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Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes

Not Applicable
Completed
Conditions
Type 1 Diabetes
Interventions
Behavioral: Remote Patient Monitoring
Registration Number
NCT04696640
Lead Sponsor
University of California, Davis
Brief Summary

This project explores the feasibility and utility of remote glucose monitoring for a cohort of children and adolescents with type 1 diabetes (T1D) cared for at UC Davis Health (UCDH).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
Inclusion Criteria
  • Diagnoses of type 1 diabetes with a duration of greater than or equal to 12 months
  • Use of a continuous glucose monitor (CGM) for greater than or equal to 6 months
  • Intention to continue receiving care at the UC Davis Health Pediatric Diabetes clinic.
Exclusion Criteria
  • Patient's CGM cannot be uploaded to Glooko

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Remote Patient MonitoringRemote Patient MonitoringAll participants who have successfully established remote data-sharing from their glucose monitors to the research team's Glooko account by conclusion of the one-month baseline period will advance to the six-month intervention period.
Primary Outcome Measures
NameTimeMethod
Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health1 month baseline period

Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period.

Change in hemoglobin A1c (HbA1c)Initiation = 1 month after enrollment, Study completion = 7 months after enrollment

HbA1c at study completion minus the HbA1c at initiation

Secondary Outcome Measures
NameTimeMethod
Remote patient monitoring surveyMonth 7 after enrollment

Survey asking about patient's experience with remote patient monitoring

Hyperglycemic rangeMonths 1-7 after enrollment

Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)

Hypoglycemic rangeMonths 1-7 after enrollment

Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)

Target Glucose RangeMonths 1-7 after enrollment

Percentage of time spent in target glucose range (generated from continuous glucose monitor)

Overall continuous glucose monitor (CGM) wear timeMonths 1-7 after enrollment

Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor)

Data-sharing experience survey1 month after enrollment

Survey asking about patient's experience with data-sharing

Trial Locations

Locations (1)

University of California-Davis

🇺🇸

Sacramento, California, United States

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