of the most common causes of kidney disease is diabetes, particularly type 2 diabetes, which has also been growing dramatically in recent decades, he said.

Chronic kidney diseased contributed to about 20,000 deaths in Australia in 2021, about 12 per cent of all deaths that year, the latest for which figures from the Australian Institute of Health and Welfare are available.

In addition to loss of kidney function, kidney disease increases the risk of a range of other health conditions, particularly heart disease and stroke, and is associated with poorer quality of life.

People with kidney disease feel tired, weak and a bit foggy-headed, they often can't think clearly, and their quality of life is therefore dramatically reduced, Prof. Perkovic said.

If they end up on dialysis it affects not just them but their family, because they have to go off and have dialysis several times a week and ... the cost of dialysis is really expensive, it's $100,000 per person per year in Australia or more.

Prof. Perkovic said there has been an increase in treatments for chronic kidney disease in recent years, but more needed to be done.

We're really starting to dramatically improve outcomes for people with diabetes and kidney disease. But that will only happen if the results are translated into action at the clinical coalface, so that's an important next step, he said.

That will require overcoming supply shortages for semaglutide and the general lag in implementing research in clinical settings. More research is also needed to determine the optimal way to use semaglutide in combination with other existing treatments.

The challenge is to get these results into clinical practice, to get the drug used by the people who will benefit from it, who will live longer without dialysis, without heart attacks, without strokes, if they take this drug.

Novo Nordisk will need to seek regulatory approval for semaglutide to be used to treat those with chronic kidney disease. Prof. Perkovic expected this would be granted, and that semaglutide would become part of guideline-based therapy.

See original here:
'Saving kidneys, hearts and lives': Diabetes drug found to reduce risk of kidney disease and death - UNSW Sydney