NCT05454891已完成不适用
Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Glucose Area Under Curve [AUC]
研究概览
简要总结
This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 13 and 19 years old, A1C > 6% at screening
- •Diagnosed with type 1 diabetes for at least one year
- •Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day
- •Currently using the Control IQ closed-loop system
- •Willing to abide by meal recommendations and study procedures
- •Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF
- •Use an Android or Apple smartphone
- •Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- •Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
- •Parent/guardian proficient in reading and writing English
- •Live in the United States, with no plans to move outside the United States during the study period
排除标准
- •A1C >10%
- •One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months
- •Used non-insulin anti-diabetic medication within the last 30 days other than metformin
- •Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
- •Pregnancy or lactation
- •Untreated or unstable hypothyroidism
- •Currently undergoing cancer treatment or systemic treatment with steroids
- •Untreated or inadequately treated mental illness
- •Current alcohol abuse
- •Current illness that would interfere with participation in the study
- •Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying
- •Celiac Disease
结局指标
主要结局
Glucose Area Under Curve [AUC]
时间窗: Baseline and 5 hours post-bolus
Area under the curve between glucose trace and starting glucose (mg/dL\* hour)
次要结局
- Percentage of time in hypoglycemic range (defined as < 70 mg/dL)(Baseline and 5 hours post-bolus)
- Percentage of time between 70-180 mg/dL(Baseline and 5 hours post-bolus)
- Insulin dosage(Baseline and 5 hours post-bolus)
- Time to baseline(Baseline and 5 hours post-bolus)
- Change in glucose(Baseline and 5 hours post-bolus)
- Peak glucose concentration(Baseline and 5 hours post-bolus)
- Percentage of time between 70-140 mg/dL(Baseline and 5 hours post-bolus)
- Percentage of time in hyperglycemic range (defined as ≥180 mg/dL);(Baseline and 5 hours post-bolus)
- Average glucose(Baseline and 5 hours post-bolus)
- Time to target(Baseline and 5 hours post-bolus)
- Time to peak glucose(Baseline and 5 hours post-bolus)
研究者
研究点 (2)
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