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

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Remote Patient Monitoring

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California-Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Remote Patient Monitoring; All 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.

Behavioral: Remote Patient Monitoring; Participants' glucose data will be monitored by the study team using population analytic reports. Participants who either have excessive hypoglycemia or hyperglycemia on these reports will be contacted by a pediatric endocrinologist (the principal investigator) to discuss any necessary adjustments to their home diabetes management plans. This intervention will be in addition to their usual care (regular visits at the UC Davis Pediatric Endocrinology clinic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health	Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period.	1 month baseline period
Change in hemoglobin A1c (HbA1c)	HbA1c at study completion minus the HbA1c at initiation	Initiation = 1 month after enrollment, Study completion = 7 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data-sharing experience survey	Survey asking about patient's experience with data-sharing	1 month after enrollment
Target Glucose Range	Percentage of time spent in target glucose range (generated from continuous glucose monitor)	Months 1-7 after enrollment
Hyperglycemic range	Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)	Months 1-7 after enrollment
Hypoglycemic range	Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)	Months 1-7 after enrollment
Overall continuous glucose monitor (CGM) wear time	Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor)	Months 1-7 after enrollment
Remote patient monitoring survey	Survey asking about patient's experience with remote patient monitoring	Month 7 after enrollment

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2021
• Primary Completion (ACTUAL): April 18, 2022
• Study Completion (ACTUAL): May 25, 2022

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1638182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No