Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes mellitus, telecare, telemedicine, insulin pump therapy
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.
Interventions
DEVICETelemonitoring of glucose values using GlucoNet device
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
France
Outcome results
None listed