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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Patient Monitoring
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California-Davis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote Patient Monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Change in hemoglobin A1c (HbA1c)
HbA1c at study completion minus the HbA1c at initiation

Secondary Outcome Measures

Data-sharing experience survey
Survey asking about patient's experience with data-sharing
Target Glucose Range
Percentage of time spent in target glucose range (generated from continuous glucose monitor)
Hyperglycemic range
Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)
Hypoglycemic range
Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)
Overall continuous glucose monitor (CGM) wear time
Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor)
Remote patient monitoring survey
Survey asking about patient's experience with remote patient monitoring

Full Information

First Posted
January 4, 2021
Last Updated
May 31, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04696640
Brief Title
Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
Official Title
Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Patient Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Patient Monitoring
Intervention Description
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).
Primary Outcome Measure Information:
Title
Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health
Description
Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period.
Time Frame
1 month baseline period
Title
Change in hemoglobin A1c (HbA1c)
Description
HbA1c at study completion minus the HbA1c at initiation
Time Frame
Initiation = 1 month after enrollment, Study completion = 7 months after enrollment
Secondary Outcome Measure Information:
Title
Data-sharing experience survey
Description
Survey asking about patient's experience with data-sharing
Time Frame
1 month after enrollment
Title
Target Glucose Range
Description
Percentage of time spent in target glucose range (generated from continuous glucose monitor)
Time Frame
Months 1-7 after enrollment
Title
Hyperglycemic range
Description
Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)
Time Frame
Months 1-7 after enrollment
Title
Hypoglycemic range
Description
Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)
Time Frame
Months 1-7 after enrollment
Title
Overall continuous glucose monitor (CGM) wear time
Description
Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor)
Time Frame
Months 1-7 after enrollment
Title
Remote patient monitoring survey
Description
Survey asking about patient's experience with remote patient monitoring
Time Frame
Month 7 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://studypages.com/s/pilot-study-of-remote-glucose-monitoring-among-pediatric-patients-with-type-1-diabetes-151947/
Description
Learn more or sign up for the study here!

Learn more about this trial

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

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