Type 1 Diabetes - January 2021
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Type 1 Diabetes - January 2021
Tidepool completes FDA submission of Tidepool Loop an automated insulin dosing app for management of Type 1 Diabetes (T1D)
07 Jan 2021
Tidepool Loop (automated insulin dosing app) – Tidepool
- Tidepool completed FDA submission of form 510(k) for Tidepool Loop intended for the management of T1D
- On Dec 22, 2020, the submission had completed FDA’s administrative acceptance review and was proceeding to substantive review as an interoperable automated glycemic controller (iAGC)
- Tidepool Loop app details:
- Objective: To provide flexibility for users and their healthcare teams to choose the compatible components in managing their care
- Indication: T1D insulin management
- Feature: Designed to connect with a variety of compatible insulin pumps and continuous glucose monitoring systems (CGM) to automatically dose insulin for the treatment of insulin-requiring diabetes to keep a user’s glucose within the desired correction range
- Supported device: iPhones and Apple watches
- Later this year, all submitted documents will be published and available at tidepool.org upon completion of FDA’s review
Tidepool Loop positioned to bring automation in Diabetes industry
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CI Scientists Remarks:
- Tidepool initiated the development of FDA-regulated mobile app in Oct’18 and in Dec’18 received $6 million grant support from JDRF and The Helmsley Charitable Trust for the development of Tidepool Loop
- Tidepool is currently partnered with Insulet, Dexcom, Medtronic, and two undisclosed medical device companies for the Tidepool Loop platform
- The app is developed using 50 user de-identified data donated voluntarily by adults with T1D, caregivers of people with T1D, independent pediatric participants with T1D, and pediatric participants with T1D paired with their caregivers
- It has submitted relevant clinical and technical documents with 510(k) submission, the review period for 510(k) is 90 days from the date of submission making end of Mar 2021 tentative time for MDUFA decision
– Tarun Raisinghani, CI Scientists