Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03725657
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2018-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
inCamp
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: