Clinical trial NCT03349489: Insulin-based Strategies to Prevent Hypoglycemia During Exercise
Official title: Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes
Exercise
Hypoglycemia
Insulin pump
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Institut de Recherches Cliniques de Montreal
First posted: 2017-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.).

Primary outcomes:
measure: Decrease in glucose levels
timeFrame: 60 minutes (exercise period)
Secondary outcomes:
measure: Percentage of time of glucose levels spent below 4 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Decremental area under the curve of glucose levels
timeFrame: 60 minutes (exercise period)
measure: Area under the curve of glucose levels < 4 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Number of patients requiring an oral treatment for hypoglycemia
timeFrame: 60 minutes (exercise period)
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: 60 minutes (exercise period)
measure: Percentage of time of glucose levels spent > 10 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Percentage of time of glucose levels spent between 4-10 mmol/L
timeFrame: 60 minutes (exercise period)
measure: Mean time (minutes) to the first hypoglycemic event
timeFrame: 60 minutes (exercise period)
measure: Amount of carbohydrates needed to treat a hypoglycemic event
timeFrame: 60 minutes (exercise period)
measure: Muscle blood flow
timeFrame: 60 minutes (exercise period)
measure: Percentage of time of glucose levels spent between 4 and 10 mmol/L
timeFrame: 4 hours following end of exercise
measure: Percentage of time of glucose levels spent < 4 mmol/L
timeFrame: 4 hours following end of exercise
measure: Percentage of time of glucose levels spent > 10 mmol/L
timeFrame: 4 hours following end of exercise
measure: Area under the curve of glucose levels < 4 mmol/L
timeFrame: 4 hours following end of exercise
measure: Number of patients requiring an oral treatment for hypoglycemia
timeFrame: 4 hours following end of exercise
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: 4 hours following end of exercise
measure: Total amount of carbohydrates needed to treat hypoglycemic events
timeFrame: 4 hours following end of exercise
measure: Percentage of time of glucose levels spent between 4 and 10 mmol/L
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
measure: Percentage of time of glucose levels spent < 4 mmol/L
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
measure: Percentage of time of glucose levels spent > 10 mmol/L
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
measure: Area under the curve of glucose levels < 4 mmol/L
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
measure: Number of patients requiring an oral treatment for hypoglycemia
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
measure: Total number of hypoglycemia episodes requiring treatment
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
measure: Total amount of carbohydrates needed to treat hypoglycemic events
timeFrame: From the end of exercise period to 6:00 next morning (11 hours)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital of the MUHC
name: Laurent Legault
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.