School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telemedicine
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility 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
Sites / Locations
- SUNY Upstate Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Usual care of type 1 diabetes at the diabetes center
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.
Outcomes
Primary Outcome Measures
hemoglobin A1c
Secondary Outcome Measures
glucose levels, hypoglycemia, quality of life, satisfaction
Full Information
NCT ID
NCT00566475
First Posted
November 29, 2007
Last Updated
October 5, 2021
Sponsor
State University of New York - Upstate Medical University
Collaborators
Department of Health and Human Services, New York State Department of Health, Children's Miracle Network
1. Study Identification
Unique Protocol Identification Number
NCT00566475
Brief Title
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Official Title
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
Department of Health and Human Services, New York State Department of Health, Children's Miracle Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Usual care of type 1 diabetes at the diabetes center
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
telemedicine
Intervention Description
School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent
Primary Outcome Measure Information:
Title
hemoglobin A1c
Time Frame
1 year
Secondary Outcome Measure Information:
Title
glucose levels, hypoglycemia, quality of life, satisfaction
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth S Weinstock, MD PhD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto E Izquierdo, MD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Study Director
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19464030
Citation
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.
Results Reference
result
Learn more about this trial
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
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