NCT04190277

Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8)

Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase. * Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6. * Then, a 3-month study phase will be performed during 12 weeks: * 1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition). * 2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition). * An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.

Conditions

• Diabetes Mellitus, Type 1
• Closed-Loop

Interventions

Type	Name	Description
DEVICE	Open-loop condition	Patient's standard insulin pump setting combined with continuous glucose monitoring sensor
DEVICE	Closed-loop condition	Closed-loop algorithm system paired with continuous glucose monitoring sensor

Timeline

• Start date: 2020-01-07
• Primary completion: 2020-03-16
• Completion: 2020-06-16
• First posted: 2019-12-09
• Last updated: 2021-04-08

Locations

9 sites across 1 country: France