A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
研究概览
简要总结
The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system.
In this cross-over study, patients will undergo the following three interventions in a random order:
(i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses
For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.
详细描述
The aim of this study is to conduct an outpatient, randomized, crossover clinical trial to compare the glycemic outcomes of a fully automated Lyumjev-pramlintide delivery system to a hybrid automated Lyumjev-placebo delivery system with carbohydrate counting in 26 adults with type 1 diabetes.
Design-
All participants will undergo three interventions in a random order:
(i) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of inulin for 8μg of pramlintide.
(ii) Fully automated Lyumjev insulin-pramlintide delivery system. 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
- •Individuals ≥ 18 years of age.
- •A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary.
- •Using insulin pump therapy for at least three months.
- •Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control.
排除标准
- •Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)).
- •Current use of glucocorticoid medication (except low, stable doses and inhaled steroids).
- •Individuals with confirmed gastroparesis.
- •Use of medication that alters gastrointestinal motility (ex: domperidone).
- •Use of hydroxyurea.
- •Planned or ongoing pregnancy.
- •Breastfeeding individuals.
- •Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
- •Diabetic ketoacidosis episode in the past month.
- •Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator.
- •Recent (< 6 months) acute macrovascular event, e.g., acute coronary syndrome.
- •Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment.
- •Known hypersensitivity to the study drugs or their excipients.
研究组 & 干预措施
Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
干预措施: Pramlintide (Drug)
Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
干预措施: Lyumjev (Drug)
Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
干预措施: Automated Insulin Delivery (AID) system (Device)
Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
干预措施: Pramlintide (Drug)
Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
干预措施: Automated Insulin Delivery (AID) system (Device)
Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
干预措施: Lyumjev (Drug)
Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses
Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios.
干预措施: Lyumjev (Drug)
结局指标
主要结局
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
时间窗: 18 days
次要结局
- Mean glucose levels.(18 days)
- Percentage of time of glucose levels spent between 3.9-7.8 mmol/L.(18 days)
- Percentage of time of glucose levels spent between 3.0-3.9 mmol/L.(18 days)
- Percentage of time of glucose levels spent between 10.0-13.9 mmol/L.(18 days)
- Standard deviation of glucose levels.(18 days)
- Total pramlintide delivery (overall, basal, and bolus).(18 days)
- Coefficient of variance of glucose levels.(18 days)
- Total insulin delivery (overall, basal, and bolus).(18 days)
- Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).(18 days)
- Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ).(18 days)
- Thematic interview analysis(18 days)
- Mean score on the Type 1 Diabetes Distress Scale (T1DDS) excluding the physician subscale.(18 days)
- Mean score on the INSPIRE questionnaire for adults (INSPIRE).(18 days)
- Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.(18 days)
研究者
Michael Tsoukas
Assistant Professor, Endocrinology & Metabolism
McGill University Health Centre/Research Institute of the McGill University Health Centre