Outcomes Beyond A1C
For years, A1C has guided regulatory decisions in the diabetes space. But this metric fails to capture the data provided by recent advances in diabetes technology – and more importantly, the daily reality of living with diabetes. We are proud to say that the diabetes community has finally come to a consensus on core glycemic metrics that will empower regulatory bodies to implement outcomes beyond A1C.
- Why Beyond A1C?
- Glycemic Outcomes Beyond A1C Consensus Conference
- More on Beyond A1C from Diabetes Care
- The diaTribe Foundation and Beyond A1C: A Timeline
- Patient-Reported Outcomes (PROs)
- Interested in learning more about the Beyond A1C movement?
Why Beyond A1C?
For the FDA and many payers, A1C is currently the “gold standard” used to assess diabetes therapy – it reflects average blood glucose levels over a two-to-three-month period, and in turn, the long-term risk of complications from high blood sugar (hyperglycemia).
But A1C has limits: it cannot capture other critical outcomes that matter to people with diabetes on a daily basis. Low blood sugar (hypoglycemia) can be fatal, and yet, A1C tells us nothing about it. New therapies may dramatically improve quality of life, but those improvements won’t necessarily show up in an A1C value. Two people can have the exact same A1C value, but spend wildly different amounts of time at high and low blood glucose values. Given recent improvements in the accuracy of glucose sensing devices, our metrics must reflect the additional data that glucose monitoring provides.
A1C isn’t a one-size-fits-all metric – a single A1C value could indicate different average blood glucose levels due to individual differences in how red blood cells and blood sugars bind – and doesn’t indicate anything about glycemic variability. Finally, measurements like A1C alone do not reflect the 24/7 nature of diabetes; the challenges can include negative feelings, such as stress, guilt, failure, exhaustion, and fear, and immense treatment burdens.
Glycemic Outcomes Beyond A1C Consensus Conference
The diaTribe Foundation has been involved in the Beyond A1C movement since 2012 (see our official timeline). In July 2017, The diaTribe Foundation held the Glycemic Outcomes Beyond A1C Consensus meeting. We convened leaders from national associations, industry, academic institutions, and patient groups to come to consensus on key glycemic metrics (below) to be used in research, therapy development, and regulatory review. See our conference resource page for more detailed coverage!
Key glycemic metrics that the Glycemic Outcomes Beyond A1C conference came to consensus on:
In June 2018, the diaTribe-led Beyond A1C Writing Group published Need for Regulatory Change to Incorporate Beyond A1C Glycemic Metrics in Diabetes Care – a groundbreaking article that synthesized the results of the consensus conference. See our press release here.
More on Beyond A1C from Diabetes Care
The diaTribe Foundation hasn’t been alone in advocating for the Beyond A1C movement. We’ve been working and writing with leading national and international experts, and we’ve highlighted a few of our favorite Beyond A1C Diabetes Care articles below.
- “Maturation of CGM and Glycemic Measurements Beyond HbA1c—A Turning Point in Research and Clinical Decisions” (Dec 2017) by Matthew Riddle, Hertzel Gertstein, & William Cefalu – A review of the clinical evidence on CGM use, definitions of measures of glycemic control outside of A1C, and how to use CGM data to improve patient care
- Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes (Dec 2017) led a Steering Committee with support from JDRF and T1D Exchange – Definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes based on an assessment of the outcome’s short- and long-term clinical impact on people with type 1 diabetes.
- International Consensus on Use of Continuous Glucose Monitoring (Dec 2017) by an international panel of CGM experts convened by the Advanced Technologies & Treatments for Diabetes (ATTD) Congress – Summarizes the ATTD consensus recommendations and represents the current understanding of how CGM results can affect outcomes
- Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations (Dec 2017) by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Technology Working Group – Recommendations for systemic improvements in clinical use and regulatory (pre- and post-marketing) handling of CGM devices
- Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials (Oct 2018) by Roy Beck et al. – Evaluation of the strong association of time in range with the development or progression of eye and kidney complications using Diabetes Control and Complications (DCCT) data to validate use of TIR as outcome measure for clinical trials
- Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (Jun 2019) by a time-in-range Working Group convened at ATTD 2019 – Summarizes the ATTD 2019 consensus recommendations and current understanding of how CGM data can affect outcomes
The diaTribe Foundation and Beyond A1C: A Timeline
Click anywhere on the graphic below to access an interactive version of the timeline with live links! (You will leave this page.)
Patient-Reported Outcomes (PROs)
Advocating for increased use of patient-reported outcomes (PROs) in clinical and regulatory settings is also one of the leading goals of the Beyond A1C movement. Measuring and incorporating outcomes that directly affect patients and caregivers into regulatory decisions would simultaneously allow people with diabetes to have a better sense of how therapies affect the psychosocial elements of their diabetes and their doctors to better understand their needs, aspirations, and life circumstances.
diaTribe attended the 2017 National Institutes of Health PRO workshop, which advocated for increased use of patient-reported outcomes in diabetes research – see coverage here.
Interested in learning more about the Beyond A1C movement? Check out our detailed coverage on diaTribe.org:
Beyond A1C:
- Going Beyond A1c – One Outcome Can’t Do It All (Aug 2016)
- What's a "Normal" A1c? When is it Misleading? (Oct 2017)
- CGM and Time-in-Range: What Do Diabetes Experts Think About Goals? (Dec 2017)
- New Diabetes Care Guidelines From ADA and EASD for Adults with Type 2 Diabetes (Oct 2018)
- Understanding Average Glucose, Standard Deviation, CV, and Blood Sugar Variability (Oct 2018)
Time-in-range:
- Time-in-Range Resource Page (Aug 2019)
- Time-in-Range: What’s an Achievable Goal with Diabetes? (Dec 2017)
- Time-in-Range Tips: Expert-Defined Goals, Plus Insights from Almost 500,000 FreeStyle Libre Users (May 2019)
- CGM and Time-in-Range: What Do Diabetes Experts Think About Goals? (Dec 2017)
- Understanding Average Glucose, Standard Deviation, CV, and Blood Sugar Variability (Oct 2018)