Clinical trial NCT02268929: A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes 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 General Medical Practices in Germany (GP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diabetes Care
First posted: 2014-10-20
Enrollment: 414
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% 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

Primary outcomes:
measure: The mean HbA1c change by 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: Albstadt
country: Germany
city: Auerbach/Vogtland
country: Germany
city: Bad Kreuznach
country: Germany
city: Beucha
country: Germany
city: Beutel/Templin
country: Germany
city: Blankenhain
country: Germany
city: Bochum
country: Germany
city: Bockenem
country: Germany
city: Borna
country: Germany
city: Bremerhaven
country: Germany
city: Cloppenburg
country: Germany
city: Dransfeld
country: Germany
city: Dresden
country: Germany
city: Düren
country: Germany
city: Elsterwerda
country: Germany
city: Essen
country: Germany
city: Essen
country: Germany
city: Essen
country: Germany
city: Föhren
country: Germany
city: Geringswalde
country: Germany
city: Giessen
country: Germany
city: Hannover
country: Germany
city: Hemsbach
country: Germany
city: Herborn
country: Germany
city: Kerpen
country: Germany
city: Krefeld
country: Germany
city: Kreuzau
country: Germany
city: Köthen
country: Germany
city: Leipzig
country: Germany
city: Loehne
country: Germany
city: Lübeck
country: Germany
city: Mainz
country: Germany
city: Mainz
country: Germany
city: Meissen
country: Germany
city: Meudt
country: Germany
city: Papenburg
country: Germany
city: Reinfeld
country: Germany
city: Riesa
country: Germany
city: Rochlitz
country: Germany
city: Rodgau
country: Germany
city: Schleiden
country: Germany
city: Schwedt
country: Germany
city: Schweich
country: Germany
city: Schweich
country: Germany
city: Siegen
country: Germany
city: Sigmaringen
country: Germany
city: Staufenberg
country: Germany
city: Trier
country: Germany
city: Weida
country: Germany
city: Wetzlar
country: Germany
Study officials:
affiliation: Roche Diabetes Care
name: Iris Vesper
role: STUDY_DIRECTOR
References: