School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborators:
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
  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:


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
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: 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
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, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014