Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Time Spent in Hypoglycemia (< 70 mg/dL)
研究概览
简要总结
The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.
详细描述
Synopsis of study protocol
This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control group). The investigators will examine group differences over a 6-month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial comparison of intervention to control across the first six months after diagnosis, the investigators will conduct a longitudinal follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18 months. The CGM system used in this study is the Dexcom G5 System with the Share function (FDA Approved). An IDE was obtained to use this system in a non-adjunctive manner. Participants will complete Phase 1 in six months. Phase 2 includes 3 more assessments conducted every six months until participants are two years post-diagnosis.
Study Procedures
Participants will be recruited at two centers: Stanford University and the Barbara Davis Center for Diabetes, University of Colorado. Participants will be enrolled while inpatient or within 1 month of diagnosis. Once identified, study staff will approach potential participants to explain the study, determine eligibility, and obtain informed consent. Once enrolled in the study, participants will be randomized. Participants will be randomized at a 2:1 ratio, intervention to control. The investigators will also stratify by age group to ensure equal representation of ages across groups. The age groups (in years) are 2-6, 7-11, and 12-17. To ensure safety in the youngest group, recruitment of participants in the age 2-6 years group will not begin until the investigators have at least 2 weeks of non-adjunctive CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on these 3 participants and if deemed safe by the DSMB, the investigators will start enrolling participants in the youngest age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, a child must meet the following criteria:
- •Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- •Time since diagnosis of no longer than one month
- •Age between 2 and 17 years
- •Parental consent (and assent from the child where applicable) to participate in the study
- •No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
- •To be eligible for the study, a parent must meet the following criteria:
- •Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- •Age of 18.0 years or older
- •Parent comprehends written English
- •Parent understands the study protocol and signs the informed consent document
排除标准
- •The presence of any of the following is an exclusion for the study:
- •Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- •Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- •Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- •Child is unable to completely avoid acetaminophen for duration of study
结局指标
主要结局
Time Spent in Hypoglycemia (< 70 mg/dL)
时间窗: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point.
Glucose Monitoring Satisfaction Survey (GMSS) - Parent
时间窗: Baseline, 24 months
The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction.
Time Spent in Blood Glucose Range (70-180mg/dL)
时间窗: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point.
次要结局
- State-Trait Anxiety Inventory(Baseline, 24 months)
- Pittsburgh Sleep Quality Index(Baseline, 24 months)
- Pediatric Quality of Life Inventory(Baseline, 24 months)
- General and Diabetes-specific Technology Use(Baseline, 24 months)
- Hypoglycemic Fear Survey(Baseline, 24 months)
- Center for Epidemiologic Studies Depression Measure(Baseline, 24 months)
- Problem Areas in Diabetes Score(Baseline, 24 months)
- Diabetes Distress Scale(Baseline, 24 months)
- Patient Health Questionnaire 9(Baseline, 24 months)
- Child Health Utility 9D(Baseline, 24 months)
- Hemoglobin A1c(Baseline, 24 months)
- Hypoglycemic Confidence Questionnaire(Baseline, 24 months)
- C-peptide(Baseline, 24 months)
研究者
Korey Hood
Clinical Professor
Stanford University