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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?

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.

 

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:

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