Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study
Phase 3
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT00324584
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.
- Detailed Description
We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Type 1 diabetes mellitus
- Age ≥ 18
- HbA1c between 7.5 and 10%
- Treated with continuous subcutaneous insulin infusion for a minimum of 3 months
Exclusion Criteria
- Unstabilized diabetic microangiopathy
- Ongoing pregnancy or planned pregnancy
- Unwilling to perform a minimum of 4 capillary blood tests per day
- Unable to use the GlucoNet device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Glycated hemoglobin HbA1c monthly mean capillary blood glucose value blood glucose variability index (MAGE Index and LBGI index) quality of life score (DQOL score) frequency of hypoglycemic episodes (<70 mg/dl)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital, Department of Endocrinology
🇫🇷Toulouse, France