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

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Device: VISITS + PDA-FIT system; Device: placebo; Device: PDA-FIT System + telephone follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT00629304

DCIC 07 08

Details and patient eligibility

About

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

Full description

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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

standard visit at 3 and 6 months

Treatment:

Device: placebo

2

Active Comparator group

Description:

PDA-FIT system + standard visit at 3 and 6 months

Treatment:

Device: VISITS + PDA-FIT system

3

Active Comparator group

Description:

PDA-FIT system + 12 telephone visits + standard visit at 6 months

Treatment:

Device: PDA-FIT System + telephone follow-up