Insulin-based Strategies to Prevent Hypoglycemia During Exercise

May 18, 2018 updated by: Dr Laurent Legault, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Reduction of insulin basal rate 40 minutes prior to exercise
Other: 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.
Active Comparator: Reduction of insulin basal rate 90 minutes prior to exercise
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decrease in glucose levels
Time Frame: 60 minutes (exercise period)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of patients requiring an oral treatment for hypoglycemia
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Total number of hypoglycemia episodes requiring treatment
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Mean time (minutes) to the first hypoglycemic event
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Percentage of time of glucose levels spent below 4 mmol/L
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Decremental area under the curve of glucose levels
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Area under the curve of glucose levels < 4 mmol/L
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Percentage of time of glucose levels spent > 10 mmol/L
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Percentage of time of glucose levels spent between 4-10 mmol/L
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Muscle blood flow
Time Frame: 60 minutes (exercise period)
60 minutes (exercise period)
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Percentage of time of glucose levels spent < 4 mmol/L
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Percentage of time of glucose levels spent > 10 mmol/L
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Area under the curve of glucose levels < 4 mmol/L
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Number of patients requiring an oral treatment for hypoglycemia
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Total number of hypoglycemia episodes requiring treatment
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Total amount of carbohydrates needed to treat hypoglycemic events
Time Frame: 4 hours following end of exercise
4 hours following end of exercise
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent < 4 mmol/L
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent > 10 mmol/L
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)
Area under the curve of glucose levels < 4 mmol/L
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)
Number of patients requiring an oral treatment for hypoglycemia
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)
Total number of hypoglycemia episodes requiring treatment
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)
Total amount of carbohydrates needed to treat hypoglycemic events
Time Frame: From the end of exercise period to 6:00 next morning (11 hours)
From the end of exercise period to 6:00 next morning (11 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Recherches Cliniques de Montreal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent Legault, Montreal Children's Hospital of the MUHC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIDE-1 bis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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