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# Glycemic Control Medical Device Guidance
- URL: https://www.fdaweb.com/glycemic-control-medical-device-guidance/
- Published: 2021-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:59:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149354

FDA has published a draft guidance, *Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus*, with study recommendations for these devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/feasibility-and-early-feasibility-clinical-studies-certain-medical-devices-intended-therapeutically?ref=fdaweb.com) says that while several legally marketed medical devices help patients manage Type 2 diabetes, there are no legally marketed devices that are intended to therapeutically improve glycemic control in patients with Type 2 diabetes.

The contents of the guidance are Introduction, Background, Scope, Clinical Study Recommendations—Purpose/Objective, Study Design and Sample Size, Study Duration and Follow-Up Schedule, Inclusion/Exclusion Criteria, Patient Demographics, Treatment Parameters/Protocol (including post-operative regimen), Safety Endpoints and Data, Effectiveness Endpoints and Data, and Statistical Analysis Considerations.