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)

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

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.

Study Overview

• Status: Completed
• Conditions: TYPE 2 DIABETES
• Intervention / Treatment: Device: placebo; Device: IVS; Device: PDAphone

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).

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13100
    • CH Aix en Provence
  • Alençon, France, 61000
    • Centre Hospitalier Intercommunal Alençon-Mamers
  • Avignon, France, 84000
    • Ch Avignon
  • Belfort, France, 90016
    • Centre Hospitalier de Belfort Montbéliard
  • Besancon, France, 25030
    • CHU Jean Minjoz
  • Caen, France, 14000
    • CHU de Caen
  • Clermont Ferrand, France, 63011
    • Hôpital Gabriel Montpied
  • Corbeil Essonnes, France, 91106
    • CH Sud Francilien
  • Dreux, France, 28100
    • CH de Dreux
  • Fort de France, France, 97261
    • CHU Pierre Zobda-Quitman
  • Grenoble, France, 38043
    • University Hospital Grenoble
  • Kremlin Bicêtre, France, 94270
    • CHU de Bicetre
  • La Rochelle, France, 17000
    • CH La Rochelle
  • Marseille, France, 13274
    • CHU Marseille Hôpitaux Sud
  • Marseille, France, 13000
    • CHU Marseille-Hôpital Nord
  • Montagis, France, 45207
    • CH de l'Agglomération Montargoise
  • Nancy, France, 54201
    • CHU Hôpital Jeanne d'Arc
  • Nanterre, France, 92000
    • CH Nanterre
  • Nantes, France, 44093
    • CHU Nantes
  • Nimes, France, 30029
    • CHU de Nîmes
  • Paris, France, 75014
    • Hôpital Cochin
  • Pessac, France, 33604
    • Hôpital Haut Levêque
  • Poitiers, France, 86000
    • CHU de Poitiers
  • Rennes, France, 35056
    • CHU Rennes
  • Saint Etienne, France, 42023
    • Chu de Saint Etienne
  • Saint Mandé, France, 94160
    • Hopital Bégin
  • Strasbourg, France, 67000
    • Centre Hospitalier Strasbourg
  • Valenciennes, France, 59322
    • Ch Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group1: Control group; face to face visit à T4mounths	Device: placebo; paper support for glycaemia face to face visit at T4mounths
Active Comparator: Group2: IVS Group; face to face visit at T4mounths plus telephone visits each 2 weeks	Device: 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.
Active Comparator: Group3: PDAphone group; PDA system face to face visit at T4mounths plus telephone visits each 2 weeks	Device: PDAphone; Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.	To T4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of absolute HbA1c difference	T0-T4 months
Comparison of evolution of HbA1c	T0 and T4 months
Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months	T0 and T4 months
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
Comparison of the average jeun glycemia the 14 days previous the visit in 4 months	T4 months
Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study	study period
Comparison of the evolution of the weight	T0 and T4 months
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
Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);	study period
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
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

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Collaborators: Novo Nordisk A/S
• Investigators: Study Chair: Pierre Yves BENHAMOU, MD PHD, University Hospital, Grenoble; Study Chair: Guillaume CHARPENTIER, MD, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 2008-A00270-55