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| Name | Class |
|---|---|
| Roche Diabetes Care | INDUSTRY |
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This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.
Outcome of both studies (RD001732 and RD001231) will be integrated and additionally reported as PDM-ProValue study program (Integrated Personalized Diabetes Management) due to the high similarity in study characteristics, design and study results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Patients treated by usual customary medical practice (Usual Care) |
|
| Intervention Group | Other | Patients treated with "Integrated Personalized Diabetes Management" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek Smart Pix Software | Device | Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean HbA1c change by Generalized Estimating Equations (GEE) methods | from Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Vesper | Roche Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albstadt | 72461 | Germany | ||||
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| Accu-Chek Smart Pix readout Device | Device | Smartpix device for data upload out from blood glucose meter devices |
|
| Auerbach/Vogtland |
| 08209 |
| Germany |
| Bad Kreuznach | 55545 | Germany |
| Beucha | 04824 | Germany |
| Beutel/Templin | 17268 | Germany |
| Blankenhain | 99444 | Germany |
| Bochum | 44805 | Germany |
| Bockenem | 31167 | Germany |
| Borna | 04552 | Germany |
| Bremerhaven | 27572 | Germany |
| Cloppenburg | 49661 | Germany |
| Dransfeld | 37127 | Germany |
| Dresden | 01309 | Germany |
| Düren | 52349 | Germany |
| Elsterwerda | 04910 | Germany |
| Essen | 45329 | Germany |
| Essen | 45355 | Germany |
| Essen | 45359 | Germany |
| Föhren | 54343 | Germany |
| Geringswalde | 09326 | Germany |
| Giessen | 35390 | Germany |
| Hanover | 30163 | Germany |
| Hemsbach | 69502 | Germany |
| Herborn | 35745 | Germany |
| Kerpen | 50169 | Germany |
| Köthen | 06366 | Germany |
| Krefeld | 47803 | Germany |
| Kreuzau | 52372 | Germany |
| Leipzig | 04315 | Germany |
| Löhne | 32584 | Germany |
| Lübeck | 23562 | Germany |
| Mainz | 55116 | Germany |
| Mainz | 55130 | Germany |
| Meissen | 01662 | Germany |
| Meudt | 56414 | Germany |
| Papenburg | 26871 | Germany |
| Reinfeld | 23858 | Germany |
| Riesa | 01589 | Germany |
| Rochlitz | 09328 | Germany |
| Rodgau | 63110 | Germany |
| Schleiden | 53937 | Germany |
| Schwedt | 16303 | Germany |
| Schweich | 54338 | Germany |
| Schweich | 54343 | Germany |
| Siegen | 57072 | Germany |
| Sigmaringen | 72488 | Germany |
| Staufenberg | 35460 | Germany |
| Trier | 54290 | Germany |
| Weida | 07570 | Germany |
| Wetzlar | 35584 | Germany |
| 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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