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Clinical Trial NCT07491133 (T1Temp) for Type 1 Diabetes Mellitus is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of Ambient Temperature on Blood Glucose and Insulin Absorption in Adults With Type 1 Diabetes (T1Temp) 30
Clinical Trial NCT07491133 (T1Temp) is an interventional study for Type 1 Diabetes Mellitus and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 30 participants. Led by Institut de Recherches Cliniques de Montreal, this study is expected to complete by 1 July 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief 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 ...
Detailed Description
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 fro...
Show MoreOfficial Title
Effect of Ambient Temperature on Insulin Absorption and Change in Blood Glucose Levels in Individuals With Type 1 Diabetes
Conditions
Type 1 Diabetes MellitusPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- T1Temp
- 2026-1330
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-07
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Type 1 diabetes
Insulin absorption
Temperature exposure
Blood glucose
Continuous glucose monitoring
Hypoglycemia
Insulin absorption
Temperature exposure
Blood glucose
Continuous glucose monitoring
Hypoglycemia
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCold exposure 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 an...Show More | 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 inclu...Show More |
Active ComparatorNeutral Temperature 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 physiologic...Show More | 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 inclu...Show More |
ExperimentalHot/Humid Exposure 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 s...Show More | 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 inclu...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in plasma glucose concentration during temperature 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. | Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in plasma insulin concentration during temperature exposure | Change in circulating insulin levels (pmol/L) from baseline across the three temperature conditions. Blood samples collected via intravenous catheter will be analyzed for plasma insulin concentration to assess temperature effects on insulin absorption from subcutaneous injection sites. | Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure. |
24-hour time in glucose range | Percentage of time spent in target glucose range (3.9-10.0 mmol/L) as measured by continuous glucose monitoring (Dexcom G7). This will assess whether temperature exposure has lasting effects on glucose control beyond the immediate exposure period. | 24 hours before and 24 hours after each temperature exposure visit. |
24-hour time above glucose range | Percentage of time spent above target glucose range (\>10.0 mmol/L) as measured by continuous glucose monitoring. This measure will identify potential hyperglycemic episodes following temperature exposure. | 24 hours before and 24 hours after each temperature exposure visit. |
24-hour time below glucose range | Percentage of time spent below target glucose range (\<3.9 mmol/L) as measured by continuous glucose monitoring. This safety measure will identify potential hypoglycemic episodes following temperature exposure. | 24 hours before and 24 hours after each temperature exposure visit. |
Continuous glucose monitor accuracy | Mean absolute relative difference (MARD) between continuous glucose monitor readings and plasma glucose measurements. This will assess whether temperature conditions affect the accuracy of glucose monitoring technology, which is critical for diabetes management during extreme weather. | During each 2-hour temperature exposure. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- Diagnosis of type 1 diabetes for more than 2 years
- Ability to provide verbal and written informed consent
- Ability to speak and understand French
- 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
Institut de Recherches Cliniques de Montreal- Cardiometabolic Health, Diabetes and Obesity Research Network
- Centre EPIC
Study Central Contact
Contact: Corinne Suppere, MSc, 514-987-5597, [email protected]
Contact: Jane Yardley, PhD, 514-987-5568, [email protected]
1 Study Locations in 1 Countries
Quebec
Institut de recherches cliniques de Montréal, Montreal, Quebec, H2W 1R7, Canada