Clinical trial NCT03725657: Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1 Diabetes Mellitus
Hypoglycemia
Exercise
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric Type1Diabetes patients

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Physical impossibility to movement, food allergy

Primary outcomes:
measure: Measure of steps through wrist accelerometer
timeFrame: three weeks
measure: Measure of energy expenditure through wrist accelerometer
timeFrame: three weeks
measure: Measure of sleep expenditure through wrist accelerometer
timeFrame: three weeks
Secondary outcomes:
measure: Measure of glycemic control through glucometer
timeFrame: three weeks
measure: Measure of insulin dosage
timeFrame: three weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Centro di Diabetologia Pediatrica "G.Stoppoloni"
Study officials:
References:
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.
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;2010:216167. doi: 10.1155/2010/216167. Epub 2010 Aug 2.
citation: 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. doi: 10.70252/NJQX2719. eCollection 2018.