Clinical trial NCT02631265: Insulin-based Strategies to Prevent Hypoglycemia During Exercise
Official title: Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Exercise
Hypoglycemia
Insulin pump
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: 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. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. Last (less than 2 months) HbA1c ≤ 12%.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) 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: Percentage of time of capillary blood glucose levels spent below 4 mmol/L
timeFrame: This outcome will be measured over 45 minutes.
Secondary outcomes:
measure: Decrease in glucose levels
timeFrame: This outcome will be measured over 45 minutes.
measure: Decremental area under the curve of sensor glucose levels
timeFrame: This outcome will be measured over 45 minutes.
measure: Area under the curve of sensor glucose levels < 4 mmol/L
timeFrame: This outcome will be measured over 45 minutes.
measure: Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
timeFrame: This outcome will be measured over 45 minutes.
measure: Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
timeFrame: This outcome will be measured over 45 minutes.
measure: Number of patients requiring an oral treatment for hypoglycemia
timeFrame: This outcome will be measured over 45 minutes.
measure: Total number of hypoglycemia episode requiring treatment
timeFrame: This outcome will be measured over 45 minutes.
measure: Percentage of time spent between 4 and 10 mmol/L
timeFrame: This outcome will be measured over 45 minutes.
measure: Mean time (minutes) to the first hypoglycemic event
timeFrame: This outcome will be measured over 45 minutes.
measure: Percentage of time spent < 4.0 mmol/L
timeFrame: This outcome will be measured over 14.75 hours.
measure: Percentage of time of sensor glucose levels spent below 4 mmol/L
timeFrame: This outcome will be measure over 45 minutes
measure: Absolute difference between capillary blood glucose levels and sensor glucose levels
timeFrame: This outcome will be measure over 45 minutes
measure: Relative difference between capillary blood glucose levels and sensor glucose levels
timeFrame: This outcome will be measure over 45 minutes
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: