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A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
CompletedNA
Sponsor: Hoffmann-La Roche
Conditions: Diabetes Mellitus, Type 2
Interventions: Accu-Chek Smart Pix Software, Accu-Chek Smart Pix readout Device
Countries: Germany
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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
Locations (50)
- 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
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