Patient Empowerment Through Predictive Personalised Decision Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in the percentage of time spent in hypoglycaemia (glucose level below 3, 9 mmol/L or 70 mg/dl)
研究概览
简要总结
Patient Empowerment through Predictive PERsonalised decision support (PEPPER) is an European Union (EU) funded research project to develop a personalised clinical decision support system for Type 1 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an artificial intelligence methodology that adapts to new situations according to past experience. The PEPPER system also incorporates a safety module that promotes safety by providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and fault detection.The principal research objectives are to assess the usability, safety, and technical proof of concept and feasibility of the PEPPER in participants with T1DM. Evaluation of safety is a priority and will be assessed throughout the clinical studies. The safety components only of the PEPPER system will initially be evaluated in an out-of-clinic environment (phase 1) and will measure incidence and percentage time spent in hypoglycaemia, evaluate usability and incidence of technical faults. Following the initial safety study, the overall PEPPER system (integrated with the CBR algorithm) will be assessed (phase 2) and the primary outcome will be percentage time spent in hypoglycaemia.
详细描述
- Description of the components of the PEPPER system:
Decision support algorithm The decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past. A combination of parameters makes up the case problem presented to the CBR algorithm. Using this information the algorithm will find a similar case scenario from the pool of previously encountered cases and recommend an improved solution (insulin dose) to achieve the best possible outcome (post-prandial blood glucose). Each new case includes information about the problem (e.g. capillary blood glucose, meal information etc), solution (recommended insulin dose) and outcome (post-prandial blood glucose).
PEPPER offers a dual architecture for both Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) therapy. In both cases, the user periodically wears a continuous glucose monitor (CGM) and an activity monitor.
Handset CSII version: The handset is a portable touch-screen device, which communicates directly with the insulin pump. Its primary function in PEPPER is to allow the user to precisely manage insulin therapy by accepting or rejecting bolus insulin dose recommendations, calculated by the CBR based decision support algorithm, via a graphical interface. In addition, it measures and automatically records glucose levels (via a built-in Blood Glucose (BG) strip reader) and allows logging of food intake and other parameters.
MDI version: This handset is a commercially available Smartphone with the insulin recommendation application running locally on a standard operating system such as iPhone Operating System (iOS) or Android. It has the same functionality as the CSII version, except that it does not have a built-in capillary blood glucose (CBG) reader but instead imports data wirelessly from external CBG monitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in the percentage of time spent in hypoglycaemia (glucose level below 3, 9 mmol/L or 70 mg/dl)
时间窗: 8 weeks
Comparison of the run-in period (2 week period) vs the intervention period (6 week period)
次要结局
- Change in the number of episodes of post-prandial hypoglycaemia (glucose level below 3,9 mmol/L or 70 mg/dl) within 4 hours(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in the post-prandial glucose level at 120 minutes (mg/dl)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in glycaemic risk measured with high blood glucose index (HBGI)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) (mg/dl)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Measurement of diabetes related problems by using Problem Areas in Diabetes (PAID) questionnaire(PAID questionnaire will be completed in the first and the last visit of the study in each phase (8 week period).)
- Number of incidence of low glucose alarms(Evaluation during the intervention period (6 week period))
- Number of incidence of high glucose alarms(Evaluation during the intervention period (6 week period))
- Number of incidence of carbohydrate adviser(Evaluation during the intervention period (6 week period))
- Number of incidence of low glucose suspend(Evaluation during the intervention period (6 week period))
- Number of incidence of fault detection alarm(Evaluation during the intervention period (6 week period))
- Change in the percentage of time in glucose target range (glucose levels 3.9-10 mmol/l or 70 - 180 mg/dl)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in the percentage of time in hyperglycaemia (glucose level above 10 mmol/l or 180 mg/dl)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in the post-prandial area under the curve (AUC) of glucose level at 4 hours (min x mmol/l)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in the post-prandial glucose level at 120 minutes (mmol/l)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in glycaemic risk measured with low blood glucose index (LBGI)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in glycaemic variability measured with continuous overall net glycemic action at 2 hours (CONGA-2) (mmol/l)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Measurement of satisfaction of diabetes treatment using Diabetes Treatment Satisfaction Questionnaire (DTSQ)(DTSQ will be completed in the first and the last visit of the study in each phase (8 week period).)
- Measurement of quality of life in patients with diabetes mellitus using Diabetes Quality of Life (DQOL) questionnaire.(DQOL questionnaire will be completed in the first and the last visit of the study in each phase (8 week period).)
- Change in the number of episodes of post-prandial hypoglycaemia (glucose level below 3,9 mmol/L or 70 mg/dl) within 6 hours(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in glycaemic variability measured with continuous overall net glycemic action at 2 hours (CONGA-2) (mg/dl)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in the post-prandial area under the curve (AUC) of glucose level at 4 hours (min x mg/dl)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Change in glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) (mmol/l)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Evaluation of usability and the treatment satisfaction of PEPPER system by using non-validated questionnaires.(Questionnaires will be completed an average 1 time per week through each phase (8 week period).)