Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Descriptive endpoints
研究概览
简要总结
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.
详细描述
This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy.
Run-in Period A total of up 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (sensor augmented pump) will be used to collect sensors and insulin data and to allow the subject to become familiar.
Study Period - Camp Following the run-in period subjects will participate in a 5 day, 4 night study period in an camp setting during which the CL feature will be studied.
Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates.
Subjects will be asked to exercise for up to 60 minutes on one day during their study period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes duration > 1 year since diagnosis
- •Sensor augmented Pump for at least 6 months
- •A1C <10.0 at time of screening visit
- •Willing to follow study instructions
- •Willing to perform ≥ 5 finger stick blood glucose measurements daily
- •Willing to perform required sensor calibrations
- •Patient capable of reading and understand instructions in English
排除标准
- •Subject is unable to tolerate tape adhesive in the area of sensor placement
- •Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- •Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- •Subject has a positive pregnancy screening test
- •Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception
- •Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit
- •Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- •Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
- •Subject has a history of a seizure disorder
- •Subject has central nervous system or cardiac disorder resulting in syncope
- •Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- •Subjects with hematocrit lower than the normal reference range per POC or local lab testing
- •Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
- •Subjects with a history of adrenal insufficiency
- •Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
研究组 & 干预措施
Hybrid-logic closed loop system
All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump.
干预措施: Hybrid-logic closed loop system (Device)
结局指标
主要结局
Descriptive endpoints
时间窗: after 4 days of camp
Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL
次要结局
- Descriptive endpoints(after 4 days of camp)