Effect of Ambient Temperature on Insulin Absorption and Change in Blood Glucose Levels in Individuals With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in plasma glucose concentration during temperature exposure
研究概览
简要总结
The goal of this clinical trial is to learn how different temperatures affect blood sugar levels in adults with type 1 diabetes. Climate change is causing more extreme hot and cold weather, and people with type 1 diabetes may be at higher risk during these temperature changes. The main questions it aims to answer are:
- Do different temperatures (cold, normal, or hot) change blood sugar levels in people with type 1 diabetes?
- How does temperature affect insulin absorption in the body?
Researchers will compare three different temperature conditions to see how each affects blood sugar levels and insulin in the body.
Participants will:
- Complete a screening visit with body measurements and questionnaires
- Attend 3 separate study visits, each in a different temperature setting:
- Cold room (10°C/50°F)
- Normal room temperature (23°C/73°F)
- Hot and humid room (36°C/97°F with 65% humidity)
- Sit for 2 hours in each temperature condition while researchers monitor their blood sugar, heart rate, and body temperature
- Wear a continuous glucose monitor for 48-72 hours before each visit
- Keep a diary of food, sleep, and activity for 24 hours before and after each visit
Each temperature visit is separated by at least 3 days. The study helps researchers understand if people with type 1 diabetes need special guidance for managing their blood sugar during extreme weather.
详细描述
Background and Rationale
Climate change is increasing the frequency of extreme weather events, including heat waves and cold snaps. People with type 1 diabetes face higher risks of illness and death during these extreme temperature periods compared to people without diabetes. However, the reasons for this increased risk are not well understood.
When insulin is injected under the skin, it forms a small reservoir from which it gradually enters the bloodstream. Temperature may affect how quickly this insulin is absorbed. Warmer temperatures increase blood flow to the skin, which could speed up insulin absorption and potentially cause blood sugar to drop too low (hypoglycemia). Colder temperatures might slow insulin absorption, leading to higher blood sugar levels (hyperglycemia).
Previous research from the 1980s showed that heating or cooling the injection site affects insulin absorption, but these studies were conducted before modern rapid-acting insulins and diabetes technologies like insulin pumps and continuous glucose monitors were available. No recent studies have examined how whole-body temperature exposure affects insulin absorption and blood sugar control in people with type 1 diabetes.
Study Design Overview
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes for more than 2 years
- •Ability to provide verbal and written informed consent
- •Ability to speak and understand French
排除标准
- •Recent and/or unstable health condition (less than 3 months) prior to enrolment
- •Any viral infection at time of participation
- •Chronic illness other than type 1 diabetes (for example: pulmonary disease, cardiovascular disease, cancer)
- •Health condition not controlled by medication
- •Pregnancy or breastfeeding (for female participants)
- •Any other health condition deemed to pose undue health risks during participation in the study
结局指标
主要结局
Change in plasma glucose concentration during temperature exposure
时间窗: Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.
The primary outcome is the change in plasma glucose levels (mmol/L) from baseline to end of exposure across the three temperature conditions (cold 10°C, neutral 23°C, hot/humid 36°C). Blood samples will be collected via intravenous catheter and analyzed for plasma glucose concentration. This measure will assess whether ambient temperature affects blood glucose control in individuals with type 1 diabetes, with the hypothesis that cold exposure may increase glucose levels due to slower insulin absorption, while heat exposure may decrease glucose levels due to faster insulin absorption.
次要结局
- Change in plasma insulin concentration during temperature exposure(Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.)
- 24-hour time in glucose range(24 hours before and 24 hours after each temperature exposure visit.)
- 24-hour time above glucose range(24 hours before and 24 hours after each temperature exposure visit.)
- 24-hour time below glucose range(24 hours before and 24 hours after each temperature exposure visit.)
- Continuous glucose monitor accuracy(During each 2-hour temperature exposure.)