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
1 other identifier
interventional
180
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Dec 2008
Longer than P75 for not_applicable type-2-diabetes
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedDecember 13, 2013
March 1, 2010
4.4 years
July 10, 2009
December 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.
To T4 months
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (3)
Group1: Control group
PLACEBO COMPARATORface to face visit à T4mounths
Group2: IVS Group
ACTIVE COMPARATORface to face visit at T4mounths plus telephone visits each 2 weeks
Group3: PDAphone group
ACTIVE COMPARATORPDA system face to face visit at T4mounths plus telephone visits each 2 weeks
Interventions
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.
Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks
Eligibility Criteria
You may qualify if:
- 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);
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
CH Aix en Provence
Aix-en-Provence, 13100, France
Centre Hospitalier Intercommunal Alençon-Mamers
Alençon, 61000, France
CH Avignon
Avignon, 84000, France
Centre Hospitalier de Belfort Montbéliard
Belfort, 90016, France
CHU Jean Minjoz
Besançon, 25030, France
CHU de Caen
Caen, 14000, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63011, France
CH sud francilien
Corbeil-Essonnes, 91106, France
CH de Dreux
Dreux, 28100, France
CHU Pierre Zobda-Quitman
Fort de France, 97261, France
University Hospital Grenoble
Grenoble, 38043, France
CH La Rochelle
La Rochelle, 17000, France
CHU de Bicêtre
Le Kremlin-Bicêtre, 94270, France
CHU Marseille-Hôpital Nord
Marseille, 13000, France
CHU Marseille Hôpitaux Sud
Marseille, 13274, France
CH de l'Agglomération Montargoise
Montagis, 45207, France
CHU Hôpital Jeanne d'Arc
Nancy, 54201, France
CH Nanterre
Nanterre, 92000, France
CHU Nantes
Nantes, 44093, France
CHU de Nimes
Nîmes, 30029, France
Hopital COCHIN
Paris, 75014, France
Hopital Haut Leveque
Pessac, 33604, France
CHU de Poitiers
Poitiers, 86000, France
CHU Rennes
Rennes, 35056, France
CHU de Saint Etienne
Saint-Etienne, 42023, France
Hôpital Bégin
Saint-Mandé, 94160, France
Centre Hospitalier Strasbourg
Strasbourg, 67000, France
Ch Valenciennes
Valenciennes, 59322, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
December 1, 2008
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
December 13, 2013
Record last verified: 2010-03