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

NACompletedINTERVENTIONAL
Enrollment

239

Participants

Timeline

Start Date

February 28, 2018

Primary Completion Date

August 20, 2020

Study Completion Date

August 20, 2020

Conditions
Diabetes Mellitus
Interventions
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.

Trial Locations (20)

13274

APHM - Hopital Sainte-Marguerite, Marseille

14033

CHU Caen Normandie, Caen

28500

Institut de diabétologie et Nutrition du Centre, Vernouillet

30900

Hopital Caremeau-CHU Nimes, Nîmes

31059

CHU de Toulouse, Toulouse

34295

CHU de Montpellier, Montpellier

38700

CHU Grenoble Alpes, La Tronche

44800

CHU de Nantes, Saint-Herblain

51092

CHU Reims, Reims

54511

CHU de Nancy, Vandœuvre-lès-Nancy

59037

CHRU de Lille, Lille

67091

CHRU de Strasbourg, Strasbourg

69200

Groupe hospitalier Les Portes du Sud, Vénissieux

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

71200

Hopital Hotel Dieu - Creusot, Le Creusot

75475

Paris Lariboisière, Paris

75679

APHP Groupe Hospitalier Cochin (Paris), Paris

76100

CHU Rouen, Rouen

80054

CHU Amiens Picardie, Amiens

86021

CHU de Poitiers, Poitiers

All Listed Sponsors
collaborator

Roche Diabetes Care

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY

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 | Biotech Hunter | Biotech Hunter