Clinical trial NCT03995498: Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Exercise
Physical activity
Carbohydrates
Hypoglycemia
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Males or females between the 7 and 16 years of old.
2. Clinical diagnosis of type 1 diabetes for at least 6 months.
3. Using continuous subcutaneous insulin infusion therapy or multiple daily injections.
4. HbA1c ≤ 12.0%.
5. Practicing team sports (soccer, basketball, hockey, tennis) at the summer camp.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
2. Severe hypoglycemic episode within two weeks of inclusion in the study.
3. Using the Medtronic 670G Insulin Pump as a treatment Mode
4. Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
5. Acute disease in the last 3 months that would affect ability to do physical activity.
6. 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).

Primary outcomes:
measure: Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L
timeFrame: 60 minutes
Secondary outcomes:
measure: Change in glucose concentrations
timeFrame: 60 minutes
measure: Mean time (minutes) to the first hypoglycemic event
timeFrame: 60 minutes
measure: Mean interstitial glucose concentration
timeFrame: 60 minutes
measure: Standard deviation of glucose concentration
timeFrame: 60 minutes
measure: Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L
timeFrame: 120 minutes
measure: Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L
timeFrame: 120 minutes
measure: Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L
timeFrame: 120 minutes
measure: Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
timeFrame: 120 minutes
measure: Total number of confirmed hypoglycemia episodes requiring treatment
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Clinical Research Institute
state: Quebec
Study officials:
affiliation: Montreal Clinical Research Institute
name: Rémi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: