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NCT00566475 Clinical Trial

School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

Official title:
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00566475
Other study ID # IRB#5302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2007
Est. completion date January 2008

Study information
Verified date October 2017
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group 5 Years to 14 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• telemedicine
School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent

Locations
Country Name City State
United States SUNY Upstate Medical University Syracuse New York

Sponsors (4)
Lead Sponsor Collaborator
State University of New York - Upstate Medical University Children's Miracle Network, Department of Health and Human Services, New York State Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Sep;155(3):374-9. doi: 10.1016/j.jpeds.2009.03.014. Epub 2009 May 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary hemoglobin A1c 1 year
Secondary glucose levels, hypoglycemia, quality of life, satisfaction 1 year
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