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Clinical Trials/NCT02848261
NCT02848261
Completed
Not Applicable

Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes

Stanford University4 sites in 1 country92 target enrollmentAugust 15, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Stanford University
Enrollment
92
Locations
4
Primary Endpoint
Time spent in blood glucose range
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).

Registry
clinicaltrials.gov
Start Date
August 15, 2016
End Date
April 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Korey Hood

Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time spent in blood glucose range

Time Frame: Change over 6 months

Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.

Pediatric Quality of Life Inventory

Time Frame: Change over 6 months

This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index(Change over 6 months)
  • A1c(Change over 6 months)
  • Diabetes Distress Scale(Change over 6 months)
  • Patient Health Questionnaire 9(Change over 6 months)
  • Problem Areas in Diabetes(Change over 6 months)
  • State-Trait Anxiety Inventory(Change over 6 months)
  • General and diabetes-specific technology use(Change over 6 months)
  • Hypoglycemic Fear Survey(Change over 6 months)
  • Hypoglycemic Confidence Questionnaire(Change over 6 months)
  • Glucose Monitoring System Satisfaction Survey(Change over 6 months)

Study Sites (4)

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