NCT05041621已完成不适用
A Single Arm Pilot Study to Assess the Feasibility of a Learning Algorithm to Automatically Adjust Basal and Bolus Recommendations for High Fat Meals and Exercise Management for Individuals With Type 1 Diabetes on MDI Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Comparison of 5 hours postprandial percentage of time below 3.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations
研究概览
简要总结
McGill artificial pancreas lab has developed a learning algorithm using a reinforcement learning approach to adjust basal and bolus recommendations for high-fat meals and exercise management for individuals with type 1 diabetes on multiple daily injections (MDI) therapy. The reinforcement learning algorithm is integrated with a mobile application that gathers insulin, meal information (carbs (if applicable) and high-fat content), mealtime glucose value, glucose trend at mealtime, and type and timing of postprandial exercise.
详细描述
The objective of this study is to assess the feasibility of a reinforcement learning algorithm to adjust basal and bolus recommendations for high-fat meals and postprandial exercise management. The investigators hypothesize that the reinforcement learning algorithm will be safe, and participants will get the benefit of improved glucose outcomes and improved patient satisfaction from the start to the end of study.
Participants (aged ≥18) will undergo multiple daily injections (MDI) therapy for 4 months using a freestyle Libre glucose sensor (Abbott Diabetes Care) and a mobile data collection application integrated with the reinforcement learning algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Signed and dated informed consent form
- •Females and males ≥ 18 years old
- •Diagnosis of type 1 diabetes of ≥ 12 months based on the clinical investigator's judgement
- •Undergoing MDI therapy
- •A self-reported diet that consists of at least 3 high-fat meals per week or participation in exercise for at least 30 minutes, two times per week
排除标准
- •Current use of any non-insulin antihyperglycemic medication (SGLT2 inhibitors, GLP 1 receptor agonists, metformin...)
- •Current use of glucocorticoid medication, except inhaled and/or at low stable doses
- •Use of isophane insulin (NPH) or intermediate-acting insulin
- •Significant clinical nephropathy, neuropathy, retinopathy as per the clinical investigator's judgement
- •Acute macrovascular event (ex: acute coronary syndrome or cardiac surgery) within 6 months of admission
- •Severe diabetes ketoacidosis and/or hypoglycemia within one month of admission
- •Other severe medical illness that the clinical investigator considers may interfere with participation in or completion of the study
- •An inability or unwillingness to comply with study procedures as per the clinical investigator's judgement
结局指标
主要结局
Comparison of 5 hours postprandial percentage of time below 3.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations
时间窗: First and last month of intervention, approximately 4 months
Comparison of 5 hours postprandial incremental area under the curve of glucose (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations
时间窗: First and last month of intervention, approximately 4 months
次要结局
- Comparison of 5 hours postprandial percentage of time between 3.9 and 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time below 2.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time above 7.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time above 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time above 13.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time below 3.3 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time above 16.7 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 5 hours postprandial percentage of time between 3.9 and 7.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 24 hours standard deviation of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours percentage of time above 13.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 5 hours postprandial standard deviation of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 24 hours incremental area under the curve of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours percentage of time below 3.3 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours percentage of time above 16.7 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 5 hours postprandial coefficient of variance of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 24 hours percentage between 3.9 and 7.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours percentage of time below 2.8 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours coefficient of variance of glucose levels (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Quality of life measure by Hypoglycemic Fear Survey - II: score is the average of 9 items and each item scores ranges 0 to 6 (average of higher scores equates to more satisfied with the treatment)(Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months)
- Comparison of 5 hours postprandial mean glucose level (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last month of intervention, approximately 4 months)
- Comparison of 24 hours percentage of time below 3.9 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours percentage between 3.9 and 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Mobile app usability questionnaire: score is the average of 16 items and each item scores ranges 0-6 (average of higher scores means higher usability)(Post-intervention, approximately 4 months)
- Comparison of 24 hours percentage of time above 10 mmol/L (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Comparison of 24 hours mean glucose level (for high-fat meals and/or postprandial exercise) of the last month algorithm recommendations with the first month recommendations(First and last week of intervention, approximately 4 months)
- Quality of life measure by Hypoglycemic Fear Survey - II: score is the average of 18 items and each item scores ranges 1 to 5 to select (average of higher scores equates to more distress)(Pre-intervention, mid-way intervention, and post-intervention, approximately 4 months)
研究者
研究点 (2)
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