Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03995498
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2019-06-20
Brief Title:
Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control
Sponsor:
Institut de Recherches Cliniques de Montreal
Organization:
Institut de Recherches Cliniques de Montreal
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 9h30 to 10h30 and from 11h00 to 12h00 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 05gkg for glucose levels between 45 to 70 mmolL and 025gkg for glucose levels between 71 to 100 mmolL and none will be given if glucose levels are between 101 and 150 mmolL When glucose levels are below 45 mmolL or above 150 mmolL the camp staff will take care of hypoglycemiahyperglycemia treatment During control sessions as per camp routine care there will be no measurement of glucose levels before the start of physical activity
At the enrollment interview in addition to collecting patients 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 9h30 to 10h30 and from 11h00 to 12h00 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 05gkg for glucose levels between 45 to 70 mmolL and 025gkg for glucose levels between 71 to 100 mmolL and none will be given if glucose levels are between 101 and 150 mmolL When glucose levels are below 45 mmolL or above 150 mmolL the camp staff will take care of hypoglycemiahyperglycemia treatment During control sessions as per camp routine care there will be no measurement of glucose levels before the start of physical activity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None