A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
NCT ID: NCT02268929
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
414 participants
INTERVENTIONAL
2014-10-14
2017-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control Group
Patients treated by usual customary medical practice (Usual Care)
Accu-Chek Smart Pix readout Device
Smartpix device for data upload out from blood glucose meter devices
Intervention Group
Patients treated with "Integrated Personalized Diabetes Management"
Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Interventions
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Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Accu-Chek Smart Pix readout Device
Smartpix device for data upload out from blood glucose meter devices
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Roche Diabetes Care
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Iris Vesper
Role: STUDY_DIRECTOR
Roche Diabetes Care
Locations
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Albstadt, , Germany
Auerbach/Vogtland, , Germany
Bad Kreuznach, , Germany
Beucha, , Germany
Beutel/Templin, , Germany
Blankenhain, , Germany
Bochum, , Germany
Bockenem, , Germany
Borna, , Germany
Bremerhaven, , Germany
Cloppenburg, , Germany
Dransfeld, , Germany
Dresden, , Germany
Düren, , Germany
Elsterwerda, , Germany
Essen, , Germany
Essen, , Germany
Essen, , Germany
Föhren, , Germany
Geringswalde, , Germany
Giessen, , Germany
Hanover, , Germany
Hemsbach, , Germany
Herborn, , Germany
Kerpen, , Germany
Köthen, , Germany
Krefeld, , Germany
Kreuzau, , Germany
Leipzig, , Germany
Löhne, , Germany
Lübeck, , Germany
Mainz, , Germany
Mainz, , Germany
Meissen, , Germany
Meudt, , Germany
Papenburg, , Germany
Reinfeld, , Germany
Riesa, , Germany
Rochlitz, , Germany
Rodgau, , Germany
Schleiden, , Germany
Schwedt, , Germany
Schweich, , Germany
Schweich, , Germany
Siegen, , Germany
Sigmaringen, , Germany
Staufenberg, , Germany
Trier, , Germany
Weida, , Germany
Wetzlar, , Germany
Countries
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Other Identifiers
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RD001231
Identifier Type: -
Identifier Source: org_study_id