Temperature Effects for Type 1 Diabetes
(T1Temp Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preliminary Visit
Participants complete medical history, lifestyle questionnaires, and body measurements
Experimental Visits
Participants undergo temperature exposure in cold, neutral, and hot/humid conditions
Follow-up
Participants are monitored for safety and effectiveness after temperature exposure
What Are the Treatments Tested in This Trial?
Interventions
- Environmental Temperature Exposure
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will be exposed to hot and humid conditions (36°C/97°F with 65% relative humidity) in an environmental chamber for 120 minutes while seated. These conditions simulate a hot summer day in Montreal and are designed to increase skin blood flow through vasodilation, potentially accelerating insulin absorption from subcutaneous depot sites. The combination of heat and humidity will induce thermal stress and sweating responses. Participants will wear standard clothing (shorts and t-shirt) with access to water as needed. The same comprehensive monitoring protocol applies: continuous measurement of core body temperature, skin temperature at four body sites, heart rate, blood pressure every 10 minutes, and blood glucose every 15 minutes. Blood samples will be collected at baseline, 60 minutes, and 120 minutes. The exposure will be terminated if core body temperature reaches ≥39.5°C.
Participants will be exposed to cold temperature (10°C/50°F) in an environmental chamber for 120 minutes while seated. This temperature is designed to induce shivering thermogenesis and increase energy expenditure by approximately 80%. The cold exposure may slow insulin absorption from subcutaneous injection sites due to reduced skin blood flow and vasoconstriction. Participants will wear standard clothing (shorts and t-shirt) with optional socks and gloves if needed for comfort. Continuous monitoring includes core body temperature via rectal probe, skin temperature at four sites, heart rate, blood pressure every 10 minutes, and blood glucose via continuous glucose monitor every 15 minutes. Blood samples will be collected at baseline, 60 minutes, and 120 minutes for plasma glucose, insulin, glucagon, and metabolic markers. The exposure will be terminated if core body temperature drops to ≤35.5°C.
Participants will be exposed to neutral room temperature (23°C/73°F) in an environmental chamber for 120 minutes while seated. This condition serves as the control/reference temperature representing typical indoor environmental conditions. At this temperature, normal thermoregulatory responses are minimal, allowing assessment of baseline insulin absorption and glucose responses without temperature-induced physiological stress. Participants will wear standard clothing (shorts and t-shirt) and undergo the same monitoring protocol as other arms: continuous core and skin temperature measurement, heart rate monitoring, blood pressure every 10 minutes, blood glucose monitoring every 15 minutes via continuous glucose monitor, and blood sampling at baseline, 60 minutes, and 120 minutes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institut de Recherches Cliniques de Montreal
Lead Sponsor
Cardiometabolic Health, Diabetes and Obesity Research Network
Collaborator
Centre EPIC
Collaborator
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