Position Statement on Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes
by Daniel Schneider, MSc
When I head to the endocrinologist to check in with my doctor, I’m usually curious and waiting for the results of that benchmark test by which we are all sometimes guilty of celebrating or harshly judging ourselves. Our Hemoglobin A1c (HbA1c), a surrogate measure of blood glucose averaged over 2-3 months, is used as the primary clinical outcome to assess diabetes control. However, using HbA1c alone leads to an incomplete picture of diabetes management and limits an outsider’s perspective on the true impact diabetes can have on a patient’s life.
A doctor cannot look at HbA1c and assume to know about waking up sweating with a low blood sugar in the middle of the night, or to know that you’ve successfully treated hyperglycemia with strategic
exercise, reducing the amount of time with a high blood sugar. Thankfully, as diabetes management technology has improved, continuous glucose monitors (CGMs) lead to a more complete picture of the short term changes associated with blood glucose management. With these changes in mind, a group made up of representatives from the major diabetes organizations in the United States attempted to identify outcomes other than HbA1c that are meaningful for patients and their physical, mental and social well-being. The groups involved included American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine
Society, and the T1D Exchange.
The committee identified 4 further clinical outcomes that impact the life and health of patients. Those outcomes are hypoglycemia (including definitions of severity), hyperglycemia (also including definitions of severity), time in range (>70 and <180mg/dl; >3.9 and <10 mmol/L), and Diabetic Ketoacidosis.
These measures create a more complete clinical picture of diabetes management, but there remains work to be done. If these outcomes are to be applied consistently to patient management, their
measurement needs to be standardized by physicians. Further, more research is needed to establish how these ͞new͟ measures affect the health outcomes of the patient.
The reality is that managing type 1 diabetes is challenging and to summarize disease management with a single outcome/number does a disservice to the patients and the doctor. Establishing these measures as appropriate clinical outcomes will serve to broaden the understanding of managing a complex and dynamic disease.
Read the whole consensus statement here.