Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT04696640 for Type 1 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
University of California, DavisPilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes 39 Pediatric Adolescent Remote
Clinical Trial NCT04696640 was an interventional study for Type 1 Diabetes that is now completed. The study started on June 3, 2021, with plans to enroll 39 participants. Led by University of California, Davis, the expected completion date was May 25, 2022. The latest data from ClinicalTrials.gov was last updated on June 2, 2022.
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).
Official Title
Pilot Study of Remote Glucose Monitoring Among Pediatric Patients With Type 1 Diabetes
Conditions
Type 1 DiabetesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 1638182
NCT ID Number
Start Date (Actual)
2021-06-03
Last Update Posted
2022-06-02
Completion Date (Estimated)
2022-05-25
Enrollment (Estimated)
39
Study Type
Interventional
PHASE
N/A
Status
Completed
Primary Purpose
Health Services Research
Design Allocation
N/A
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRemote Patient Monitoring 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. | 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...Show More |
Primary Outcome Measures
Secondary 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 |
| 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 |
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
1 Year
Eligible Sexes
All
- 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.
- Patient's CGM cannot be uploaded to Glooko
University of California, Davis235 active studies to exploreNo contact data.
1 Study Locations in 1 Countries
California
University of California-Davis, Sacramento, California, 95817, United States