Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments accu-chek smart pix software, accu-chek smart pix readout device
Sponsor Hoffmann-La Roche
Collaborator Roche Diabetes Care Deutschland GmbH
Start date October 2014
End date January 2017
Trial size 474 participants
Trial identifier NCT02268929, RD001231

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
Patients treated by usual customary medical practice (Usual Care)
accu-chek smart pix readout device
Smartpix device for data upload out from blood glucose meter devices
(Other)
Patients treated with "Integrated Personalized Diabetes Management"
accu-chek smart pix software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)

Primary Outcomes

Measure
The mean HbA1c change by Generalized Estimating Equations (GEE) methods
time frame: from Baseline to 12 months

Secondary Outcomes

Measure
Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.