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School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00566475
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Department of Health and Human Services
New York State Department of Health
Children's Miracle Network
Information provided by (Responsible Party):
Roberto Izquierdo, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: telemedicine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
No Intervention: 1
Usual care of type 1 diabetes at the diabetes center
Experimental: 2
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.
Other: telemedicine
School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent




Primary Outcome Measures :
  1. hemoglobin A1c [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. glucose levels, hypoglycemia, quality of life, satisfaction [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566475


Locations
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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
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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
Publications of Results:
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Responsible Party: Roberto Izquierdo, Professor of Medicine and Pediatrics, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00566475    
Other Study ID Numbers: IRB#5302
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases