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

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).

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.

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.

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