It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Tandem's new infusion set is approved, Dexcom G7 compatibility with the Omnipod 5 iPhone app announced, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more!

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Episode transcription with links:

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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Tandem gets FDA clearance for a new infusion set. The company shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won clearance for its SteadiSet Infusion Set.

SteadiSet features an integrated inserter with a hidden needle designed for one-handed insertion. It received clearance to deliver insulin for up to three days of use. However, Tandem plans to submit a separate request to extend the indicated use time to up to seven days. It doesn’t expect to begin commercial activities for SteadiSet until after it receives clearance for the extended use time.

Many of us have been following this since Tandem acquired CapBio back in 2022.. it’s been pretty hush hush – CapBio has never accepted my requests for interviews, so I’m excited to see this approval, mostly because my son really really needs it!

https://www.drugdeliverybusiness.com/tandem-capbio-fda-clearance-insulin-infusion-set/

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Insulet just announced via an email to health care providers that Dexcom G7 compatibility with the Omnipod 5 iPhone app will be released IN THE COMING WEEKS! Great news for people with #t1d and

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Sernova announces positive interim data from its ongoing Phase 1/2 clinical trial in patients with T1D. this is their Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today

Interim data from 12 patients with transplanted human donor islet cells show patients achieving insulin independence, islet cell engraftment in Cell Pouch, islet function, islet survival, improved glycemic control, improved patient reported quality of life (QOL) and improved awareness of hypoglycemia and increased sensitivity to severe hypoglycemic symptoms. Improvement in patient outcomes was correlated with a cumulative increase in the quantity of transplanted islets. Based on these findings, the study is on track to meet its primary and secondary endpoints, and the confirmatory Cohort C is expected to initiate in H2 2025.

 

Clinical trials with iPSC islet-like clusters from Sernova’s partner, Evotec, are anticipated to begin in 2026 after completion of Cohort C of the ongoing trial. These interim findings, with 8 of 12 patients achieving insulin independence so far, support the thesis that Sernova’s high volume ten channel Cell Pouch, used in Cohort B, plus an optimised immune suppression regimen, has the potential to achieve insulin independence, without portal vein transplant, in our planned clinical trial with Evotec’s high quality iPSC islet-like clusters.

Measured HbA1c (a blood test that shows the average blood sugar levels over the past 2-3 months) in patients with Cell Pouch alone, showed that 9 of 12 patients had a reduced value within the American Diabetes Association (ADA) recommended range of