Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise

Type 1 Diabetes Mellitus Clinical Trial

— RIDE-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03845114
• Other study ID #: RIDE-2
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2023
• Source: Institut de Recherches Cliniques de Montreal
• Contact: Corinne Suppère, M.Sc.
• Phone: 514-987-5597
• Email: corinne.suppere[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Regular exercise is associated with many health benefits for individuals with type 1 diabetes. However, immediate and delayed exercise-induced hypoglycemia is frequent and thus the main limiting factor for physical activity practice in this population. To reduce the risk of exercise-induced hypoglycemia, two types of adjustments may be considered by patients with type 1 diabetes : pre-meal insulin-dose reduction and carbohydrate supplements. Few evidence-based recommendations are available for patients using insulin pump to adjust insulin doses in order to limit exercise-induced hypoglycemia. The objective of this study is to address the magnitude of the needed reduction during two types of frequently practiced exercise (continuous vs. interval exercise) known to have a different impact on blood glucose reduction.

Description:

Each study participant will be admitted at IRCM one to five days after sensor insertion. Participants will be asked to change their pump catheter 24 to 36 hours prior to the intervention visit. On the day of the intervention visit, participants will have a standardized lunch (45-65g CHO for females and 60-80g CHO for males ) at 12:00 and will be asked not to eat afterwards (except for correction of hypoglycemia). Participants will be asked not to exercise (excluding light exercise such as walking or taking the stairs) the day before and the day of the intervention visit. Participants will be asked not to consume caffeine after 12:00 the day of the intervention. The day before the intervention and the day of the intervention, participants will be asked to refrain from alcohol consumption. Participants will be blinded to the strategy used during the exercise intervention. Participants will be admitted at IRCM at 14:00. A catheter will be installed for plasma glucose and insulin measurements. At 14:30, insulin basal rate will be reduced by 40% or 80% depending of randomization. At 15:30, participants will undertake a continuous exercise (60-minute exercise on the ergocycle at 60% of VO2 peak) or an interval exercise (2-minutes alternating intervals at 85% and 50% of VO2peak for 50-minutes, with 5-minutes at 45% VO2peak at the start and the end of exercise). As a safety measure, plasma glucose will be measured every 10 minutes. Participants will be blinded to sensor glucose levels as well as plasma glucose measurements. At 17:00, the participant will be discharged if glucose levels are above 5.5 mmol/L. Participants will be asked to eat a standardized dinner at home (45-65g CHO for females and 60-80g CHO for males). Participants will have the freedom to choose at what time they wish to have dinner but it will have to be similar on all intervention visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: February 15, 2024
• Est. primary completion date: December 15, 2023
• 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, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

Other:
• Continous exercise
60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
• Interval exercise
Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
• Reduction of basal insulin by 40%
Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.
• Reduction of basal insulin by 80%
Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in plasma glucose levels during exercise	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
Secondary	Percentage of time of plasma glucose levels spent below 4 mmol/L		60 minutes
Secondary	Decremental area under the curve of plasma glucose levels		60 minutes
Secondary	Area under the curve of plasma glucose levels < 4 mmol/L		60 minutes
Secondary	Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L		60 minutes
Secondary	Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L		60 minutes
Secondary	Number of patients requiring an oral treatment for hypoglycemia		60 minutes
Secondary	Total number of hypoglycemia episodes requiring treatment		60 minutes
Secondary	Percentage of time of plasma glucose levels spent > 10 mmol/L		60 minutes
Secondary	Percentage of time of plasma glucose levels spent between 4-10 mmol/L		60 minutes
Secondary	Mean time to the first hypoglycemic event		60 minutes
Secondary	Amount of carbohydrates needed to treat a hypoglycemic event		60 minutes