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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 50
- 主要终点
- The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
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.
干预措施: Accu-Chek Smart Pix readout Device (Device)
Intervention group
Patients are treated according to the concept "Integrated personalized diabetes management".
干预措施: Accu-Chek Smart Pix Software (Device)
结局指标
主要结局
The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods
时间窗: 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.
次要结局
- Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods(12 months)