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).

Hoffmann-La Roche0 sites414 target enrollmentOctober 14, 2014

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 414
Primary Endpoint: The mean HbA1c change by Generalized Estimating Equations (GEE) methods
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2014

End Date

February 9, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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