Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche Diabetes Care | INDUSTRY |
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Patients treated by usual customary medical practice (Usual Care) in the out-patient facility i.e. Diabetes specialized medical practice, Medical Care Center or hospital outpatient clinic. |
|
| Intervention group | Other | Patients are treated according to the concept "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 means of Generalized Estimating Equations (GEE) methods | The difference in the HbA1c change after 12 months between the Intervention group and the Control group is analyzed by means of generalized estimating equations (Generalized Estimating Equations [GEE]) methods (population averaged model) and here, robust assessors (so-called sandwich assessors) for the standard errors are provided. The dependent variable is the HbA1c change after 12 months, while the HbA1c baseline considers the gender and the age as factors of influence (covariates) in the GEE model. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iris Vesper | Roche Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Altenstadt | 63674 | Germany | |||
| Internistische Gemeinschaftspraxis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Accu-Chek Smart Pix readout Device | Device | Smartpix device for data upload out of blood glucose meter devices |
|
| Augsburg |
| 86179 |
| Germany |
| Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM) | Bad Mergentheim | 97980 | Germany |
| Private Practice | Bad Säckingen | 79713 | Germany |
| Private Practice | Berlin | 01627 | Germany |
| MVZ am Bahnhof Spandau | Berlin | 13597 | Germany |
| Gemeinschaftspraxis | Bitburg | 54634 | Germany |
| Private Practice | Buxtehude | 21614 | Germany |
| Praxis Kugler | Cologne | 50858 | Germany |
| Private Practice | Cuxhaven | 27474 | Germany |
| Diabetologicum Dresden | Dresden | 01219 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Gemeinschaftspraxis Schaden | Düsseldorf | 40212 | Germany |
| Private Practice | Essen | 45329 | Germany |
| Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin | Falkensee | 14612 | Germany |
| Private Practice | Frankfurt am Main | 60326 | Germany |
| Gemeinschaftspraxis | Fulda | 36039 | Germany |
| Private Practice | Gelnhausen | 63571 | Germany |
| Hausärztliche internistische Gemeinschaftspraxis Giessen | Giessen | 35390 | Germany |
| Diabetes- und Gesundheitszentrum Göttingen | Göttingen | 37073 | Germany |
| Private Practice | Gummersbach | 51645 | Germany |
| Private Practice | Hamburg | 21109 | Germany |
| Diabeteszentrum | Hamburg | 22119 | Germany |
| Private Practice | Hanau | 63450 | Germany |
| Integriertes Diabetiker-Zentrum Hannover | Hanover | 30159 | Germany |
| Gemeinschaftspraxis | Herne | 44653 | Germany |
| Gemeinschaftspraxis im Altstadt-Carree | Hessen | 36037 | Germany |
| Private Practice | Immenhausen | 34376 | Germany |
| Universitätsklinikum Jena, Klinik für Innere Medizin III | Jena | 07743 | Germany |
| Diabeteszentrum Kassel | Kassel | 34117 | Germany |
| Internistische Praxis Lampertheim | Lampertheim | 68623 | Germany |
| Private Practice | Lauf (Pegnitz) | 91207 | Germany |
| Private Practice | Laupheim | 88471 | Germany |
| Private Practice | Lingen | 49808 | Germany |
| Diabetes-Zentrum Neustadt | Neustadt am Rübenberge | 31535 | Germany |
| Diabetologische Schwerpunktpraxis | Nordrhein-Westfalen | 46537 | Germany |
| Private Practice | Offenbach | 63065 | Germany |
| Diabetes Praxis Oranienburg | Oranienburg | 16515 | Germany |
| Arztpraxis fur Allg-Med | Pirna | 01796 | Germany |
| Private Practice | Porta Westfalica | 32457 | Germany |
| Private Practice | Rehburg-Loccum | 31547 | Germany |
| Gemeinschaftspraxis | Rhaunen | 55624 | Germany |
| Pivate Practice | Rüsselsheim am Main | 65428 | Germany |
| Ambulanzzentrum Schweinfurt | Schweinfurt | 97421 | Germany |
| Versdias Gmbh | Sulzbach-Rosenberg | 92237 | Germany |
| Private Practice | Trier | 54292 | Germany |
| Gemeinschaftspraxis am Bärenplatz | Villingen-Schwenningen | 78054 | Germany |
| Diabetolog. Schwerpunktpraxis | Wiesbaden | 65183 | Germany |
| Internistische Praxis | Zierenberg | 34289 | Germany |
| Arztpraxis Zossen / Dabendorf | Zossen | 15806 | Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided