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
  Purpose

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.


Condition Intervention
TYPE 2 DIABETES
Device: placebo
Device: IVS
Device: PDAphone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: December 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937703

Locations
France
CH Aix en Provence
Aix en Provence, France, 13100
Centre Hospitalier Intercommunal Alençon-Mamers
Alençon, France, 61000
CH Avignon
Avignon, France, 84000
Centre Hospitalier de Belfort Montbéliard
Belfort, France, 90016
CHU Jean Minjoz
Besancon, France, 25030
CHU de Caen
Caen, France, 14000
Hôpital Gabriel Montpied
Clermont Ferrand, France, 63011
CH sud francilien
Corbeil Essonnes, France, 91106
CH de Dreux
Dreux, France, 28100
CHU Pierre Zobda-Quitman
Fort de France, France, 97261
University Hospital Grenoble
Grenoble, France, 38043
CHU de Bicêtre
Kremlin Bicêtre, France, 94270
CH La Rochelle
La Rochelle, France, 17000
CHU Marseille-Hôpital Nord
Marseille, France, 13000
CHU Marseille Hôpitaux Sud
Marseille, France, 13274
CH de l'Agglomération Montargoise
Montagis, France, 45207
CHU Hôpital Jeanne d'Arc
Nancy, France, 54201
CH Nanterre
Nanterre, France, 92000
CHU Nantes
Nantes, France, 44093
CHU de Nimes
Nimes, France, 30029
Hopital COCHIN
Paris, France, 75014
Hopital Haut Leveque
Pessac, France, 33604
CHU de Poitiers
Poitiers, France, 86000
CHU Rennes
Rennes, France, 35056
CHU de Saint Etienne
Saint Etienne, France, 42023
Hôpital Bégin
Saint Mandé, France, 94160
Centre Hospitalier Strasbourg
Strasbourg, France, 67000
Ch Valenciennes
Valenciennes, France, 59322
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Novo Nordisk A/S
Investigators
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
  More Information

No publications provided

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT00937703     History of Changes
Other Study ID Numbers: 2008-A00270-55
Study First Received: July 10, 2009
Last Updated: December 12, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014