A Randomized, Controlled, Crossover Pilot Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Artificial Pancreas Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Each participant's percentage of time glucose levels spent in the target range
研究概览
简要总结
The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.
详细描述
The aim of this pilot study is to generate additional data of (i) a Fiasp-alone artificial pancreas with carbohydrate-matched boluses, compared to (ii) a Fiasp-plus-Pramlintide fully automated artificial pancreas with no meal announcement in an outpatient free-living setting. The study is not powered, nor aims to answer a scientific hypothesis related to the efficacy of the pramlintide and insulin closed-loop systems.
Design
The investigators will undertake a randomized crossover study to compare the following strategies:
- Insulin-alone artificial pancreas with carbohydrate-matched boluses
- Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
- Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
Each participant will be offered the opportunity to further participate in two optional additional arms: 4. Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide. 5. Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Females and males ≥ 18 years of age.
- •Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- •Use of insulin pump therapy for at least 3 months.
- •Effective birth-control use in individuals of childbearing potential. Individuals of child-bearing potential must agree to use a highly effective method of birth control.
排除标准
- •Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2I (sodium-glucose transporter), GLP-1(glucagon-like peptide), Metformin, etc.).
- •Current use of glucocorticoid medication (except low, stable does and inhaled steroids).
- •Individuals with confirmed gastroparesis.
- •Use of medication that alters gastrointestinal motility.
- •Planned or ongoing pregnancy.
- •Breastfeeding individuals.
- •Severe hypoglycemia requiring hospitalization in the past three months.
- •Severe diabetic ketoacidosis episode in the past three months.
- •Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- •Recent (< 6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
研究组 & 干预措施
Fiasp-and-pramlintide fully automated system (8μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
干预措施: Fiasp (Drug)
Fiasp-and-pramlintide fully automated system (8μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
干预措施: Artificial Pancreas (Device)
Fiasp-and-pramlintide fully automated system (8μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
干预措施: Pramlintide (Drug)
Fiasp-alone with carbohydrate-matched boluses
The Fiasp-alone intervention will have a 14 hour duration. During which, carbohydrate counting will inform insulin bolus doses based on insulin to carbohydrate ratios.
干预措施: Fiasp (Drug)
Aspart-and-pramlintide fully automated system (10μg)
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
干预措施: Artificial Pancreas (Device)
Aspart-and-pramlintide fully automated system (10μg)
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
干预措施: Pramlintide (Drug)
Aspart-and-pramlintide fully automated system (10μg)
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
干预措施: Aspart (Drug)
Fiasp-and-pramlintide fully automated system (10μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
干预措施: Fiasp (Drug)
Fiasp-and-pramlintide fully automated system (10μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
干预措施: Artificial Pancreas (Device)
Fiasp-and-pramlintide fully automated system (10μg)
Fiasp and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 10μg of pramlintide.
干预措施: Pramlintide (Drug)
Aspart-and-pramlintide fully automated system (8μg)
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
干预措施: Artificial Pancreas (Device)
Aspart-and-pramlintide fully automated system (8μg)
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
干预措施: Pramlintide (Drug)
Aspart-and-pramlintide fully automated system (8μg)
Aspart and pramlintide artificial pancreas with no meal announcement. Ratio of 1 unit of insulin for 8μg of pramlintide.
干预措施: Aspart (Drug)
结局指标
主要结局
Each participant's percentage of time glucose levels spent in the target range
时间窗: 42 +/- 28 hours
Time in target range (3.9-10.0 mmol/L).
次要结局
- Total basal insulin delivery for each participant(42 +/- 28 hours)
- Each participant's mean glucose levels(42 +/- 28 hours)
- Each participant's standard deviation of glucose levels(42 +/- 28 hours)
- Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L(42 +/- 28 hours)
- Each participant's percentage of time of glucose levels spent below 3.9 mmol/L(42 +/- 28 hours)
- Each participant's percentage of time of glucose levels spent below 3.0 mmol/L(42 +/- 28 hours)
- Each participant's percentage of time of glucose levels spent above 10.0 mmol/L(42 +/- 28 hours)
- Each participant's percentage of time of glucose levels spent above 13.9 mmol/L(42 +/- 28 hours)
- Each participant's percentage of time of glucose levels spent above 16.7 mmol/L(42 +/- 28 hours)
- Total pramlintide delivery for each participant(28 +/- 28 hours)
- Each participant's coefficient of variance of glucose levels(42 +/- 28 hours)
- Total insulin delivery for each participant(42 +/- 28 hours)
- Total bolus insulin delivery for each participant(42 +/- 28 hours)
研究者
Michael Tsoukas
Michael Tsoukas M.D., Principal Investigator, Assistant Professor, Endocrinology & Metabolism, McGill University Health Centre/Research Institute of the McGill University Health Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre