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Continuous Glucose Monitor Use in School

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tandy Aye, Stanford University
ClinicalTrials.gov Identifier:
NCT01364766
First received: May 31, 2011
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes.


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Impact of Continuous Glucose Monitor Use in the Classroom/School Environment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • CGM usefulness score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes Comfort score [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. Recent technological advancements in diabetes management have resulted in increased use of devices during class/school. Although many studies have examined the quality of life and the impact on the family and subject of these devices, to our knowledge this is the first study that will examine the impact of the continuous glucose monitor during class/school. To our knowledge, this is first study to involve the teachers. The results of this study is particularly important since the future of diabetes therapy will be to use continuous glucose monitors and insulin pumps to develop a closed loop system of insulin therapy or "artificial pancreas."

  Eligibility

Ages Eligible for Study:   1 Year to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Anyone with diabetes mellitus who is wearing a continous glucose sensor and is in school.

Criteria

Inclusion Criteria:

Diabetes use continuous glucose monitor in school

Exclusion Criteria not using a continuous glucose monitor

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364766

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Tandy Aye MD Stanford University
  More Information

No publications provided

Responsible Party: Tandy Aye, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01364766     History of Changes
Other Study ID Numbers: SU-08122010-6709
Study First Received: May 31, 2011
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013