Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients

Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

Secondary Objectives :

1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system
2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system
3. Satisfaction of patients and physicians towards the PDA-FIT system

Inclusion Criteria:

• type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
• age > 18 y.o.
• intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
• chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion

Exclusion Criteria:

• patient with unstable associated evolutive pathology
• patient who need a more frequent diabetic follow up (than in the protocol)
• patient with a education teaching within the 3 months before inclusion
• patient with a hemoglobinopathy
• patient with toxicomania, alcoholism or psychological troubles
• type 2 diabetes patients
• patient who don't need strict metabolic objectives
• pregnant or parturient women
• person with no freedom (prisoner)