Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

NCT ID: NCT00848822

Last Updated: 2011-04-15

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

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this project is to look at how sleep affects glucose values in children with Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to the body's own internal rhythm also known as the circadian rhythm.

Detailed Description

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Diabetes Mellitus (DM) is one of the most prevalent chronic pediatric diseases, affecting 2.80 cases per 1000 youth between the ages of 10 and 19. Since the crux of diabetes management is glucose regulation, any further challenges such as stress and/or poor sleep may make glucose regulation even more difficult. Mounting evidence supports the association between inadequate sleep and obesity as well as metabolic syndrome. Despite emerging findings supporting that total sleep time (TST) may contribute to the risk of obesity and/or metabolic complications, less research has been focused on Type 1 Diabetes Mellitus (T1DM) and on other sleep parameters.

Participants will have a Continuous Glucose Monitor (CGM) and actigraph placed which they will wear for 5 days. At the end of the 5 days, they will return the glucose meter, CGM, and actigraph to a clinic staff or research team member to download their data. They will provide us with a glucose log that contains the glucose levels obtained from a fingerstick capillary glucose meter. In this log, participants will also record their activities, meals, and insulin administered. They will also provide us with a sleep diary. In addition, participants will have the option for the child to undergo polysomnography (sleep study) for one night in their home or two nights in the sleep lab.

Conditions

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Type 1 Diabetes Mellitus Sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Type I Diabetes Mellitus
* Age of 10-16 year old

Exclusion Criteria

* Significant Developmental Delay
* Any other condition that in the opinion of the medical treatment team would interfere with his/her ability to participate
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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University of Arizona

Principal Investigators

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Priti G Patel, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Michelle Perfect, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Arizona

Locations

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Steele Research Memorial Foundation, Angel Clinic for Children with Diabetes and Endocrine Disorders

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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SEARCH for Diabetes in Youth Study Group; Liese AD, D'Agostino RB Jr, Hamman RF, Kilgo PD, Lawrence JM, Liu LL, Loots B, Linder B, Marcovina S, Rodriguez B, Standiford D, Williams DE. The burden of diabetes mellitus among US youth: prevalence estimates from the SEARCH for Diabetes in Youth Study. Pediatrics. 2006 Oct;118(4):1510-8. doi: 10.1542/peds.2006-0690.

Reference Type BACKGROUND
PMID: 17015542 (View on PubMed)

Matyka KA, Crawford C, Wiggs L, Dunger DB, Stores G. Alterations in sleep physiology in young children with insulin-dependent diabetes mellitus: relationship to nocturnal hypoglycemia. J Pediatr. 2000 Aug;137(2):233-8. doi: 10.1067/mpd.2000.107186.

Reference Type BACKGROUND
PMID: 10931417 (View on PubMed)

Pillar G, Schuscheim G, Weiss R, Malhotra A, McCowen KC, Shlitner A, Peled N, Shehadeh N. Interactions between hypoglycemia and sleep architecture in children with type 1 diabetes mellitus. J Pediatr. 2003 Feb;142(2):163-8. doi: 10.1067/mpd.2003.66.

Reference Type BACKGROUND
PMID: 12584538 (View on PubMed)

Taras H, Potts-Datema W. Sleep and student performance at school. J Sch Health. 2005 Sep;75(7):248-54. doi: 10.1111/j.1746-1561.2005.00033.x.

Reference Type BACKGROUND
PMID: 16102087 (View on PubMed)

Other Identifiers

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08-1108-01

Identifier Type: -

Identifier Source: org_study_id

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