A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
PDMProValueDSP
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 Diabetes Specialized Medical Practices in Germany (DSP)
1 other identifier
interventional
558
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
Started May 2014
Typical duration for not_applicable
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
May 14, 2014
CompletedFirst Submitted
Initial submission to the registry
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2017
CompletedNovember 14, 2017
November 1, 2017
2.9 years
June 3, 2014
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods
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.
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) in the out-patient facility i.e. Diabetes specialized medical practice, Medical Care Center or hospital outpatient clinic.
Intervention group
OTHERPatients are treated according to the concept "Integrated personalized diabetes management".
Interventions
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Smartpix device for data upload out of 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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Roche Diabetes Carecollaborator
Study Sites (50)
Private Practice
Altenstadt, 63674, Germany
Internistische Gemeinschaftspraxis
Augsburg, 86179, Germany
Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM)
Bad Mergentheim, 97980, Germany
Private Practice
Bad Säckingen, 79713, Germany
Private Practice
Berlin, 01627, Germany
MVZ am Bahnhof Spandau
Berlin, 13597, Germany
Gemeinschaftspraxis
Bitburg, 54634, Germany
Private Practice
Buxtehude, 21614, Germany
Praxis Kugler
Cologne, 50858, Germany
Private Practice
Cuxhaven, 27474, Germany
Diabetologicum Dresden
Dresden, 01219, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Gemeinschaftspraxis Schaden
Düsseldorf, 40212, Germany
Private Practice
Essen, 45329, Germany
Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin
Falkensee, 14612, Germany
Private Practice
Frankfurt am Main, 60326, Germany
Gemeinschaftspraxis
Fulda, 36039, Germany
Private Practice
Gelnhausen, 63571, Germany
Hausärztliche internistische Gemeinschaftspraxis Giessen
Giessen, 35390, Germany
Diabetes- und Gesundheitszentrum Göttingen
Göttingen, 37073, Germany
Private Practice
Gummersbach, 51645, Germany
Private Practice
Hamburg, 21109, Germany
Diabeteszentrum
Hamburg, 22119, Germany
Private Practice
Hanau, 63450, Germany
Integriertes Diabetiker-Zentrum Hannover
Hanover, 30159, Germany
Gemeinschaftspraxis
Herne, 44653, Germany
Gemeinschaftspraxis im Altstadt-Carree
Hessen, 36037, Germany
Private Practice
Immenhausen, 34376, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin III
Jena, 07743, Germany
Diabeteszentrum Kassel
Kassel, 34117, Germany
Internistische Praxis Lampertheim
Lampertheim, 68623, Germany
Private Practice
Lauf (Pegnitz), 91207, Germany
Private Practice
Laupheim, 88471, Germany
Private Practice
Lingen, 49808, Germany
Diabetes-Zentrum Neustadt
Neustadt am Rübenberge, 31535, Germany
Diabetologische Schwerpunktpraxis
Nordrhein-Westfalen, 46537, Germany
Private Practice
Offenbach, 63065, Germany
Diabetes Praxis Oranienburg
Oranienburg, 16515, Germany
Arztpraxis fur Allg-Med
Pirna, 01796, Germany
Private Practice
Porta Westfalica, 32457, Germany
Private Practice
Rehburg-Loccum, 31547, Germany
Gemeinschaftspraxis
Rhaunen, 55624, Germany
Pivate Practice
Rüsselsheim am Main, 65428, Germany
Ambulanzzentrum Schweinfurt
Schweinfurt, 97421, Germany
Versdias Gmbh
Sulzbach-Rosenberg, 92237, Germany
Private Practice
Trier, 54292, Germany
Gemeinschaftspraxis am Bärenplatz
Villingen-Schwenningen, 78054, Germany
Diabetolog. Schwerpunktpraxis
Wiesbaden, 65183, Germany
Internistische Praxis
Zierenberg, 34289, Germany
Arztpraxis Zossen / Dabendorf
Zossen, 15806, 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
June 3, 2014
First Posted
June 5, 2014
Study Start
May 14, 2014
Primary Completion
April 10, 2017
Study Completion
April 10, 2017
Last Updated
November 14, 2017
Record last verified: 2017-11