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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)

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT00937703
First received: July 10, 2009
Last updated: December 12, 2013
Last verified: March 2010

July 10, 2009
December 12, 2013
December 2008
May 2013   (final data collection date for primary outcome measure)
Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group. [ Time Frame: To T4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00937703 on ClinicalTrials.gov Archive Site
  • Comparison of absolute HbA1c difference [ Time Frame: T0-T4 months ] [ Designated as safety issue: No ]
  • Comparison of evolution of HbA1c [ Time Frame: T0 and T4 months ] [ Designated as safety issue: No ]
  • Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months [ Time Frame: T0 and T4 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: T0 and T4 months ] [ Designated as safety issue: No ]
  • Comparison of the average jeun glycemia the 14 days previous the visit in 4 months [ Time Frame: T4 months ] [ Designated as safety issue: No ]
  • Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study [ Time Frame: study period ] [ Designated as safety issue: Yes ]
  • Comparison of the evolution of the weight [ Time Frame: T0 and T4 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: T0 and T4 months ] [ Designated as safety issue: No ]
  • Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit); [ Time Frame: study period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin
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.

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).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
TYPE 2 DIABETES
  • Device: placebo
    paper support for glycaemia face to face visit at T4mounths
  • 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.

  • Device: PDAphone
    Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks
  • Placebo Comparator: Group1: Control group
    face to face visit à T4mounths
    Intervention: Device: placebo
  • Active Comparator: Group2: IVS Group
    face to face visit at T4mounths plus telephone visits each 2 weeks
    Intervention: Device: IVS
  • Active Comparator: Group3: PDAphone group
    PDA system face to face visit at T4mounths plus telephone visits each 2 weeks
    Intervention: Device: PDAphone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00937703
2008-A00270-55
No
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Novo Nordisk A/S
Study Chair: Guillaume CHARPENTIER, MD Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Study Chair: Pierre Yves BENHAMOU, MD PHD University Hospital, Grenoble
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP