Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring

Type 2 Diabetes Clinical Trial

— VDiSC  

Official title:

Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765358
• Other study ID #: VDiSC
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: December 22, 2022

Study information

• Verified date: April 2024
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Other:
• Virtual Clinic
CGM, Clinical Care Support and Behavioral Health Support

Locations

Country	Name	City	State
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C (HbA1c)	Percentage of red blood cells with glucose coated hemoglobin	26 weeks
Secondary	Time Spent With Glucose 70-180 mg/dL	Percentage of 24 hour period with blood glucose in target range of 70-180 mg/dL	26 weeks