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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Accu-Chek Smart Pix Software
* Device: Accu-Chek Smart Pix readout Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>Patients treated by usual customary medical practice (Usual Care) | Device: Accu-Chek Smart Pix readout Device<br>* Smartpix device for data upload out from blood glucose meter devices<br>|
| Other: Intervention Group<br>Patients treated with Integrated Personalized Diabetes Management | Device: Accu-Chek Smart Pix Software<br>* Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean HbA1c change by Generalized Estimating Equations (GEE) methods |  | from Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods |  | 12 months |