Type 1 Diabetes MellitusRIDE-2NCT03845114
Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise
A study testing Continous exercise, Interval exercise and Reduction of basal insulin by 40% in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
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. 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?
- Continous exercise, Interval exercise and Reduction of basal insulin by 40%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Jun 2019to 30 Aug 2024
- 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
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
McGill University Health Center
Montreal, Quebec
About this study
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
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Continous exercise, Interval exercise, Reduction of basal insulin by 40%, Reduction of basal insulin by 80%
- Keywords
- Type 1 diabetes, Exercise, Hypoglycemia
- 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.
Continous exerciseOther
60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
Interval exerciseOther
Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
Reduction of basal insulin by 40%Other
Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.
Reduction of basal insulin by 80%Other
Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.
| Study group | Role | What they receive |
|---|---|---|
| Continuous exercise - Basal insulin reduced by 40% | Active comparator | Not described Receives: Other: Continous exercise; Other: Reduction of basal insulin by 40% |
| Continuous exercise - Basal insulin reduced by 80% | Active comparator | Not described Receives: Other: Continous exercise; Other: Reduction of basal insulin by 80% |
| Interval exercise - Basal insulin reduced by 40% | Active comparator | Not described Receives: Other: Interval exercise; Other: Reduction of basal insulin by 40% |
| Interval exercise - Basal insulin reduced by 80% | Active comparator | Not described Receives: Other: Interval exercise; Other: Reduction of basal insulin by 80% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes
Secondary outcomes (11)
Percentage of time of plasma glucose levels spent below 4 mmol/L
Measured: 60 minutes
Decremental area under the curve of plasma glucose levels
Measured: 60 minutes
Area under the curve of plasma glucose levels < 4 mmol/L
Measured: 60 minutes
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Measured: 60 minutes
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Measured: 60 minutes
Number of patients requiring an oral treatment for hypoglycemia
Measured: 60 minutes
Total number of hypoglycemia episodes requiring treatment
Measured: 60 minutes
Percentage of time of plasma glucose levels spent > 10 mmol/L
Measured: 60 minutes
Percentage of time of plasma glucose levels spent between 4-10 mmol/L
Measured: 60 minutes
Mean time to the first hypoglycemic event
Measured: 60 minutes
Amount of carbohydrates needed to treat a hypoglycemic event
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start30 Jun 2019
- Primary completion15 Dec 2023
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845114
- Sponsor's protocol ID
- RIDE-2
- Acronym
- RIDE-2
- Status last verified
- Nov 2024
- First submitted
- 15 Feb 2019
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03845114
- Acronym / sponsor ID
- RIDE-2 / RIDE-2
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes, Exercise, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 19 Feb 2019 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continuous exercise - Basal insulin reduced by 40% | Active comparator | Other: Continous exercise, Other: Reduction of basal insulin by 40% |
| Continuous exercise - Basal insulin reduced by 80% | Active comparator | Other: Continous exercise, Other: Reduction of basal insulin by 80% |
| Interval exercise - Basal insulin reduced by 40% | Active comparator | Other: Interval exercise, Other: Reduction of basal insulin by 40% |
| Interval exercise - Basal insulin reduced by 80% | Active comparator | Other: Interval exercise, Other: Reduction of basal insulin by 80% |
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 |
|---|---|---|
| Continous exercise60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity). | Other | Continuous exercise - Basal insulin reduced by 40%, Continuous exercise - Basal insulin reduced by 80% |
| Interval exerciseParticipants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity). | Other | Interval exercise - Basal insulin reduced by 40%, Interval exercise - Basal insulin reduced by 80% |
| Reduction of basal insulin by 40%Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset. | Other | Continuous exercise - Basal insulin reduced by 40%, Interval exercise - Basal insulin reduced by 40% |
| Reduction of basal insulin by 80%Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset. | Other | Continuous exercise - Basal insulin reduced by 80%, Interval exercise - Basal insulin reduced by 80% |
Primary outcome
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
11 secondary outcomes
Percentage of time of plasma glucose levels spent below 4 mmol/L
Time frame: 60 minutes
Decremental area under the curve of plasma glucose levels
Time frame: 60 minutes
Area under the curve of plasma glucose levels < 4 mmol/L
Time frame: 60 minutes
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time frame: 60 minutes
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time frame: 60 minutes
Number of patients requiring an oral treatment for hypoglycemia
Time frame: 60 minutes
Total number of hypoglycemia episodes requiring treatment
Time frame: 60 minutes
Percentage of time of plasma glucose levels spent > 10 mmol/L
Time frame: 60 minutes
Percentage of time of plasma glucose levels spent between 4-10 mmol/L
Time frame: 60 minutes
Mean time to the first hypoglycemic event
Time frame: 60 minutes
Amount of carbohydrates needed to treat a hypoglycemic event
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous exercise, Interval exercise and Reduction of basal insulin by 40% in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal 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: finished, as of the sponsor's last update on 6 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in plasma glucose levels during exercise (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.