Insulin-based Strategies to Prevent Hypoglycemia During Exercise

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

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. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 minutes prior to exercise.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Exercise 2; Device: Dexcom G4 Platinum; Drug: Insulin; Device: Insulin pump; Other: Exercise 1

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre
      • Contact: Laurent Legault; Email: laurent.legault@muhc.mcgill.ca
    • Montréal, Quebec, Canada, H2W 1R7
      • Recruiting
      • Institut de Recherches Cliniques de Montreal
      • Contact: Semah Tagougui; Email: semah.tagougui@ircm.qc.ca

Participation Criteria

Eligibility Criteria

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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reduction of insulin basal rate 40 minutes prior to exercise	Other: Exercise 2; Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.; Device: Dexcom G4 Platinum; The Dexcom G4 Platinum will be used to measure continuous glucose levels.; Drug: Insulin; Participant's usual fast-acting insulin analog will be used.; Device: Insulin pump; Participant's insulin pump will be used to infuse insulin.
Active Comparator: Reduction of insulin basal rate 90 minutes prior to exercise	Device: Dexcom G4 Platinum; The Dexcom G4 Platinum will be used to measure continuous glucose levels.; Drug: Insulin; Participant's usual fast-acting insulin analog will be used.; Device: Insulin pump; Participant's insulin pump will be used to infuse insulin.; Other: Exercise 1; Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in glucose levels	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 (exercise period)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients requiring an oral treatment for hypoglycemia	60 minutes (exercise period)
Total number of hypoglycemia episodes requiring treatment	60 minutes (exercise period)
Mean time (minutes) to the first hypoglycemic event	60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event	60 minutes (exercise period)
Percentage of time of glucose levels spent below 4 mmol/L	60 minutes (exercise period)
Decremental area under the curve of glucose levels	60 minutes (exercise period)
Area under the curve of glucose levels < 4 mmol/L	60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L	60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L	60 minutes (exercise period)
Percentage of time of glucose levels spent > 10 mmol/L	60 minutes (exercise period)
Percentage of time of glucose levels spent between 4-10 mmol/L	60 minutes (exercise period)
Muscle blood flow	60 minutes (exercise period)
Percentage of time of glucose levels spent between 4 and 10 mmol/L	4 hours following end of exercise
Percentage of time of glucose levels spent < 4 mmol/L	4 hours following end of exercise
Percentage of time of glucose levels spent > 10 mmol/L	4 hours following end of exercise
Area under the curve of glucose levels < 4 mmol/L	4 hours following end of exercise
Number of patients requiring an oral treatment for hypoglycemia	4 hours following end of exercise
Total number of hypoglycemia episodes requiring treatment	4 hours following end of exercise
Total amount of carbohydrates needed to treat hypoglycemic events	4 hours following end of exercise
Percentage of time of glucose levels spent between 4 and 10 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent < 4 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent > 10 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Area under the curve of glucose levels < 4 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Number of patients requiring an oral treatment for hypoglycemia	From the end of exercise period to 6:00 next morning (11 hours)
Total number of hypoglycemia episodes requiring treatment	From the end of exercise period to 6:00 next morning (11 hours)
Total amount of carbohydrates needed to treat hypoglycemic events	From the end of exercise period to 6:00 next morning (11 hours)

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Institut de Recherches Cliniques de Montreal
• Investigators: Principal Investigator: Laurent Legault, Montreal Children's Hospital of the MUHC

Publications and helpful links

General Publications

• Tagougui S, Legault L, Heyman E, Messier V, Suppere C, Potter KJ, Pigny P, Berthoin S, Taleb N, Rabasa-Lhoret R. Anticipated Basal Insulin Reduction to Prevent Exercise-Induced Hypoglycemia in Adults and Adolescents Living with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):307-315. doi: 10.1089/dia.2021.0375. Epub 2022 Apr 27.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Hypoglycemia; Exercise; Type 1 diabetes; Insulin pump
• 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-1 bis

Drug and device information, study documents

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