Continuous Glucose Monitor Use in School

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tandy Aye, Stanford University
ClinicalTrials.gov Identifier:
NCT01364766
First received: May 31, 2011
Last updated: April 13, 2016
Last verified: April 2016
  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

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 ]

Enrollment: 40
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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
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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 13, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 26, 2016