Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Physical activity; Other: FreeStyle Libre; Other: SenseWear Armband

• Registration Number: NCT03995498
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-07-01
• Primary Completion: 2019-08-09
• Study Completion: 2019-12-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual camp protocol	SenseWear Armband	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.
Individualized carbohydrate intake	Physical activity	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.
Usual camp protocol	Physical activity	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.
Usual camp protocol	FreeStyle Libre	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.
Individualized carbohydrate intake	FreeStyle Libre	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.
Individualized carbohydrate intake	SenseWear Armband	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.

Primary Outcome Measures

Name	Time	Method
Percentage of time of interstitial glucose concentrations spent between 4.0-10.0 mmol/L	60 minutes

Secondary Outcome Measures

Name	Time	Method
Change in glucose concentrations	60 minutes
Percentage of time of interstitial glucose concentrations spent above 10.0 mmol/L	120 minutes
Mean time (minutes) to the first hypoglycemic event	60 minutes
Standard deviation of glucose concentration	60 minutes
Number of participants with an exercise-induced hypoglycemia below 4.0 mmol/L	120 minutes
Mean interstitial glucose concentration	60 minutes
Percentage of time of interstitial glucose concentrations spent below 4.0 mmol/L	120 minutes
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L	120 minutes
Total number of confirmed hypoglycemia episodes requiring treatment	120 minutes

Trial Locations

Locations (1)

Montreal Clinical Research Institute; 🇨🇦 Montréal, Quebec, Canada