NCT04308291

The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.

The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France (EQOL Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: —

Summary

The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.

Detailed description

Local, post-market, non-interventional, prospective, single-arm, multi-center study of patients pediatric and adult. The study is conducted according to the same schedule as the routine follow-up of patients: 1. RUN-IN PHASE: Subject will start a run-in phase in an out of hospital setting, as per standard practice of the site. The objective of the run-in phase is to train the subjects on the MiniMed™ 780G insulin pump, assess subjects' compliance and ability to comprehend the study procedures and tolerance of wearing the sensor and transmitter continuously. It is expected that during the run-in phase the MiniMed™ 780G insulin pump will be set in Manual mode and all the algorithms are switched off, and baseline Continuous Glucose Monitoring (CGM) data will be collected. The expected duration of the run-in phase is approximately 2 weeks. At the end of the run-in phase the MiniMed™ 780G insulin pump will be set in Auto Mode and the date of activation will be collected and identified as a start of the study phase. Data from the MiniMed™ 780G insulin pump will be uploaded in the CareLink™ as per standard practice, before Auto Mode activation. 2. 6 AND 12 MONTHS FOLLOW UP: Follow-up visits will be performed according to the therapy management standard of care at 6 and 12 months after Auto Mode activation in the study. Approximately 300 patients (children and adults) will be enrollment in the study in approximately 32 sites in France.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MiniMed™ 780G System	Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care.

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-05-19
• Completion: 2022-10-27
• First posted: 2020-03-16
• Last updated: 2024-07-08
• Results posted: 2024-07-08

Locations

32 sites across 1 country: France

Regulatory

• FDA-regulated device study