A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
PDM-ProValueGP
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).
1 other identifier
interventional
414
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2014
Typical duration for not_applicable diabetes-mellitus-type-2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2014
CompletedFirst Submitted
Initial submission to the registry
October 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2017
CompletedNovember 24, 2017
November 1, 2017
2.2 years
October 16, 2014
November 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The mean HbA1c change by Generalized Estimating Equations (GEE) methods
from Baseline to 12 months
Secondary Outcomes (1)
Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods
12 months
Study Arms (2)
Control Group
OTHERPatients treated by usual customary medical practice (Usual Care)
Intervention Group
OTHERPatients treated with "Integrated Personalized Diabetes Management"
Interventions
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Smartpix device for data upload out from blood glucose meter devices
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Roche Diabetes Carecollaborator
Study Sites (50)
Unknown Facility
Albstadt, 72461, Germany
Unknown Facility
Auerbach/Vogtland, 08209, Germany
Unknown Facility
Bad Kreuznach, 55545, Germany
Unknown Facility
Beucha, 04824, Germany
Unknown Facility
Beutel/Templin, 17268, Germany
Unknown Facility
Blankenhain, 99444, Germany
Unknown Facility
Bochum, 44805, Germany
Unknown Facility
Bockenem, 31167, Germany
Unknown Facility
Borna, 04552, Germany
Unknown Facility
Bremerhaven, 27572, Germany
Unknown Facility
Cloppenburg, 49661, Germany
Unknown Facility
Dransfeld, 37127, Germany
Unknown Facility
Dresden, 01309, Germany
Unknown Facility
Düren, 52349, Germany
Unknown Facility
Elsterwerda, 04910, Germany
Unknown Facility
Essen, 45329, Germany
Unknown Facility
Essen, 45355, Germany
Unknown Facility
Essen, 45359, Germany
Unknown Facility
Föhren, 54343, Germany
Unknown Facility
Geringswalde, 09326, Germany
Unknown Facility
Giessen, 35390, Germany
Unknown Facility
Hanover, 30163, Germany
Unknown Facility
Hemsbach, 69502, Germany
Unknown Facility
Herborn, 35745, Germany
Unknown Facility
Kerpen, 50169, Germany
Unknown Facility
Köthen, 06366, Germany
Unknown Facility
Krefeld, 47803, Germany
Unknown Facility
Kreuzau, 52372, Germany
Unknown Facility
Leipzig, 04315, Germany
Unknown Facility
Löhne, 32584, Germany
Unknown Facility
Lübeck, 23562, Germany
Unknown Facility
Mainz, 55116, Germany
Unknown Facility
Mainz, 55130, Germany
Unknown Facility
Meissen, 01662, Germany
Unknown Facility
Meudt, 56414, Germany
Unknown Facility
Papenburg, 26871, Germany
Unknown Facility
Reinfeld, 23858, Germany
Unknown Facility
Riesa, 01589, Germany
Unknown Facility
Rochlitz, 09328, Germany
Unknown Facility
Rodgau, 63110, Germany
Unknown Facility
Schleiden, 53937, Germany
Unknown Facility
Schwedt, 16303, Germany
Unknown Facility
Schweich, 54338, Germany
Unknown Facility
Schweich, 54343, Germany
Unknown Facility
Siegen, 57072, Germany
Unknown Facility
Sigmaringen, 72488, Germany
Unknown Facility
Staufenberg, 35460, Germany
Unknown Facility
Trier, 54290, Germany
Unknown Facility
Weida, 07570, Germany
Unknown Facility
Wetzlar, 35584, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iris Vesper
Roche Diabetes Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2014
First Posted
October 20, 2014
Study Start
October 14, 2014
Primary Completion
January 11, 2017
Study Completion
February 9, 2017
Last Updated
November 24, 2017
Record last verified: 2017-11