Status:
COMPLETED
A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Roche Diabetes Care
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2017
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT02268929
Start Date
October 14 2014
End Date
February 9 2017
Last Update
November 24 2017
Active Locations (50)
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1
Albstadt, Germany, 72461
2
Auerbach/Vogtland, Germany, 08209
3
Bad Kreuznach, Germany, 55545
4
Beucha, Germany, 04824