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School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00566475
First received: November 29, 2007
Last updated: December 29, 2009
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • hemoglobin A1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose levels, hypoglycemia, quality of life, satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Izquierdo R, Morin PC, Bratt K, Moreau Z, Meyer S, Ploutz-Snyder R, Wade M, Weinstock RS. School-centered telemedicine for children with type 1 diabetes mellitus. J Pediatr 2009;155:374-379.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ruth S. Weinstock MD PhD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00566475     History of Changes
Other Study ID Numbers: IRB#5302
Study First Received: November 29, 2007
Last Updated: December 29, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013