Effect of Ambient Temperature on Blood Glucose and Insulin Absorption in Adults With Type 1 Diabetes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorInstitut de Recherches Cliniques de Montreal

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of type 1 diabetes for more than 2 years

Ability to provide verbal and written informed consent

Ability to speak and understand French

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Environmental Temperature Exposure

    Other intervention

    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 body temperatures or blood pressure changes, and immediate availability of warming/cooling interventions and hypoglycemia treatment protocols.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Cold exposureExperimental treatment 1 intervention
Group B: Neutral TemperatureActive comparator 1 intervention
Group C: Hot/Humid ExposureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.

Secondary outcomes

1

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.

Time frame
Measured at baseline, 60 minutes, and 120 minutes during each 2-hour environmental chamber exposure.
2

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.

Time frame
24 hours before and 24 hours after each temperature exposure visit.
3

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.

Time frame
24 hours before and 24 hours after each temperature exposure visit.
4

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.

Time frame
24 hours before and 24 hours after each temperature exposure visit.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut de Recherches Cliniques de Montreal

Lead sponsor

Cardiometabolic Health, Diabetes and Obesity Research Network

Collaborator

Centre EPIC

Collaborator

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