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

NCT ID: NCT03725657

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-29

Study Completion Date

2019-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type1 Diabetes Mellitus Hypoglycemia Exercise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric

Pediatric Type1 Diabetes Mellitus patients

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Physical impossibility to movement, food allergy
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Angela Zanfardino

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro di Diabetologia Pediatrica "G.Stoppoloni"

Naples, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21204959 (View on PubMed)

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.

Reference Type RESULT
PMID: 20811595 (View on PubMed)

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.

Reference Type RESULT
PMID: 29541338 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

inCamp1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.