Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The percentage of time spent > 140 mg/dl on CGM
研究概览
简要总结
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy controls (n=45) -
- •Age 10-25 years
- •BMI <85th percentile
- •Baseline health at enrollment
- •CF controls (n=45) -
- •Age 10-25 years
- •Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
- •Baseline health at enrollment (no inclusion/exclusion criteria for CF patients based on lung function, BMI, pancreatic insufficiency, or genotype)
- •CF prediabetes & CFRD (n=70)
- •Age 10-25 years
- •Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
- •History of abnormal oral glucose tolerance testing (2h-glucose >140, fasting plasma glucose >100,1hr glucose >200)
- •If taking medication that affects glucose metabolism (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose over the past 3 months
排除标准
- •Healthy controls -
- •Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%
- •BMI ≥85th percentile
- •Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)
- •Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)
- •Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)
- •CF participants -
- •Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
- •Varying doses of medication affecting glucose metabolism in the past 3 months
- •Pulmonary exacerbation associated with hospitalization, or systemic steroid requirement in the preceding 6 weeks
结局指标
主要结局
The percentage of time spent > 140 mg/dl on CGM
时间窗: 7 days
Percentage of time above normal glucose cut-point.
次要结局
- The percentage of time spent < 60 mg/dl on CGM(7 days)
- The percentage of time spent > 120 mg/dl on CGM(7 days)
- The percentage of time spent > 200 mg/dl on CGM(7 days)
- The percentage of time spent < 70 mg/dl on CGM(7 days)
- The number of excursions > 200mg/dl in 24 hours for one week(7 days)