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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
414
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Smartpix device for data upload out from blood glucose meter devices
The mean HbA1c change by Generalized Estimating Equations (GEE) methods
Time frame: from Baseline to 12 months
Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods
Time frame: 12 months
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Albstadt, Germany
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Auerbach/Vogtland, Germany
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Bad Kreuznach, Germany
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Beucha, Germany
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Beutel/Templin, Germany
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Blankenhain, Germany
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Bochum, Germany
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Bockenem, Germany
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Borna, Germany
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Bremerhaven, Germany
...and 40 more locations