A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
- Conditions
- Type II Diabetes Mellitus
- Interventions
- Device: Accu-Chek Smart Pix readout DeviceDevice: Accu-Chek Smart Pix Software
- Registration Number
- NCT02156349
- Lead Sponsor
- Hoffmann-La Roche
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 558
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Accu-Chek Smart Pix readout Device Patients treated by usual customary medical practice (Usual Care) in the out-patient facility i.e. Diabetes specialized medical practice, Medical Care Center or hospital outpatient clinic. Intervention group Accu-Chek Smart Pix Software Patients are treated according to the concept "Integrated personalized diabetes management".
- Primary Outcome Measures
Name Time Method The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods from Baseline to 12 months The difference in the HbA1c change after 12 months between the Intervention group and the Control group is analyzed by means of generalized estimating equations (Generalized Estimating Equations \[GEE\]) methods (population averaged model) and here, robust assessors (so-called sandwich assessors) for the standard errors are provided. The dependent variable is the HbA1c change after 12 months, while the HbA1c baseline considers the gender and the age as factors of influence (covariates) in the GEE model.
- Secondary Outcome Measures
Name Time Method Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods 12 months
Trial Locations
- Locations (29)
Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM)
🇩🇪Bad Mergentheim, Germany
Diabetes- und Gesundheitszentrum Göttingen
🇩🇪Gottingen, Germany
Diabetologicum Dresden
🇩🇪Dresden, Germany
Gemeinschaftspraxis Schaden
🇩🇪Dusseldorf, Germany
Diabetes-Zentrum Neustadt
🇩🇪Neustadt am Rübenberge, Germany
Diabeteszentrum
🇩🇪Hamburg, Germany
Integriertes Diabetiker-Zentrum Hannover
🇩🇪Hannover, Germany
Private Practice
🇩🇪Trier, Germany
Internistische Gemeinschaftspraxis
🇩🇪Augsburg, Germany
Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin
🇩🇪Falkensee, Germany
Gemeinschaftspraxis
🇩🇪Rhaunen, Germany
Diabetolog. Schwerpunktpraxis
🇩🇪Wiesbaden, Germany
Internistische Praxis
🇩🇪Zierenberg, Germany
Hausärztliche internistische Gemeinschaftspraxis Giessen
🇩🇪Giessen, Germany
Internistische Praxis Lampertheim
🇩🇪Lampertheim, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin III
🇩🇪Jena, Germany
Praxis Kugler
🇩🇪Koln, Germany
Diabetologische Schwerpunktpraxis
🇩🇪Nordrhein-Westfalen, Germany
MVZ am Bahnhof Spandau
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Gemeinschaftspraxis im Altstadt-Carree
🇩🇪Hessen, Germany
Diabetes Praxis Oranienburg
🇩🇪Oranienburg, Germany
Pivate Practice
🇩🇪Russelsheim, Germany
Arztpraxis fur Allg-Med
🇩🇪Pirna, Germany
Gemeinschaftspraxis am Bärenplatz
🇩🇪Villingen-Schwenningen, Germany
Versdias Gmbh
🇩🇪Sulzbach-Rosenberg, Germany
Diabeteszentrum Kassel
🇩🇪Kassel, Germany
Ambulanzzentrum Schweinfurt
🇩🇪Schweinfurt, Germany
Arztpraxis Zossen / Dabendorf
🇩🇪Zossen, Germany