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

ARAIR Assistance

Status: Terminated

Conditions: Type I Diabetes

Treatments: Device: Captor CGM Enlite®; Device: MiniMed™ 640G; Device: SmartGuard®

Study type: Interventional

Funder types: Other

Identifiers

NCT03653533

2017-A01988-45

Details and patient eligibility

About

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.

Full 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)

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

8 participants in 3 patient groups

MiniMed™ 640G alone

Other group

Description:

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.

Treatment:

Device: MiniMed™ 640G

MiniMed™ 640G + Captor CGM Enlite®

Other group

Description:

insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.

Treatment:

Device: MiniMed™ 640G

Device: Captor CGM Enlite®

MiniMed™ 640G + Captor + SmartGuard®

Other group

Description:

insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.

Treatment:

Device: SmartGuard®

Device: MiniMed™ 640G

Device: Captor CGM Enlite®