Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients

Completed

• Conditions: Type1 Diabetes Mellitus; Hypoglycemia; Exercise

• Registration Number: NCT03725657
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity.

The investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

Detailed Description

Background and Aims Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. Few studies confirm this hypothesis but none evaluated the correlation between steps, energy expenditure, sleep time and glycemic control and insulin dosage.

Methods and Materials 60 patients with type 1 diabetes, aged 10 to 12 years, in multiinjection insulin therapy observed for 21 days (one week of camp, one week before and one after it). Food program was the same both at home and during the camp. They checked glycemia almost 5 times a day. A wrist accelerometer was used to evaluate sleep, steps and energy expenditure.

All data were recorded in a daily diary.

Study Timeline

• Study First Submitted: 2018-10-28
• Study Start: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Status Verified: 2019-09
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• diabetes onset > 1 year, multiple injection insulin therapy

Exclusion Criteria

• Physical impossibility to movement, food allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of steps through wrist accelerometer	three weeks	number of steps
Measure of sleep expenditure through wrist accelerometer	three weeks	hours of sleep
Measure of energy expenditure through wrist accelerometer	three weeks	kcal

Secondary Outcome Measures

Name	Time	Method
Measure of glycemic control through glucometer	three weeks	mmol/L
Measure of insulin dosage	three weeks	Units/kg

Trial Locations

Locations (1)

Centro di Diabetologia Pediatrica "G.Stoppoloni"; 🇮🇹 Naples, Italy