ADA Consensus Report Outcome Measures Beyond HbA1C for Type 1 Diabetes


In July 2017, over in the US the

DiaTribe Foundation put their shoulders

to the wheel. In a news item, Beyond

A1c, by Jeemin Kwon, Lynn Kennedy,

Adam Brown, and Kelly Close reported

that the DiaTribe Foundation gathered

leaders in the diabetes community

to host a discussion on Glycaemic

Outcomes Beyond A1c: Standardization

and Implementation. The report said,

"With the #beyondA1c movement having

taken great strides in the previous year,

because A1c alone is not enough, the

gathering convened experts from the

US and Europe to reach a consensus on

which glycaemic outcomes beyond A1c

are important and how to report them in a

standardized way."

Glycaemic outcomes that were

discussed included measures such as

low blood sugar (hypoglycaemia), time

spent in-range, and high blood sugar

(hyperglycaemia). This work had begun

a few years earlier in November 2014

when the DiaTribe Foundation worked

with the FDA, JDRF and ADA where

representatives of the diabetes community

identified key goals for outcomes for the

'beyond A1c' movement.

A major goal was to help the FDA

(American Federal Drugs Administration)

to understand that continuous glucose

monitoring (CGM) is now accurate enough

to measure these critical outcomes,

which may not be captured by A1c

alone. Patient advocate Stephen Shaul

told researchers, regulators, and drug

and device manufacturers at the event,

"Patients have CGM data and are using

it now. What you need to do is catch up

to us."

Attendees at the event all agreed

that A1c is not enough and using CGM

to measure additional outcomes could

meaningfully change how therapies are

developed. For instance, a new drug that

does not change A1c, but reduces highs

and lows would be very meaningful to

people with diabetes. As CGM is the best

tool available to measure that benefit, it

was suggested that the FDA should use

CGM data in trials to fully appreciate nonA1c outcomes

that significantly impact

people with diabetes.

Consensus vote

In November 2017 an ADA Consensus

Report entitled, Outcome Measures

Beyond HbA1C for Type 1 Diabetes,

whereby a Type 1 Diabetes Outcomes

Program had been launched to develop

consensus definitions for a set of priority

outcomes for T1D. The ADA's Chief

Scientific, Medical and Mission Officer,

William T. Cefalu, MD commented, "This

Consensus Report is a significant step

towards providing standardized methods

for improving how we evaluate therapies

and technologies designed to treat and

assist in the management of T1D and the

prevention of its complications. Together,

expanded data provided by CGMs along

with uniform definitions will ultimately help

us provide more carefully crafted and

individualized diabetes care plans, and

thus improve health outcomes as well as

patient quality of life. Partnerships such as

the Type 1 Diabetes Outcomes Program,

convened by JDRF, are essential for us to

make these important shifts across the

diabetes landscape-from clinical care to

It's important for healthcare providers to take into

account patients' quality of life, which is more

difficult to measure than HbA1c, yet can greatly

impact outcomes."


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  7. Leicester Diabetes Centre, JDRF, Rachel Connor JDRF, T1Exchange
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  12. Accu-Chek Mobile blood glucose system
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  14. The tyranny of HbA1c time to talk now about Time in Range
  15. The fallacy of average, why HbA1c isn't good enough
  16. ADA Consensus Report Outcome Measures Beyond HbA1C for Type 1 Diabetes
  17. hypoglycaemia, hyperglycaemia, time in range
  18. patient quality of life
  19. Continuous glucose monitoring is showing the limitations of HbA1c
  20. HbA1c, mean glucose, Time in Range
  21. Ascensia Contour Next One Diabetes blood test meters
  22. My Diabetes Kit Debbie Green
  23. My Diabetes Kit Debbie Green, Accu-Chek Roche, Medtronic
  24. My Diabetes Kit Debbie Green, Accu-Chek Roche, Medtronic
  25. London Medical, London Diabetes Centre, private diabetes clinic
  26. Spirit Healthcare, Chris Barker, Leicester, Empower
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