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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696640
• Other study ID #: 1638182
• Status: Completed
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 25, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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).

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Data-sharing experience survey	Survey asking about patient's experience with data-sharing	1 month after enrollment
Secondary	Target Glucose Range	Percentage of time spent in target glucose range (generated from continuous glucose monitor)	Months 1-7 after enrollment
Secondary	Hyperglycemic range	Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor)	Months 1-7 after enrollment
Secondary	Hypoglycemic range	Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor)	Months 1-7 after enrollment
Secondary	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
Secondary	Remote patient monitoring survey	Survey asking about patient's experience with remote patient monitoring	Month 7 after enrollment

External Links

•   Learn more or sign up for the study here!