During 2023, few fields can lay claim to the same amount of advancement in technology as diabetes management.

The celebration of new technologies in diabetes continued during Summer 2023, with the US FDA’s clearance of the Mobi insulin pump from Tandem Diabetes Care in mid-July and a pair of clearances for the BlueStar diabetes platform from Welldoc in August.

Table of Contents

Mobi

On July 11, 2023, Tandem Diabetes Care announced the FDA clearance of the Tandem Mobi insulin pump for use in people aged 6 years and older with diabetes. Billed as the world’s smallest durable automated insulin delivery device, with the device less than half the size of the t:slim X2 pump and able to fit in a coin pocket, be clipped to clothing, or worn on-body with an adhesive sleeve.

Fully controllable from a mobile app or an on-pump button and featuring a 200-unit insulin cartridge, the pump is designed for use as part of an AID system and comes with Control-IQ technology.1

BlueStar

The first clearance in August 2023 for BlueStar was announced by Welldoc on August 15, 2023. The 510(k) clearance from the FDA, which marked the 10th such clearance from the FDA for Welldoc, enables the BlueStar platform to use connected insulin dosing data in personalized bolus insulin dosing recommendations. According to Welldoc, this function will be made commercially available in 2024.2

Just more than a week later on August 23, 2023, Welldoc announced it had received its 11th 510(k) clearance from the FDA—again, for the BlueStar diabetes platform. Building on the aforementioned August 15, 2023, clearance, the latest clearance allows BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring device.3

In this special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss their experience with the Tandem Mobi pump from the ADCES 2023 meeting and offer perspective on what the Welldoc clearances mean for people with diabetes and care providers.

References:

  1. Campbell P. Tandem Mobi Insulin Pump, billed as World’s smallest insulin pump, receives FDA clearance. HCP Live. July 12, 2023. Accessed September 2, 2023. https://www.hcplive.com/view/tandem-mobi-insulin-pump-billed-as-world-s-smallest-insulin-pump-receives-fda-clearance.
  2. Welldoc. Welldoc receives 10th 510(k) clearance from FDA for award-winning diabetes Platform Bluestar® – Welldoc: Chronic care platform. Welldoc. August 15, 2023. Accessed September 2, 2023. https://www.welldoc.com/news/welldoc-10th-510k-clearance-fda-diabetes-platform/.
  3. Welldoc. Welldoc receives 11th 510(k) clearance from FDA for award-winning diabetes Platform Bluestar® – Welldoc: Chronic care platform. Welldoc. August 23, 2023. Accessed September 2, 2023.

link

Leave a Reply

Your email address will not be published. Required fields are marked *