Trials / Completed
CompletedNCT02156349
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
Integrated Personalized Diabetes Management (Integrated PDM): Prospective, Randomized, Controlled Intervention Study for the Evaluation of the Effectiveness and the Benefit of Integrated PDM in the Care of People With Type 2 Diabetes in Diabetes Specialized Medical Practices in Germany (DSP)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 558 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Accu-Chek Smart Pix Software | Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM) |
| DEVICE | Accu-Chek Smart Pix readout Device | Smartpix device for data upload out of blood glucose meter devices |
Timeline
- Start date
- 2014-05-14
- Primary completion
- 2017-04-10
- Completion
- 2017-04-10
- First posted
- 2014-06-05
- Last updated
- 2017-11-14
Locations
50 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02156349. Inclusion in this directory is not an endorsement.