Evaluation of the Efficacy and Safety of DBL-4pen Mobile Application in Patients With Type 2 Diabetes

NAUnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

January 31, 2025

Conditions
Diabetes Mellitus, Type 2
Interventions
DEVICE

Use of the device DBL-4pen

"During the treatment period, the patient will use~* the DBL-4pen device (consisting of a software hosting the Diabeloop algorithm installed on a smartphone)~* the associated device #1: Dexcom G6, Continuous Glucose Monitoring (CGM)~* the associated device #2: Two Mallya caps for their rapid- and long-acting insulin pens.~The regulation algorithm hosted by DBL-4pen software recommends insulin doses to be administrated by the patient."

Trial Locations (4)

31400

CHU Toulouse - Hôpital de Rangueil, Toulouse

38000

CHU Grenoble, Grenoble

67000

CHRU de Strasbourg - Hôpital Civil, Strasbourg

91100

CH Sud Francilien, Corbeil-Essonnes

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Icadom

INDUSTRY

lead

Diabeloop

INDUSTRY