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Clinical Trials/NCT03725657
NCT03725657
Completed
Not Applicable

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

University of Campania "Luigi Vanvitelli"1 site in 1 country60 target enrollmentOctober 29, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type1 Diabetes Mellitus
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
60
Locations
1
Primary Endpoint
Measure of steps through wrist accelerometer
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2018
End Date
September 18, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela Zanfardino

Principal Investigator

University of Campania "Luigi Vanvitelli"

Eligibility Criteria

Inclusion Criteria

  • diabetes onset \> 1 year, multiple injection insulin therapy

Exclusion Criteria

  • Physical impossibility to movement, food allergy

Outcomes

Primary Outcomes

Measure of steps through wrist accelerometer

Time Frame: three weeks

number of steps

Measure of sleep expenditure through wrist accelerometer

Time Frame: three weeks

hours of sleep

Measure of energy expenditure through wrist accelerometer

Time Frame: three weeks

kcal

Secondary Outcomes

  • Measure of glycemic control through glucometer(three weeks)
  • Measure of insulin dosage(three weeks)

Study Sites (1)

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