Type 1 DiabetesNCT03995498
Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control
A study testing Physical activity, FreeStyle Libre and SenseWear Armband in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
The objective of this study is to test whether an individualized carbohydrate intake based on weight and pre physical activity glucose level is more effective than usual camp care to improve glucose control in children and adolescents engaging in team sports (basketball, soccer, hockey) during a summer camp. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Physical activity, FreeStyle Libre and SenseWear Armband
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 30 Dec 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females between the 7 and 16 years of old.
- Clinical diagnosis of type 1 diabetes for at least 6 months.
- Using continuous subcutaneous insulin infusion therapy or multiple daily injections.
- HbA1c ≤ 12.0%.
- Practicing team sports (soccer, basketball, hockey, tennis) at the summer camp.
Who cannot join
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within two weeks of inclusion in the study.
- Using the Medtronic 670G Insulin Pump as a treatment Mode
- Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
- Acute disease in the last 3 months that would affect ability to do physical activity.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control During Team Sports in Children and Adolescents With Type 1 Diabetes: A Carowanis Camp Study
The objective of this study is to test whether an individualized carbohydrate intake based on weight and pre physical activity glucose level is more effective than usual camp care to improve glucose control in children and adolescents engaging in team sports (basketball, soccer, hockey) during a summer camp.
At the enrollment interview, in addition to collecting patient's information (age, sex, diabetes duration, recent A1c, type of treatment, insulin doses body weight, concomitant diseases, diabetes complications and history of severe hypoglycemia), a continuous glucose monitoring system (FreeStyle Libre) will be installed by a nurse. At least, eight sports sessions per participant are planned for this study. In a randomized order, the individualized carbohydrate intake will be applied during at least 4 interventions sport sessions while at least 4 with matching types of sports will be used as control sessions. Two sport sessions are routinely scheduled at the camp each day; from 9h:30 to 10h:30 and from 11h:00 to 12h:00. For intervention sessions that involve individualized carbohydrate intake, the FreeStyle Libre will be scanned 0-10 minutes before the start of the team sport. Carbohydrates will then be given in the amount of 0.5g/kg for glucose levels between 4.5 to 7.0 mmol/L and 0.25g/kg for glucose levels between 7.1 to 10.0 mmol/L and none will be given if glucose levels are between 10.1 and 15.0 mmol/L. When glucose levels are below 4.5 mmol/L or above 15.0 mmol/L, the camp staff will take care of hypoglycemia/hyperglycemia treatment. During control sessions, as per camp routine care, there will be no measurement of glucose levels before the start of physical activity.
- Conditions
- Type 1 Diabetes
- Being tested
- Physical activity, FreeStyle Libre, SenseWear Armband
- Keywords
- Exercise, Physical activity, Carbohydrates, 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.
Physical activityOther
Participants will engage in team sports exercise twice a day: from 9h:30 to 10h:30 and from 11h:00 to 12h:00.
FreeStyle LibreOther
Glucose levels will be measured by the FreeStyle Libre
SenseWear ArmbandOther
Energy expenditure during physical activity sessions will be measured with the SenseWear Armband.
| Study group | Role | What they receive |
|---|---|---|
| Individualized carbohydrate intake | Active comparator | Based on glucose sensor level, carbohydrate (orange juice, Oasis classic) will then be given as follow:
If sensor glucose level is under < 4.5 mmol/L, the camp staff will treat hypoglycemia according to the camp procedure, If sensor glucose level is between 4.5 and 7.0 mol/L, 0.5g of CHO/kg body weight will be given, If sensor glucose level is between 7.1 and 10.0 mmol/L, 0.25g of CHO/kg body weight will be given, If sensor glucose level is between 10.1 and 15.0 mmol/L, no CHO will be given, If sensor glucose level is > 15.1 mmol/L, the camp staff will treat hyperglycemia according to the camp procedure. Receives: Other: Physical activity; Other: FreeStyle Libre; Other: SenseWear Armband |
| Usual camp protocol | Active comparator | As per camp routine care, there will be no mandatory glucose level measurement before the start of physical activity if no symptoms of hypoglycemia or hyperglycemia appear. Receives: Other: Physical activity; Other: FreeStyle Libre; Other: SenseWear Armband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L
Measured: 60 minutes
Secondary outcomes (9)
Change in glucose concentrations
Measured: 60 minutes
Mean time (minutes) to the first hypoglycemic event
Measured: 60 minutes
Mean interstitial glucose concentration
Measured: 60 minutes
Standard deviation of glucose concentration
Measured: 60 minutes
Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L
Measured: 120 minutes
Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L
Measured: 120 minutes
Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L
Measured: 120 minutes
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Measured: 120 minutes
Total number of confirmed hypoglycemia episodes requiring treatment
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Jul 2019
- Primary completion9 Aug 2019
- Study completion30 Dec 2019
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
- None (open label)
- Enrolment
- 41 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, Montreal Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995498
- Sponsor's protocol ID
- SNACK-camp
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2019
- Last updated
- 11 Jun 2020
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control During Team Sports in Children and Adolescents With Type 1 Diabetes: A Carowanis Camp Study
- ClinicalTrials.gov ID
- NCT03995498
- Acronym / sponsor ID
- SNACK-camp
- Conditions
- Type 1 Diabetes
- Keywords
- Exercise, Physical activity, Carbohydrates, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 24 Jun 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.
The objective of this study is to test whether an individualized carbohydrate intake based on weight and pre physical activity glucose level is more effective than usual camp care to improve glucose control in children and adolescents engaging in team sports (basketball, soccer, hockey) during a summer camp.
At the enrollment interview, in addition to collecting patient's information (age, sex, diabetes duration, recent A1c, type of treatment, insulin doses body weight, concomitant diseases, diabetes complications and history of severe hypoglycemia), a continuous glucose monitoring system (FreeStyle Libre) will be installed by a nurse. At least, eight sports sessions per participant are planned for this study. In a randomized order, the individualized carbohydrate intake will be applied during at least 4 interventions sport sessions while at least 4 with matching types of sports will be used as control sessions. Two sport sessions are routinely scheduled at the camp each day; from 9h:30 to 10h:30 and from 11h:00 to 12h:00. For intervention sessions that involve individualized carbohydrate intake, the FreeStyle Libre will be scanned 0-10 minutes before the start of the team sport. Carbohydrates will then be given in the amount of 0.5g/kg for glucose levels between 4.5 to 7.0 mmol/L and 0.25g/kg for glucose levels between 7.1 to 10.0 mmol/L and none will be given if glucose levels are between 10.1 and 15.0 mmol/L. When glucose levels are below 4.5 mmol/L or above 15.0 mmol/L, the camp staff will take care of hypoglycemia/hyperglycemia treatment. During control sessions, as per camp routine care, there will be no measurement of glucose levels before the start of physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized carbohydrate intake | Active comparator | Other: Physical activity, Other: FreeStyle Libre, Other: SenseWear ArmbandBased on glucose sensor level, carbohydrate (orange juice, Oasis classic) will then be given as follow: If sensor glucose level is under < 4.5 mmol/L, the camp staff will treat hypoglycemia according to the camp procedure, If sensor glucose level is between 4.5 and 7.0 mol/L, 0.5g of CHO/kg body weight will be given, If sensor glucose level is between 7.1 and 10.0 mmol/L, 0.25g of CHO/kg body weight will be given, If sensor glucose level is between 10.1 and 15.0 mmol/L, no CHO will be given, If sensor glucose level is > 15.1 mmol/L, the camp staff will treat hyperglycemia according to the camp procedure. |
| Usual camp protocol | Active comparator | Other: Physical activity, Other: FreeStyle Libre, Other: SenseWear ArmbandAs per camp routine care, there will be no mandatory glucose level measurement before the start of physical activity if no symptoms of hypoglycemia or hyperglycemia appear. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females between the 7 and 16 years of old.
- Clinical diagnosis of type 1 diabetes for at least 6 months.
- Using continuous subcutaneous insulin infusion therapy or multiple daily injections.
- HbA1c ≤ 12.0%.
- Practicing team sports (soccer, basketball, hockey, tennis) at the summer camp.
Key exclusion criteria (6 listed)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within two weeks of inclusion in the study.
- Using the Medtronic 670G Insulin Pump as a treatment Mode
- Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
- Acute disease in the last 3 months that would affect ability to do physical activity.
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 |
|---|---|---|
| Physical activityParticipants will engage in team sports exercise twice a day: from 9h:30 to 10h:30 and from 11h:00 to 12h:00. | Other | Individualized carbohydrate intake, Usual camp protocol |
| FreeStyle LibreGlucose levels will be measured by the FreeStyle Libre | Other | Individualized carbohydrate intake, Usual camp protocol |
| SenseWear ArmbandEnergy expenditure during physical activity sessions will be measured with the SenseWear Armband. | Other | Individualized carbohydrate intake, Usual camp protocol |
Primary outcome
Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L
Time frame: 60 minutes
9 secondary outcomes
Change in glucose concentrations
Time frame: 60 minutes
Mean time (minutes) to the first hypoglycemic event
Time frame: 60 minutes
Mean interstitial glucose concentration
Time frame: 60 minutes
Standard deviation of glucose concentration
Time frame: 60 minutes
Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L
Time frame: 120 minutes
Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L
Time frame: 120 minutes
Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L
Time frame: 120 minutes
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Time frame: 120 minutes
Total number of confirmed hypoglycemia episodes requiring treatment
Time frame: 120 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 11 Jun 2020.
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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
Montreal Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity, FreeStyle Libre and SenseWear Armband 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 5 inclusion and 6 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 interstitial glucose concentrations spent between 4.0-10.0 mmol/L (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 11 Jun 2020.