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

Exercise Clinical Trial

— inCamp  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725657
• Other study ID #: inCamp1
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: September 18, 2019

Study information

• Verified date: September 2019
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

Inclusion Criteria:

• diabetes onset > 1 year, multiple injection insulin therapy

Exclusion Criteria:

• Physical impossibility to movement, food allergy

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Exercise
• Hypoglycemia
• Type1 Diabetes Mellitus

Locations

Country	Name	City	State
Italy	Centro di Diabetologia Pediatrica "G.Stoppoloni"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Bunn JA, Navalta JW, Fountaine CJ, Reece JD. Current State of Commercial Wearable Technology in Physical Activity Monitoring 2015-2017. Int J Exerc Sci. 2018 Jan 2;11(7):503-515. eCollection 2018. — View Citation

Kelly D, Hamilton JK, Riddell MC. Blood glucose levels and performance in a sports cAMP for adolescents with type 1 diabetes mellitus: a field study. Int J Pediatr. 2010;2010. pii: 216167. doi: 10.1155/2010/216167. Epub 2010 Aug 2. — View Citation

Miller AR, Nebesio TD, DiMeglio LA. Insulin dose changes in children attending a residential diabetes camp. Diabet Med. 2011 Apr;28(4):480-6. doi: 10.1111/j.1464-5491.2010.03220.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of steps through wrist accelerometer	number of steps	three weeks
Primary	Measure of energy expenditure through wrist accelerometer	kcal	three weeks
Primary	Measure of sleep expenditure through wrist accelerometer	hours of sleep	three weeks
Secondary	Measure of glycemic control through glucometer	mmol/L	three weeks
Secondary	Measure of insulin dosage	Units/kg	three weeks