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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1: Control group | Placebo Comparator | face to face visit à T4mounths |
|
| Group2: IVS Group | Active Comparator | face to face visit at T4mounths plus telephone visits each 2 weeks |
|
| Group3: PDAphone group | Active Comparator | PDA system face to face visit at T4mounths plus telephone visits each 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Device | paper support for glycaemia face to face visit at T4mounths |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group. | To T4 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Aix en Provence | Aix-en-Provence | 13100 | France | |||
| Centre Hospitalier Intercommunal Alençon-Mamers |
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| IVS |
| Device |
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 | Device | Patients will receive PDA phone system. They will hace face to face visit at T4mounths and telephone visits each 2 weeks |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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