Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise

NCT03845114 | Completed

• 1 other identifier: RIDE-2
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

Regular exercise is associated with many health benefits for individuals with type 1 diabetes. However, immediate and delayed exercise-induced hypoglycemia is frequent and thus the main limiting factor for physical activity practice in this population. To reduce the risk of exercise-induced hypoglycemia, two types of adjustments may be considered by patients with type 1 diabetes : pre-meal insulin-dose reduction and carbohydrate supplements. Few evidence-based recommendations are available for patients using insulin pump to adjust insulin doses in order to limit exercise-induced hypoglycemia. The objective of this study is to address the magnitude of the needed reduction during two types of frequently practiced exercise (continuous vs. interval exercise) known to have a different impact on blood glucose reduction.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes; Exercise; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Decrease in plasma glucose levels during exercise

  Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise

  60 minutes

Secondary Outcomes (11)

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

  60 minutes

• Decremental area under the curve of plasma glucose levels

  60 minutes

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

  60 minutes

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

  60 minutes

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

  60 minutes

Study Arms (4)

Continuous exercise - Basal insulin reduced by 40%

ACTIVE COMPARATOR

Other: Continous exercise; Other: Reduction of basal insulin by 40%

Continuous exercise - Basal insulin reduced by 80%

ACTIVE COMPARATOR

Other: Continous exercise; Other: Reduction of basal insulin by 80%

Interval exercise - Basal insulin reduced by 40%

ACTIVE COMPARATOR

Other: Interval exercise; Other: Reduction of basal insulin by 40%

Interval exercise - Basal insulin reduced by 80%

ACTIVE COMPARATOR

Other: Interval exercise; Other: Reduction of basal insulin by 80%

Interventions

Continous exercise OTHER

60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

Continuous exercise - Basal insulin reduced by 40%; Continuous exercise - Basal insulin reduced by 80%

Interval exercise OTHER

Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

Interval exercise - Basal insulin reduced by 40%; Interval exercise - Basal insulin reduced by 80%

Reduction of basal insulin by 40% OTHER

Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.

Continuous exercise - Basal insulin reduced by 40%; Interval exercise - Basal insulin reduced by 40%

Reduction of basal insulin by 80% OTHER

Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.

Continuous exercise - Basal insulin reduced by 80%; Interval exercise - Basal insulin reduced by 80%

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 14 years of old.
• Clinical diagnosis of type 1 diabetes for at least two years.
• The subject will have been on insulin pump therapy for at least 3 months.
• Last (less than 2 months) HbA1c ≤ 10%.

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy 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
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (2)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

McGill University Health Center

Montreal, Quebec, 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: Full professor

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: June 30, 2019
• Primary Completion: December 15, 2023
• Study Completion: August 30, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

CA (2)