Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

NCT ID: NCT03995498

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-12-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individualized carbohydrate intake

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.

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: 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

Intervention Type: OTHER

Glucose levels will be measured by the FreeStyle Libre

SenseWear Armband

Intervention Type: OTHER

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

Usual camp protocol

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.

Group Type: ACTIVE_COMPARATOR

Physical activity

Intervention Type: 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

Intervention Type: OTHER

Glucose levels will be measured by the FreeStyle Libre

SenseWear Armband

Intervention Type: OTHER

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

Interventions

Physical activity

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

FreeStyle Libre

Glucose levels will be measured by the FreeStyle Libre

Intervention Type: OTHER

SenseWear Armband

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rémi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Montreal Clinical Research Institute

Locations

Montreal Clinical Research Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

SNACK-camp

Identifier Type: -

Identifier Source: org_study_id