Patient Empowerment Through Predictive Personalised Decision Support (PEPPER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 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 or Smartphone with PEPPER application running and participants can administer an insulin bolus with their usual 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.
Secure web server Revision: The handset wirelessly reports the user's case history to the secure portal, a web site which allows the clinician to add new patients, and review the cases to decide which ones should be kept. A case comprises multiple parameters such as carbohydrate intake, BG reading, meal composition, physical activity and hormone cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Adults ≥18years of age
- •Diagnosis of T1DM for > 1 year
- •On MDI using a basal-bolus insulin regime or CSII (insulin pump) for at least 6 month
- •Structured education done and good ability perform carbohydrates (CHO) counting
- •HbA1c ≥ 48mmol/mol and ≤ 86mmol/mol
- •Using insulin carbohydrates ratio (ICR) and insulin sensitivity factor (ISF) to calculate the mealtime bolus
- •An understanding of and willingness to follow the protocol and sign the informed consent
- •CBG measurements at least 2 times per day for calibration of the CGM
排除标准
- •Severe episode of hypoglycaemia (requiring 3rd party assistance) in the 6 months prior to enrolment
- •Diabetic ketoacidosis in the last 6 months prior to enrolment
- •Impaired awareness of hypoglycaemia (based on Clarke score)
- •Pregnancy, breastfeeding or intention of becoming pregnant over time of study procedures
- •Enrolled in other clinical trials
- •Have active malignancy or under investigation for malignancy
- •Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour
- •Gastroparesis
- •Autonomic neuropathy
- •Macrovascular complications (acute coronary syndrome, transient ischaemic attack, cerebrovascular event within the last 12 months prior to enrolment in the study)
- •Visual impairment including unstable proliferative retinopathy
- •Reduced manual dexterity
- •Inpatient psychiatric treatment
- •Abnormal renal function test results (calculated Glomerular Filtration Rate (GFR) <40 mL/min/1.73m2)
- •Liver cirrhosis
- •Not tributary to optimization to insulin therapy
- •Abuse of alcohol or recreational drugs
- •Oral steroids
- •Regular use of the acetaminophen, beta-blockers or any other medication that the investigator believes is a contraindication to the participant's participation.
- •Participant withdrawal criteria:
- •Loss of capacity to give informed consent
- •The subject has a serious event related to study
- •Cessation of MDI of insulin as usual care for T1DM
- •Severe hypoglycaemia
- •Diabetic ketoacidosis
- •Positive pregnancy test
- •Terminal illness
- •Investigators initiated discontinuation of study due to participant or equipment concerns
研究组 & 干预措施
PEPPER
In the phase 1 participants will use PEPPER safety system (with the CBR algorithm enabled) and in the phase 2 participants will use whole PEPPER system (with the CBR algorithm integrated).
干预措施: PEPPER system (Device)
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: Comparison of the run-in period (2 week period) vs the intervention period (6 week period)
The primary outcome is the percentage of time spent in hypoglycaemia defined as glucose level below 3.9 mmol/L (measurement used in UK) or below 70 mg/dl (measurement used in Spain).
次要结局
- Number of incidence of low glucose alarms(Evaluation during the intervention period (6 week period))
- Number of incidence of low glucose suspend(Evaluation during the intervention period (6 week period))
- 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 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))
- 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))
- 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 high blood glucose index (HBGI)(Comparison of the run-in period (2 week period) vs the intervention period (6 week period))
- Number of incidence of fault detection alarm(Evaluation during the intervention period (6 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 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 mean amplitude of glycaemic excursions (MAGE) (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))
- 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 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 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 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 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 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).)
- 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).)
- 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).)
研究者
José Manuel Fernández-Real
Principal Investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta