Medtronic Treat to Range (TTR) Closed-Loop Control: Tuning a Treat-to-Range Controller for the Effects of High and Low Glycemic Index Meals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
研究概览
简要总结
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
详细描述
The purpose of this study is to demonstrate the safety and efficacy of a closed-loop "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a "hybrid" system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.
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
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
- •Age 15 years to less than 30 years old.
- •HbA1c < 10%.
- •Subject has used a downloadable insulin pump for at least 3 months.
- •Parent/guardian and subject understand the study protocol and agree to comply with it.
- •Subject comprehends written English.
- •Subject has a home computer with email access.
- •For females, subject not intending to become pregnant during the study.
- •No expectation that subject will be moving out of the area of the clinical center during the study.
- •Informed Consent Form signed by the subject or guardian.
- •Subjects cannot have had a severe hypoglycemic event described as a seizure, loss of consciousness requiring an emergency department visit or hospitalization within 6 months of enrollment.
排除标准
- •Asthma if treated with systemic or inhaled corticosteroids in the last 6 months; Subject has taken oral or injectable corticosteroids within the last 30 days; Current use of oral/inhaled Glucocorticoids
- •Cystic fibrosis
- •Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- •Use of non-insulin medications that may affect blood glucose (eg Symlin),
- •Systolic blood pressure >140 on screening; Diastolic blood pressure >90 on screening
- •History of seizure or loss of consciousness in the last 6 months.
- •Adhesive allergies; Active skin condition that would affect sensor placement
- •History of heart disease
- •Active Graves disease;
- •Currently on beta blocker medication;
- •Unwilling or unable to follow the protocol;
- •History of diagnosed medical eating disorder;
- •History of known illicit drug abuse or prescription drug abuse;
- •History of current alcohol abuse;
- •History of visual impairment which would not allow subject to participate
- •Currently participating in an investigational study (drug or device);
- •Other major illness that in the judgment of the investigator might interfere with the completion of the protocol: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
研究组 & 干预措施
TTR controller
The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
干预措施: TTR controller (Medtronic) (Device)
结局指标
主要结局
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
时间窗: Day of hospital admission (12 hours)
A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.
次要结局
未报告次要终点
研究者
Bruce A. Buckingham
Director, Pediatric Endocrinology
Stanford University