Last updated on August 2019

A French Study to Evaluate the Usefulness of Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus.

Brief description of study

This study will evaluate the usefulness of using a long term subcutaneously inserted continuous glucose monitoring (CGM) sensor in patients with insulin treated Type 1 or Type 2 Diabetes Mellitus. The study will be conducted in France. Patients will be enrolled into two cohorts and randomized into two groups within each cohorts.

Detailed Study Description

324 patients will be included in this study: 159 in cohort 1 and 165 in cohort 2. The cohort 1 will be focused on participants with Type 1 or Type 2 Diabetes with an HbA1c > 8% whereas cohort 2 will be focused on participants with Type 1 Diabetes spending more than 1.5 hour with sensor glucose < 70 mg/dL per day including excursions below 54 mg/dL as a mean for at least 28 days.

Clinical Study Identifier: NCT03445065

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