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School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566475
First Posted: December 3, 2007
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Department of Health and Human Services
New York State Department of Health
Children's Miracle Network
Information provided by:
State University of New York - Upstate Medical University
  Purpose
The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.

Condition Intervention
Type 1 Diabetes Other: telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • hemoglobin A1c [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • glucose levels, hypoglycemia, quality of life, satisfaction [ Time Frame: 1 year ]

Enrollment: 41
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
usual care
Experimental: 2
Telemedicine intervention in the school involving school personnel, the child with diabetes and at least 1 parent of the child
Other: telemedicine
School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
  • Grade K-8
  • Age 5-14 at time of enrollment
  • Consent of student, parent and school
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566475


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Department of Health and Human Services
New York State Department of Health
Children's Miracle Network
Investigators
Principal Investigator: Ruth S Weinstock, MD PhD State University of New York - Upstate Medical University
Study Director: Roberto E Izquierdo, MD State University of New York - Upstate Medical University
  More Information

Publications:
Responsible Party: Ruth S. Weinstock MD PhD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00566475     History of Changes
Other Study ID Numbers: IRB#5302
First Submitted: November 29, 2007
First Posted: December 3, 2007
Last Update Posted: October 17, 2017
Last Verified: December 2009

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