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

Sponsors

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Source 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.

Overall Status Completed
Start Date October 29, 2018
Completion Date September 18, 2019
Primary Completion Date September 18, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Measure of steps through wrist accelerometer three weeks
Measure of energy expenditure through wrist accelerometer three weeks
Measure of sleep expenditure through wrist accelerometer three weeks
Secondary Outcome
Measure Time Frame
Measure of glycemic control through glucometer three weeks
Measure of insulin dosage three weeks
Enrollment 60
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- diabetes onset > 1 year, multiple injection insulin therapy

Exclusion Criteria:

- Physical impossibility to movement, food allergy

Gender: All

Minimum Age: 10 Years

Maximum Age: 12 Years

Location
Facility: Centro di Diabetologia Pediatrica "G.Stoppoloni"
Location Countries

Italy

Verification Date

September 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Campania "Luigi Vanvitelli"

Investigator Full Name: Angela Zanfardino

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Arm Group

Label: Pediatric

Description: Pediatric Type1 Diabetes Mellitus patients

Acronym inCamp
Patient Data Undecided
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov