Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump

Not Applicable

Terminated

• Conditions: Type I Diabetes
• Interventions: Device: MiniMed™ 640G; Device: Captor CGM Enlite®; Device: SmartGuard®

• Registration Number: NCT03653533
• Lead Sponsor: ARAIR Assistance

Brief Summary

This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.

Detailed Description

The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.

There are several phases:

* phase 1: insulin pump without captor (12 weeks)

* phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks)

* phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks)

* phase 4: insulin pump without captor (4 weeks)

Study Timeline

• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Study Start: 2019-01-07
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• type I diabetic patients undr basal/prandial diet
• treated by insuline
• with no insuline pump during at least 3 months
• with HbA1C dosed during the 3 months before inclusion

Exclusion Criteria

• minor patients
• pregnant woman
• already participating to another studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MiniMed™ 640G + Captor CGM Enlite®	Captor CGM Enlite®	insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
MiniMed™ 640G + Captor + SmartGuard®	Captor CGM Enlite®	insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
MiniMed™ 640G + Captor CGM Enlite®	MiniMed™ 640G	insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
MiniMed™ 640G + Captor + SmartGuard®	SmartGuard®	insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
MiniMed™ 640G alone	MiniMed™ 640G	MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
MiniMed™ 640G + Captor + SmartGuard®	MiniMed™ 640G	insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.

Primary Outcome Measures

Name	Time	Method
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function	6 days	The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function

Trial Locations

Locations (1)

Pole Sante Sud Le Mans; 🇫🇷 Le Mans, France