Clinical trial NCT02156349: A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diabetes Care
First posted: 2014-06-05
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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% (≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods
timeFrame: from Baseline to 12 months
Secondary outcomes:
measure: Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods
timeFrame: 12 months
Other outcomes:
Locations:
city: Altenstadt
country: Germany
facility: Private Practice
city: Augsburg
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Bad Mergentheim
country: Germany
facility: Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM)
city: Bad Sackingen
country: Germany
facility: Private Practice
city: Berlin
country: Germany
facility: Private Practice
city: Berlin
country: Germany
facility: MVZ am Bahnhof Spandau
city: Bitburg
country: Germany
facility: Gemeinschaftspraxis
city: Buxtehude
country: Germany
facility: Private Practice
city: Cuxhaven
country: Germany
facility: Private Practice
city: Dresden
country: Germany
facility: Diabetologicum Dresden
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Dusseldorf
country: Germany
facility: Gemeinschaftspraxis Schaden
city: Essen
country: Germany
facility: Private Practice
city: Falkensee
country: Germany
facility: Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin
city: Frankfurt am Main
country: Germany
facility: Private Practice
city: Fulda
country: Germany
facility: Gemeinschaftspraxis
city: Gelnhausen
country: Germany
facility: Private Practice
city: Giessen
country: Germany
facility: Hausärztliche internistische Gemeinschaftspraxis Giessen
city: Gottingen
country: Germany
facility: Diabetes- und Gesundheitszentrum Göttingen
city: Gummersbach
country: Germany
facility: Private Practice
city: Hamburg
country: Germany
facility: Private Practice
city: Hamburg
country: Germany
facility: Diabeteszentrum
city: Hanau
country: Germany
facility: Private Practice
city: Hannover
country: Germany
facility: Integriertes Diabetiker-Zentrum Hannover
city: Herne
country: Germany
facility: Gemeinschaftspraxis
city: Hessen
country: Germany
facility: Gemeinschaftspraxis im Altstadt-Carree
city: Immenhausen
country: Germany
facility: Private Practice
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Innere Medizin III
city: Kassel
country: Germany
facility: Diabeteszentrum Kassel
city: Koln
country: Germany
facility: Praxis Kugler
city: Lampertheim
country: Germany
facility: Internistische Praxis Lampertheim
city: Lauf (Pegnitz)
country: Germany
facility: Private Practice
city: Laupheim
country: Germany
facility: Private Practice
city: Lingen
country: Germany
facility: Private Practice
city: Neustadt am Rübenberge
country: Germany
facility: Diabetes-Zentrum Neustadt
city: Nordrhein-Westfalen
country: Germany
facility: Diabetologische Schwerpunktpraxis
city: Offenbach
country: Germany
facility: Private Practice
city: Oranienburg
country: Germany
facility: Diabetes Praxis Oranienburg
city: Pirna
country: Germany
facility: Arztpraxis fur Allg-Med
city: Porta Westfalica
country: Germany
facility: Private Practice
city: Rehburg-Loccum
country: Germany
facility: Private Practice
city: Rhaunen
country: Germany
facility: Gemeinschaftspraxis
city: Russelsheim
country: Germany
facility: Pivate Practice
city: Schweinfurt
country: Germany
facility: Ambulanzzentrum Schweinfurt
city: Sulzbach-Rosenberg
country: Germany
facility: Versdias Gmbh
city: Trier
country: Germany
facility: Private Practice
city: Villingen-Schwenningen
country: Germany
facility: Gemeinschaftspraxis am Bärenplatz
city: Wiesbaden
country: Germany
facility: Diabetolog. Schwerpunktpraxis
city: Zierenberg
country: Germany
facility: Internistische Praxis
city: Zossen
country: Germany
facility: Arztpraxis Zossen / Dabendorf
Study officials:
affiliation: Roche Diabetes Care
name: Iris Vesper
role: STUDY_DIRECTOR
References: