Diabetes Dialogue: June 2024 Updates in Diabetes Tech and Type 1 Diabetes

News
Podcast

This episode covers the clearance of 2 new OTC CGMs from Abbott, JDRF becoming Breakthrough T1D, and the FDA clearance of the CamAPS FX for people with T1D

Chapters

00:00 - Intro

00:40 - Abbott OTC CGM

06:20 - Diabetes Technology Pipeline

10:45 - JDRF Rebrands as Breakthrough T1D

15:15 -US FDA Clearance of CamAPS FX

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide a June 2024 update focusing on a trio of topics across the spectrum of diabetes management. In the episode, hosts discuss the US Food and Drug Administration (FDA) clearance of 2 new over-the-counter (OTC) continuous glucose monitoring (CGM) systems from Abbott, the renaming of JDRF to Breakthrough T1D, and the FDA clearance of the CamAPS FX for people with type 1 diabetes.

Over-the-Counter CGMs

After spotlighting Dexcom’s Stelo in a previous episode, hosts started off this episode by discussing Abbott’s announcement of US Food and Drug Administration clearance for a pair of new OTC CGM devices: the Lingo and the Libre Rio.1

Billed by Abbott as a consumer biowearable, the Lingo is designed for use by consumers 18 years and older looking to improve their overall health by offering them the ability to track glucose and provide personalized insights as well as customized coaching. The Lingo will feature a biosensor designed to be worn on the upper arm with a 14-day wear period. Data obtained by the sensor will be continuously streamed to a smartphone application for the user.1

Unlike the Lingo, the Libre Rio is billed by Abbott as the company’s first OTC system for those with type 2 diabetes who do not use insulin and manage their diabetes with lifestyle modifications. The system boasts a measurement range of 40 to 400 mg/dL.1

JDRF becomes Breakthrough T1D

On June 04, 2024, the JDRF announced it would be changing its name and will now be called Breakthrough T1D. Announced in a simulcast during the organization’s annual Government Day Conference, the new name is a reflection of the medical community’s recognition that type 1 diabetes can develop at any age, regardless of family history.2

“As an adult and scientist living with type 1 diabetes, I believe our new name, Breakthrough T1D, will help to deepen engagement and support across the entire community as we drive toward curing type 1 diabetes,” said Aaron J. Kowalski, PhD, chief executive officer of Breakthrough T1D.2

CamAPS FX

To complete the episode, the hosts celebrate a long-awaited announcement for those up to date on developments in diabetes technology: the US FDA approval of CamAPS FX.3,4

A prescription-only mobile application developed by CamDiab Ltd, CamAPS FX is designed for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in people 2 years of age or older. However, much of the excitement surrounding the algorithm revolves around it being the first of its kind for use in pregnant patients who may have complications with type 1 diabetes.3,4

Compatible with other interoperable devices that meet pre-specified acceptance criteria, the application works with an integrated continuous glucose monitor to control a compatible insulin pump. At the time of clearance by the US FDA, the CamAPS FX closed-loop algorithm had already received clearance for a similar indication in Europe and been used by more than 27,000 people in 15 countries.3,4

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Sanofi, and others.

References:

  1. Abbott. Abbott receives U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems. Abbott MediaRoom. June 10, 2024. Accessed June 17, 2024. https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-U-S-FDA-Clearance-for-Two-New-Over-the-Counter-Continuous-Glucose-Monitoring-Systems.
  2. Breakthrough T1D. JDRF is now Breakthrough T1D . Breakthrough T1D. June 4, 2024. Accessed June 17, 2024. https://www.breakthrought1d.org/for-the-media/press-releases/breakthrough-t1d-is-now-breakthrough-t1d/.
  3. Office of the Commissioner. FDA roundup: May 24, 2024. U.S. Food and Drug Administration. May 24, 2024. Accessed June 17, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-may-24-2024.
  4. University of Cambridge. US Food and Drug Administration approves Cambridge-developed artificial pancreas. University of Cambridge. May 24, 2024. Accessed June 17, 2024. https://www.cam.ac.uk/research/news/us-food-and-drug-administration-approves-cambridge-developed-artificial-pancreas.
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