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A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
CompletedNA
Sponsor: Hoffmann-La Roche
Conditions: Type II Diabetes Mellitus
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% (≥ 58,47 mmol/mol respectively), blood withdrawal for measurement in the last 90 days before study visit 1 (patient's inclusion) * longer-term care (at least for the duration of the 12-month study participation) by the trial site * insured by the statutory health insurance (GKV) as a compulsory member 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: * Treatment of diabetes with insulin pump (CSII) * Methodic and continuous with the use of particular software for processing of SMBG data - by the patient and at visits in the practice by the physician/diabetes educator - in the past 12 months before study participation.presence of terminal renal failure (eGFR \< 15ml/min) / dialysis and/or a loss of sight (visual acuity ≤ 0,05 of the better eye) * Existing tumor illness (primary tumor/local recurrence/ metastases except Basal Cell Carcinoma) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). Within a tumor free time of \< 5 years Medical Affairs will decide about individual cases * permanent use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy * known alcohol and drug abuse 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)
- Altenstadt, Germany
- Augsburg, Germany
- Bad Mergentheim, Germany
- Bad Säckingen, Germany
- Berlin, Germany
- Berlin, Germany
- Bitburg, Germany
- Buxtehude, Germany
- Cologne, Germany
- Cuxhaven, Germany
- Dresden, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Falkensee, Germany
- Frankfurt am Main, Germany
- Fulda, Germany
- Gelnhausen, Germany
- Giessen, Germany
- Göttingen, Germany
- Gummersbach, Germany
- Hamburg, Germany
- Hamburg, Germany
- Hanau, Germany
- Hanover, Germany
- Herne, Germany
- Hessen, Germany
- Immenhausen, Germany
- Jena, Germany
- Kassel, Germany
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