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

TYPE 2 DIABETES Clinical Trial

— TELEDIAB-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937703
• Other study ID #: 2008-A00270-55
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: December 12, 2013
• Start date: December 2008
• Est. completion date: May 2013

Study information

• Verified date: March 2010
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• TYPE 2 DIABETES

Intervention

Device:
• placebo
paper support for glycaemia face to face visit at T4mounths
• IVS
patients transmit their glycaemia to the IVS, which advises them the insulin amount recommended by their physician in this situation. Face to face visit at T4mounths plus telephone visits each 2 weeks.
• PDAphone
Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks

Locations

Country	Name	City	State
France	CH Aix en Provence	Aix en Provence
France	Centre Hospitalier Intercommunal Alençon-Mamers	Alençon
France	CH Avignon	Avignon
France	Centre Hospitalier de Belfort Montbéliard	Belfort
France	CHU Jean Minjoz	Besancon
France	CHU de Caen	Caen
France	Hôpital Gabriel Montpied	Clermont Ferrand
France	CH sud francilien	Corbeil Essonnes
France	CH de Dreux	Dreux
France	CHU Pierre Zobda-Quitman	Fort de France
France	University Hospital Grenoble	Grenoble
France	CHU de Bicêtre	Kremlin Bicêtre
France	CH La Rochelle	La Rochelle
France	CHU Marseille Hôpitaux Sud	Marseille
France	CHU Marseille-Hôpital Nord	Marseille
France	CH de l'Agglomération Montargoise	Montagis
France	CHU Hôpital Jeanne d'Arc	Nancy
France	CH Nanterre	Nanterre
France	CHU Nantes	Nantes
France	CHU de Nimes	Nimes
France	Hopital COCHIN	Paris
France	Hopital Haut Leveque	Pessac
France	CHU de Poitiers	Poitiers
France	CHU Rennes	Rennes
France	CHU de Saint Etienne	Saint Etienne
France	Hôpital Bégin	Saint Mandé
France	Centre Hospitalier Strasbourg	Strasbourg
France	Ch Valenciennes	Valenciennes

Sponsors (2)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète	Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.		To T4 months	No
Secondary	Comparison of absolute HbA1c difference		T0-T4 months	No
Secondary	Comparison of evolution of HbA1c		T0 and T4 months	No
Secondary	Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months		T0 and T4 months	No
Secondary	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		T0 and T4 months	No
Secondary	Comparison of the average jeun glycemia the 14 days previous the visit in 4 months		T4 months	No
Secondary	Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study		study period	Yes
Secondary	Comparison of the evolution of the weight		T0 and T4 months	No
Secondary	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)		T0 and T4 months	No
Secondary	Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);		study period	No
Secondary	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		4 months	No
Secondary	Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician		4 months	No