Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Continuous glucose monitor (CGM) % time >140 mg/dL
研究概览
简要总结
This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.
详细描述
Specific Aims:
Perform randomized controlled trial of intensive follow-up of stage 2 T1D participants utilizing continuous glucose monitoring (CGM) technology and early education of families to guide early insulin therapy with the goals of:
maintaining HbA1c less than 7.0%. avoiding adverse outcomes: ER visits, hospitalizations, DKA and severe hypoglycemia improving diabetes knowledge through optimal planned education as opposed to 'a crash course' at unexpected diagnosis event.
evaluating patient/caregiver satisfaction with diabetes care received evaluating impact of activity on glycemic profile Collect longitudinal biomarkers of beta-cell stress and dysfunction in stage 2 T1D.
Use longitudinal CGM data combined with "gold-standard" OGTT and HbA1c measures to provide evidence for CGM-based diagnostic criteria for stage 2 and stage 3 T1D.
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 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Continuous glucose monitor (CGM) % time >140 mg/dL
时间窗: Baseline and 3, 6, 9 and 12 months
Data obtained for Dexcom G6 wear with at least 5 days of data at each time point. Continuous glucose monitor (CGM) % time \>140 mg/dL will be analyzed using linear mixed models incorporating data from all 5 time points, with an interaction between group and time to test for differences in change in outcome over time. Contrast statements will be used to test for comparisons of intervention vs controls.
Change in Diabetes Knowledge from baseline to 6 month follow-up.
时间窗: Baseline, 6 months
35-item diabetes questionnaire with possible responses true/false/don't know. Total score is the number of correct answers out of 35, with more correct answers indicating higher knowledge. Change from baseline to 6-month follow-up will be compared between groups
次要结局
- Change in HbA1c(Baseline and 3, 6, 9 and 12 months)
- Change in C-peptide response to Oral Glucose Tolerance Test (OGTT)(Baseline, 6 months, 12 months)
- Change in insulin response to Oral Glucose Tolerance Test (OGTT)(Baseline, 6 months, 12 months)
- Change in Pediatric Quality of Life Inventory (PedsQL 4.0) score over time(Baseline and 3, 6, 9 and 12 months)
- % with HbA1c <7.0%(Baseline and 3, 6, 9 and 12 months)
- Continuous glucose monitor (CGM) mean sensor glucose level (mg/dL)(Baseline and 3, 6, 9 and 12 months)
- Continuous glucose monitor (CGM) standard deviation sensor glucose level (mg/dL)(Baseline and 3, 6, 9 and 12 months)
- Continuous glucose monitor (CGM) coefficient of variation sensor glucose level (mg/dL)(Baseline and 3, 6, 9 and 12 months)
- Continuous glucose monitor (CGM) % time in range 60-140 mg/dL(Baseline and 3, 6, 9 and 12 months)
- Diabetes attitude survey change over time(Baseline, 6 months, 12 months)