Clinical trial NCT00848822: Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus
Official title: Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Sleep
Keywords: Pediatrics
Sleep
Glucose regulation
Type 1 Diabetes Mellitus
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pariticipants will be recruited from the Angel Clinic for Children with Diabetes and Endocrine Disorders which is part of University Medical Center in Tucson, Arizona

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: This study could help find if there are particular times of day or times during sleep that change glucose the most.
timeFrame: 12 months
Secondary outcomes:
measure: This study may help make recommendations about the best time to test glucose values and better help children with Type 1 Diabetes Mellitus control their glucose levels.
timeFrame: 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Steele Research Memorial Foundation, Angel Clinic for Children with Diabetes and Endocrine Disorders
state: Arizona
Study officials:
affiliation: University of Arizona
name: Priti G Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of Arizona
name: Michelle Perfect, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.