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Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00848822
Enrollment
50
Registered
2009-02-20
Start date
2009-02-28
Completion date
2010-07-31
Last updated
2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Type 1 Diabetes Mellitus

Keywords

Pediatrics, Sleep, Glucose regulation, Type 1 Diabetes Mellitus

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.

Interventions

None listed

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
This study could help find if there are particular times of day or times during sleep that change glucose the most.12 months

Secondary

MeasureTime frame
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.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026