NCT03445065

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

Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) \>8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose \<70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]).

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Eversense XL CGM System	The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
DEVICE	Usual SMBG or FGM device used by participants	Commercially available products in France for self-monitoring of blood glucose (SMBG) or flash glucose monitoring (FGM) were considered as comparators for this study.

Timeline

• Start date: 2018-02-28
• Primary completion: 2020-08-20
• Completion: 2020-08-20
• First posted: 2018-02-26
• Last updated: 2021-09-10
• Results posted: 2021-09-10

Locations

20 sites across 1 country: France

Regulatory

• FDA-regulated device study