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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.

NCT02156349

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
  • + 20 more on CT.gov