Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

NCT03995498 | Completed

• 1 other identifier: SNACK-camp
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Physical activity; Carbohydrates; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

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

  60 minutes

Secondary Outcomes (9)

• Change in glucose concentrations

  60 minutes

• Mean time (minutes) to the first hypoglycemic event

  60 minutes

• Mean interstitial glucose concentration

  60 minutes

• Standard deviation of glucose concentration

  60 minutes

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

  120 minutes

Study Arms (2)

Individualized carbohydrate intake

ACTIVE COMPARATOR

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.

Other: Physical activity; Other: FreeStyle Libre; Other: SenseWear Armband

Usual camp protocol

ACTIVE COMPARATOR

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.

Other: Physical activity; Other: FreeStyle Libre; Other: SenseWear Armband

Interventions

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.

Individualized carbohydrate intake; Usual camp protocol

FreeStyle Libre OTHER

Glucose levels will be measured by the FreeStyle Libre

Individualized carbohydrate intake; Usual camp protocol

SenseWear Armband OTHER

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

Individualized carbohydrate intake; Usual camp protocol

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
• 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).

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Montreal Clinical Research Institute

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rémi Rabasa-Lhoret

  Montreal Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: July 1, 2019
• Primary Completion: August 9, 2019
• Study Completion: December 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CA (1)