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NCT Number: NCT03995498

Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

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.

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Key information

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Clinical Research Institute

Montreal, Quebec, H2W 1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Physical activity

Other

Participants will engage in team sports exercise twice a day: from 9h:30 to 10h:30 and from 11h:00 to 12h:00.

FreeStyle Libre

Other

Glucose levels will be measured by the FreeStyle Libre

SenseWear Armband

Other

Energy expenditure during physical activity sessions will be measured with the SenseWear Armband.

Primary outcomes

  1. Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L

    Time frame: 60 minutes

Secondary outcomes

  1. Change in glucose concentrations

    Time frame: 60 minutes

  2. Mean time (minutes) to the first hypoglycemic event

    Time frame: 60 minutes

  3. Mean interstitial glucose concentration

    Time frame: 60 minutes

  4. Standard deviation of glucose concentration

    Time frame: 60 minutes

  5. Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L

    Time frame: 120 minutes

  6. Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L

    Time frame: 120 minutes

  7. Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L

    Time frame: 120 minutes

  8. Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L

    Time frame: 120 minutes

  9. Total number of confirmed hypoglycemia episodes requiring treatment

    Time frame: 120 minutes

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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