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Completed

NCT Number: NCT03725657

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

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.

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Key information

Conditions

Type1 Diabetes Mellitus Behavior Exercise Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Diabetologia Pediatrica "G.Stoppoloni"

Naples, 80100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes onset > 1 year, multiple injection insulin therapy

Exclusion criteria

  • Physical impossibility to movement, food allergy

Treatment and study plan

Primary outcomes

  1. Measure of steps through wrist accelerometer

    Time frame: three weeks

    number of steps

  2. Measure of energy expenditure through wrist accelerometer

    Time frame: three weeks

    kcal

  3. Measure of sleep expenditure through wrist accelerometer

    Time frame: three weeks

    hours of sleep

Secondary outcomes

  1. Measure of glycemic control through glucometer

    Time frame: three weeks

    mmol/L

  2. Measure of insulin dosage

    Time frame: three weeks

    Units/kg

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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

Acronym: inCamp

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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