Status:
COMPLETED
Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin
Lead Sponsor:
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
TYPE 2 DIABETES
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-mak...
Detailed 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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00937703
Start Date
December 1 2008
End Date
May 1 2013
Last Update
December 13 2013
Active Locations (28)
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1
CH Aix en Provence
Aix-en-Provence, France, 13100
2
Centre Hospitalier Intercommunal Alençon-Mamers
Alençon, France, 61000
3
CH Avignon
Avignon, France, 84000
4
Centre Hospitalier de Belfort Montbéliard
Belfort, France, 90016