Smart MDI Study (CIP343)

NAActive, not recruitingINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

December 6, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Diabetes Mellitus, Type 1
Interventions
DEVICE

Smart MDI System

"The Smart MDI system consists of the InPen™ system and Simplera™ system.~The InPen™ system includes a reusable smart bolus insulin pen injector with Bluetooth combined with the InPen™ app to help users take insulin doses.~And InPen™ app which communicates with the InPen™ injector and compatible continuous glucose monitoring (CGM) devices to collect and display information on insulin delivered by the injector as well as current and past glucose values.~The Simplera™ system consists of a disposable integrated sensor-transmitter platform (Simplera™ Sensor) and the Simplera™ app which receives data from the Simplera™ sensor via Bluetooth Low Energy (BLE) radio signal"

Trial Locations (17)

Unknown

Antwerp University Hospital, Antwerp

Hospital Universitaire Bruxelles Erasme, Brussels

UZ Leuven, Leuven

CHU Liege, Liège

IKEM, Prague

CHRU de Brest service diabetologie endocrinologie, Brest

Center for DIABeCare, Hospices Civils de Lyon, Lyon

CHU Nimes, Nîmes

Hospital Rangueil, Toulouse

Zentrum fur digitale Diabetologie Hamburg, Hamburg

Hannoversche Kinderheilanstalt, Hanover

MVZ Stoffwechselmedizin Leipzig, Leipzig

University of Bari Aldo Moro, Bari

ASST Spedali Civili Brescia, Brescia

Sahlgrenska University Hospital, Gothenburg

Uddevalla Hospital, Uddevalla

Hogsbo Narsjukhus, Västra Frölunda

All Listed Sponsors
lead

Medtronic Diabetes

INDUSTRY

NCT06645834 - Smart MDI Study (CIP343) | Biotech Hunter | Biotech Hunter