A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients. (PDMProValueDSP)
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|ClinicalTrials.gov Identifier: NCT02156349|
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes Mellitus||Device: Accu-Chek Smart Pix Software Device: Accu-Chek Smart Pix readout Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||558 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||May 14, 2014|
|Actual Primary Completion Date :||April 10, 2017|
|Actual Study Completion Date :||April 10, 2017|
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.
Device: Accu-Chek Smart Pix readout Device
Smartpix device for data upload out of blood glucose meter devices
Patients are treated according to the concept "Integrated personalized diabetes management".
Device: Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
- The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods [ Time Frame: from Baseline to 12 months ]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.
- Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156349
|Study Director:||Iris Vesper||Roche Diabetes Care Deutschland GmbH|