Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus
NCT ID: NCT00848822
Last Updated: 2011-04-15
Study Results
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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COMPLETED
50 participants
OBSERVATIONAL
2009-02-28
2010-07-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age of 10-16 year old
Exclusion Criteria
* Any other condition that in the opinion of the medical treatment team would interfere with his/her ability to participate
10 Years
16 Years
ALL
No
Sponsors
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University of Arizona
OTHER
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
Countries
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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.
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.
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.
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.
Other Identifiers
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08-1108-01
Identifier Type: -
Identifier Source: org_study_id
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