This article reports key findings from recent randomized, observational, and retrospective studies investigating use of CGM in type 2 diabetes (T2D) individuals treated with basal insulin only and/or noninsulin therapies. Data from 29 studies were reviewed and analyzed. Both randomized and prospective/retrospective studies have demonstrated significant glycemic improvement, reductions in diabetes-related events and hospitalization rates, and cost benefits of persistent CGM use by individuals with T2D who are treated with basal insulin only, basal plus noninsulin medications, and noninsulin medications without insulin. In 23 (79%) of the 29 studies reviewed, investigators reported associations between CGM and improvements in HbA1c and/or key CGM metrics. These findings, alone, provide strong evidence that supports providing access to this technology to those with T2D who are less intensively treated. The narrative presents an evidence-based rationale for expanded access to CGM within the T2D basal insulin only and/or noninsulin treated population. Recent clinical guidelines from the American Diabetes Association and American Association of Clinical Endocrinology now endorse CGM use in individuals treated with nonintensive insulin regimens. Access in the basal insulin only population has expanded since the start of this project. CGM should be made readily available to all individuals with diabetes who are able to use this technology safely and effectively.
Prescribing of CGM in clinical practice and payer coverage criteria have expanded considering the wealth of evidence and expert recommendations supporting more widespread use. As the body of evidence continues to grow, a new supplement in Diabetes Technology & Therapeutics offers insights from leading clinicians on the latest findings and practical application of CGM. The supplement highlights real-world evidence and the unique role of CGM in the management of hypoglycemia and enhancing behavior modification among users of the technology. Special consideration is given to the economic impact of CGM and access issues that may be of particular interest to payer and managed care decision makers.
HbA1c has been a mainstay for assessing glycemic management for the better part of 40 years, largely due to its robust correlation with diabetic vascular complications as demonstrated in the Diabetes Control and Complications Trial (DCCT). As CGM becomes more firmly established as standard of care, there is now a growing body of literature showing that TIR also is strongly associated with chronic complications. Dr. Roy W. Beck recently reviewed this evidence in light of a post hoc analysis of the DEVOTE trial by Bergenstal et al. Managed care and payer decision makers will find this expert commentary useful as it concisely summarizes the data demonstrating the validity of TIR as a clinical measure in diabetes care.
Beck RW. The Association of Time in Range and Diabetic Complications: The Evidence Is Strong. Diabetes Technol Ther. 2023;25:375-377. doi: 10.1089/dia.2023.0141.
Despite Medicare making strides toward improving access with expanded coverage criteria in recent years, experts in the field of endocrinology are speaking out on the importance of reaching underserved populations with the “potentially life-changing benefits” of CGM technology. In addition to expanded coverage eligibility, Richard M. Bergenstal, MD, noted that access to CGM must be simplified by making the technology more readily available in clinic and community settings. To support these efforts, Irl B. Hirsch, MD, called on the role of patient and provider education for driving appropriate uptake and utilization. Managed care and payer professionals will find these expert insights valuable for addressing disparities in diabetes care and outcomes among members affected by SDOH.
International diabetes experts recently collaborated to provide recommendations on how to optimize CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These consensus recommendations have been endorsed by key professional organizations, including the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, Diabetes India, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. This recommended standardized approach to CGM data collection and reporting in clinical trials will encourage the use of uniform metrics and enhance the interpretability of CGM data. Managed care and payer professionals should note that these metrics offer a body of useful information beyond HbA1c to inform therapeutic and treatment decisions, particularly related to hypoglycemia, postprandial hyperglycemia, and glucose variability.
Battelino T, Alexander CM, Amiel SA, et al. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023;11:42-57.
Pharmacy professionals and a payer representative convened an expert panel to connect available evidence and the panelists’ extensive experiences on the value of RT-CGM in improving patient quality of life. In addition, the panelists provided practical approaches to bring awareness, accessibility, and the utility of rtCGM to positively impact patient quality of life in practical applications. Managed care and payer professionals will find these real-world insights useful in characterizing the value of RT-CGM in health plan populations when making coverage determinations.
“Real-Time Continuous Glucose Monitoring: Timely Opportunities to Improve Quality of Life.” CGM Live Virtual Crossfire Series Recap. Part 2. Pharmacy Times Continuing Education. August 2021.
An expert panel composed of pharmacists and a payer professional discussed the value of RT-CGM and the role pharmacists and pharmacy technicians have in optimizing diabetes management. By making RT-CGM available to and allowing pharmacy professionals to work alongside patients, health care stakeholders can leverage the information offered by this technology to optimize diabetes management and mitigate disease impact. The panelists noted that coverage of RT-CGM through the pharmacy benefit facilitates access by allowing patients to fill their prescription directly at community pharmacies. The panelists’ insights are of use to managed care and payer professionals in determining optimal coverage policies for RT-CGM to improve outcomes among members with diabetes.
“Real-Time Continuous Glucose Monitoring: Implications for Pharmacists.” CGM Live Virtual Crossfire Series Recap. Part 1. Pharmacy Times Continuing Education. May 2021.
A roundtable convened by the American Pharmacists Association reviewed the substantial body of evidence demonstrating that CGM is associated with improved glycemic control for patients with both T1D and T2D. Leading experts participating in the roundtable noted that CGM remains underutilized and that disparities in care are evident. One specific barrier to expanded utilization called out by the participants was the lack of an adequate number of providers who offer the service. Developing community pharmacy-based CGM services has been proposed as a logical solution for expanding patient access. Supporting this approach are the abundant data showing that pharmacist involvement in patient care for diabetes improves outcomes and reduces overall costs of care. Managed care and payer professionals will find this in-depth review and discussion valuable for developing their own policies for CGM coverage and access in the pharmacy setting.
American Pharmacists Association Foundation. “Expanding Access to Continuous Glucose Monitoring Technology in Community Pharmacies.” Practices Insights. May 2022.
According to a survey administered by Employee Benefit News, at least 70% of employees find high stress, depression, asthma, or diabetes disruptive enough to affect their everyday lives, including work and other responsibilities. In response, the vast majority of employers (84%) are offering digital health tools in some form that can help employees manage common chronic conditions, although only an average of 50% of employees take advantage of these benefits. Research shows employees want flexible options that offer new innovative tools to treat their chronic conditions, in addition to education to help them get started with a new program. Third-party technology vendors can assist in driving employee engagement, mitigating rising health care costs, and creating better outcomes for employees. Managed care and payer professionals will find these insights useful for developing programs that offer value to purchasers of health care.
“Optimizing Digital Health Tools to Retain and Engage Employees.” Employee Benefit News Supplement.