Dexcom Announces Global Rollout of G7, as reported by Andrew Briskin for diaTribe.org, 10 October 2022.
Dexcom, one of the leading manufacturers of CGM, announced on Oct. 4 that its latest product, the Dexcom G7, is now available for people with diabetes, ages 2 and up, in five additional countries: United Kingdom, Ireland, Germany, Austria, and Hong Kong. This marks the first widespread release of the device, in several countries across the world.
Earlier in the year, the G7 received clearance to be sold to people with diabetes in the European Union. Since then, the device was released in a limited rollout in the UK. In the United States, the device is still under FDA review, with the company targeting a start date for the limited US launch before the end of 2022.
Read more: Dexcom Announces Global Rollout of G7
Can Type 2 Diabetes Drugs Help People with Type 1? was written by Andrew Briskin for diaTribe.org, 10 October 2022.
Like people who have type 2 diabetes, people with type 1 deal with high glucose levels and risk of complications. In addition, some people with type 1 diabetes, especially older individuals, may struggle with weight management and these classes of medicines are very helpful with weight management.
New medications – like GLP-1 receptor agonists, SGLT-2 inhibitors, and “dual” GIP/GLP-1 receptor agonist Mounjaro (tirzepatide) – have shown to help people lower glucose levels, lose weight, and protect against complications like heart and kidney disease. However, these drugs are only approved for those with type 2.
Experts at the European Association for the Study of Diabetes (EASD) 2022 meeting in Stockholm agreed that it’s time for a change. These leading clinicians and researchers discussed the latest data suggesting that GLP-1s, SLGT-2s, and combinations of these therapies could benefit people with type 1 diabetes.
- Dr. Jerry Greenfield, an endocrinologist and clinical researcher at the Garvan Institute of Medical Research in Sydney, Australia, discussed GLP-1 receptor agonists. “Current therapies address [the need for] insulin but do not target other metabolic defects in many people with type 1 diabetes, such as insulin resistance, weight gain, or excess cardiovascular risk,” he said.
After summarizing these unmet needs in type 1 diabetes care, Greenfield said that many people with type 1 have asked their healthcare providers to prescribe GLP-1 receptor agonists. Though some clinicians have started to prescribe these drugs “off-label” – without FDA approval – many still avoid prescribing them to people with T1D. Also, as Greenfield emphasized, there have not been enough large-scale clinical trials exploring the use of GLP-1 receptor agonists in people with type 1.
- Dr. Parth Narendran, professor of diabetes medicine at the University of Birmingham in the UK, highlighted several studies that have explored SGLT-2 inhibitors in people with type 1 diabetes.
Narendran presented this table, summarizing studies of three SGLT-2 inhibitors in people with type 1 diabetes, showing average reductions in A1C, daily insulin dose, and body weight. There was also evidence that, similar to effects in those with type 2, SGLT-2 inhibitors slowed the progression of chronic kidney disease in people with type 1. However, he said that previous studies have shown that taking SGLT-2 inhibitors has come with a higher risk for diabetic ketoacidosis (DKA). He acknowledged that there are risks to prescribing SLGT-2s “off-label” to people with type 1 diabetes. “Perhaps using ketone monitors could help patients monitor their levels to avoid the safety concern [of DKA],” he said.
- Dr. Husam Ghanimn, research associate professor of endocrinology at the State University of New York at Buffalo, suggested that a combination of these drugs may also be effective for people with type 1 diabetes. He presented results from a small study exploring the effects of an SLGT-2 inhibitor in individuals with type 1 who were already taking a GLP-1 receptor agonist and insulin. The study found that adding the SGLT-2 inhibitor significantly lowered A1C, without increasing the risk of hypoglycemia.
Read more: Can Type 2 Diabetes Drugs Help People with Type 1?
New research details the microbial origins of Type 1 diabetes was posted by the University of Oregon for MedicalXpress.com, 13 October 2022.
Almost a decade ago, University of Oregon graduate student Jennifer Hampton Hill made a fortuitous find: A protein made by gut bacteria that triggered insulin-producing cells to replicate. She has continued researching this protein, called BefA, as a postdoc at the University of Utah. And Karen Guillemin’s lab at the University of Oregon has kept studying BefA, too. Alongside other colleagues, they’ve now uncovered new insights into what BefA does and why bacteria make it.
Those discoveries have “important, profound implications,” said Guillemin. “If we understand how BefA works, it could give us a way to stimulate beta cell production therapeutically.” That could someday lead to treatments for Type 1 diabetes, which affects millions of people worldwide. The researchers reported their findings in a paper published October 13 in Cell Metabolism.
Microbiome stimulation of immune development helps properly educate the immune system and prevent autoimmunity. Guillemin’s team’s work suggests an additional role for the microbiome: It stimulates the growth of the beta cell population early in development, buffering against later depletion by autoimmune attack. Beta cell population growth “is happening at the same time that microbial communities are diversifying in the gut,” said Hill. “A hallmark of diabetes is kids who develop it tend to have a less diverse gut microbiome. It’s possible they’re missing some of the bacteria that make BefA.”
BefA can disrupt the membranes of many kinds of cells, both bacterial and animal, they showed. It makes sense that gut bacteria would attack competing bacteria. But unexpectedly, they also found that BefA’s attacks on the membranes of insulin-producing cells triggered those cells to reproduce.
The finding suggests that bacterial warfare in the gut can have collateral beneficial effects on the body, boosting the population of cells that can make insulin throughout the lifespan.
FDA starts advisory program pilot to reduce ‘valley of death’ risk for medical devices was written by Nick Paul Taylor for MedTechDive.com, 12 October 2022.
Innovative medical devices often never make it from development and trial into the hands of practitioners and patients, instead becoming lost in a “valley of death.” TAP was a contentious part of the FDA’s MDUFA V proposal. After reviewing the agency’s original plan, the industry said it had “a fundamentally different view of the MDUFA program and its purposes.” However, the two sides ultimately reached a compromise, agreeing to run a multiyear pilot program to assess the viability of the idea.
With MDUFA V now signed into law, the FDA is pushing ahead with the pilot program. The agency will start a soft launch phase in January, during which it will enroll up to 15 devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices. The regulator chose OHT2 because of its history of granting breakthrough device designations, workload, staffing levels, and experience.
TAP will build on the FDA’s experience of running the breakthrough and early feasibility programs, as well as its engagement of sponsors as they were preparing to seek emergency use authorization during the COVID-19 pandemic. The FDA said it is establishing “a dedicated cadre” of advisors to support the pilot.
Read more: FDA starts advisory program pilot to reduce ‘valley of death’ risk for medical devices
Stop killing devices? What are they saying? No devices get killed in the land of FDA make believe? I immediately sent a note to the program officer and applied for the non existent FDA patient position in the Total Product Life Cycle Advisory Program.
Wait until they get that email. LOL It will be hoot. I am so glad I got the chance to read about it here. If they ask, I will tell them I heard about TPLC from a distinguished web site in CA. I might even get you named in the Federal Register. LOL