Type II Diabetes Mellitus
Conditions
Keywords
Diabetes
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.
Interventions
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Smartpix device for data upload out of blood glucose meter devices
Sponsors
Roche Diabetes Care
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods | from Baseline to 12 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods | 12 months |
Countries
Germany
Outcome results
None listed