Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia (ALPPHY)

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Diabetes, Type 1

Treatments

Device: Minimed 640G with smartguard off

Device: Minimed 640G with smartguard activated

Study type

Interventional

Funder types

Other

Identifiers

NCT02657213

38RC15.110

Details and patient eligibility

About

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia.

The study should show:

A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline.
A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 or insulin-dependent diabetic patients
Patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment
Affiliation to the french social security system or equivalent
People who signed the consent form

Exclusion criteria

Patient who have difficulty to understand the French language
Patient can not be raised to the use of an insulin pump, or a glucose sensor
Patient visually impaired
Patient hard of hearing
Pregnant woman or woman having a project of pregnancy within 6 months
Persons referred to in Articles L1121-5 to L1121-8 CSP: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.