Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise (RIDE-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Continous exercise; Other: Reduction of basal insulin by 40%; Other: Reduction of basal insulin by 80%; Other: Interval exercise

Detailed Description

Each study participant will be admitted at IRCM one to five days after sensor insertion. Participants will be asked to change their pump catheter 24 to 36 hours prior to the intervention visit. On the day of the intervention visit, participants will have a standardized lunch (45-65g CHO for females and 60-80g CHO for males ) at 12:00 and will be asked not to eat afterwards (except for correction of hypoglycemia). Participants will be asked not to exercise (excluding light exercise such as walking or taking the stairs) the day before and the day of the intervention visit. Participants will be asked not to consume caffeine after 12:00 the day of the intervention. The day before the intervention and the day of the intervention, participants will be asked to refrain from alcohol consumption. Participants will be blinded to the strategy used during the exercise intervention. Participants will be admitted at IRCM at 14:00. A catheter will be installed for plasma glucose and insulin measurements. At 14:30, insulin basal rate will be reduced by 40% or 80% depending of randomization. At 15:30, participants will undertake a continuous exercise (60-minute exercise on the ergocycle at 60% of VO2 peak) or an interval exercise (2-minutes alternating intervals at 85% and 50% of VO2peak for 50-minutes, with 5-minutes at 45% VO2peak at the start and the end of exercise). As a safety measure, plasma glucose will be measured every 10 minutes. Participants will be blinded to sensor glucose levels as well as plasma glucose measurements. At 17:00, the participant will be discharged if glucose levels are above 5.5 mmol/L. Participants will be asked to eat a standardized dinner at home (45-65g CHO for females and 60-80g CHO for males). Participants will have the freedom to choose at what time they wish to have dinner but it will have to be similar on all intervention visits.

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinne Suppère, M.Sc.; Phone Number: 514-987-5597; Email: corinne.suppere@ircm.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Recruiting
      • Institut de Recherches Cliniques de Montreal
      • Principal Investigator: Remi Rabasa-Lhoret
      • Contact: Corinne Suppère
    • Montreal, Quebec, Canada
      • Not yet recruiting
      • McGill University Health Center
      • Principal Investigator: Laurent Legault
      • Contact: Laurent Legault

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Abnormal blood panel and/or anemia.
4. Ongoing pregnancy.
5. Severe hypoglycemic episode within two weeks of screening.
6. 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).
7. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous exercise - Basal insulin reduced by 40%	Other: Continous exercise; 60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).; Other: Reduction of basal insulin by 40%; Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.
Active Comparator: Continuous exercise - Basal insulin reduced by 80%	Other: Continous exercise; 60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).; Other: Reduction of basal insulin by 80%; Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.
Active Comparator: Interval exercise - Basal insulin reduced by 40%	Other: Reduction of basal insulin by 40%; Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.; Other: Interval exercise; Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
Active Comparator: Interval exercise - Basal insulin reduced by 80%	Other: Reduction of basal insulin by 80%; Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.; Other: Interval exercise; Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of patients requiring an oral treatment for hypoglycemia	60 minutes
Total number of hypoglycemia episodes requiring treatment	60 minutes
Percentage of time of plasma glucose levels spent > 10 mmol/L	60 minutes
Percentage of time of plasma glucose levels spent between 4-10 mmol/L	60 minutes
Mean time to the first hypoglycemic event	60 minutes
Amount of carbohydrates needed to treat a hypoglycemic event	60 minutes

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): February 15, 2024

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypoglycemia; Exercise; Type 1 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: RIDE-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No