June 16, 2020
Clinical Outcomes
Article / Publication

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

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June 16, 2020
Clinical Outcomes
Article / Publication

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

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June 16, 2020
Clinical Outcomes
Article / Publication

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.

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June 16, 2020
Economic Outcomes
Article / Publication

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

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June 16, 2020
Clinical Outcomes
Article / Publication

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.

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June 15, 2020
Economic Outcomes
Article / Publication

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)

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June 15, 2020
Clinical Outcomes
Webinar / Archive

Source: IQVIA

Key Takeaway: This webinar presented 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. The slides presented are available to help you learn about the Time-in-Range movement and gain an understanding about what’s to come in the realm of diabetes care management.

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June 15, 2020
Coverage and Benefit Design
Guidelines / Policy

Source: Centers for Medicare & Medicaid Services

Key Takeaway: CMS expanded Medicare coverage for therapeutic CGMs. Most notably, eliminating a requirement that beneficiaries use four fingerstick tests per day prior to accessing CGM. According to the local coverage determination, “there is no evidence to support that frequent SMBG (≥4 times per day) as a prerequisite for initiating CGM use is predictive of improved health outcomes”.

New Coverage Criteria (Effective July 18, 2021)

The revised LCD indicates that Medicare coverage for CGMs will be available if the beneficiary meets the following criteria:

  1. The beneficiary has diabetes mellitus; and,
  2. The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
  3. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,
  4. 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 (1-3) above are met; and,
  5. 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.
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June 15, 2020
Coverage and Benefit Design
Article / Publication

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.

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June 15, 2020
Clinical Outcomes
Economic Outcomes
Webinar / Archive

Source: AMCP Science and Innovation Theater Webinar

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