NCT04696640

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 3, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

January 4, 2021

Last Update Submit

May 31, 2022

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Data-sharing experience survey

    1 month after enrollment

  • Target Glucose Range

    Months 1-7 after enrollment

  • Hyperglycemic range

    Months 1-7 after enrollment

  • Hypoglycemic range

    Months 1-7 after enrollment

  • Overall continuous glucose monitor (CGM) wear time

    Months 1-7 after enrollment

  • +1 more secondary outcomes

Study Arms (1)

Remote Patient Monitoring

EXPERIMENTAL

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

Interventions

Remote Patient MonitoringBEHAVIORAL

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).

Remote Patient Monitoring

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient's CGM cannot be uploaded to Glooko

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Crossen SS, Romero CC, Lewis C, Glaser NS. Remote glucose monitoring is feasible for patients and providers using a commercially available population health platform. Front Endocrinol (Lausanne). 2023 Feb 2;14:1063290. doi: 10.3389/fendo.2023.1063290. eCollection 2023.

    PMID: 36817610DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

June 3, 2021

Primary Completion

April 18, 2022

Study Completion

May 25, 2022

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)