Temperature Effects for Type 1 Diabetes
(T1Temp Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to examine how different temperatures affect blood sugar levels in adults with type 1 diabetes. Researchers seek to determine if extreme weather changes, such as very cold or hot days, impact the body's insulin absorption, which is crucial for managing diabetes. Participants will sit in rooms set to cold, normal, and hot temperatures to observe the effects on their blood sugar and insulin levels. Individuals who have had type 1 diabetes for more than two years and can speak and understand French may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance diabetes management strategies.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that environmental temperature exposure is safe for people with type 1 diabetes?
Past studies have shown mixed effects of cold weather on people with diabetes. Some research suggests that cold temperatures can hinder blood sugar control by reducing the body's insulin efficiency, leading to higher blood sugar levels. However, other studies have found that brief cold exposure can help the body maintain effective insulin use.
Regarding hot and humid weather, research shows that high temperatures can impact insulin use. Heat can make it harder for the body to lower blood sugar levels, increasing the risk of diabetes-related health issues during very hot weather.
Overall, both cold and hot conditions can affect blood sugar and insulin use differently. However, these changes have not been linked to serious safety problems in the controlled settings of studies. While temperature changes can impact blood sugar, they have not been associated with immediate safety concerns in research environments.12345Why are researchers excited about this trial?
Unlike standard treatments for Type 1 Diabetes, which typically involve insulin therapy and dietary management, this trial explores how environmental temperature exposure affects insulin absorption and glucose metabolism. Researchers are excited because the cold exposure aims to boost energy expenditure through shivering thermogenesis, potentially altering how the body absorbs insulin by reducing skin blood flow. Meanwhile, the hot/humid exposure may enhance insulin absorption due to increased skin blood flow from vasodilation. These innovative approaches could lead to new ways to manage glucose levels by simply adjusting environmental conditions.
What evidence suggests that this trial's temperature conditions could affect blood sugar levels in type 1 diabetes?
This trial will explore how different environmental temperatures affect blood sugar management in individuals with type 1 diabetes. Participants in the cold exposure arm will face cold temperatures, which research suggests might reduce the body's responsiveness to insulin, potentially complicating blood sugar control. Some studies indicate that cold can lower fasting blood sugar levels, though this effect varies among individuals. Meanwhile, participants in the hot/humid exposure arm will encounter conditions that may cause insulin to work faster due to increased blood flow to the skin, potentially lowering blood sugar levels and increasing the risk of hypoglycemia. The neutral temperature arm will serve as a control to assess baseline insulin absorption and glucose responses without temperature-induced physiological stress. This trial aims to understand how both very cold and very hot weather can affect blood sugar control in different ways.15678
Are You a Good Fit for This Trial?
This trial is for adults who have had type 1 diabetes for over 2 years, can speak and understand French, and are generally healthy. People with other chronic illnesses, recent or unstable health conditions, viral infections, or those who are pregnant or breastfeeding cannot participate.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
Trial Overview
The study tests how different room temperatures (cold, normal, hot/humid) affect blood sugar levels and insulin absorption in people with type 1 diabetes. Each participant experiences all three temperature settings on separate days while their glucose and vital signs are monitored.
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
Citations
Impact of cold waves on diabetes-related morbidity and mortality
The meta-analysis revealed a 40% increase in diabetes-related mortality risk (relative risk: 1.40, 95% confidence interval: 1.25–1.58) and a ...
Short-duration cold exposure decreases fasting-induced ...
In conclusion, cold exposure had no effect on REE but decreased fasting-induced glucose intolerance which was accompanied by a maintained insulin sensitivity.
Does a Cold Shower Really Lower Blood Sugar? Expert ...
The authors noted that while the evidence is not yet conclusive, there is a growing interest in the therapeutic potential of cold exposure. " ...
4.
digitalcommons.georgefox.edu
digitalcommons.georgefox.edu/cgi/viewcontent.cgi?article=1039&context=dmscDeliberate Cold Exposure as Augmentation for Diabetic ...
Four studies were conducted with a water temperature of 18° C, one at 14°. C, two studies at 10° C, one study with variable temperatures ...
Effect of Ambient Temperature on Blood Glucose and ...
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 ...
Managing Diabetes in Cold Weather
Cold weather can spike your blood sugar in a few ways. But you don't have to let the weather get the upper hand. Here are tips to help you stay on top of your ...
Type 1 Diabetes and Cold Weather
Cold temperatures can make it harder to manage your blood sugar, as they trigger reactions that reduce insulin sensitivity. [7]. “Cold weather ...
Effect of climate change, extreme temperatures (heat and cold ...
The results of this study revealed that extreme temperatures significantly increase the adverse diabetes-related events, hospitalizations, (ED ...
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