Insulin-based Strategies to Prevent Hypoglycemia During Exercise

NCT02631265 | Completed

• 1 other identifier: RIDE-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Exercise; Hypoglycemia; Insulin pump

Outcome Measures

Primary Outcomes (1)

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

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

  This outcome will be measured over 45 minutes.

Secondary Outcomes (13)

• Decrease in glucose levels

  This outcome will be measured over 45 minutes.

• Decremental area under the curve of sensor glucose levels

  This outcome will be measured over 45 minutes.

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

  This outcome will be measured over 45 minutes.

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

  This outcome will be measured over 45 minutes.

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

  This outcome will be measured over 45 minutes.

Study Arms (3)

Reduction of insulin basal rate at the time of exercise

ACTIVE COMPARATOR

Other: Exercise 1

Reduction of insulin basal rate 20 minutes prior to exercise

ACTIVE COMPARATOR

Other: Exercise 2

Reduction of insulin basal rate 40 minutes prior to exercise

ACTIVE COMPARATOR

Other: Exercise 3

Interventions

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).

Reduction of insulin basal rate at the time of exercise

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).

Reduction of insulin basal rate 20 minutes prior to exercise

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).

Reduction of insulin basal rate 40 minutes prior to exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Rémi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 16, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)