Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin (TELEDIAB-2)

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

Status: Completed

Conditions: TYPE 2 DIABETES

Treatments: Device: PDAphone; Device: placebo; Device: IVS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00937703

2008-A00270-55

Details and patient eligibility

About

TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

Full description

Secondary objectives :

1. • To compare the 2 methods of telemonitoring employed.
2. • To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.
3. • To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes since more than 3 years and claiming a strict balance glycemic;
• Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);
• Patients uncontrolled with HbA1c ≥ 7.5% and < 10% at the inclusion.
• BMI < 40 ;
• Patients requiring a insulin treatment
• Patients agree to start a slow insulin treatment
• Patients already practising the glycemic self-monitoring or agree to learn it and practise it;
• Patients able to include/understand operation and to use the PDA-phone and/or the SVI;
• Patient not taking part in another biomedical research study
• Patients agree to carry out at least 2 finger sticks per day;
• More than 18 years, there is no higher age limit.

Exclusion criteria

• Patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come;
• Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study
• Patients requiring a transitory passage to insulin;
• Patients needing a hospitalization for the adaptation of insulin doses;
• Patients presenting a cardiologic event
• Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;
• Patients suffering from drug-addiction, alcoholism or psychological troubles
• Type 1 or secondary diabetes
• Patients who don't need strict metabolic objectives;
• Pregnant or parturient patients
• person with no freedom.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups, including a placebo group

Group1: Control group

Placebo Comparator group

Description:

face to face visit à T4mounths

Treatment:

Device: placebo

Group2: IVS Group

Active Comparator group

Description:

face to face visit at T4mounths plus telephone visits each 2 weeks

Treatment:

Device: IVS

Group3: PDAphone group

Active Comparator group

Description:

PDA system face to face visit at T4mounths plus telephone visits each 2 weeks

Treatment:

Device: PDAphone