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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03725657

Acronym

inCamp

Enrollment

Registered

2018-10-31

Start date

2018-10-29

Completion date

2019-09-18

Last updated

2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Hypoglycemia, Type1 Diabetes Mellitus

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 12 Years

Inclusion criteria

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

Exclusion criteria

* Physical impossibility to movement, food allergy

Design outcomes

Primary

Measure	Time frame	Description
Measure of steps through wrist accelerometer	three weeks	number of steps
Measure of energy expenditure through wrist accelerometer	three weeks	kcal
Measure of sleep expenditure through wrist accelerometer	three weeks	hours of sleep

Secondary

Measure	Time frame	Description
Measure of glycemic control through glucometer	three weeks	mmol/L
Measure of insulin dosage	three weeks	Units/kg

Countries

Italy

Outcome results