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

Study Overview
=================
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.

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 Diabetes Specialized Medical Practices in Germany (DSP)

Conditions
-----------------
Type II Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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) in the out-patient facility i.e. Diabetes specialized medical practice, Medical Care Center or hospital outpatient clinic. | Device: Accu-Chek Smart Pix readout Device<br>* Smartpix device for data upload out of blood glucose meter devices<br>|
| Other: Intervention group<br>Patients are treated according to the concept 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods | The difference in the HbA1c change after 12 months between the Intervention group and the Control group is analyzed by means of generalized estimating equations (Generalized Estimating Equations [GEE]) methods (population averaged model) and here, robust assessors (so-called sandwich assessors) for the standard errors are provided. The dependent variable is the HbA1c change after 12 months, while the HbA1c baseline considers the gender and the age as factors of influence (covariates) in the GEE model. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes