Status:
COMPLETED
Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Lead Sponsor:
Jaeb Center for Health Research
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study was to evaluate a virtual diabetes clinic model, for adults with either type 1 diabetes or type 2 diabetes, that supports integration of CGM into diabetes self-management a...
Detailed Description
Although demand for endocrinology care continues to grow, access to specialized care may be impacted by geographic isolation and a shortage in the number of endocrinologists in the United States. CGM ...
Eligibility Criteria
Inclusion
- Age \>18 years old
- Diagnosis of type 1 diabetes or type 2 diabetes and using insulin therapy (at least 3 injections of insulin per day or insulin pump that is compatible with Tidepool software); Multiple daily injection (MDI) users must be willing to use a device provided by the study that records the injection dosages and/or enter insulin dosing information through an app
- See a healthcare provider at least once a year
- Resident of United States and plan to reside in the U.S. for the duration of the study (This requirement is due to virtual clinic license requirements and U.S. use restrictions for some study software and devices. Not all U.S. states may be eligible for inclusion due to virtual clinic license status.)
- Use either an Android or iOS smartphone that is compatible with app requirements that are needed for the study
- Access to a compatible computer with internet
- Understand written and spoken English
- Willing and able to follow the study procedures as instructed
Exclusion
- Current use of a closed loop system where an insulin pump and CGM share information and insulin dose is automatically adjusted based on glucose reading
- Current CGM use where Time in Range is ≥60.0% or Time \<54% is ≤1.0%.
- Current use of any off-label glucose-lowering medications for diabetes type (Example: T1D use of non-insulin, anti-diabetic medications including SGLT2 inhibitors). Use of such medications during the study will also be prohibited.
- Females who are pregnant, intending to become pregnant, or breastfeeding during the study
- Current renal dialysis or plan to begin renal dialysis during the study
- Active cancer treatment
- Extreme visual or hearing impairment that would impair ability to use real-time CGM
- Known adhesive allergy/prior skin reaction or skin reaction identified during the blinded CGM use phase that would preclude continued CGM use
- Participation in a different diabetes management study during the study
- Planned relocation to a state other than current state of residence during the study if virtual clinic is not licensed in the new state. Individuals working routinely in a state other than current state of residence in the next six months are also ineligible if the virtual clinic is not licensed in that state.
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT04765358
Start Date
August 24 2020
End Date
December 22 2022
Last Update
April 16 2024
Active Locations (1)
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1
Jaeb Center for Health Research
Tampa, Florida, United States, 33647