A Pilot Study Evaluating the Safety and Performance of an Artificial Pancreas With Carbohydrate Suggestion for Patients With Type 1 Diabetes Prone to Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of CGM time in glucose range 70-180 mg/dl during the study.
研究概览
简要总结
Achieving near-normoglycemia has been established as the main objective for most patients with Type 1 Diabetes (T1D). Automated insulin delivery (AID) systems, the so-called artificial pancreas (AP) or closed-loop systems, may represent the ideal solution, especially for patients not reaching the therapeutic goals with multiples doses of insulin or open-loop delivery systems. Despite the advances in recent years that have proven the efficacy and safety of these devices in clinical trials and clinical practice settings, such evidence cannot be extrapolated to highly unstable patients, as problematic hypoglycemia remains an exclusion criterion in most of the trials.
The SAFE-AP system is a single-hormone hybrid closed-loop controller based on a proportional derivative with an insulin feedback controller that integrates a safety layer with insulin-on-board constraints and sliding mode reference conditioning. The hybrid closed-loop system includes a second safety feedback loop with a controller that triggers carbohydrate recommendations to the patient. Both control loops are coordinated to ensure that the counter-regulatory effect of rescue carbohydrates is not counteracted with insulin. Such system has been previously proven effective in unannounced exercise, one of the main challenges in AID systems development. Additionally, the algorithm has been recently tailored to achieve a better control in the subgroup of T1D patients prone to hypoglycemia.
In this project, a rigorous clinical testing of the SAFE-AP system will be carried out in 12 patients with T1D and problematic hypoglycemia, despite treatment with continuous subcutaneous insulin infusion. The safety and performance of the system will be evaluated in a 32-hour pilot study, including 4 meals, one overnight period and 2 unannounced aerobic exercise sessions. The study will be performed in a hospital setting with the on-site supervision of a specialized nurse and a diabetologist, as well as an engineer in remote control.
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
- •Subjects aged 18 or more with Type 1 Diabetes for at least 5 years.
- •Treated with continuous subcutaneous insulin infusion (CSII) for at least six months.
- •Trained to carbohydrate counting.
- •Subjects prone to hypoglycemia, despite optimal diabetes management and hypoglycemia-specific education programs, as defined by >4 hypoglycemic episodes per week and at least one of the following:
- •Occurrence of at least 2 severe hypoglycemic episodes during the last 2 years (need for third party).
- •Occurrence of at least 1 severe hypoglycemic episode during the last 2 years and high glycemic variability (coefficient of variation >36%).
- •Impaired awareness of hypoglycemia (Clarke test ≥4).
- •Physical examination, laboratory data and EKG without alterations. Abnormalities considered clinically irrelevant by the investigator will not be exclusion criteria.
- •Negative SARS-CoV-2 PCR test performed at arrival.
- •Subject willing to wear the SAFE-AP system continuously throughout the study.
排除标准
- •Pregnancy and breastfeeding.
- •History of drug or alcohol abuse.
- •Progressive fatal disease.
- •Clinically relevant microvascular complications (macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine or other systematic, apart from T1D, which may hamper the implementation of the clinical study protocol or interpretation of results study.
- •Scheduled surgery during the study period.
- •Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study.
- •Subjects who are unlikely to meet the clinical study protocol, eg. uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study.
- •Using an experimental drug or device during the past 30 days.
结局指标
主要结局
Percentage of CGM time in glucose range 70-180 mg/dl during the study.
时间窗: From 12 AM of the first day of study until 4 PM of the second day of study
次要结局
- Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during postprandial period(Defined as 4 hours since mealtime)
- Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during the study(From 22 PM of the first day of study until 7 AM of the second day of study)
- Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during exercise and recovery(Defined as 3 hours after exercise initiation)
- Percentage of CGM time in glucose range 70-180 mg/dl during nighttime(From 22 PM of the first day of study until 7 AM of the second day of study)
- Percentage of CGM time in glucose range 70-180 mg/dl during exercise and recovery(Defined as 3 hours after exercise initiation)
- Percentage of CGM time in glucose range 70-180 mg/dl during postprandial period(Defined as 4 hours since mealtime)
- Percentage of CGM time in hypoglycemia (<70 mg/dL and <54 mg/dL) during nighttime(From 22 PM of the first day of study until 7 AM of the second day of study)
- Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during nighttime(From 22 PM of the first day of study until 7 AM of the second day of study)
- Number of acute metabolic events during the study(From 22 PM of the first day of study until 7 AM of the second day of study)
- Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during the study(From 22 PM of the first day of study until 7 AM of the second day of study)
- Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during exercise and recovery(Defined as 3 hours after exercise initiation)
- Percentage of CGM time in hyperglycemia (>180 mg/dL and >250 mg/dL) during postprandial period(Defined as 4 hours since mealtime)
- Glucose coefficient of variation during the study(From 22 PM of the first day of study until 7 AM of the second day of study)
- Number of hypoglycemic events(From 22 PM of the first day of study until 7 AM of the second day of study)
- Number of carbohydrate rescue events during the study(From 22 PM of the first day of study until 7 AM of the second day of study)
研究者
Ignacio Conget
Head of Endocrinology and Nutrition Department, Principal Investigator
Hospital Clinic of Barcelona