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

Roche

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Device: Accu-Chek Smart Pix Software

Device: Accu-Chek Smart Pix readout Device

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02268929

RD001231

Details and patient eligibility

About

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.

Full 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.

Enrollment

414 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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