A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Time in target
研究概览
简要总结
The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 12 years of age.
- •Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
- •The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- •Insulin pump therapy for at least 6 months.
- •HbA1c ≤ 12%.
排除标准
- •Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc....).
- •Current use of glucocorticoid medication.
- •Use of medication that alters gastrointestinal motility.
- •Planned or ongoing pregnancy.
- •Breastfeeding individuals.
- •Severe hypoglycemic episode within one month of admission.
- •Severe diabetes keto-acidosis episode within one month of admission.
- •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.
- •Known hypersensitivity to any of the study drugs or their excipients.
- •Individuals with hypoglycemia unawareness.
- •Individuals with confirmed gastroparesis.
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- •Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
- •Study Discontinuation/Withdrawal
- •Failure to comply with the protocol.
- •After an event which the PI believes it is not in the best interest for the patient to continue the trial.
研究组 & 干预措施
Simple Meal Announcement
Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal.
干预措施: Fiasp+Pramlintide Closed-Loop System (Combination Product)
Full Carbohydrate counting
The carbohydrate content of the meal selected by the participant will be entered into the dosing algorithm by a member of the study team at the onset of the meal to compute the insulin prandial bolus.
干预措施: Fiasp Closed-Loop System (Device)
结局指标
主要结局
Time in target
时间窗: 24 hours
Time spent in target range (between 4.0 mmol/L and 10 mmol/L)
Time in hypoglycemia
时间窗: 24 hours
Time spent in hypoglycemic range (below 4.0 mmol/L)
Time in hyperglycemia
时间窗: 24 hours
Time spent in hyperglycemic range (above 10.0 mmol/L)
次要结局
未报告次要终点