Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in the percentage of time in glucose target range (glucose levels 3.9-10 mmol/l or 70 - 180 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 objective is to demonstrate safety, feasibility and usability of the PEPPER system compared to a standard bolus calculator.
详细描述
- 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 (postprandial blood glucose). Each new case includes information about the problem (e.g. capillary blood glucose, meal information etc), solution (recommended insulin dose) and outcome (postprandial blood glucose).
PEPPER offers a dual architecture for both Multiple Daily Injections (MDI) and 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 with PEPPER application running.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 automatically records glucose levels 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 Handset in CSII version, except that is not connected to insulin pump and patients have to administrate insulin by insulin pens.
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
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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 Gold 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
结局指标
主要结局
Change in the percentage of time in glucose target range (glucose levels 3.9-10 mmol/l or 70 - 180 mg/dl)
时间窗: 6 months
次要结局
- Change in the post-prandial area under the curve (AUC) of glucose level at 4 hours(6 months)
- Measurement of diabetes related problems by using Problem Areas in Diabetes (PAID) questionnaire(6 months)
- Number of incidence of high glucose alarms(6 months)
- Change in the post-prandial area under the curve (AUC) of glucose level at 6 hours(6 months)
- Change in glycaemic risk measured with low blood glucose index (LBGI)(6 months)
- Change in glycosylated hemoglobin (HbA1c) value(6 months)
- Change in the number of episodes of post-prandial hypoglycaemia (glucose level below 3,9 mmol/L or 70 mg/dl) within 4 hours(6 months)
- Change in glycaemic risk measured with high blood glucose index (HBGI)(6 months)
- Change in glycaemic variability measured with continuous overall net glycemic action at 2 hours (CONGA-2)(6 months)
- Change in weight (kg)(6 months)
- Change in the number of episodes of post-prandial hypoglycaemia (glucose level below 3,9 mmol/L or 70 mg/dl) within 6 hours(6 months)
- Change in the percentage of time in hypoglycaemia (glucose level below 3, 9 mmol/L or 70 mg/dl)(6 months)
- Change in the post-prandial area under the curve (AUC) (< 3,9 mmol/l or <70 mg/dl) of glucose level at 6 hours(6 months)
- Measurement of satisfaction of diabetes treatment using Diabetes Treatment Satisfaction Questionnaire (DTSQ)(6 months)
- Change in insulin dose requirements(6 months)
- Measurement of quality of life in patients with diabetes mellitus using Diabetes Quality of Life (DQOL) questionnaire(6 months)
- Change in the percentage of time in hyperglycaemia (glucose level above 10 mmol/l or 180 mg/dl)(6 months)
- Change in the post-prandial area under the curve (AUC) (< 3,9 mmol/l or <70 mg/dl) of glucose level at 4 hours(6 months)
- Change in glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)(6 months)
- Evaluation of usability of PEPPER system by conducting the usability test(6 months)
- Measurement of health-related quality of life by using EQ-5D questionnaire(6 months)
- Number of incidence of low glucose alarms(6 months)
- Number of incidence of carbohydrate recommender(6 months)
- Number of incidence of low glucose suspend(6 months)
- Number of incidence of fault detection alarm(6 months)
- Number of technical faults of the PEPPER safety system (any of the components listed above)(6 months)
研究者
José Manuel Fernández-Real
Principal Investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta