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

Roche

Status: Completed

Conditions: Type II Diabetes Mellitus

Treatments: Device: Accu-Chek Smart Pix Software; Device: Accu-Chek Smart Pix readout Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02156349

RD001732

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: 558 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% (≥ 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Control Group

Other group

Description:

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.

Treatment:

Device: Accu-Chek Smart Pix readout Device

Intervention group

Other group

Description:

Patients are treated according to the concept "Integrated personalized diabetes management".

Treatment:

Device: Accu-Chek Smart Pix Software