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It’s In the News, a look at the top stories and headlines from the diabetes community happening now. Top stories this week: FDA approval for a pancreatic islet cell therapy to treat type 1, stem cell research moves ahead, big news from the ADA Scientific Sessions about what’s next for medications like Mounjaro and a pill form of semaglutide. Dexcom announces a sensor for people with type 2 who don’t use insulin, Libre moves ahead with Ketone monitoring and more.
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Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines happening now
In the news is brought to you by the T1D Exchange a nonprofit organization dedicated to improving outcomes for the entire T1D population.
Big week of news following the 2023 ADA Scientific Sessions conference. What follows is just the tip of the information iceberg, so please follow the links in the show notes to much more.
Top story though isn’t from ADA – but a new FDA approval.. for a pancreatic islet cell therapy to treat type 1. It’s called donislecel, developed from cadaver donors and giving as a single infusion straight into the liver. Immunosuppression is required to maintain cell viability, just as it is required to support a transplanted kidney or other organ.
Approval was based on what seems to be a very small study – 30 people with type 1 who had hypoglycemic unawareness and who received between one and three infusions of donislecel. After one year, 11 people did not need to dose insulin.. 10 stayed that way for more than five years. But five people in the study were not able to stop dosing insulin at all. This method is different from what Vertex and Sernova are trying to do with stem cell therapy.
Vertex moves forward on their clinical trial of islet stem cell therapy. All six patients treated with VX-880 had undetectable fasting C-peptide (endogenous insulin secretion) at baseline, a history of recurrent SHEs in the year prior to treatment and required an average of 34.0 units of insulin per day. Following treatment, all six patients demonstrated endogenous insulin secretion, improved glycemic control as measured by HbA1c, improved time-in-range on continuous glucose monitoring, and reduction or elimination of exogenous insulin use. Two patient are completely insulin independent after one year – with an A1C of 5.3 compard to 8.6 at baseline.. the other 6.0 with a 7.6 at baseline – again the ”after” number is without taking insulin.
As a result of these safety and efficacy data in Parts A and B, the independent data review committee has recommended moving to Part C of the trial, which allows for concurrent dosing of patients at the full target dose of VX-880.
Sernova also reports good results with their cell pouch system. Five of the six patients who have completed implantation continue to experience insulin independence for periods ranging from six months to more than three years. The sixth patient only recently completed the protocol-defined islet transplants.. so no results yet. There is a second group testing a larger cell pouch.
Big news from ADA about all of the type 2 and obesity drugs you’ve likely heard about.. here are some headlines:
SURMOUNT-2 clinical trial evaluating tirzepatide – brand name Mounjaro – for weight loss in adults with obesity or overweight and type 2 diabetes.
Average weight loss was 15.7% at the highest dose, with many other health benefits such as lower A1C levels; reduction in waist circumference, and body mass index; and improvements in cardiometabolic disease risk factors such as lipid levels, cholesterol, and blood pressure.
That 15 percent weight loss was about 34 pounds and the a1c reduction for half of those in the study went down to 5.7 which is considered nondiabetic. Mounjaro is currently approved for type 2 and the FDA could approve Mounjaro regardless of diabetes status later this year.
A study called PIONEER looks at oral semaglutides – some calling it the Ozempic pill. When compared to other anti-diabetic medications such as Jardiance, Januvia and Victoza, people taking the oral semaglutide say 1% or or more reduction of HbA1c compared to those treated with other anti-diabetic medicines. They also were more like to achieve a 5% or more reduction of body weight. Note: this was not a study comparing a semaglutide pill with the same type of injection.
And look for two additional new drugs to treat obesity in the next few years.. orforglipron, is easier to use and to produce, and it will probably be cheaper than existing treatments. The second, retatrutide, has an unprecedented level of efficacy, and could raise the bar for pharmacological obesity treatment.
Orforglipron and retatrutide both mimic hormones produced by the lining of the gut in response to certain nutrients. These hormones help to slow the passage of food through the digestive tract and lower appetite by acting on receptors in the brain — both effects that reduce people’s desire to eat and help them to lose weight. Orfoglipron is a non-peptide molecule that researchers say is easy to produce and is a pill.. a lower price is anticipated for this one. Retratritude looks like it could help people lose even more weight than Mounjaro.
Dexcom announces a new product in the US – coming in 2024 – designed for people with type 2 who don’t use insulin. This will be built on the G7 hardware, but with different software and a 15 day sensor.
CEO Kevin Sayer also announced that the G7 will be able to share data direct to the apple watch
Abbott will partner with Weight Watchers – people who have been prescribed one of Abbott’s FreeStyle Libre 14-Day or FreeStyle Libre 2 sensors and who are using the WeightWatchers diet plan to see their CGM data directly in the WeightWatchers app.
This is also a study where Abbott will launch two pilot programs directed at using CGM data to help people with Type 2 diabetes adjust and manage their dietary habits, regardless of whether they’re on insulin therapy.
A little bit more news about Abbott’s dual glucose and ketone sensor under development. Announced a last year’s ADA, the company says it’s moving forward through R&D
Separately from the Type 2 CGM push, Taub also offered an update on the dual glucose ketone sensor that’s currently under development at Abbott and that the company first announced at last year’s ADA conference. The sensor will be aimed at catching rising ketone levels as early as possible to help avoid cases of diabetic ketoacidosis. An Abbot executive says – quote – “There’s so much that we stand to learn about ketones because there hasn’t been a continuous sensor for them before, so there’s really very little we know about the evolution of ketones “
Beta Bionics has received FDA 510(k) clearance for the compatibility of the Fiasp Pumpcart prefilled insulin cartridge with the iLet automated insulin-delivery system.
The iLet is a bionic pancreas that fully automates 100% of all user insulin doses, providing users with the choice of three insulins, Novolog; Humalog; and Fiasp Pumpcart.
The device eases diabetes management in everyday life and almost eliminates the expertise that has been required in the past to set up and manage a traditional insulin pump. In May 2023, Beta Bionics was awarded FDA approval for the iLet device.
The iLet manages glucose levels with just a meal announcement and is paired with a Dexcom G6 Continuous Glucose Monitoring System for glucose readings.
All that is required for set-up is the user’s weight. While there is a need for carbohydrate awareness, no carb counting is necessary. Bolusing, correction factors, insulin-to-carb ratios, and pre-set basal rates are also unnecessary.
Beta Bionics president and CEO Sean Saint said: “Beta Bionics has been working tirelessly to create an insulin delivery system that offers less burden and more convenience for the type 1 community. Since launching last month, the iLet bionic pancreas is now available and clinics and users are being trained on its simple design and easy management features.
“When Fiasp Pumpcart prefilled cartridges are available, users will save time not having to manually fill cartridges and will have more choice for their diabetes management.”
Oura – the ring that tracks your sleep – will start sending info to three CGM info companies.. January, Supersapiens and Veri. All three of these companies provide software based off of the Libre CGM. These companies will now be receiving sleep scores and other biometric data from Oura so they can see how these measurements affect users’ glucose levels and overall health.
Just a fun fact here – there is a Facebook group called type 1 diabetics for 50 plus years. And it looks like this week they passed over 1500 members.
On the podcast next week.. I sat down with Dexcom’s new Chief Commercial officer to talk about their announcements from this week about the type 2 market and other features important to people with type 1. Our last epoisde is all about Kickass Healthy LADA
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.