PDM-ProValueGP: A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control Group Patients treated by usual customary medical practice (Usual Care) |
Device: Accu-Chek Smart Pix readout Device
Smartpix device for data upload out from blood glucose meter devices
|
| Other: Intervention Group Patients treated with "Integrated Personalized Diabetes Management" |
Device: Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
|
Outcome Measures
Primary Outcome Measures
- The mean HbA1c change by Generalized Estimating Equations (GEE) methods [from Baseline to 12 months]
Secondary Outcome Measures
- Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Existence of a signed Informed Consent form (before any study procedure)
-
Diagnosed Type 2 diabetes mellitus
-
Age =18 years
-
Insulin therapy for =6 months: BOT, SIT, CT or ICT
-
HbA1c =7.5% within the last 6 weeks before study visit 1 (patient's inclusion)
-
Longer-term diabetes care by the trial site (at least for the duration of the 12-month study participation)
-
General practitioner is the primary practitioner in the diabetes care of the patient
-
Insured by the statutory health insurance (GKV) as a statutory or voluntarily insured member or as a family co-insured member
-
Willing and able to participate in the study and to follow the study procedures, among other things sufficient command of the German language, spoken and written
Exclusion Criteria:
-
Diabetes treatment by insulin pump therapy (CSII)
-
Experience with the use of special software for systematic processing of SMBG data, e.g. the Accu-Chek® Smart Pix System/Software, the Accu-Chek® 360° Software and/or the Diabetes Software DIABASS
-
Presence of terminal renal failure / dialysis and/or a loss of sight or a tumor illness
-
Chronic use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy
-
Known alcohol, drug and medication abuse
-
Known metabolic disorders and/or disorders or therapies that could lead to or have led to wrong measured results (e.g. with the blood glucose measurement)
-
Existing pregnancy, breast-feeding or plan to become pregnant during study participation
-
Physical illness and/or psychological disorder with the result that the patient cannot implement the medical treatment recommendations independently
-
Dependency relationship to the sponsor or to the investigator, e.g. as a professional colleague or family member
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albstadt | Germany | 72461 | ||
| 2 | Auerbach/Vogtland | Germany | 08209 | ||
| 3 | Bad Kreuznach | Germany | 55545 | ||
| 4 | Beucha | Germany | 04824 | ||
| 5 | Beutel/Templin | Germany | 17268 | ||
| 6 | Blankenhain | Germany | 99444 | ||
| 7 | Bochum | Germany | 44805 | ||
| 8 | Bockenem | Germany | 31167 | ||
| 9 | Borna | Germany | 04552 | ||
| 10 | Bremerhaven | Germany | 27572 | ||
| 11 | Cloppenburg | Germany | 49661 | ||
| 12 | Dransfeld | Germany | 37127 | ||
| 13 | Dresden | Germany | 01309 | ||
| 14 | Düren | Germany | 52349 | ||
| 15 | Elsterwerda | Germany | 04910 | ||
| 16 | Essen | Germany | 45329 | ||
| 17 | Essen | Germany | 45355 | ||
| 18 | Essen | Germany | 45359 | ||
| 19 | Föhren | Germany | 54343 | ||
| 20 | Geringswalde | Germany | 09326 | ||
| 21 | Giessen | Germany | 35390 | ||
| 22 | Hannover | Germany | 30163 | ||
| 23 | Hemsbach | Germany | 69502 | ||
| 24 | Herborn | Germany | 35745 | ||
| 25 | Kerpen | Germany | 50169 | ||
| 26 | Krefeld | Germany | 47803 | ||
| 27 | Kreuzau | Germany | 52372 | ||
| 28 | Köthen | Germany | 06366 | ||
| 29 | Leipzig | Germany | 04315 | ||
| 30 | Loehne | Germany | 32584 | ||
| 31 | Lübeck | Germany | 23562 | ||
| 32 | Mainz | Germany | 55116 | ||
| 33 | Mainz | Germany | 55130 | ||
| 34 | Meissen | Germany | 01662 | ||
| 35 | Meudt | Germany | 56414 | ||
| 36 | Papenburg | Germany | 26871 | ||
| 37 | Reinfeld | Germany | 23858 | ||
| 38 | Riesa | Germany | 01589 | ||
| 39 | Rochlitz | Germany | 09328 | ||
| 40 | Rodgau | Germany | 63110 | ||
| 41 | Schleiden | Germany | 53937 | ||
| 42 | Schwedt | Germany | 16303 | ||
| 43 | Schweich | Germany | 54338 | ||
| 44 | Schweich | Germany | 54343 | ||
| 45 | Siegen | Germany | 57072 | ||
| 46 | Sigmaringen | Germany | 72488 | ||
| 47 | Staufenberg | Germany | 35460 | ||
| 48 | Trier | Germany | 54290 | ||
| 49 | Weida | Germany | 07570 | ||
| 50 | Wetzlar | Germany | 35584 |
Sponsors and Collaborators
- Hoffmann-La Roche
- Roche Diabetes Care Deutschland GmbH
Investigators
- Study Director: Iris Vesper, Roche Diabetes Care Deutschland GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD001231