The Effects of Continuous Glucose Monitoring Interventions in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in HbA1c
研究概览
简要总结
The goal of this pilot longitudinal study is to investigate whether intermittent use of the Dexcom G7 continuous glucose monitor, together with pediatric endocrinology follow-up, diabetes education, and psychological support, can improve glucose control in children and adolescents with high-risk type 1 diabetes in the Dominican Republic.
The study will include 40 participants, 10 to 19 years of age, from two pediatric diabetes care centers. Participants will use the Dexcom G7 during two short monitoring periods in the early part of the study. Each participant will use six sensors in total. Between and after these monitoring periods, participants will return to their usual finger-stick glucose monitoring with a glucometer. Participants and their families will also attend scheduled medical visits, diabetes education sessions, and psychological support sessions.
Study information will be collected from medical records, laboratory results, Dexcom Clarity reports, participant glucose logs, study forms, and questionnaires.
The study will assess changes in HbA1c, time in range, average glucose, glucose variability, low and high blood glucose episodes, adverse events, diabetes-related distress, fear of hypoglycemia, and satisfaction with glucose monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c >9.0%
- •Age range: 10-19 years
- •Disposition and availability for patients and families to attend scheduled provider meetings, as well as general diabetic educational and psychological support meetings throughout the whole study. Namely, meeting every 2 weeks for the first 3 months and then every 4 weeks until completion of study for next 12 months.
- •Willingness and ability to provide signed voluntary consent form. Date and signature is requested however based on literacy levels a patient can provide consent verbally as long as there is a witness who is 18 years or older and demonstration of acknowledgement of information provided.
排除标准
- •Diagnosis of T1D within the past 12 months
- •Previous or current use of CGM like FreeStyle Libre 2, Dexcom (G6, G7), or similar devices from other companies not mentioned
- •Current use of continuous insulin pump in combination with CGM use at present or prior to study
- •Residence location with greater than 3 hours of travel time distance from each health center in setting of cost and feasibility for families to travel on frequent necessary basis
- •Current steroid therapy orally or intravenously.
- •Medical comorbidities including chronic renal disease, hemoglobinopathies, leukemia, hematologic or oncologic conditions that can affect glycemia
- •Pregnancy
结局指标
主要结局
Change in HbA1c
时间窗: Baseline, 3 months, 6 months, 9 months and 12 months
Change in % CGM Time in Range
时间窗: Baseline, Month 1 and Month 4
次要结局
- Mean sensor glucose(Month 1 and Month 4)
- % CGM Time in tight range(Month 1 and Month 4)
- % CGM time spent above range(Month 1 and Month 4)
- % CGM time below range(Month 1 and Month 4)
- CGM glycemic variability(Month 1 and Month 4)
- Episodes of diabetic ketoacidosis(Throughout study follow-up duration of 12 months)
- Episodes of severe hypoglycemia(Throughout study follow-up duration of 12 months)
- Change in Fear of Hypoglycemia(Baseline and Month 3)
- Change in Diabetes-Related Distress(Baseline and Month 3)
- Satisfaction With Glucose Monitoring(Month 6)