Podcast Summary: Diabetes Connections | Type 1 Diabetes

Host: Stacey Simms
Episode Title: In the News...Tandem's new infusion set approved, Sernova cell-pouch moves forward, GLP-1 meds for T1D, and more!
Release Date: May 16, 2025

Episode Overview

In this concise, news-focused episode, host Stacey Simms delivers the latest and most important headlines from the Type 1 diabetes community. She covers recent advancements in diabetes technology, significant clinical trial updates, new research studies, and industry changes impacting people with Type 1 diabetes and their caregivers.

Key Discussion Points & Insights

1. Tandem Diabetes’ “Steady Set” Infusion Set Approved

• [00:30] Tandem Diabetes’ Capillary Biomedical subsidiary received FDA clearance for the Steady Set infusion set.
  • Features: Integrated inserter, hidden needle, one-handed insertion, approved for 3 days' use.
  • Tandem intends to seek approval for 7 days' use before launching.
  • Context: “Many of us have been following this since Tandem acquired CatBio...and it’s been pretty hush hush.” — Stacey Simms [01:13]

2. Omnipod 5 and Dexcom G7 Compatibility Update

• [01:26] Healthcare providers are being notified about the upcoming compatibility between the Omnipod 5 iPhone app and the Dexcom G7.
  • No official launch date yet, but an update is expected within weeks.
  • “Something many of you have been waiting for for a while.” — Stacey [01:37]

3. Sernova’s Cell-Pouch Clinical Trial Progress

• [01:51] Sernova announced promising results for its cell-pouch “biohybrid organ,” aimed as a functional cure.
  • Out of 12 participants, 8 became insulin independent; all achieved and maintained A1C < 7.
  • “Still very early, but a lot more to come.” — Stacey [02:14]
  • Notable considering Vertex’s recent halt on a similar therapy.

4. Adult-Onset Type 1 and Cardiovascular Risk

• [02:35] European Heart Journal study: Adults diagnosed with Type 1 face increased CVD risk and no better prognosis than early-onset cases.
  • Study based on a registry of over 10,000 people.
  • Main identified risk factors: smoking, poor glucose control, obesity.
  • Adult-onset patients less likely to use insulin pumps/assistive devices.
  • Researchers recommend stopping smoking, managing weight, and embracing assistive technology for better outcomes.

5. Breakthrough T1D: Quality of Life & Demographics Studies

• [03:22] Two newly published peer-reviewed articles shed light on living with Type 1:
  • Article 1: Insulin therapy and current tech “are not meeting the needs” due to high daily burden, ongoing risk of complications, and need for progress in cell-based therapies.
  • Article 2: Demographic analysis outlines current and future trends in the Type 1 population in the US.
  • “You can read that in the show notes... every article and story I talk about does have further information...” — Stacey [03:55]

6. Research Recruitment: GLP-1 (Tirzepatide) for T1D

• [04:17] Participants sought for a Lilly-sponsored study of Tirzepatide (Manjaro/Zepbound) in T1D.
  • Current approval is for T2D, but early research suggests similar benefits for T1D (BG control, organs, etc.).
  • Requirements: T1D for at least a year, age over 18, A1C between 7-10.5.
  • “Again go to diabetes-connections.com and learn more.” — Stacey [05:06]

7. Roche Diagnostics: Major US CGM Investment

• [05:17] Roche announces $550 million expansion in Indianapolis to produce Accu-Chek SmartGuard CGM devices (currently Europe-only).
  • Unclear if/when US approval will be sought for this CGM.
  • Site already manufactures Accu-Chek test strips.

8. GoPen: Refillable Insulin Pen Approved

• [05:56] FDA clears GoPen, a user-refillable insulin pen.
  • Reduces per-dose cost compared to disposables; refilled from standard vials.
  • Won ADA’s Innovation Challenge.
  • Product not yet on the market; manufacturing still ramping up.

9. Ascensia’s Eversense 365: Award-Winning CGM Solution

• [06:32] Eversense 365 CGM won “Best New Technology Solution” in the 2025 MedTech Breakthrough Awards.
  • Also received gold at the Edison Awards.
  • First pump partnership: SQL MedTech’s Twist Pump.
  • Previous episode features in-depth interview with Ascensia’s president. [06:48]

10. Dexcom Leadership Change

• [07:01] Jake Leach promoted to President and COO at Dexcom.
  • Longtime leader, deeply involved since Dexcom’s first commercial CGM.
  • Stacey jokes: “I think Jake Leach is best known around here as the person I questioned the most about Direct to watch.” [07:17]

Notable Quotes & Memorable Moments

• On Tandem’s hush-hush development:

  • “CatBio has never accepted my requests for interviews. So I'm really excited to see this approval and I'm hoping to learn more.” — Stacey Simms [01:12]

• On burdens not met by today’s therapies:

  • “They talk about the significant daily burden, let alone premature death and complications, and talks about accelerating cell therapies.” — Stacey Simms [03:41]

• On the importance of using technology in adult T1D:

  • “The prognosis, these researchers say can be significantly improved by stopping smoking, preventing obesity and improving glucose control by using aid systems and other tools.” — Stacey Simms [02:58]

• On Jake Leach’s new role:

  • “I think Jake Leach is best known around here as the person I questioned the most about Direct to watch. So we will be sure to talk to him again soon.” — Stacey Simms [07:17]

Useful Timestamps for Important Segments

| Topic | Timestamp | |----------------------------------------------------|-------------| | Tandem’s New Infusion Set | 00:30 – 01:24 | | Omnipod 5 + Dexcom G7 Compatibility | 01:26 – 01:49 | | Sernova Clinical Trial Results | 01:51 – 02:18 | | Adult-Onset T1D & Cardiovascular Risk | 02:35 – 03:18 | | Breakthrough T1D’s Published Studies | 03:22 – 04:16 | | Recruitment: GLP-1 Research (Tirzepatide) | 04:17 – 05:06 | | Roche CGM Facility Expansion | 05:17 – 05:55 | | GoPen User-Refillable Insulin Pen Approval | 05:56 – 06:30 | | Eversense 365 CGM Accolades & Pump Integration | 06:32 – 07:00 | | Dexcom Front Office Change (Jake Leach) | 07:01 – 07:30 |

Summary

This episode offers a fast-paced, information-rich roundup of the latest Type 1 diabetes news and technological advancements. Stacey Simms’s signature mix of warmth, enthusiasm, and accountability brings the community’s pressing issues to the forefront. Listeners stay up to date on everything from new infusion sets and CGM systems to clinical trial breakthroughs, potential drug expansions, and leadership shifts at major companies. For more resources and study details, visit the episode’s show notes at diabetes-connections.com.