Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

NACompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Type 1 Diabetes
Interventions
DEVICE

MiniMed™640G and Suspend before low

"All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON.~Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase."

DEVICE

MiniMed™640G

Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.

Trial Locations (14)

Unknown

CHU de Besançon, Besançon

CHU Grenoble, Grenoble

APHM - La Conception, Marseille

CHU Montpellier - Hôpital Lapeyronie, Montpellier

Ospedale Papa Giovanni XXIII, Bergamo

Ospedale S. Raffaele, Milan

Ospedale S. Gionanni di Dio, Olbia

Groene Hart Ziekenhuis, Gouda

Maasstad Ziekenhuis, Rotterdam

UMC Utrecht, Utrecht

Isala, Zwolle

Manchester Diabetes Center, Manchester

HG2 7SX

Harrogate District Hospital, Harrogate

SE5 9NU

King's College London, London

All Listed Sponsors
lead

Medtronic Diabetes

INDUSTRY

NCT02733991 - Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes | Biotech Hunter | Biotech Hunter