Insulin-based Strategies to Prevent Hypoglycemia During Exercise

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03349489
• Other study ID #: RIDE-1 bis
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: January 2019

Study information

• Verified date: May 2018
• Source: McGill University Health Center
• Contact: Semah Tagougui
• Phone: 514-987-5500
• Email: semah.tagougui[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Institut de recherches cliniques de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

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