NCT02268929CompletedNot Applicable
Integrated Personalized Diabetes Management (Integrated PDM):Prospective, Randomized, Controlled Intervention Study for the Evaluation of the Effectiveness and the Benefit of Integrated PDM in the Care of People With Type 2 Diabetes in General Medical Practices in Germany (GP).
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 414
- Locations
- 50
- Primary Endpoint
- The mean HbA1c change by Generalized Estimating Equations (GEE) methods
Study Overview
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 in patients with Type 2 Diabetes. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.
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 study characteristics, design and study results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
Other
Patients treated by usual customary medical practice (Usual Care)
Intervention: Accu-Chek Smart Pix readout Device (Device)
Intervention Group
Other
Patients treated with "Integrated Personalized Diabetes Management"
Intervention: Accu-Chek Smart Pix Software (Device)
Outcomes
Primary Outcomes
The mean HbA1c change by Generalized Estimating Equations (GEE) methods
Time Frame: from Baseline to 12 months
Secondary Outcomes
- Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods(12 months)
Investigators
Study Sites (50)
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