Skip to main content
OpenTrials
Completed

NCT Number: NCT02631265

Insulin-based Strategies to Prevent Hypoglycemia During Exercise

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 2 months) HbA1c ≤ 12%.

Exclusion criteria

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Abnormal blood panel and/or anemia.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
  • Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).

Treatment and study plan

Exercise 1

Other

Participants will be admitted at IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Exercise 2

Other

Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Exercise 3

Other

Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Primary outcomes

  1. Percentage of time of capillary blood glucose levels spent below 4 mmol/L

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

Secondary outcomes

  1. Decrease in glucose levels

    Time frame: This outcome will be measured over 45 minutes.

    Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until the end of exercise. This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  2. Decremental area under the curve of sensor glucose levels

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  3. Area under the curve of sensor glucose levels < 4 mmol/L

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  4. Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  5. Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  6. Number of patients requiring an oral treatment for hypoglycemia

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  7. Total number of hypoglycemia episode requiring treatment

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  8. Percentage of time spent between 4 and 10 mmol/L

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  9. Mean time (minutes) to the first hypoglycemic event

    Time frame: This outcome will be measured over 45 minutes.

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  10. Percentage of time spent < 4.0 mmol/L

    Time frame: This outcome will be measured over 14.75 hours.

    This time frame corresponds to the post-exercise period, from the end of the exercise until 7:00 the next morning.

  11. Percentage of time of sensor glucose levels spent below 4 mmol/L

    Time frame: This outcome will be measure over 45 minutes

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  12. Absolute difference between capillary blood glucose levels and sensor glucose levels

    Time frame: This outcome will be measure over 45 minutes

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

  13. Relative difference between capillary blood glucose levels and sensor glucose levels

    Time frame: This outcome will be measure over 45 minutes

    This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults With Type 1 Diabetes Using Insulin Pump Therapy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2015
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.