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Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical activity
FreeStyle Libre
SenseWear Armband
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Exercise, Physical activity, Carbohydrates, Hypoglycemia

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Montreal Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Individualized carbohydrate intake

Usual camp protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in glucose concentrations
Mean time (minutes) to the first hypoglycemic event
Mean interstitial glucose concentration
Standard deviation of glucose concentration
Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L
Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L
Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Total number of confirmed hypoglycemia episodes requiring treatment

Full Information

First Posted
June 20, 2019
Last Updated
June 8, 2020
Sponsor
Institut de Recherches Cliniques de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT03995498
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Exercise, Physical activity, Carbohydrates, Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized carbohydrate intake
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual camp protocol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
Participants will engage in team sports exercise twice a day: from 9h:30 to 10h:30 and from 11h:00 to 12h:00.
Intervention Type
Other
Intervention Name(s)
FreeStyle Libre
Intervention Description
Glucose levels will be measured by the FreeStyle Libre
Intervention Type
Other
Intervention Name(s)
SenseWear Armband
Intervention Description
Energy expenditure during physical activity sessions will be measured with the SenseWear Armband.
Primary Outcome Measure Information:
Title
Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Change in glucose concentrations
Time Frame
60 minutes
Title
Mean time (minutes) to the first hypoglycemic event
Time Frame
60 minutes
Title
Mean interstitial glucose concentration
Time Frame
60 minutes
Title
Standard deviation of glucose concentration
Time Frame
60 minutes
Title
Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L
Time Frame
120 minutes
Title
Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L
Time Frame
120 minutes
Title
Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L
Time Frame
120 minutes
Title
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Time Frame
120 minutes
Title
Total number of confirmed hypoglycemia episodes requiring treatment
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret
Organizational Affiliation
Montreal Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Clinical Research Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada

12. IPD Sharing Statement

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Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

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