School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

This study has been completed.

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
Information provided by:	State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:	NCT00566475

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

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

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
1: No Intervention usual care
2: Experimental 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

Responsible Party:	SUNY Upstate Medical University ( Ruth S. Weinstock MD PhD )
Study ID Numbers:	IRB#5302
Study First Received:	November 29, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00566475
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009