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

Study Overview
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Brief Summary
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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).

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Remote Patient Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Patient Monitoring<br>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<br>* 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).<br>|

What is the study measuring?
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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 |