Researchers created and evaluated the viability of a Virtual Diabetes Specialty Clinic (VDiSC), a virtual model that enables full diabetes care remotely, in a recent study that was published in JAMA Network Open.
For the self-management of diabetes, VDiSC combines and supports continuous glucose monitoring (CGM). Additionally, this platform offers behavioral health assistance for issues associated with diabetes and aids in the assessment of decision-support for technological use.
Background
In addition to the rising prevalence of diabetes in the United States, there are currently only one endocrinologist for every 4,375 diabetic patients. Despite substantial proof of its clinical benefits, the majority of primary care settings do not employ CGM, even though they routinely manage diabetic patients.
The use of technology in the treatment of diabetes is hampered by a number of problems, including a shortage of resources trained to handle CGMs, a lack of technology readiness, and difficulties with insurance coverage.
Previous research has demonstrated that CGM has a number of clinical advantages, including lowering hemoglobin A1c (HbA1c) levels, raising time in range (TIR) values to 180 mg/dL, reducing the frequency of hypoglycemia, and enhancing quality-of-life (QoL) assessments.
Through telehealth services, remote access to CGM is simple. In individuals with type 1 diabetes (T1D), for instance, the ONBOARD research reported the clinical advantages of CGM employing a comprehensive telemedicine intervention. Without an in-person visit, remote CGM may also enable clinicians and diabetes patients to agree on changes to therapy.
About the study
Between August 24, 2020, and May 26, 2022, researchers gathered participants for the current cross-sectional web survey via the CVS Health Clinical Trial Services, referrals from endocrinology clinics, and primary care facilities in the United States.
All T1 or T2D patients in the United States who were 18 years of age or older who utilized an insulin pump or daily injections but not a CGM were eligible to participate. TIR values of 54 mg/dL or below were required for patients utilizing CGM to be eligible for the research.
For their virtual encounters, every study participant needed a smartphone and internet connectivity. The minimum follow-up period for the study was 26 weeks.
All study materials, including Dexcom G6 sensors, were sent directly to participants by the research team. Using these supplies, eligible participants who did not use CGM obtained baseline values.
The Certified Diabetes Care and Education Specialist (CDCES) confirmed the demographic information and medical history that each study participant self-reported. In addition, CDCES offered CGM training courses for managing diabetes before the three remote training sessions.
CDCES instructed research participants in CGM initiation during the first session, covering how to insert sensors, turn on alerts and alarms, upload data, and visualize it.
The second training session provided information on data visualization tools, self-management of meals, physical activity, and insulin dosing. Additional CGM instructions were provided at the third session to enable participants customize CGM use and address any issues.
At baseline, 12 and 26 weeks, all participants had fingerstick blood sample collection. For the purpose of measuring HbA1c, these samples were mailed.
A number of questionnaires were also filled out by participants at the beginning and at four, eight, twelve, and 26 weeks. Some participants who scored high enough on any of these questionnaires to qualify for a positive screen received behavioral counseling.
Researchers checked their CGM glucose results to corroborate any participant reports of severe hypoglycemia, diabetic ketoacidosis, or other serious diabetes-related complications. The satisfaction with diabetes treatment and psychosocial factors was self-reported by all study participants.
Utilization of the CGM, CGM measurements for hypo- and hyperglycemia, TIR, average glucose levels, glycemic variability, and HbA1c results were all effectiveness outcomes. All participants were required to start using CGMs, finish at least one training session, and supply CGM data for at least 168 hours.
Study results
160 and 74, respectively, had T1D and T2D, while 123 of the 234 patients in the study were female. The study cohort had a mean age of 47 and a median duration of diabetes of 20 years. Participants with T1D and T2D used their CGMs on average for six months at 96% and 94%, respectively.
Participants with T1D experienced mean HbA1c levels that decreased from 7.8% to 7.1% from baseline at three months and 7.1% at six months, respectively, with an average TIR rise of 11% over the course of six months. Similar results were observed in T2D individuals, with mean HbA1c decreased from 8.1% to 7.1% at baseline, 7.1% at three months, and 7.1% at six months, with an increase in TIR of 18% over the course of six months.
The average proportion of TIR values less than 70 mg/dL and 54 mg/dL reduced in T1D patients over a six-month period by 0.8% and 0.3%, respectively. With a mean percentage of TIR readings of less than 70 mg/dL and 54 mg/dL in 0.5% and 0.07%, respectively, during six months, hypoglycemia was uncommon in the T2D group.
Each patient's needs were met by the study's CGM intervention in conjunction with thorough diabetes education, treatment, and behavioral support. In addition to the clinical advantages, approximately 99% of the participants had favorable CGM experiences that improved their diabetes management, regardless of the type of diabetes they had.
Therefore, 71% and 95%, respectively, of participants with T1D and T2D, claimed that CGM assisted them in altering their eating habits. Furthermore, the majority of young people with T1D prefer to get high-quality care virtually and at home.
CGM's Influence on Remote Diabetes Care
According to the study, patients have reported improved glucose control, longer times in the target range, and pleasant experiences as a result of the integration of CGM with comprehensive diabetes education, care, and behavioral support. The advantages of this strategy go beyond the specific patient since it enables primary doctors to deliver speciality treatment without requiring in-person exams. This has important ramifications for eradicating health inequities, especially for diabetic patients who are unable to get in-person care. This innovative strategy, which incorporates CGM into a model of a virtual clinic, is demonstrating promising outcomes in improving diabetes care.
An All-Inclusive Diabetes Care Strategy
The study, which is funded by the Helmsley Charitable Trust, seeks to assess how well the virtual speciality clinic approach can improve clinical and psychological outcomes for people with diabetes. The clinic offers mental health therapy and help for insulin doses in addition to CGM training using a fully virtual model. Patients receive training from the care team, which includes Certified Diabetes Care and Education Specialists (CDCES), on how to utilize their CGM and control insulin dose. In addition, the presence of trained psychologists and behavioral health coaches offers essential mental health assistance to those coping with the difficulties of diabetes.
Measuring Success and Looking Future
A number of outcomes are intended to be measured by the study, including the use of CGMs, health outcomes, and the utilization of, and costs associated with, healthcare services and decision-support systems. Additionally, it aims to evaluate the effect of mental health services. The ultimate goal is to determine whether having access to modern diabetic technologies and virtual speciality care may improve diabetes health, regardless of location.
Results from a pilot trial completed in 2019 already point to positive developments, with participants reporting improved blood glucose control and quality of life. The current study aims to further assess the effect of the virtual clinic model on glycemic control and overall diabetes care based on these findings.
Health Disparities Reduction Through Virtual Care
The virtual clinic approach has the potential to transform how people with diabetes can access technology and care, particularly in rural locations where access to specialized care may be constrained. The project aims to offer evidence in favor of the extension of virtual care models to reduce barriers to specialty care access by proving the value of virtual specialty care. This highlights the potential for virtual clinics and cutting-edge diabetic technologies to lower health inequities and enhance diabetes care.
The Conclusions
According to their glycemic results and CGM measures, the diabetic patients in the VDiSC trial all benefited clinically from a virtual clinic treatment paradigm.
Additionally, the research approach allowed primary doctors to provide speciality treatment for diabetes-related conditions like foot and eye exams without necessitating in-person assessments. This methodology also lessened health disparities for diabetic patients who couldn't get in-person care and promoted the use of technologies that support diabetes self-management.
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