Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Glycemic Control
研究概览
简要总结
The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.
详细描述
Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division
- •Most recent HbA1c >= 8.5%
- •Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM
- •Patients and families must be willing to come to diabetes clinic once a month for 4 months
排除标准
- •Inability to understand and/or speak the English language
- •Pregnancy
- •Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study
结局指标
主要结局
Glycemic Control
时间窗: Baseline and visit 4
Serum hemoglobin A1c (HbA1c) will be measured in all groups at the baseline visit and visit 4.
次要结局
- Number of Hypoglycemic Excursions (CGM Glucose <70 mg/dL)(Total from baseline to visit 4)
- Satisfaction With Intensive Diabetes Clinic and Usage of the Continuous Glucose Monitor(Visit 4)
- Adherence to Prescribed Diabetes Regimen(Baseline and visit 4)
- Diabetes Knowledge(Baseline and month 4)
- Insulin Dose Changes(Baseline and visit 4)
研究者
Sarah A. MacLeish
Physician
University Hospitals Cleveland Medical Center