School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: telemedicine

• Registration Number: NCT00566475
• Lead Sponsor: State University of New York - Upstate Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2017-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	telemedicine	Usual care at the diabetes center supplemented by a telemedicine intervention in the school involving school personnel, the child with diabetes and at least 1 parent of the child. The diabetes center NP conducts videovisits with the school nurse, patient (child) +/- parent monthly.

Primary Outcome Measures

Name	Time	Method
hemoglobin A1c	1 year

Secondary Outcome Measures

Name	Time	Method
glucose levels, hypoglycemia, quality of life, satisfaction	1 year

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States