NCT00566475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

November 29, 2007

Last Update Submit

October 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • hemoglobin A1c

    1 year

Secondary Outcomes (1)

  • glucose levels, hypoglycemia, quality of life, satisfaction

    1 year

Study Arms (2)

1

NO INTERVENTION

Usual care of type 1 diabetes at the diabetes center

2

EXPERIMENTAL

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

Interventions

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

2

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ruth S Weinstock, MD PhD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR
  • Roberto E Izquierdo, MD

    State University of New York - Upstate Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Pediatrics

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 14, 2021

Record last verified: 2017-10

Locations