School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus

NCT ID: NCT00566475

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Usual care of type 1 diabetes at the diabetes center

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

telemedicine

Intervention Type OTHER

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

Interventions

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telemedicine

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

Children's Miracle Network

OTHER

Sponsor Role collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Izquierdo

Professor of Medicine and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruth S Weinstock, MD PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Roberto E Izquierdo, MD

Role: STUDY_DIRECTOR

State University of New York - Upstate Medical University

Locations

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SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19464030 (View on PubMed)

Other Identifiers

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IRB#5302

Identifier Type: -

Identifier Source: org_study_id