In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Unanticipated Device Effect (UADE)
研究概览
简要总结
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.
详细描述
A total of up to 95 subjects with type 1 diabetes (age 14-75 years old) will be enrolled at up to 8 investigational centers in order to reach a minimum of 60 subjects who will complete the study (N=minimum 40 adult subjects, 22-75 years old) and N=minimum 15 pediatric subjects (14-21 years old). Subjects will be evaluated in an in-clinic setting with induction of hypoglycemia by increasing their basal rate using a standardized titration tool referred to in protocol as rate of change basal increase algorithm (Buckingham, Diabetes Care 5, 2010). Total duration of frequent sample testing (FST) using Yellow Springs Instrument (YSI) may be up to 19 hours.
Subjects will undergo in-clinic testing on Sensor Day 1.
All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
The In-Clinic part of the study consists of hypoglycemic induction and an observation period.
Hypoglycemic induction ends when one of the following 3 criteria is met, whichever comes first:
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 14-75 years of age at time of screening
- •Subject has a clinical diagnosis of type 1 diabetes, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
- •Inclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- •On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
- •Adequate venous access as assessed by investigator or appropriate staff
排除标准
- •Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- •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 urine or serum pregnancy screening test
- •Subject is female, sexually active without use of contraception and plans to become pregnant during the course of the study
- •Subject has had a hypoglycemic induced 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 (Hct) lower than the normal reference range for age per 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
Predictive Low Glucose Management (PLGM)
To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor
干预措施: Predictive Low Glucose Management Feature in Insulin pump (Device)
结局指标
主要结局
Unanticipated Device Effect (UADE)
时间窗: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of incidence of UADE during in-clinic procedures
Severe Hypoglycemia
时间窗: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of incidence of severe hypoglycemia during in-clinic procedures
Diabetic Ketoacidosis
时间窗: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of DKA during in-clinic procedures
Rescue Events During In-clinic Procedues
时间窗: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Serious Adverse Events (SAE)
时间窗: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
Evaluation of incidence of SAE during in-clinic procedures
次要结局
未报告次要终点