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Continuous Glucose Monitoring

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National Institute for Health and Care Excellence (NICE) Medtech Innovation Briefing for Dexcom G6 Real-Time CGM – November 2020

Source:

Key Takeaway: The intended place in therapy is as an alternative to routine blood glucose monitoring in people (over 2 years old), including pregnant women, with type 1 or type 2 diabetes, who use multiple daily insulin injections or use insulin pumps and are self-managing their diabetes.  Dexcom G6 could reduce costs and would benefit the healthcare system by improving long-term outcomes, reducing the need for intensive treatment and, in the short term, reducing severe hypoglycaemic events leading to hospital admissions. Remote care may reduce the need for hospital visits.


Continuous Glucose Monitoring in Adults with Type 1 Diabetes: Real-World Data from the German/Austrian Prospective Diabetes Follow-Up Registry

Source:

Key Takeaway: Real-world data from the German/Austrian Prospective Diabetes Follow-Up Registry showed real-time continuous glucose monitoring was associated with a higher percentage of Time-in-Range and improved metabolic stability as compared to intermittent scanning continuous glucose monitoring.


Effects of Continuous Glucose Monitoring on Metrics of Glycemic Control in Diabetes: A Systematic Review With Meta-analysis of Randomized Controlled Trials

Source:

Key Takeaway: A recent systematic review and meta-analysis of 15 randomized controlled trials involving 2,461 patients showed greater improvement in mean hemoglobin A1c, time in target range, and time above range with use of real-time continuous glucose monitoring as compared to intermittently scanned continuous glucose monitoring.


Uninterrupted Continuous Glucose Monitoring Access is Associated with a Decrease in HbA1c in Youth with Type 1 Diabetes and Public Insurance

Source:

Key Takeaway: In a Medicaid population of youth with Type 1 Diabetes, uninterrupted continuous glucose monitoring (CGM) use was associated with improvements in hemoglobin A1c. Interruptions in use—primarily due to gaps in insurance coverage of CGM—were associated with increased hemoglobin A1c, supporting initial and ongoing CGM coverage in high-risk, publicly insured demographics.


Demonstrating the Clinical Impact of Continuous Glucose Monitoring Within an Integrated Healthcare Delivery System

Source:

Key Takeaway:  Recent data from a prospective, randomized study conducted by Intermountain Health suggests that real-time CGM can reduce healthcare utilization and decrease the overall cost of care compared to SMBG. Participants reported that real-time CGM data were helpful in modifying their nutrition, physical activity, stress, and medication adherence.  


A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

Source:

Key Takeaway: In a 16-week trial funded by the NIDDK and Tandem Diabetes Care, 101 children ages 6-13 with type 1 diabetes were randomized to a closed-loop system of insulin delivery (n=78) or the control group (n=23) where patients used a sensor-augmented insulin pump.  Children using the closed-loop system, consisting of a t:slim X2 insulin pump with Control-IQ  technology and a Dexcom G6 CGM, saw a significant time in range (TIR) improvement (target 70-180 mg/dL) from 53% at baseline to 67% (equivalent to 3.4 more hours per day; p<0.001) at the end of the study.  The control group saw a smaller TIR increase from 51% at baseline to 55% at the end of the study.  Notably, TIR increased most significantly overnight with children reaching 80% overnight TIR compared to 54% in the control group.  The treatment effect was evident in the first month and appeared consistent over 4 months.  Control-IQ technology demonstrated benefits across a broad range of baseline characteristics and proved easy to use for children and their parents.


Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes

Source: Journal of the American Medical Association

Key Takeaway: Six-month, multicenter, randomized controlled trial using the Dexcom G5. The baseline population had diverse racial/ethnic backgrounds (38% Hispanic or non-white), high baseline HbA1c levels, and 41% had public health insurance. The trial showed a 0.4% A1c advantage in favor of CGM over BGM (p=0.01; baseline: 8.9%). Moreover, more than twice as many in the CGM group as compared to the BGM group achieved an A1c reduction ≥0.5% (44% vs. 21%, p=0.005) and over four-times as many participants in the CGM group vs. the BGM group saw an A1c reduction of ≥1% (25% vs. 6%, p=0.003). The CGM group also saw a 1.7 hour/day advantage vs. BGM on time-in-range (70-180 mg/dl) (p<0.001). Over two-thirds of the CGM group were using CGM at least five days/week by the end of the six-month study – the highest CGM use observed for adolescents in a study to date. Moreover, the CGM group reported significantly higher glucose monitoring satisfaction, measured via the Glucose Monitoring Satisfaction Survey score, at 26 weeks than the BGM group . Newer models of CGM devices that eliminate fingerstick calibration should lead to improved wearability and glycemic control even beyond the measured benefits observed in this trial. Improved glycemic control early in diabetes duration may prevent diabetes complications later in adulthood, making CGM an attractive option for this population.

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes Graph


Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes A Randomized Clinical Trial

Source: Journal of the American Medical Association

Key Takeaway:Older populations are more prone than younger populations to severe hypoglycemic episodes, which in turn contribute to dementia, risk of falls, glycemic variability, and mortality. To study whether CGM could reduce hypoglycemia incidence, Pratley and colleagues performed a randomized clinical trial that compared the effect of CGM (n = 103) with BGM (n = 100) in older adults (median age, 68 years) with type 1 diabetes in 22 diabetes centers across the US. The primary outcome was reduction in hypoglycemia (glucose <70mg/dL) over 6 months. Results showed that the median time in hypoglycemia was reduced from 73 minutes to 39 minutes per day in the CGM group compared with no change (from 68 minutes to 70 minutes per day) in the BGM group, an adjusted between group reduction of 27 minutes per day (95% CI, −40 to −16 min/d). Additionally, the median percentage of time with blood glucose levels below the range for severe hypoglycemia (glucose <54mg/dL) reached the goal per international guidelines (<14min/d in older adults). Moreover, only 1 severe hypoglycemic event (glucose <54mg/dL) occurred in the CGM group vs 10 in the BGM group, with 5 of those events involving seizure or loss of consciousness. 83% of participants in the CGM group used CGM at least 6 days per week during month 6 and the results did not differ by level of cognitive impairment, education level, or age. In summary, CGM reduced the time spent in the severe hypoglycemic range, which has health care use, mortality, morbidity, and economic benefits.

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes Graph


Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)

Source: BMJ Open Diabetes Research and Care

Key takeaway: A real-life observational study demonstrated the effectiveness of flash glucose monitoring (FGM) in participants with diabetes over a 12 month period.  Data from the Netherlands Nationwide Registry showed the use of FGM results in improved well-being, decreased disease burden, and is associated with a 0.4% reduction of HbA1c after 12 months (p < 0.001).  Results from a patient-reported outcome measures questionnaire revealed significant reductions in work absenteeism and diabetes-related hospital admissions. 


Leveraging Diabetes Health Technology in Managed Care and Coverage Considerations for Real-Time Continuous Glucose Monitoring

Announcing a new white paper based on key findings from the Therapeutic CGM Health Care Stakeholder Summit held on November 7, 2019, in Washington, DC. The stakeholder panel included payer and employer leadership along with clinical experts in the field of endocrinology. The purpose was to gather input pertinent to the coverage and application of therapeutic continuous glucose monitoring (CGM) in managed care settings. Clinical evidence supporting the clinical and economic value of rtCGM was presented and the insights of these health care stakeholders were captured en route to formulating coverage policy recommendations for the future. This input is intended to advance the uptake and appropriate coverage of evidence-based health technology interventions by managed care organizations (MCOs) and various payers.

Click here to download the white paper.

Click here to download the white paper in black and white.


Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring

Source: Diabetes Care

Key Takeaways: CGM has emerged as a new standard of care for individuals with insulin-treated diabetes. Two types of CGM systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM). rtCGM systems automatically transmit a continuous stream of glucose data to the user, provide alerts and active alarms, and transmit glucose data in real time to a smart phone and/or other display device. The current isCGM system provides the same type of data but requires the user to purposely scan the sensor to obtain information, and it does not have alerts and alarms. Both CGM technologies have significant advantages over self-monitoring of blood glucose; however, differences in the features and capabilities of the two approaches must be considered when guiding patient selection of the system that meets their individual needs.


Continuous Glucose Monitoring: An Emerging Standard of Care

Source: American Journal of Managed Care

Key Takeaway: The use of CGM is proven to reduce A1C, reduce time spent in hypo- and hyperglycemia and improve time in range (TIR) for Type 1 and Type 2 patients using intensive insulin, defined as multiple daily injections of insulin or getting insulin through an insulin pump.  This has resulted in guidelines and recommendations from professional societies such as the ADA recommending CGM as a standard of care for Type 1 and Type 2 patients using intensive insulin.  CGM is an important monitoring tool that is best accessed by providers and patients in the pharmacy channel.


Continuous Glucose Monitoring with Dexcom G6

Source: First Report Managed Care

Key Takeaway: Diabetes is a complex chronic disease that for some Type 1 and Type 2 patients requires the use of intensive insulin defined as 3 or more injections/day or insulin through a pump.  The adverse consequences of using insulin are severe and can result in a coma, seizure or even death which leads many patients and caregivers deciding to use less insulin as prescribed preventing achievement of glycemic goals.  Real-time CGM with alerts/alarms, remote monitoring and reporting can help patients use their insulin safely and effectively to achieve lower A1Cs, spend less time in hypo- and hyperglycemia and spend more time in range (TIR).  The benefits of CGM are seen when it is used to make diabetes treatment decisions such as insulin dosing, diet and lifestyle in a timely manner.  Accessing CGM devices via a pharmacy benefit allows patients to start CGM faster, stay safe while using insulin and engage pharmacists, providing additional support and interventions that have been shown to improve diabetes outcomes.


Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range

Source: Diabetes Care

Key Takeaway: Successful utilization of CGM technology in routine clinical practice remains relatively low due to a lack of clear and agreed-upon glycemic targets that both diabetes teams and people with diabetes can work toward.  In February 2019, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address this issue and established targets for time in range (TIR), time below range (TBR) and time above range (TAR).  These are metrics that only CGM can measure and overcome the limitations of metrics such as A1C which are reflective of a 3 month average of glycosylated hemoglobin and does not account for day to day glycemic variability or factors such as anemia which can skew A1C low.

CGM-based Targets for Different Diabetes Populations


Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes

Source: Diabetes Technology & Therapeutics

Key Takeaway: CGM initiated within the first year of T1D diagnosis was effective in lowering and maintaining A1C for 2.5 years and reduced the frequency of ED visits related to hypoglycemia and hyperglycemia irrespective of insulin delivery method.


Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study

Source: The Journal of Clinical Endocrinology & Metabolism

Key Takeaway: Nationwide reimbursement of real-time CGM improved HbA1c, fear of hypoglycemia, and QOL as well as economic indicators including work absenteeism and hospital admissions for acute diabetes complications.

The Value of rtCGM: Reduction in Hospitalizations and Work Absenteeism
  Pre-Reimbursement for rtCGM Post-Reimbursement for rtCGM P Value
  (n = 496) (n = 379)  
Patients with      
    Hospitalizations due to hypoglycemia and/or ketoacidosis 77 (16%) 14 (4%) <0.0005
    Hospitalizations due to hypoglycemia 59 (11%) 12 (3%) <0.0005
    Hospitalizations due to ketoacidosis 23 (5%) 4 (1%) 0.092
    Work absenteesim* 123 (25%) 36 (9%) <0.0005
Days (per 100 patient years) of       
    Hospitalizations due to hypoglycemia and/or ketoacidosis 53.5 17.8 <0.0005
    Hospitalizations due to hypoglycemia 38.5 12.5 0.001
    Hospitalizations due to ketoacidosis 14.9 5.3 0.220
    Work absenteeism 494.5 233.8 0.001

Data are n (%).

*Work absenteeism of at least half a day. Patient-reported hospital admissions were validated by clinicians.

Reference: Charleer S, et al. Clin Endocrinol Metab. 2018;103(3):1224–1232

The Value of rtCGM: Improved Population Glycemic Control


Reference: Charleer S, Mathieu C, Nobels F, et al. J Clin Endocrinol Metab. 2018;103(3):1224-1232.


Real Time CGM Studies: Effect of Continuous Glucose Monitoring on Glycemic Control in Adults with Type 1 Diabetes Using Insulin Injections – The DIAMOND Randomized Clinical Trial

Source: Journal of the American Medical Association

Key Takeaway: In the DIAMOND RCT, patients using multiple daily injections of insulin with type 1 diabetes who were randomly assigned to real-time CGM (rtCGM) had improved glycemic control vs. the SMBG group. This benefit was seen across patient groups regardless of baseline A1C, age, education level, or math ability. In addition, the rtCGM group spent 79% less time in nocturnal hypoglycemia, and also demonstrated a greater increase in hypoglycemic confidence and a greater decrease in diabetes distress vs. the SMBG group.


Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program

Source: Diabetes Technology & Therapeutics

Key Takeaway: Among the real-time CGM (rtCGM) users, the change in HbA1c was greatest in the highest HbA1c subgroup with similar decreases seen in both the T1D and T2D groups. Notably, adherence remained high in those with baseline HbA1c > 9% and the improvements seen were achieved without the need for additional medications. Thus, the costs of rtCGM in patients with high HbA1c may be offset by avoiding treatment intensification and the longer-term savings achieved by lowering HbA1c levels in poorly controlled diabetes populations.


Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults with Type 1 Diabetes Treated with Multiple Daily Insulin Injections – The GOLD Randomized Clinical Trial

Source: Journal of the American Medical Association

Key Takeaway: In the GOLD trial, glycemic control was improved with use of rtCGM compared with conventional treatment; however, increases in A1C and hypoglycemic events occurred when patients reverted back to SMBG during the crossover/washout period, suggesting that the effectiveness of CGM depends on uninterrupted use during treatment with MDI. Additionally, the study showed reductions in severe and nocturnal hypoglycemia as well as in glycemic variability and improved hypoglycemic confidence for rtCGM users.


Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study

Source: Diabetes Care

Key Takeaway: The COMISAIR study is the longest running real-world real-time CGM (rtCGM) study performed to date. In this study, the continuous use of rtCGM had a sustained and durable benefit with regards to glycemic control over a 3-year time period, with rtCGM being superior to self-monitoring of blood glucose in reducing A1C, hypoglycemia, and glycemic variability in individuals with type 1 diabetes regardless of their insulin delivery method.

Observational COMISAIR Study in Patients With T1D Who Chose Insulin Delivery Method (MDI or Pump) and Monitoring Method (SMBG or CGM), Staying on Chosen Therapy for 3 Years


Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes

Source: The New England Journal of Medicine 

Key Takeaway: This 6 month randomized trial showed use of a closed-loop system using the t:slim X2 insulin pump with Control-IQ Technology, (Tandem Diabetes Care) and a continuous glucose monitor (Dexcom G6, Dexcom) was safe and effective compared to sensor-augmented pump therapy (SAP). Participants in the closed-loop group achieved 70% time in range overall which meets the International Consensus Guidelines for people with diabetes. The closed-loop group also achieved significant improvements in hyperglycemia, HbA1c, mean glucose, and hypoglycemia (< 70 mg/dL < 54 mg/dL) as compared with the SAP group. Glycemic benefits were seen in the first month of the trial and were sustained over the entire 6-month period. Over 90% of participants said they trusted the device and found Control-IQ technology easy to use.

*Full article available for a fee


Intermittently Scanned CGM: Novel Glucose-sensing Technology and Hypoglycaemia in Type 1 Diabetes: A Multicentre, Non-masked, Randomised Controlled Trial

Source: The Lancet

Key Takeaway: This study conducted in Europe with over 300 participants found novel flash glucose testing reduced the time adults with well controlled type 1 diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups.


Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

Source: Diabetes Therapy

Key Takeaway: Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG.


Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living with Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study

Source: Diabetes Care

Key Takeaway: Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.

A1C From Baseline to 12 Months After Initiation of isCGM


Diabetes Technology: Standards of Medical Care in Diabetes – 2020

Source: Diabetes Care

Key Takeaway: The ADA Standards of Medical Care in Diabetes provides the most authoritative and current guidelines for diabetes care. The recommendations are intended to provide clinicians, patients, researchers and payers with the components of diabetes care, general treatment goals, and tools to evaluate the quality of care. Following are ADA recommendations regarding CGM:

American Diabetes Association

rtCGM should be used continuously for maximal benefit. 

isCGM should be scanned frequently throughout the day (minimum of once every 8 hours)

CGM and T1D

  • Real-time CGM (rtCGM) and intermittently scanned CGM (isCGM) are useful to lower A1C and/or reduce hypoglycemia in adults who are not meeting glycemic targets, have hypoglycemia episodes, and/or unawareness (RT-CGM (A); IS-CGM (C))
  • rtCGM may be used to improve A1C levels and neonatal outcomes in pregnant women (A)
  • Should be considered in all children and adolescents to improve glucose control regardless of insulin delivery method (B)

CGM and T2D

  • Useful tool, when used in conjunction with insulin therapy, to lower A1C and/or reduce hypoglycemia in adults with T2D who are not meeting glycemic targets (B)

Level of Clinical Evidence: A = Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered; B = Supportive evidence from well-conducted cohort studies; C = Supportive evidence from poorly controlled or uncontrolled studies


Continuous Glucose Monitoring: A Consensus Conference of the American Association of Clinical Endocrinologists and American College of Endocrinology

Source: American Association of Clinical Endocrinologists

Conclusion: CGM improves glycemic control, reduces hypoglycemia, and may reduce overall costs of diabetes management. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes.


Advancing Glycemic Management in People with Diabetes

Source: The IQIVA Institute

About the report: The incorporation of time in range (TIR) metrics alongside HbA1c is expected to enhance the way in which diabetes is managed in the future, and subsequently, reduce the overall societal and economic burden. To assess the value of improving TIR from its current state to the minimum consensus target of 70% and 80% TIR, the IQVIA Core Diabetes Model was used to estimate cost reductions in complications and costs associated with improving TIR. Using this model, improvements in TIR were estimated to reduce the risk of developing diabetes-related complications resulting in a conservative reduction of $2.1-7 billion in costs over a 10-year period, based on the relationship between TIR and HbA1c. The addition of incrementally reducing hypoglycemic events in people with Type 1 Diabetes by 40% and improving TIR to 80% generated a total 10-year cost reduction of $6.7-9.7 billion. This reduction in costs represents a conservative estimate.

10-Year Cost Reduction  by Improving TIR in People with T1 and T2 Diabetes to 70% and 80% TIR (US$Bn)


Free On-demand Webinar: A Movement in Diabetes: Using Time-in-Range

Source: Applied Clinical Trials

Key Takeaway: This webinar presents the first estimation of reduction in complications and costs associated with improving time-in-range per research found in the Advancing Glycemic Management in People with Diabetes report. You will hear directly from an advocate for people with diabetes about the Time-in-Range movement and gain an understanding about what’s to come in the realm of diabetes care management.


A Cost Offset Analysis (COA) Comparing Real-Time Continuous Glucose Monitoring (RT-CGM) With Intermittent Scanning Continuous Glucose Monitoring (IS-CGM) in Type 1 Diabetes (T1D) Subjects With Impaired Hypoglycemia Awareness in Eight Countries

Source: Value in Health. 2019: Volume 22 S572. doi: 10.1016/j.jval.2019.09

Key Takeaway: A recent RCT comparing an rt-CGM and is-CGM device demonstrated differences in %TIR over several glucose ranges allowing for projection of potential clinical outcomes. A COA was performed comparing these clinical cost offsets for rt-CGM and is-CGM in people with T1D (n=2,000) and impaired awareness of hypoglycemia (IAH; ~30% of people with T1D), applied to eight countries each over a one-year period. The demonstrated differences in %TIR spent at low, optimal, and high glucose ranges are likely to translate into significant clinical and economic benefits for rt-CGM compared with is-CGM.


Cost Offset Analysis (COA) Comparing Real-Time Continuous Glucose Monitoring (RT-CGM) With Self-Monitoring of Blood Glucose (SMBG) in People With Type 1 Diabetes in Eight Countries

Source: Advanced Technologies & Treatments in Diabetes

Key Takeaway: A cost offset analysis (COA) was performed comparing potential clinical cost offsets for reduced HbA1c, severe hypoglycemia, and diabetic ketoacidosis using a rt-CGM system compared with SMBG alone in people with Type 1 Diabetes (T1D) and uncontrolled glycemia, in eight countries (n=5,000 per country), over a one-year time period. This modelling study demonstrates significant potential clinical and economic benefits for rt-CGM compared with SMBG in people with T1D.


Recent News

  • Effective July 1, 2020, NC Medicaid coverage of therapeutic Continuous Glucose Monitoring (CGM) products will transition from the Durable Medical Equipment (DME) Program to the Outpatient Pharmacy Point of Sale Program. The products will be included on the NC Medicaid and Health Choice Preferred Drug List (PDL). The PDL Preferred therapeutic CGM products will be the Dexcom G5 and G6.
  • Effective July 15, 2020, HCSC considers long-term continuous glucose monitoring of glucose levels in interstitial fluid medically necessary in patients with diabetes (Type 1 or Type 2 DM) who are willing and able to use the device, have adequate medical supervision, and are on multiple daily doses of insulin or an insulin pump. (Reference: Medical Policy Number DME101.005)

  • Effective April 1, 2020, Blue KC will also offer coverage for Continuous Glucose Monitors (CGMs) as a pharmacy benefit. While members can continue to utilize their DME benefits instead of pharmacy benefits for CGMs, some brands may eventually no longer be available through DME suppliers. Additionally, the process of obtaining a CGM through the pharmacy is likely a more timely, convenient, and overall better member experience.

  • Effective April 20, 2020 Aetna considers the long-term (greater than 1 week) therapeutic use of continuous glucose monitoring devices medically necessary in adults aged 18 years and older with type 1 diabetes, adults with type 2 diabetes using intensive insulin regimens (multiple (3 or more) daily injections or insulin pump therapy) who are not meeting glycemic targets, and for younger persons with type 1 diabetes.

  • Effective April 1st 2020  United Health Care covers long-term CGM for individuals with type 1 or type 2 diabetes when certain criteria are met.
  • Effective April 1, 2020, therapeutic continuous glucose monitors (CGMs) will be a benefit of Texas Medicaid for individuals with type 1 or type 2 diabetes who meet medical criteria.
  • Missouri Medicaid’s Pharmacy Program will begin covering the Dexcom G6 Continuous Glucose Monitoring (CGM) System as the preferred CGM system effective April 2, 2020.


CMS-1682R – Therapeutic CGM Category

Source: Centers for Medicare & Medicaid Services

Key Takeaway: Recognizing the value of CGM, and in response to the recent FDA approvals of CGM as a replacement for fingersticks, CMS created a benefit category for therapeutic CGMs, providing for coverage of these devices under the following conditions:

  1. The beneficiary has diabetes mellitus (Refer to the “ICD-10 Codes that are Covered” section of the LCD-related Policy Article for applicable diagnoses); and,
  2. The beneficiary has been using a BGM and performing frequent (four or more times a day) testing; and,
  3. The beneficiary is insulin-treated with multiple (three or more) daily injections of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump; and,
  4. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,
  5. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; and,
  6. Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan.

Current Eligibility Requirements for CGM Coverage Are Harmful, Costly, and Unjustified

Source: Diabetes Technology and Therapeutics

Key Takeaway: There is growing and compelling evidence that CGM coverage should be offered to all patients who can benefit from this technology regardless of diabetes type and history of SMBG use. The current restrictions, which are based on outdated evidence and questionable assessments, are not supported in the literature. Moreover, they ignore the burden frequent SMBG places on individuals. Given the growing prevalence of diabetes, the persistent preponderance of individuals with suboptimal glycemic control, and the exorbitant and largely preventable cost of diabetes complications, opinion-based constraints should not continue to supplant evidence-based clinical management.


Medicaid Coverage

Rx Coverage Pediatrics Only (published coverage policy)
Type 1 Type 2 No Published Coverage Policy
Type 1    

 

 

*Map updated September 1, 2020

Medicaid Policies


Commercial Coverage

National

Regional


The Clinical and Economic Value of Continuous Glucose Monitoring and Improved Time in Range

Source: AMCP Science and Innovation Theater Webinar


Improving Outcomes in Intensively Treated Type 1 and Type 2 Diabetes with Continuous Glucose Monitoring

Source: AMCP Science and Innovation Theater Webinar


Commercial and Medicaid Formulary Dossiers for Dexcom G6 Continuous Glucose Monitoring Systems Available

Source: FormularyDecisions.comSM


The New Standard of Care: Continuous Glucose Monitoring in Pharmacy Practice

Source: RxInsider

 


Free On-demand Archive: Continuous Glucose Monitoring: Complete Care Management Solution for Diabetes

Intended Audience: Case Managers – During the CCMC New World Symposium that took place from February 28, 2019, to March 2, 2019, Nicholas B. Argento, MD, FACE, Diabetes Technology Director of Maryland Endocrine in Columbia, Maryland, presented a satellite breakfast symposium on continuous glucose monitoring (CGM) that was sponsored by Dexcom.

 

 

Click here to read about this presentation in CareManagement.


Leading CGM Innovation with Dexcom G6® – The Only Fully Interoperable, Zero Fingerstick CGM System – A Science & Innovation Theater held in conjunction with the Academy of Managed Care Pharmacy’s Annual Meeting 2019

Source: AMCP Science and Innovation Theater Webinar

Description: Dexcom G6® is the first CGM to receive the integrated CGM classification by the FDA. Dexcom G6® is approved for use as a standalone CGM and for integration with bluetooth connected insulin pens and automated insulin delivery systems. This presentation will highlight Dexcom’s technology, connected ecosystem, Google/Verily partnership, and future developments including EHR integration, population-level insights, and decision support algorithms.


Comparison of Attributes and Performance of Self-Inserted Therapeutic CGM Systems

 

Product Attributes and Performance G6® CGM System (Dexcom)1 FreeStyle® Libre 2 Flash Glucose Monitoring System (Abbott)2– US
Monitoring method Real-Time CGM Intermittent Scan CGM
Continuous data availability Data available every 5 min without user intervention Data available every 1 min with user intervention (i.e. user must scan sensor)
FDA classification Integrated CGM Integrated CGM (limited)
Approved for use with automated insulin delivery (AID) systems, including closed loop and insulin suspend systems Yes No
CMS Medicare coverage Yes Yes
Age indication (years) 2+ 4+
Factory-calibrated Yes (manual calibration optional) Yes
Indicated for use in diabetes treatment decisions Yes Yes
Confirmation blood glucose test required before making treatment decisions during the first 12 hours of sensor wear No Yes
Built-in blood glucose meter N/A Yes
Ease of use/sensor insertion No assembly required; 4 steps No assembly required; 3 steps
Sensor wear 10 days 14 days
Sensor warm-up time 2 h 1 h
Sensor life, adults >18
(% sensors working at end of maximum indicated use)
 93.5% @ 10 days 71.1% @ 14 days
82.2% @ 10 days
Sensor expiration warning Yes; 24 h, 6 h, 2 h, 30 min No
FDA approved sensor sites Abdomen (adults)
Abdomen, buttocks (pediatrics)
Upper arm
Moisture protection (sensor/transmitter) Water resistant up to 8 feet for 24 h Water resistant up to 3 feet for 30 min
Insulin pump integration Yes; Tandem t:slim X2® with AID No
Smart insulin pen integration Yes; Companion InPen™ No
Mobile device connectivity Yes; Apple iOS and Android via Bluetooth (list of supported devices available at http://www.dexcom.com/compatibility) No; Reader (Bluetooth enabled) must be within 1.5 in of sensor to scan via NFC and within 20 feet to receive alarms
Smart watch compatibility Yes; (list of supported devices available at http://www.dexcom.com/compatibility) No
Voice-enabled/hands-free Yes; G6 app compatible with Siri No
Real-time remote monitoring/data sharing Yes No
Protective Safeguards (alerts/alarms):
– Customizable threshold alerts/alarms (low/high) Yes; default settings 70 low; 250 high (optional) Yes; default settings 70 low; 240 high (optional)
– Predictive low glucose alert (< 55 mg/dL within 20 mins) Yes (optional); 84% detection rate3 No
– Urgent low glucose alarm at 55 mg/dL Yes No
– Rapidly rising/falling rate of change alerts Yes (optional) No
– Alert schedule (i.e. different alert setting at night) Yes (optional) No
– Share alerts/alarms in real-time Yes; up to 10 followers (optional) No
– Signal loss alert/alarm Yes (optional) Yes
– Repeat alerts/alarms Yes (optional) No; alarms occur one time and will not repeat if they are dismissed, ignored alarms will repeat every 5 min
Predictive arrows Yes Yes
Trend graphs 1, 3, 6, 12, 24 h 8, 24 h
Data storage Data automatically stored
without user intervention
 
Data stored when user scans the sensor.
Sensor must be scanned at least once every 8 h to prevent data loss
Cloud-based data management program/ data streaming Yes; Dexcom CLARITY®, Glooko®, Tidepool®
Automatic via G6 App;
Manual download G6 Receiver
Yes; LibreView®, Glooko®, Tidepool®
Manual download Reader
 
Smart phone push notifications with glucose insights, coaching, decision support (opt-in) Yes; via CLARITY® Mobile App No
EHR integration capability Yes – Epic, Cerner (limited availability) N/A
Overall accuracy:
– MARD (average % discrepancy between sensor readings and YSI glucose) 9.0% (overall)*
9.8% (ages 18+)*
7.7% (ages 6-17)*
9.9% (ages 2-5)
9.7% (overall)
9.2% (ages 18+)
9.7% (ages 6-17)
11.8% (ages 4-5)
– % 20/20 (% of readings within + 20 mg/dL or 20% of the YSI glucose) 91.9% (ages 18+)
95.8% (ages 6-17)
92.4% (ages 18+)
91.6% (ages 6-17)
– Day 1 %20/20 91% (ages 18+)
91.3% (ages 6-17)
87.5% (ages 18+)
84.1% (ages 6-17)
*Data from Study 2 – Automatic Applicator (commercially available product)
Accuracy during rapid rates of change
(Concurrence of sensor readings with YSI- measured rates of change):
– Rapidly Falling
> 2 mg/dL/min
53.3% (ages 18+)
47.9% (ages 6-17)
34.4% (ages 18+)
44.1% (ages 6-17)
– Rapidly Rising
> 2 mg/dL/min
71.3% (ages 18+)
67.1% (ages 6-17)
49.0% (ages 18+)
50.2% (ages 6-17)
Time lag Mean 3.7 + 3.1 min4 Not reported
Known interfering substances Hydroxyurea;
Acetaminophen (if exceeding maximum dose of > 1 g every 6 h in adults)
Ascorbic Acid at doses > 500 mg may cause falsely higher readings
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ADA Standards of Care Recommendations
& Level of Clinical Evidence5
 
 
 
A = Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered
 
B = Supportive evidence from well-conducted cohort studies
 
C = Supportive evidence from poorly controlled or uncontrolled studies
Real-time CGM (rtCGM) is useful to lower A1C and/or reduce hypoglycemia in adults with type 1 diabetes who are not meeting glycemic targets, have hypoglycemia episodes, and/or unawareness (A) Intermittently scanned CGM (isCGM) is useful to lower A1C and/or reduce hypoglycemia in adults with type 1 diabetes who are not meeting glycemic targets, have hypoglycemia episodes, and/or unawareness (C)
rtCGM should be considered in all children and adolescents to improve glucose control regardless of insulin delivery method (B) isCGM should be considered in all children and adolescents to improve glucose control regardless of insulin delivery method (B)
rtCGM is a useful tool when used in conjunction with insulin therapy to lower A1c and/or reduce hypoglycemia in adults with type 2 diabetes who are not meeting glycemic targets (B) isCGM is a useful tool when used in conjunction with insulin therapy to lower A1c and/or reduce hypoglycemia in adults with type 2 diabetes who are not meeting glycemic targets (B)
rtCGM should be used as close to daily as possible for maximal benefit (A) isCGM should be scanned frequently, at a minimum once every 8 h (A)
rtCGM may be used to improve AIC levels and neonatal outcomes in pregnant women with type 1 diabetes (B) No ADA recommendation
Automated insulin delivery systems should be considered in adults with type 1 diabetes who have the skills to use them in order to improve time in range and reduce A1C and hypoglycemia (A); These systems may also be useful to improve glycemia in children (B) Not approved for use with AID systems

 
References:
1Dexcom G6 CGM System User Guide 2018; 2Abbott FreeStyle Libre 2 Flash Glucose Monitoring System User Guide US 2020;3Wadwa RP, Laffel LM., et al. Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. Diabetes Technol Ther 2018; 20(6): 395-402.4Shah VN, Laffel LM, et al. Performance of a factory-calibrated, real-time continuous glucose monitoring system utilizing an automated sensor applicator. Diabetes Technol Ther 2018;20(6):428-433.5ADA Standards of Medical Care in Diabetes-2020.