Type 1 Diabetes MellitusNCT03214107
Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
A study testing Exercise and Snack in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. 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 and Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2017to 2 Aug 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 one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
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).
- Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Exercise, Snack
- Keywords
- Exercise, Hypoglycemia, Carbohydrates
- 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.
ExerciseOther
Participants will be admitted at IRCM at 14:00. At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). During exercise, capillary glucose levels will be measured every 10 minutes. At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour. At 17:30, the participant will be discharged.
SnackOther
Full snack or Distributed snack
| Study group | Role | What they receive |
|---|---|---|
| Full snack given before exercise | Active comparator | A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise Receives: Other: Exercise; Other: Snack |
| Distributed snack over exercise period | Active comparator | A snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise. Receives: Other: Exercise; Other: Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
This time frame corresponds to the exercise period and the 1 hour following it
Measured: This outcome will be measured over 120 minutes
Secondary outcomes (36)
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels spent below 4 mmol/L
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Decrease in glucose levels
Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Increase in glucose level
Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants requiring an oral treatment for hypoglycemia
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Total number of hypoglycemia episodes requiring treatment
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels spent above 10 mmol/L
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Mean time (minutes) to the first hypoglycemic event
Measured: This outcome will be measured for the exercise period only (60 minutes)
Mean glucose levels
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Standard deviation of glucose levels
Measured: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels between 4 and 10 mmol/L
Dinner time will be up to the patient.
Measured: From the end of the exercise period to dinner time.
Percentage of time of glucose levels between 4 and 10 mmol/L
Measured: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L
Measured: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L
Measured: From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Dinner time will be up to the patient.
Measured: From the end of the exercise period to dinner time
Percentage of time of glucose levels spent below 4 mmol/L
Measured: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Measured: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Measured: From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Dinner time will be up to the patient
Measured: From the end of the exercise period to dinner time
Percentage of time of glucose levels spent above 10 mmol/L
Measured: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Measured: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Measured: From the end of the exercise period to 6:00 next morning (13.5 hours)
Number of participants requiring treatment for hypoglycemia
Dinner time will be up to the patient
Measured: From the end of the exercise period to dinner time
Number of participants requiring treatment for hypoglycemia
Measured: From the end of the exercise period to midnight (7.5 hours)
Number of participants requiring treatment for hypoglycemia
Measured: From midnight to 6:00 next morning (6 hours)
Number of participants requiring treatment for hypoglycemia
Measured: From the end of the exercise period to 6:00 next morning (13.5 hours)
Number of hypoglycemic episodes requiring treatment
Dinner time will be up to the patient
Measured: From the end of the exercise period to dinner time
Number of hypoglycemic episodes requiring treatment
Measured: From the end of the exercise period to midnight (7.5 hours)
Number of hypoglycemic episodes requiring treatment
Measured: From midnight to 6:00 next morning (6 hours)
Number of hypoglycemic episodes requiring treatment
Measured: From the end of the exercise period to 6:00 next morning (13.5 hours)
Mean glucose levels
Dinner time will be up to the patient
Measured: From the end of the exercise period to dinner time
Mean glucose levels
Measured: From the end of the exercise period to midnight (7.5 hours)
Mean glucose levels
Measured: From midnight to 6:00 next morning (6 hours)
Mean glucose levels
Measured: From the end of the exercise period to 6:00 next morning (13.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start3 Aug 2017
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
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
- None (open label)
- Enrolment
- 37 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
- Remi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214107
- Sponsor's protocol ID
- SNACK-1
- Status last verified
- Jun 2020
- First submitted
- 6 Jul 2017
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goulet-Gelinas L, Saade MB, Suppere C, Fortin A, Messier V, Taleb N, Tagougui S, Shohoudi A, Legault L, Henderson M, Rabasa-Lhoret R. Comparison of two carbohydrate intake strategies to improve glucose control during exercise in adolescents and adults with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1238-1246. doi: 10.1016/j.numecd.2020.12.011. Epub 2020 Dec 17.
PubMed 33632598
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03214107
- Acronym / sponsor ID
- SNACK-1
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Exercise, Hypoglycemia, Carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 11 Jul 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.
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full snack given before exercise | Active comparator | Other: Exercise, Other: SnackA snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise |
| Distributed snack over exercise period | Active comparator | Other: Exercise, Other: SnackA snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise. |
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 one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
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 |
|---|---|---|
| ExerciseParticipants will be admitted at IRCM at 14:00. At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). During exercise, capillary glucose levels will be measured every 10 minutes. At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour. At 17:30, the participant will be discharged. | Other | Distributed snack over exercise period, Full snack given before exercise |
| SnackFull snack or Distributed snack | Other | Distributed snack over exercise period, Full snack given before exercise |
Primary outcome
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Time frame: This outcome will be measured over 120 minutes
This time frame corresponds to the exercise period and the 1 hour following it
36 secondary outcomes
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Decrease in glucose levels
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Increase in glucose level
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Number of participants requiring an oral treatment for hypoglycemia
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Total number of hypoglycemia episodes requiring treatment
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Mean time (minutes) to the first hypoglycemic event
Time frame: This outcome will be measured for the exercise period only (60 minutes)
Mean glucose levels
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Standard deviation of glucose levels
Time frame: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From the end of the exercise period to dinner time.
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels between 4 and 10 mmol/L
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From the end of the exercise period to dinner time
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels spent below 4 mmol/L
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From the end of the exercise period to dinner time
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From the end of the exercise period to midnight (7.5 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From midnight to 6:00 next morning (6 hours)
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Number of participants requiring treatment for hypoglycemia
Time frame: From the end of the exercise period to dinner time
Number of participants requiring treatment for hypoglycemia
Time frame: From the end of the exercise period to midnight (7.5 hours)
Number of participants requiring treatment for hypoglycemia
Time frame: From midnight to 6:00 next morning (6 hours)
Number of participants requiring treatment for hypoglycemia
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Number of hypoglycemic episodes requiring treatment
Time frame: From the end of the exercise period to dinner time
Number of hypoglycemic episodes requiring treatment
Time frame: From the end of the exercise period to midnight (7.5 hours)
Number of hypoglycemic episodes requiring treatment
Time frame: From midnight to 6:00 next morning (6 hours)
Number of hypoglycemic episodes requiring treatment
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
Mean glucose levels
Time frame: From the end of the exercise period to dinner time
Mean glucose levels
Time frame: From the end of the exercise period to midnight (7.5 hours)
Mean glucose levels
Time frame: From midnight to 6:00 next morning (6 hours)
Mean glucose levels
Time frame: From the end of the exercise period to 6:00 next morning (13.5 hours)
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 11 Jun 2020.
- Derived from this study: PubMed 33632598Goulet-Gelinas L, Saade MB, Suppere C, Fortin A, Messier V, Taleb N, Tagougui S, Shohoudi A, Legault L, Henderson M, Rabasa-Lhoret R. Comparison of two carbohydrate intake strategies to improve glucose control during exercise in adolescents and adults with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1238-1246. doi: 10.1016/j.numecd.2020.12.011. Epub 2020 Dec 17.
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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.
Remi 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 and Snack in people with Type 1 Diabetes Mellitus, 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 11 Jun 2020. 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 glucose levels spent between 4-10 mmol/L (time frame: This outcome will be measured over 120 minutes). 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 NCT03214107, 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 11 Jun 2020.