Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

April 14, 2011 updated by: University of Arizona
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Steele Research Memorial Foundation, Angel Clinic for Children with Diabetes and Endocrine Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This study could help find if there are particular times of day or times during sleep that change glucose the most.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Priti G Patel, M.D., University of Arizona
  • Principal Investigator: Michelle Perfect, PhD, Univeristy of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 14, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-1108-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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