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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
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TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months
Secondary Objectives :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | standard visit at 3 and 6 months |
|
| 2 | Active Comparator | PDA-FIT system + standard visit at 3 and 6 months |
|
| 3 | Active Comparator | PDA-FIT system + 12 telephone visits + standard visit at 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Device | Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of HbA1c mean between the 3 groups | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute HbA1c differences (M0-M6) | inclusion and M6 | |
| HbA1c changes at M0, M3 and M6 | inclusion, M3 and M6 | |
| Percentage of patients reaching HbA1c <7.5% at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Yves BENHAMOU, MD PHD | University Hospital, Grenoble | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Belfort Montbéliard | Belfort | Belfort | 90016 | France | ||
| CHU Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21266648 | Derived | Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25. |
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| VISITS + PDA-FIT system | Device | patients will have face to face visits at 3 and 6 months + PDA-FIT system |
|
|
| PDA-FIT System + telephone follow-up | Device | patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months |
|
|
| 6 months |
| Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit | 14 days prior to inclusion and prior to M6 |
| Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period | study period |
| Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit | week before inclusion and prior to M6 |
| 8-point blood glucose profiles at inclusion and 6 months | inclusion and M6 |
| Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire | inclusion and M6 |
| Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory | study period |
| Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time | study period |
| Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care | 6 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 | 6 months |
| Besançon |
| Besancon |
| 25030 |
| France |
| CH SUD Francilien | Corbeil-Essonnes | Corbeil Essonnes | 91100 | France |
| University Hospital Grenoble | Grenoble | Grenoble | 38043 | France |
| CHRU Lille | Lille | Lille | 59037 | France |
| Hopital Edouard Herriot | Lyon | Lyon | 69003 | France |
| CHU Marseille Hôpitaux Sud | Marseille | Marseille | 13274 | France |
| Chu Montpellier | Montpellier | Montpellier | 34295 | France |
| CHU Hôpital Jeanne d'Arc | Nancy | Nancy | 54201 | France |
| CHU Nantes | Nantes | Nantes | 44093 | France |
| Hopital Hotel Dieu | Paris | Paris | 75004 | France |
| Hopital COCHIN | Paris | Paris | 75014 | France |
| HOPITAL Saint Louis | Paris | Paris | 75475 | France |
| Hopital Haut Leveque | Pessac | Pessac | 33604 | France |
| CHU Rennes | Rennes | Rennes | 35056 | France |
| Hopital Bellevue | Saint-Etienne | Saint Etienne | 42055 | France |
| Centre Hospitalier Strasbourg | Strasbourg | Strasbourg | 67000 | France |
| CHU Toulouse | Toulouse | Toulouse | 31403 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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