A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients. (PDMProValueDSP)

This is an interventional diagnostic trial for Type II Diabetes Mellitus focused on measuring Diabetes Read More

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% (≥ 58,47 mmol/mol respectively), blood withdrawal for measurement in the last 90 days before study visit 1 (patient's inclusion)
• longer-term care (at least for the duration of the 12-month study participation) by the trial site
• insured by the statutory health insurance (GKV) as a compulsory member 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:

• Treatment of diabetes with insulin pump (CSII)
• Methodic and continuous with the use of particular software for processing of SMBG data - by the patient and at visits in the practice by the physician/diabetes educator - in the past 12 months before study participation.presence of terminal renal failure (eGFR < 15ml/min) / dialysis and/or a loss of sight (visual acuity ≤ 0,05 of the better eye)
• Existing tumor illness (primary tumor/local recurrence/ metastases except Basal Cell Carcinoma) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). Within a tumor free time of < 5 years Medical Affairs will decide about individual cases
• permanent use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy
• known alcohol and drug abuse 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