Clinical Trials Directory

Trials / Completed

CompletedNCT03725657

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

Using a Wrist-worn Accelerometer to Find a Correlation Between Exercise, Glycaemia and Insulin Dose in Type 1 Pediatric Patients, During a Camp: inCamp Study

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
University of Campania Luigi Vanvitelli · Academic / Other
Sex
All
Age
10 Years – 12 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2018-10-29
Primary completion
2019-09-18
Completion
2019-09-18
First posted
2018-10-31
Last updated
2019-09-19

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03725657. Inclusion in this directory is not an endorsement.