Long-Term Improvements in Glycemic Control with Dexcom CGM Use in Adults with Noninsulin-Treated Type 2 Diabetes.

Aims: The objective of this real-world, observational study was to evaluate change in continuing glucose monitoring (CGM) metrics for 1 year after CGM initiation in adults with noninsulin-treated type 2 diabetes (T2D). Methods: Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D, ≥18 years, gender, no insulin use, and had a baseline percent time in range (TIR) 70-180 mg/dL of ≤70%. Outcomes were change in CGM metrics from baseline to 6 and 12 months overall and for younger (<65 years) and older (≥65 years) cohorts. Additional analyses explored the relationship between use of the high alert feature and change in TIR and time in tight range (TITR) 70-140 mg/dL. Results: CGM users (n = 3,840) were mean (SD) 52.5 (11.2) years, 47.9% female, mean TIR was 41.7% (21.4%), and 12.4% of participants were ≥65 years. Significant improvement in all CGM metrics not meeting target values at baseline was observed at 6 months, with continued improvement at 12 months. Mean baseline TIR increased by 17.3% (32.1%) from 41.7% (21.4%) to 59.0% (28.9%), and mean glucose management indicator decreased by 0.5% (1.2%) from 8.1% (0.9%) to 7.6% (1.1%) (both P < 0.001). Participants who maintained or customized the high alert default setting of 250 mg/dL had a greater increase in TIR and TITR compared with participants who disabled the alert. Days of CGM use over 12 months were high in 84.7% (15.9%). Conclusion: In this large, real-world study of adults with suboptimally controlled T2D not using insulin, Dexcom CGM use was associated with meaningful improvements in glycemic control over 12 months. Use of the high alert system feature was positively associated with glycemic outcomes. High use of CGM over 12 months suggests benefits related to consistent CGM use in this population.

Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Disparities in prevalence and treatment of diabetes, cardiovascular and chronic kidney diseases - Recommendations from the taskforce of the guideline workshop.

There is a mounting clinical, psychosocial, and socioeconomic burden worldwide as the prevalence of diabetes, cardiovascular disease (CVD), and chronic kidney disease (CKD) continues to rise. Despite the introduction of therapeutic interventions with demonstrated efficacy to prevent the development or progression of these common chronic diseases, many individuals have limited access to these innovations due to their race/ethnicity, and/or socioeconomic status (SES). However, practical guidance to providers and healthcare systems for addressing these disparities is often lacking. In this article, we review the prevalence and impact of healthcare disparities derived from the above-mentioned chronic conditions and present broad-based recommendations for improving access to quality care and health outcomes within the most vulnerable populations.

The Current and Future Role of Insulin Therapy in the Management of Type 2 Diabetes: A Narrative Review.

Early initiation of intensive insulin therapy has been demonstrated to be effective in controlling glycemia and possibly preserving beta-cell function. Innovations in insulin formulations and delivery systems continue. However, we have seen an acceleration in the development of new classes of diabetes medications for individuals with type 2 diabetes and obesity, such as, for example, glucagon-like peptide-1 receptor agonists (GLP-1 RAs). These formulations have been shown to confer significant benefits in achieving good glycemic control with reduced hypoglycemia risk, weight loss, and cardiorenal protection. Therefore, it is reasonable to question whether there is still a role for insulin therapy in the management of type 2 diabetes. However, there are clear limitations inherent to GLP-1 RA therapy, including high rates of suboptimal adherence and treatment discontinuation due to high cost and side effects, which diminish long-term efficacy, and supply issues. In addition, newer formulations have shown improvements in convenience and tolerability, and have been shown to be even more effective when used in conjunction with basal insulin. In this narrative review, we discuss current evidence that supports GLP-1 RA use in combination with insulin therapy and the potential pitfalls of reliance on GLP-1 RAs as a substitute for insulin therapy.

Comparison of Control-IQ and open-source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study.

AIM: To compare open-source AndroidAPS (AAPS) and commercially available Control-IQ (CIQ) automated insulin delivery (AID) systems in a prospective, open-label, single-arm clinical trial. METHODS: Adults with type 1 diabetes who had been using AAPS by their own decision entered the first 3-month AAPS phase then were switched to CIQ for 3 months. The results of this treatment were compared with those after the 3-month AAPS phase. The primary endpoint was the change in time in range (% TIR; 70-80 mg/dL). RESULTS: Twenty-five people with diabetes (mean age 34.32 ± 11.07 years; HbA1c 6.4% ± 3%) participated in this study. CIQ was comparable with AAPS in achieving TIR (85.72% ± 7.64% vs. 84.24% ± 8.46%; P = .12). Similarly, there were no differences in percentage time above range (> 180 and > 250 mg/dL), mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; P = .21) or HbA1c (6.3% ± 2.1% vs. 6.4% ± 3.1%; P = .59). Percentage time below range (< 70 and < 54 mg/dL) was significantly lower using CIQ than AAPS. Even although participants were mostly satisfied with CIQ (63.6% mostly agreed, 9.1% strongly agreed), they did not plan to switch to CIQ. CONCLUSIONS: The CODIAC study is the first prospective study investigating the switch between open-source and commercially available AID systems. CIQ and AAPS were comparable in achieving TIR. However, hypoglycaemia was significantly lower with CIQ.

Data from network meta-analyses can inform clinical practice guidelines and decision-making in diabetes management: perspectives of the taskforce of the guideline workshop.

In recent years, several novel agents have become available to treat individuals with type 2 diabetes (T2D), such as sodium-glucose cotransporter-2 inhibitors (SGLT-2i), tirzepatide, which is a dual glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA)/glucagon-like peptide-1 receptor agonist (GLP-1 RA), and finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA) that confers significant renal and cardiovascular benefits in individuals with (CKD). New medications have the potential to improve the lives of individuals with diabetes. However, clinicians are challenged to understand the benefits and potential risks associated with these new and emerging treatment options. In this article, we discuss how use of network meta-analyses (NMA) can fill this need.

Coverage for Continuous Glucose Monitoring for Individuals with Type 2 Diabetes Treated with Nonintensive Therapies: An Evidence-Based Approach to Policymaking.

Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) who are treated with intensive insulin regimens. Based on this evidence, CGM is now a standard of care for individuals within these diabetes populations and widely covered by commercial and public insurers. Moreover, 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. However, despite increasing evidence supporting CGM use for individuals treated with less-intensive insulin therapy or noninsulin medications, insurance coverage is limited or nonexistent. This narrative review reports key findings from recent randomized, observational, and retrospective studies investigating use of CGM in T2D individuals treated with basal insulin only and/or noninsulin therapies and presents an evidence-based rationale for expanding access to CGM within this population.

All Children Deserve to Be Safe, Mothers Too: Evidence and Rationale Supporting CGM Use in Gestational Diabetes Within the Medicaid Population.

Gestational diabetes mellitus (GDM) is a common metabolic disease of pregnancy that threatens the health of several million women and their offspring. The highest prevalence of GDM is seen in women of low socioeconomic status. Women with GDM are at increased risk of adverse maternal outcomes, including increased rates of Cesarean section delivery, preeclampsia, perineal tears, and postpartum hemorrhage. However, of even greater concern is the increased risk to the fetus and long-term health of the child due to elevated glycemia during pregnancy. Although the use of continuous glucose monitoring (CGM) has been shown to reduce the incidence of maternal and fetal complications in pregnant women with type 1 diabetes and type 2 diabetes, most state Medicaid programs do not cover CGM for women with GDM. This article reviews current statistics relevant to the incidence and costs of GDM among Medicaid beneficiaries, summarizes key findings from pregnancy studies using CGM, and presents a rationale for expanding and standardizing CGM coverage for GDM within state Medicaid populations.

G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe.

AIMS: Current continuous glucose monitoring (CGM) devices provide features that alert individuals with diabetes about their current and impending adverse glycaemic events. The use of these features has been associated with glycaemic improvements. However, how these features are utilised under real-world conditions has not been well studied. We queried a large database to quantify utilisation of the Dexcom G6 system features and how utilisation impacted glycaemic outcomes within a cohort of European users. METHODS: This 6-month retrospective, observational, large database analysis utilised anonymised data from a sample of 47,784 Europe-based G6 users. Primary outcome measures were associations between utilisation and customisation of High/Low threshold alerts, 'urgent low soon' (ULS) alert, and established CGM metrics. RESULTS: Users in the Germany, Austria, Switzerland region (n = 20,257), the Nordic countries (n = 10,314), United Kingdom (n = 9006), Italy (n = 4747), France (n = 2130) and Spain (1330) were included. All alert features were utilised by >75% of the cohort across all regions/countries and age groups. Enabling the Low alert and ULS alert was associated with lower percentage of time below range compared to disabling the Low alert (p < 0.001). Enabling the High alert was associated with higher percentage of time in range (%TIR) and lower percentage of time above range (%TAR) %TAR compared to disabling the High alert (p < 0.001). Paediatric patients and older adults tended to set a higher threshold for High/Low alerts, while younger adults tended to use lower threshold values for High/Low alerts. CONCLUSIONS: Individuals who utilised the Dexcom G6 features showed better glycaemic control, particularly among those who utilised more sensitive High alert and Low alert settings, than users who did not utilise the system features.

Use of Retrospective Continuous Glucose Monitoring Data Is Underrated and Underused.

Access to real-time glucose data in real time allows users to make informed decisions about their insulin dosages, appropriate carbohydrate intake, exercise, and other health behaviors. Programmable alarms and alerts warn users about current and/or impending acute glycemic events. However, the value and utility of retrospective data analysis for clinical decision-making have gone mostly unrecognized. This article presents a series of patient case examples that illustrate how our use of retrospective data enables us to identify and effectively address patterns of problematic glycemia.

Guideline Development for Medical Device Technology: Issues for Consideration.

Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.

Assessment of Glucose Monitoring Adherence in Medicare Beneficiaries with Insulin-Treated Diabetes.

Background: We investigated the potential associations between race/ethnicity and adherence to prescribed glucose monitoring in a sample of Medicare beneficiaries with diabetes and how adherence to the method used impacted diabetes-related inpatient hospitalizations and associated costs among beneficiaries with intensive insulin-treated diabetes. Methods: This 12-month retrospective analysis utilized Centers for Medicare & Medicaid Services data to identify Medicare beneficiaries who used intensive insulin therapy from January through December 2018 and classified them into four groups: (1) persons using real-time continuous glucose monitoring (rtCGM), (2) persons using any method of blood glucose monitoring (BGM) who followed prescribed use patterns (adherent), (3) persons who were prescribed BGM but were nonadherent in its use, and (4) no record of any form of BGM. Analyses compared these groups and the role that comorbidities (Charlson Comorbidity Index [CCI]), and race/ethnicity played on group assignment, diabetes-related inpatient hospitalizations, and costs. Results: Among the 1,329,061 persons assessed, 38.14% had no record of glucose monitoring and 35.42% were BGM nonadherent. Similarly, among the 629,514 beneficiaries with a CCI risk score of ≥2, 466,646 (74.13%) were either nonadherent to BGM or had no monitoring record. The percentage of White (3.65%) rtCGM adherent beneficiaries was significantly larger than Black (1.58%) and Hispanic (1.28%) beneficiaries, both P < 0.0001. Hospitalizations and costs were higher for Black and Hispanic beneficiaries versus Whites within the risk score ≥ 2 group regardless of glucose monitoring method. Conclusions: Race is associated with increased hospitalizations and costs associated with diabetes care and absence of any form of BGM was associated with higher rates of comorbidities. Persons of color were less likely to use rtCGM despite Medicare coverage. New initiatives that promote diabetes self-management education and support services are needed to improve utilization of glucose monitoring within the Medicare diabetes population.

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice.

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Increase Access, Reduce Disparities: Recommendations for Modifying Medicaid CGM Coverage Eligibility Criteria.

Numerous studies have demonstrated the clinical value of continuous glucose monitoring (CGM) in type 1 diabetes (T1D) and type 2 diabetes (T2D) populations. However, the eligibility criteria for CGM coverage required by the Centers for Medicare & Medicaid Services (CMS) ignore the conclusive evidence that supports CGM use in various diabetes populations that are currently deemed ineligible. In an earlier article, we discussed the limitations and inconsistencies of the agency's CGM eligibility criteria relative to current scientific evidence and proposed practice solutions to address this issue and improve the safety and care of Medicare beneficiaries with diabetes. Although Medicaid is administered through CMS, there is no consistent Medicaid policy for CGM coverage in the United States. This article presents a rationale for modifying and standardizing Medicaid CGM coverage eligibility across the United States.

Lower Glycated Hemoglobin with Real-Time Continuous Glucose Monitoring Than with Intermittently Scanned Continuous Glucose Monitoring After 1 Year: The CORRIDA LIFE Study.

Background: The aim was to compare the efficacy of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) focusing on glycated hemoglobin (HbA1c) as the primary endpoint. Methods: The CORRIDA LIFE was a 12-month, real-world, nonrandomized study that is part of the CORRIDA clinical trials program. The study compared rtCGM (Dexcom G5 or G6) and isCGM (FreeStyle Libre 14-Day; Abbott) in adults with type 1 diabetes (T1D). Only patients on multiple daily insulin injections or continuous subcutaneous insulin infusion with no automatic functions were included in this study. Primary outcome was the difference in HbA1c between study groups at 12 months. Results: One hundred ninety-one adults with T1D (mean age 40 ± 13 years, HbA1c 8.1% ± 3.4% [65 ± 14 mmol/mol]) participated in this study; 81 patients initiated rtCGM and 110 initiated isCGM. After 12-months, HbA1c was significantly lower with rtCGM versus isCGM (7.1% ± 3.1% [54.1 ± 10.1 mmol/mol] vs. 7.7% ± 3.3% [61.2 ± 12.2 mmol/mol]), P = 0.0001. The percentage of time in hypoglycemia (<70 mg/dL [<3.9 mmol/L]) was lower among rtCGM vs. isCGM participants [4.3% ± 2.8% vs. 6.4% ± 5.3%], P = 0.003). Patients with rtCGM spent less time in clinically significant hypoglycemia (<54 mg/dL [<3.0 mmol/L]) (0.9% ± 1.0% vs. 2.3% ± 2.5%, P < 0.0001) and more time in target range (70-180 mg/dL [3.9-10 mmol/L]) than isCGM users (67.5% ± 14.8% vs. 57.8% ± 17.0%), P = 0.0002. Conclusions: rtCGM was superior to isCGM in HbA1c, hypoglycemia, and other glycemic outcomes. Our findings provide guidance to clinicians when discussing monitoring options with their patients. The study was registered at www.clinicaltrials.gov (NCT04759495).

How use of continuous glucose monitoring can address therapeutic inertia in primary care.

A significant proportion of individuals with diabetes have suboptimal glycemic management. Studies have shown that persistent hyperglycemia significantly increases the risks for both acute and long-term microvascular and macrovascular complications of diabetes. A key contributor to suboptimal glycemic management is therapeutic inertia in which clinicians delay intensifying therapy when patients are not meeting their glycemic goals. During the past five years, an increasing number of individuals with type 1 diabetes (T1D) and insulin-treated type 2 diabetes (T2D) have adopted the use of continuous glucose monitoring (CGM) for daily measurement of glucose levels. As demonstrated in numerous clinical trials and real-world observational studies, use of CGM improves glycated hemoglobin (HbA1c) and reduces the occurrence and severity of hypoglycemia. However, for primary care clinicians who are unfamiliar with using CGM, integrating this technology into clinical practice can be daunting. In this article, we discuss the benefits and rationale for using CGM compared with traditional blood glucose monitoring (BGM), review the evidence supporting the clinical value of CGM in patients with T1D and T2D, and describe how use of CGM in primary care can facilitate appropriate and more timely therapy adjustments.

Association Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes.

Little is known about the impact of real-time continuous glucose monitoring (rtCGM) on diabetes-related medical costs within the type 2 diabetes (T2D) population. A retrospective analysis of administrative claims data from the Optum Research Database was conducted. Changes in diabetes-related health care resource utilization costs were expressed as per-patient-per-month (PPPM) costs. A total of 571 T2D patients (90% insulin treated) met study inclusion criteria. Average PPPM for diabetes-related medical costs decreased by -$424 (95% confidence interval [CI] -$816 to -$31, P = 0.035) after initiating rtCGM. These reductions were driven, in part, by reductions in diabetes-related inpatient medical costs: -$358 (95% CI -$706 to -$10, P = 0.044). Inpatient hospital admissions were reduced on average -0.006 PPPM (P = 0.057) and total hospital days were reduced an average of -0.042 PPPM (P = 0.139). These findings provide real-world evidence that rtCGM use was associated with diabetes-related health care resource utilization cost reductions in patients with T2D.

Lost in Translation: A Disconnect Between the Science and Medicare Coverage Criteria for Continuous Subcutaneous Insulin Infusion.

Numerous studies have demonstrated the clinical value and safety of insulin pump therapy in type 1 diabetes and type 2 diabetes populations. However, the eligibility criteria for insulin pump coverage required by the Centers for Medicare & Medicaid Services (CMS) discount conclusive evidence that supports insulin pump use in diabetes populations that are currently deemed ineligible. This article discusses the limitations and inconsistencies of the insulin pump eligibility criteria relative to current scientific evidence and proposes workable solutions to address this issue and improve the safety and care of all individuals with diabetes.

What's Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring.

Numerous studies have demonstrated the clinical value of continuous glucose monitoring (CGM) in type 1 diabetes and type 2 diabetes populations. However, the eligibility criteria for CGM coverage required by the Centers for Medicare & Medicaid Services (CMS) ignore conclusive evidence that supports CGM use in various diabetes populations that are currently deemed ineligible. This article discusses the limitations and inconsistencies of the CMS eligibility criteria relative to current scientific evidence and proposes workable solutions to address this issue and improve the safety and care of all individuals with diabetes.

The Digital/Virtual Diabetes Clinic: The Future Is Now-Recommendations from an International Panel on Diabetes Digital Technologies Introduction.

The increasing prevalence of diabetes, combined with a growing global shortage of health care professionals (HCP), necessitates the need to develop new approaches to diabetes care delivery to expand access to care, lessen the burden on people with diabetes, improve efficiencies, and reduce the unsustainable financial liability on health systems and payers. Use of digital diabetes technologies and telehealth protocols within a digital/virtual diabetes clinic has the potential to address these challenges. However, several issues must be resolved to move forward. In February 2020, organizers of the Advanced Technologies & Treatments for Diabetes Annual Conference convened an international panel of HCP, researchers, patient advocates, and industry representatives to review the status of digital diabetes technologies, characterize deficits in current technologies, and identify issues for consideration. Since that meeting, the importance of using telehealth and digital diabetes technologies has been demonstrated amid the global coronavirus disease (COVID-19) pandemic. This article summarizes the panel's discussion of the opportunities, obstacles, and requisites for advancing the use of these technologies as a standard of care for the management of diabetes.