Clinical trial NCT00937703: Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin
Official title: Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TYPE 2 DIABETES
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2009-07-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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-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.

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-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).

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.
timeFrame: To T4 months
Secondary outcomes:
measure: Comparison of absolute HbA1c difference
timeFrame: T0-T4 months
measure: Comparison of evolution of HbA1c
timeFrame: T0 and T4 months
measure: Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months
timeFrame: T0 and T4 months
measure: Comparison of percentage of patients within the objective glycemic (the last 3 days Jeun Glycemia average with between 0.73 and 1.08 g/l) at the end of the study, and the average time allowing to achieve this goal
timeFrame: T0 and T4 months
measure: Comparison of the average jeun glycemia the 14 days previous the visit in 4 months
timeFrame: T4 months
measure: Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study
timeFrame: study period
measure: Comparison of the evolution of the weight
timeFrame: T0 and T4 months
measure: Comparison of evolution of the quality of life at the beginning and at the end of the study (the scale of quality of life DHP as well as the items of dimension Satisfaction of the DQOL)
timeFrame: T0 and T4 months
measure: Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);
timeFrame: study period
measure: Comparison of the satisfaction of the patients and physicians with the system and willingness to carry on the use of the system in routine care
timeFrame: 4 months
measure: Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician
timeFrame: 4 months
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: CH Aix en Provence
city: Alençon
country: France
facility: Centre Hospitalier Intercommunal Alençon-Mamers
city: Avignon
country: France
facility: CH Avignon
city: Belfort
country: France
facility: Centre Hospitalier de Belfort Montbéliard
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Caen
country: France
facility: CHU de Caen
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Corbeil Essonnes
country: France
facility: CH sud francilien
city: Dreux
country: France
facility: CH de Dreux
city: Fort de France
country: France
facility: CHU Pierre Zobda-Quitman
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Kremlin Bicêtre
country: France
facility: CHU de Bicêtre
city: La Rochelle
country: France
facility: CH La Rochelle
city: Marseille
country: France
facility: CHU Marseille-Hôpital Nord
city: Marseille
country: France
facility: CHU Marseille Hôpitaux Sud
city: Montagis
country: France
facility: CH de l'Agglomération Montargoise
city: Nancy
country: France
facility: CHU Hôpital Jeanne d'Arc
city: Nanterre
country: France
facility: CH Nanterre
city: Nantes
country: France
facility: CHU Nantes
city: Nimes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hopital COCHIN
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
city: Saint Mandé
country: France
facility: Hôpital Bégin
city: Strasbourg
country: France
facility: Centre Hospitalier Strasbourg
city: Valenciennes
country: France
facility: Ch Valenciennes
Study officials:
affiliation: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
name: Guillaume CHARPENTIER, MD
role: STUDY_CHAIR
affiliation: University Hospital, Grenoble
name: Pierre Yves BENHAMOU, MD PHD
role: STUDY_CHAIR
References: