Clinical trial NCT04765358: Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Official title: Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 and use of decision support technology.

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 use has been endorsed for individuals with T1D by the American Diabetes Association, the American Association of Clinical Endocrinologists, the Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes. Despite these recommendations and the compelling evidence of the benefits of CGM, many individuals with T1D or insulin-using T2D have not incorporated CGM into their diabetes management.

The study was designed to assess feasibility and efficacy of establishing a virtual diabetes clinic with a focus on introduction and training related to use of CGM technology and ongoing CGM use to minimize such rate-limiting factors as geography, cost and access to specialty care. The virtual diabetes clinic model included a comprehensive care team with support for diabetes technology such as CGM and decision support to align with current recommendations in diabetes care. The virtual diabetes clinic model also included mental health screening and support services, particularly for diabetes-related issues.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years old
2. 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
3. See a healthcare provider at least once a year
4. 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.)
5. Use either an Android or iOS smartphone that is compatible with app requirements that are needed for the study
6. Access to a compatible computer with internet
7. Understand written and spoken English
8. Willing and able to follow the study procedures as instructed

Exclusion Criteria:

1. 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
2. Current CGM use where Time in Range is ≥60.0% or Time \<54% is ≤1.0%.
3. 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.
4. Females who are pregnant, intending to become pregnant, or breastfeeding during the study
5. Current renal dialysis or plan to begin renal dialysis during the study
6. Active cancer treatment
7. Extreme visual or hearing impairment that would impair ability to use real-time CGM
8. Known adhesive allergy/prior skin reaction or skin reaction identified during the blinded CGM use phase that would preclude continued CGM use
9. Participation in a different diabetes management study during the study
10. 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.

Primary outcomes:
measure: Hemoglobin A1C (HbA1c)
timeFrame: 26 weeks
Secondary outcomes:
measure: Time Spent With Glucose 70-180 mg/dL
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Jaeb Center for Health Research
state: Florida
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Grazia Aleppo, MD
role: STUDY_CHAIR
affiliation: Jaeb Center for Health Research
name: Robin L Gal, MSPH
role: PRINCIPAL_INVESTIGATOR
References: