Effect of Ambient Temperature on Insulin Absorption and Change in Blood Glucose Levels in Individuals With Type 1 Diabetes
Study explores how temperature affects blood sugar and insulin in type 1 diabetes
Plain English Summary
Effect of Ambient Temperature on Blood Glucose and Insulin Absorption in Adults With Type 1 Diabetes is a Not Applicable clinical trial sponsored by Institut de Recherches Cliniques de Montreal studying Type 1 Diabetes Mellitus. This study tests how cold, normal, and hot temperatures impact blood sugar levels and insulin absorption in adults with type 1 diabetes. It is for adults diagnosed with type 1 diabetes for over two years. Participants will spend 2 hours in three different temperature-controlled rooms (cold, normal, hot) and wear a glucose monitor. Alternatives include managing diabetes with current guidelines and monitoring blood sugar closely, especially during weather changes. The trial aims to enroll 30 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with type 1 diabetes for at least 2 years can join. You must be able to understand and speak French. You cannot join if you have had a recent unstable health condition (within 3 months), a viral infection, or other chronic illnesses besides type 1 diabetes. Pregnant or breastfeeding individuals and those with uncontrolled health conditions cannot participate. This trial is studying Type 1 Diabetes Mellitus, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how much blood sugar levels change during exposure to different temperatures, helping to understand if temperature directly affects glucose control. The specific primary outcome measures are: Change in plasma glucose concentration during temperature exposure (Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it addresses how climate change and extreme weather may affect the daily management of type 1 diabetes, a condition already sensitive to environmental factors. This research targets Type 1 Diabetes Mellitus, where improved treatment options are needed.
Investor Insight
This trial could inform new management strategies for type 1 diabetes, potentially impacting a significant patient population and offering a competitive edge to sponsors developing climate-resilient d
Is This Trial Right for Me?
Ask your doctor if this study is right for you, especially if you live in an area with extreme weather. You will attend three separate visits, each lasting 2 hours in a different temperature room, with monitoring of your blood sugar and body vitals. You will wear a continuous glucose monitor for a few days around each visit and keep a diary of your food, sleep, and activity. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: NONE
- Enrollment: 30 participants
Interventions
- OTHER: Environmental Temperature Exposure — Systematic exposure to controlled temperature and humidity conditions in a specialized environmental chamber. Each exposure lasts 120 minutes with participants remaining seated throughout. All exposures include standardized pre-exposure preparation (60-minute baseline period at room temperature), continuous physiological monitoring, standardized clothing, and identical blood sampling schedules. Safety protocols include continuous staff supervision, predetermined stopping criteria for extreme bod
Primary Outcomes
- Change in plasma glucose concentration during temperature exposure (Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.)
Secondary Outcomes
- 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.)
Full Eligibility Criteria
Inclusion Criteria: * Diagnosis of type 1 diabetes for more than 2 years * Ability to provide verbal and written informed consent * Ability to speak and understand French Exclusion Criteria: * 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
Trial Locations
- Institut de recherches cliniques de Montréal, Montreal, Quebec, Canada
Frequently Asked Questions
What is clinical trial NCT07491133?
NCT07491133 is a Not Applicable INTERVENTIONAL study titled "Effect of Ambient Temperature on Blood Glucose and Insulin Absorption in Adults With Type 1 Diabetes." It is currently not yet recruiting and is sponsored by Institut de Recherches Cliniques de Montreal. The trial targets enrollment of 30 participants.
What conditions does NCT07491133 study?
This trial investigates treatments for Type 1 Diabetes Mellitus. The primary condition under study is Type 1 Diabetes Mellitus.
What treatments are being tested in NCT07491133?
The interventions being studied include: Environmental Temperature Exposure (OTHER). Systematic exposure to controlled temperature and humidity conditions in a specialized environmental chamber. Each exposure lasts 120 minutes with participants remaining seated throughout. All exposures include standardized pre-exposure preparation (60-minute baseline period at room temperature), continuous physiological monitoring, standardized clothing, and identical blood sampling schedules. Safety protocols include continuous staff supervision, predetermined stopping criteria for extreme bod
What does Not Applicable mean for NCT07491133?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07491133?
This trial is currently "Not Yet Recruiting." It started on 2026-03. The estimated completion date is 2027-07.
Who is sponsoring NCT07491133?
NCT07491133 is sponsored by Institut de Recherches Cliniques de Montreal. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07491133?
The trial aims to enroll 30 participants. The trial has not yet started recruiting.
How is NCT07491133 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs none masking.
What are the primary outcomes being measured in NCT07491133?
The primary outcome measures are: Change in plasma glucose concentration during temperature exposure (Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07491133 being conducted?
This trial is being conducted at 1 site, including Montreal, Quebec (Canada).
Where can I find official information about NCT07491133?
The official record for NCT07491133 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07491133. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07491133 testing in simple terms?
This study tests how cold, normal, and hot temperatures impact blood sugar levels and insulin absorption in adults with type 1 diabetes. It is for adults diagnosed with type 1 diabetes for over two years.
Why is this trial significant?
This trial is important because it addresses how climate change and extreme weather may affect the daily management of type 1 diabetes, a condition already sensitive to environmental factors.
What are the potential risks of participating in NCT07491133?
Potential risks include discomfort from extreme temperatures and minor discomfort from blood draws. Close monitoring is in place to stop the study if any participant experiences unsafe physiological changes. Changes in blood sugar levels during the study could require adjustments to insulin or food intake. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07491133?
Ask your doctor if this study is right for you, especially if you live in an area with extreme weather. You will attend three separate visits, each lasting 2 hours in a different temperature room, with monitoring of your blood sugar and body vitals. You will wear a continuous glucose monitor for a few days around each visit and keep a diary of your food, sleep, and activity. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07491133 signal from an investment perspective?
This trial could inform new management strategies for type 1 diabetes, potentially impacting a significant patient population and offering a competitive edge to sponsors developing climate-resilient d This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will spend 2 hours in three different temperature-controlled rooms (cold, normal, hot) and wear a glucose monitor. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Type 1 Diabetes Mellitus Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.