Type 1 Diabetes
Conditions
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).
Interventions
BEHAVIORALRemote 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).
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of remote glucose monitoring for pediatric T1D patients who receive care at UC Davis Health | 1 month baseline period | Proportion of participants who have successfully established remote glucose monitoring by the end of the baseline period. |
| Change in hemoglobin A1c (HbA1c) | Initiation = 1 month after enrollment, Study completion = 7 months after enrollment | HbA1c at study completion minus the HbA1c at initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperglycemic range | Months 1-7 after enrollment | Percentage of time spent in hyperglycemic range (generated from continuous glucose monitor) |
| Hypoglycemic range | Months 1-7 after enrollment | Percentage of time spent in hypoglycemic range (generated from continuous glucose monitor) |
| Data-sharing experience survey | 1 month after enrollment | Survey asking about patient's experience with data-sharing |
| Remote patient monitoring survey | Month 7 after enrollment | Survey asking about patient's experience with remote patient monitoring |
| Overall continuous glucose monitor (CGM) wear time | Months 1-7 after enrollment | Percentage of time spent wearing continuous glucose monitor (generated from continuous glucose monitor) |
| Target Glucose Range | Months 1-7 after enrollment | Percentage of time spent in target glucose range (generated from continuous glucose monitor) |
Countries
United States
Outcome results
None listed