Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00848822
First received: February 18, 2009
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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.


Condition
Type 1 Diabetes Mellitus
Sleep

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848822

Locations
United States, Arizona
Steele Research Memorial Foundation, Angel Clinic for Children with Diabetes and Endocrine Disorders
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Priti G Patel, M.D. University of Arizona
Principal Investigator: Michelle Perfect, PhD Univeristy of Arizona
  More Information

Publications:
Responsible Party: Priti Patel, M.D., University of Arizona
ClinicalTrials.gov Identifier: NCT00848822     History of Changes
Other Study ID Numbers: 08-1108-01
Study First Received: February 18, 2009
Last Updated: April 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Pediatrics
Sleep
Glucose regulation
Type 1 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014