A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Accu-Chek Smart Pix readout Device; Device: Accu-Chek Smart Pix Software

• Registration Number: NCT02268929
• Lead Sponsor: Hoffmann-La Roche

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.

Study Timeline

• Study Start: 2014-10-14
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-20
• Primary Completion: 2017-01-11
• Study Completion: 2017-02-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Accu-Chek Smart Pix readout Device	Patients treated by usual customary medical practice (Usual Care)
Intervention Group	Accu-Chek Smart Pix Software	Patients treated with "Integrated Personalized Diabetes Management"

Primary Outcome Measures

Name	Time	Method
The mean HbA1c change by Generalized Estimating Equations (GEE) methods	from Baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods	12 months