Type 1 DiabetesNCT02631265
Insulin-based Strategies to Prevent Hypoglycemia During Exercise
A study testing Exercise 1, Exercise 2 and Exercise 3 in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site 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 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exercise 1, Exercise 2 and Exercise 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 12%.
Who cannot join
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) 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
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults 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. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.
- Conditions
- Type 1 Diabetes
- Being tested
- Exercise 1, Exercise 2, Exercise 3
- 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 IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
Exercise 2Other
Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
Exercise 3Other
Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
| Study group | Role | What they receive |
|---|---|---|
| Reduction of insulin basal rate at the time of exercise | Active comparator | Not described Receives: Other: Exercise 1 |
| Reduction of insulin basal rate 20 minutes prior to exercise | Active comparator | Not described Receives: Other: Exercise 2 |
| Reduction of insulin basal rate 40 minutes prior to exercise | Active comparator | Not described Receives: Other: Exercise 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of capillary blood glucose levels spent below 4 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Secondary outcomes (13)
Decrease in glucose levels
Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until the end of exercise. This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Decremental area under the curve of sensor glucose levels
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Area under the curve of sensor glucose levels < 4 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Number of patients requiring an oral treatment for hypoglycemia
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Total number of hypoglycemia episode requiring treatment
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Percentage of time spent between 4 and 10 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Mean time (minutes) to the first hypoglycemic event
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measured over 45 minutes.
Percentage of time spent < 4.0 mmol/L
This time frame corresponds to the post-exercise period, from the end of the exercise until 7:00 the next morning.
Measured: This outcome will be measured over 14.75 hours.
Percentage of time of sensor glucose levels spent below 4 mmol/L
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measure over 45 minutes
Absolute difference between capillary blood glucose levels and sensor glucose levels
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measure over 45 minutes
Relative difference between capillary blood glucose levels and sensor glucose levels
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
Measured: This outcome will be measure over 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- 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
- NCT02631265
- Sponsor's protocol ID
- RIDE-1
- Status last verified
- Sep 2017
- First submitted
- 10 Dec 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. 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 With Type 1 Diabetes Using Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT02631265
- Acronym / sponsor ID
- RIDE-1
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 Dec 2015 (estimated)
- 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. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reduction of insulin basal rate at the time of exercise | Active comparator | Other: Exercise 1 |
| Reduction of insulin basal rate 20 minutes prior to exercise | Active comparator | Other: Exercise 2 |
| Reduction of insulin basal rate 40 minutes prior to exercise | Active comparator | Other: Exercise 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 2 months) HbA1c ≤ 12%.
Key exclusion criteria (7 listed)
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) 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 IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males). | Other | Reduction of insulin basal rate at the time of exercise |
| Exercise 2Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males). | Other | Reduction of insulin basal rate 20 minutes prior to exercise |
| Exercise 3Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males). | Other | Reduction of insulin basal rate 40 minutes prior to exercise |
Primary outcome
Percentage of time of capillary blood glucose levels spent below 4 mmol/L
Time frame: This outcome will be measured over 45 minutes.
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
13 secondary outcomes
Decrease in glucose levels
Time frame: This outcome will be measured over 45 minutes.
Decremental area under the curve of sensor glucose levels
Time frame: This outcome will be measured over 45 minutes.
Area under the curve of sensor glucose levels < 4 mmol/L
Time frame: This outcome will be measured over 45 minutes.
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
Time frame: This outcome will be measured over 45 minutes.
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L
Time frame: This outcome will be measured over 45 minutes.
Number of patients requiring an oral treatment for hypoglycemia
Time frame: This outcome will be measured over 45 minutes.
Total number of hypoglycemia episode requiring treatment
Time frame: This outcome will be measured over 45 minutes.
Percentage of time spent between 4 and 10 mmol/L
Time frame: This outcome will be measured over 45 minutes.
Mean time (minutes) to the first hypoglycemic event
Time frame: This outcome will be measured over 45 minutes.
Percentage of time spent < 4.0 mmol/L
Time frame: This outcome will be measured over 14.75 hours.
Percentage of time of sensor glucose levels spent below 4 mmol/L
Time frame: This outcome will be measure over 45 minutes
Absolute difference between capillary blood glucose levels and sensor glucose levels
Time frame: This outcome will be measure over 45 minutes
Relative difference between capillary blood glucose levels and sensor glucose levels
Time frame: This outcome will be measure over 45 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 13 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
1 site 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 Exercise 3 in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of time of capillary blood glucose levels spent below 4 mmol/L (time frame: This outcome will be measured over 45 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 13 Sep 2017.