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Insulin-based Strategies to Prevent Hypoglycemia During Exercise

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ClinicalTrials.gov Identifier: NCT03349489
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Institut de Recherches Cliniques de Montreal
Information provided by (Responsible Party):
Dr Laurent Legault, McGill University Health Center

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. 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Exercise 1 Other: Exercise 2 Device: Dexcom G4 Platinum Drug: Insulin Device: Insulin pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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 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.

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.




Primary Outcome Measures :
  1. Decrease in glucose levels [ Time Frame: 60 minutes (exercise period) ]
    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


Secondary Outcome Measures :
  1. Percentage of time of glucose levels spent below 4 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  2. Decremental area under the curve of glucose levels [ Time Frame: 60 minutes (exercise period) ]
  3. Area under the curve of glucose levels < 4 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  4. Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  5. Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  6. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: 60 minutes (exercise period) ]
  7. Total number of hypoglycemia episodes requiring treatment [ Time Frame: 60 minutes (exercise period) ]
  8. Percentage of time of glucose levels spent > 10 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  9. Percentage of time of glucose levels spent between 4-10 mmol/L [ Time Frame: 60 minutes (exercise period) ]
  10. Mean time (minutes) to the first hypoglycemic event [ Time Frame: 60 minutes (exercise period) ]
  11. Amount of carbohydrates needed to treat a hypoglycemic event [ Time Frame: 60 minutes (exercise period) ]
  12. Muscle blood flow [ Time Frame: 60 minutes (exercise period) ]
  13. Percentage of time of glucose levels spent between 4 and 10 mmol/L [ Time Frame: 4 hours following end of exercise ]
  14. Percentage of time of glucose levels spent < 4 mmol/L [ Time Frame: 4 hours following end of exercise ]
  15. Percentage of time of glucose levels spent > 10 mmol/L [ Time Frame: 4 hours following end of exercise ]
  16. Area under the curve of glucose levels < 4 mmol/L [ Time Frame: 4 hours following end of exercise ]
  17. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: 4 hours following end of exercise ]
  18. Total number of hypoglycemia episodes requiring treatment [ Time Frame: 4 hours following end of exercise ]
  19. Total amount of carbohydrates needed to treat hypoglycemic events [ Time Frame: 4 hours following end of exercise ]
  20. Percentage of time of glucose levels spent between 4 and 10 mmol/L [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]
  21. Percentage of time of glucose levels spent < 4 mmol/L [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]
  22. Percentage of time of glucose levels spent > 10 mmol/L [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]
  23. Area under the curve of glucose levels < 4 mmol/L [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]
  24. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]
  25. Total number of hypoglycemia episodes requiring treatment [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]
  26. Total amount of carbohydrates needed to treat hypoglycemic events [ Time Frame: From the end of exercise period to 6:00 next morning (11 hours) ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349489


Contacts
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Contact: Semah Tagougui 514-987-5500 ext 3295 semah.tagougui@ircm.qc.ca
Contact: Virginie Messier 514-987-5500 ext 3227 virginie.messier@ircm.qc.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Laurent Legault       laurent.legault@muhc.mcgill.ca   
Institut de recherches cliniques de Montréal Recruiting
Montréal, Quebec, Canada, H2W 1R7
Contact: Semah Tagougui       semah.tagougui@ircm.qc.ca   
Sponsors and Collaborators
McGill University Health Center
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Laurent Legault Montreal Children's Hospital of the MUHC

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Responsible Party: Dr Laurent Legault, MD, FRCP, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03349489     History of Changes
Other Study ID Numbers: RIDE-1 bis
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Laurent Legault, McGill University Health Center:
Type 1 diabetes
Exercise
Hypoglycemia
Insulin pump

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs