Type 1 Diabetes MellitusNCT03349489
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
A study testing Exercise 1, Exercise 2 and Dexcom G4 Platinum in people with Type 1 Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Exercise 1, Exercise 2 and Dexcom G4 Platinum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 18 May 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least two years.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 10%.
Who cannot join
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- 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).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Semah Tagougui, semah.tagougui@ircm.qc.ca
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Laurent Legault, laurent.legault@muhc.mcgill.ca
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Exercise 1, Exercise 2, Dexcom G4 Platinum, Insulin, Insulin pump
- Keywords
- Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise 1Other
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.
Exercise 2Other
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.
Dexcom G4 PlatinumDevice
The Dexcom G4 Platinum will be used to measure continuous glucose levels.
InsulinDrug
Participant's usual fast-acting insulin analog will be used.
Insulin pumpDevice
Participant's insulin pump will be used to infuse insulin.
| Study group | Role | What they receive |
|---|---|---|
| Reduction of insulin basal rate 40 minutes prior to exercise | Active comparator | Not described Receives: Other: Exercise 2; Device: Dexcom G4 Platinum; Drug: Insulin; Device: Insulin pump |
| Reduction of insulin basal rate 90 minutes prior to exercise | Active comparator | Not described Receives: Other: Exercise 1; Device: Dexcom G4 Platinum; Drug: Insulin; Device: Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in glucose levels
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
Measured: 60 minutes (exercise period)
Secondary outcomes (26)
Percentage of time of glucose levels spent below 4 mmol/L
Measured: 60 minutes (exercise period)
Decremental area under the curve of glucose levels
Measured: 60 minutes (exercise period)
Area under the curve of glucose levels < 4 mmol/L
Measured: 60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Measured: 60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Measured: 60 minutes (exercise period)
Number of patients requiring an oral treatment for hypoglycemia
Measured: 60 minutes (exercise period)
Total number of hypoglycemia episodes requiring treatment
Measured: 60 minutes (exercise period)
Percentage of time of glucose levels spent > 10 mmol/L
Measured: 60 minutes (exercise period)
Percentage of time of glucose levels spent between 4-10 mmol/L
Measured: 60 minutes (exercise period)
Mean time (minutes) to the first hypoglycemic event
Measured: 60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event
Measured: 60 minutes (exercise period)
Muscle blood flow
Measured: 60 minutes (exercise period)
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Measured: 4 hours following end of exercise
Percentage of time of glucose levels spent < 4 mmol/L
Measured: 4 hours following end of exercise
Percentage of time of glucose levels spent > 10 mmol/L
Measured: 4 hours following end of exercise
Area under the curve of glucose levels < 4 mmol/L
Measured: 4 hours following end of exercise
Number of patients requiring an oral treatment for hypoglycemia
Measured: 4 hours following end of exercise
Total number of hypoglycemia episodes requiring treatment
Measured: 4 hours following end of exercise
Total amount of carbohydrates needed to treat hypoglycemic events
Measured: 4 hours following end of exercise
Percentage of time of glucose levels spent between 4 and 10 mmol/L
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent < 4 mmol/L
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent > 10 mmol/L
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Area under the curve of glucose levels < 4 mmol/L
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Number of patients requiring an oral treatment for hypoglycemia
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Total number of hypoglycemia episodes requiring treatment
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Total amount of carbohydrates needed to treat hypoglycemic events
Measured: From the end of exercise period to 6:00 next morning (11 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start18 May 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherches Cliniques de Montreal
- Responsible party
- Principal investigator, Dr Laurent Legault, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Laurent Legault, Principal investigator, Montreal Children's Hospital of the MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349489
- Sponsor's protocol ID
- RIDE-1 bis
- Status last verified
- May 2018
- First submitted
- 17 Nov 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35099281
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT03349489
- Acronym / sponsor ID
- RIDE-1 bis
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Institut de Recherches Cliniques de Montreal
- Study start
- 18 May 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduction of insulin basal rate 40 minutes prior to exercise | Active comparator | Other: Exercise 2, Device: Dexcom G4 Platinum, Drug: Insulin, Device: Insulin pump |
| Reduction of insulin basal rate 90 minutes prior to exercise | Active comparator | Other: Exercise 1, Device: Dexcom G4 Platinum, Drug: Insulin, Device: Insulin pump |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least two years.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 10%.
Key exclusion criteria (7 listed)
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise 1Participants 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. | Other | Reduction of insulin basal rate 90 minutes prior to exercise |
| Exercise 2Participants 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. | Other | Reduction of insulin basal rate 40 minutes prior to exercise |
| Dexcom G4 PlatinumThe Dexcom G4 Platinum will be used to measure continuous glucose levels. | Device | Reduction of insulin basal rate 40 minutes prior to exercise, Reduction of insulin basal rate 90 minutes prior to exercise |
| InsulinParticipant's usual fast-acting insulin analog will be used. | Drug | Reduction of insulin basal rate 40 minutes prior to exercise, Reduction of insulin basal rate 90 minutes prior to exercise |
| Insulin pumpParticipant's insulin pump will be used to infuse insulin. | Device | Reduction of insulin basal rate 40 minutes prior to exercise, Reduction of insulin basal rate 90 minutes prior to exercise |
Primary outcome
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
26 secondary outcomes
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: 60 minutes (exercise period)
Decremental area under the curve of glucose levels
Time frame: 60 minutes (exercise period)
Area under the curve of glucose levels < 4 mmol/L
Time frame: 60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time frame: 60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time frame: 60 minutes (exercise period)
Number of patients requiring an oral treatment for hypoglycemia
Time frame: 60 minutes (exercise period)
Total number of hypoglycemia episodes requiring treatment
Time frame: 60 minutes (exercise period)
Percentage of time of glucose levels spent > 10 mmol/L
Time frame: 60 minutes (exercise period)
Percentage of time of glucose levels spent between 4-10 mmol/L
Time frame: 60 minutes (exercise period)
Mean time (minutes) to the first hypoglycemic event
Time frame: 60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event
Time frame: 60 minutes (exercise period)
Muscle blood flow
Time frame: 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
Percentage of time of glucose levels spent < 4 mmol/L
Time frame: 4 hours following end of exercise
Percentage of time of glucose levels spent > 10 mmol/L
Time frame: 4 hours following end of exercise
Area under the curve of glucose levels < 4 mmol/L
Time frame: 4 hours following end of exercise
Number of patients requiring an oral treatment for hypoglycemia
Time frame: 4 hours following end of exercise
Total number of hypoglycemia episodes requiring treatment
Time frame: 4 hours following end of exercise
Total amount of carbohydrates needed to treat hypoglycemic events
Time frame: 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)
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)
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)
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)
Number of patients requiring an oral treatment for hypoglycemia
Time frame: 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)
Total amount of carbohydrates needed to treat hypoglycemic events
Time frame: From the end of exercise period to 6:00 next morning (11 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Derived from this study: PubMed 35099281Tagougui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Legault principal investigator
Montreal Children's Hospital of the MUHC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise 1, Exercise 2 and Dexcom G4 Platinum in people with Type 1 Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semah Tagougui (514-987-5500 ext. 3295, semah.tagougui@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in glucose levels (time frame: 60 minutes (exercise period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03349489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.