Can A Virtual Diabetes Clinic Improve Time in Range?
By Frida Velcani
A fully virtual six-month clinical trial is recruiting 300 people with type 1 and type 2 diabetes who are interested in trying continuous glucose monitoring (CGM) with personal support. The study will determine how access to virtual diabetes care with CGM impacts Time in Range (TIR).
Clinical Trials Identifier: NCT04765358
Trial name: Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Diabetes type: Type 1 and Type 2
What is the trial testing?
This study will evaluate whether access to a virtual diabetes clinic can improve Time in Range (TIR) for people with diabetes using continuous glucose monitors (CGM). All interactions will take place outside of a clinical setting and will include an introduction to CGM, as well as support with insulin dosing and mental health. Read more about the study here.
The virtual clinic team will provide 300 participants with a CGM and teach them how to use it. Participants will use CGM for six months and complete psychosocial screening surveys at the start and throughout the study. Certified Diabetes Care and Education Specialists (CDCES) will provide insulin dosing advice. People experiencing mental health challenges will be offered support by behavioral health coaches. In addition to the surveys, participants will be asked to provide fingerstick samples every three months with an at-home test kit that can measure A1C and share their CGM data with researchers. After six months, participants can choose to continue using CGM for an additional 26 weeks. The study will be “unblinded,” meaning that every person involved will be able to view and act on their glucose data in real-time.
What is the trial measuring?
The researchers will evaluate participants’ TIR at 26 weeks and 52 weeks (for those who continue to use CGM past the first phase).
Why is this trial new and important?
Telemedicine is becoming increasingly common for people with diabetes to receive expert guidance, especially during the COVID-19 pandemic. Introducing people with diabetes to CGM through virtual care may be important for a few reasons:
Many people with diabetes have difficulty accessing diabetes care and technology, especially in rural areas where less than 2% of healthcare professionals are located. This can lead to disparities in health outcomes based on where people live. Virtual specialty clinics can make care delivery more equitable by introducing people with diabetes to technological advances like CGM and allowing them to have access to endocrinologists regardless of their location.
CGM can benefit all people with diabetes by providing them with real-time glucose levels and trends. Studies have shown that CGM use and higher TIR can improve mood and quality of life and reduce the risk of long-term complications such as heart disease, kidney disease, eye disease, and neuropathy. This study may teach and encourage more people with diabetes to incorporate CGM and metrics like TIR into their diabetes management.
Trial length: 26 to 52 weeks
Trial location: The trial is fully remote and open to people in most states in the US. The study is coordinated by the Jaeb Center for Health Research in Tampa, Florida.
Are you interested?
You may be eligible to join the study if you:
Are over the age of 18
Have type 1 or type 2 diabetes and use an insulin pump (must be compatible with Tidepool software) or take at least three injections of insulin per day
Visit a healthcare professional at least once a year
Plan to stay in the US for the entire study
Use an Android smartphone or iPhone
Have access to a computer with internet
Understand written and spoken English
Have not used a real-time CGM in the last 12 months
You can see a full list of eligibility and exclusion criteria here.
For more information: Please contact the VDiSC Study Team (813-975-8690 or [email protected]).