Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise (RIDE-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03845114
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
McGill University Health Center
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Continous exercise Other: Interval exercise Other: Reduction of basal insulin by 40% Other: Reduction of basal insulin by 80% Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous exercise - Basal insulin reduced by 40% Other: Continous exercise
60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

Other: Reduction of basal insulin by 40%
Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.

Active Comparator: Continuous exercise - Basal insulin reduced by 80% Other: Continous exercise
60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

Other: Reduction of basal insulin by 80%
Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.

Active Comparator: Interval exercise - Basal insulin reduced by 40% Other: Interval exercise
Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

Other: Reduction of basal insulin by 40%
Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.

Active Comparator: Interval exercise - Basal insulin reduced by 80% Other: Interval exercise
Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).

Other: Reduction of basal insulin by 80%
Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.




Primary Outcome Measures :
  1. Decrease in plasma glucose levels during exercise [ Time Frame: 60 minutes ]
    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 plasma glucose levels spent below 4 mmol/L [ Time Frame: 60 minutes ]
  2. Decremental area under the curve of plasma glucose levels [ Time Frame: 60 minutes ]
  3. Area under the curve of plasma glucose levels < 4 mmol/L [ Time Frame: 60 minutes ]
  4. Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L [ Time Frame: 60 minutes ]
  5. Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L [ Time Frame: 60 minutes ]
  6. Number of patients requiring an oral treatment for hypoglycemia [ Time Frame: 60 minutes ]
  7. Total number of hypoglycemia episodes requiring treatment [ Time Frame: 60 minutes ]
  8. Percentage of time of plasma glucose levels spent > 10 mmol/L [ Time Frame: 60 minutes ]
  9. Percentage of time of plasma glucose levels spent between 4-10 mmol/L [ Time Frame: 60 minutes ]
  10. Mean time to the first hypoglycemic event [ Time Frame: 60 minutes ]
  11. Amount of carbohydrates needed to treat a hypoglycemic event [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT03845114


Contacts
Layout table for location contacts
Contact: Sémah Tagougui 514-987-5500 ext 3295 semah.tagougui@ircm.qc.ca

Locations
Layout table for location information
Canada, Quebec
Institut de recherches cliniques de Montréal Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Sémah Tagougui         
Principal Investigator: Rémi Rabasa-Lhoret         
McGill University Health Center Not yet recruiting
Montreal, Quebec, Canada
Contact: Laurent Legault         
Principal Investigator: Laurent Legault         
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
McGill University Health Center
Investigators
Layout table for investigator information
Principal Investigator: Rémi Rabasa-Lhoret Institut de recherches cliniques de Montréal

Layout table for additonal information
Responsible Party: Rémi Rabasa-Lhoret, Full professor, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03845114     History of Changes
Other Study ID Numbers: RIDE-2
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal:
Type 1 diabetes
Exercise
Hypoglycemia

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