Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03725657
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2018-10-28
Brief Title:
Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
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:
None
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?:
None