A Pilot Study of Activity-Based Bolus Decisions in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Continuous Glucose Monitor metrics
研究概览
简要总结
The purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in Type 1 Diabetes.
详细描述
Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. The aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes for at least one year
- •Using an insulin pump for at least 6 months
- •Uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections
- •Access to internet and willing to upload data during the study
- •Willingness to maintain consistent activity regimen for 28 day collection period
- •Females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. A negative urine/blood pregnancy test will be required for all women of child bearing potential. Subjects who become pregnant will be discontinued from the study.
- •Demonstration of proper mental status and cognition for the study.
- •An understanding of and willingness to follow the protocol and sign the informed consent.
排除标准
- •Diabetic ketoacidosis (DKA) in the 6 months prior to enrollment.
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
- •Pregnancy and intent to become pregnant during trial.
- •Use of acetaminophen is not allowed when CGM is in use
- •Use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide [GLP]-1 agonists, metformin)
- •Currently uses a clearly defined method for insulin bolusing to compensate for significant activity (e.g. marathon runner who uses temporary basal rates routinely and has separate basal profiles to account for exercise)
- •Inability to be physically active for more than 30 minutes per day.
- •Current enrollment in another intervention clinical trial.
研究组 & 干预措施
Activity on Board
Blinded CGM data will be collected prior to the Experimental Admission to determine the insulin bolus that will be determined by the activity on board calculator. Subjects will wear a continuous glucose monitor during the study admission.
干预措施: Activity on Board (Other)
Usual Diabetes Care
Subjects will use their usual diabetes care, including basal rate, correction factor and carbohydrate-insulin ratio. Subjects will determine their own insulin usage during the Control Admission. Subjects will wear a continuous glucose monitor during the study admission.
干预措施: Usual Diabetes Care (Other)
结局指标
主要结局
Continuous Glucose Monitor metrics
时间窗: about 9-12 hours
Record CGM metrics with the primary outcome analysis of percentage time \<70 mg/dL by CGM following exercise comparing the experimental to control admission
次要结局
未报告次要终点
研究者
Marc Breton
Principal Investigator
University of Virginia