A global committee of leading diabetes organisations has for the first time issued a consensus statement identifying and defining meaningful outcome measures for people with type 1 diabetes (T1D) beyond HbA1c.
In both clinical and research settings, diabetes management is assessed based on the glycated haemoglobin level, or HbA1c, which provides an average measure of blood glucose control over a three-month period. Despite the importance of this measure in clinical management, there are limitations on what HbA1c tells individuals and healthcare professionals about their diabetes. Given that T1D is a chronic condition, much of what people with T1D experience on a day to day basis are not captured within this single measure.
Outcomes such as time in range, and number of episodes of hypoglycaemia are extremely relevant to whether new treatments will actually improve quality of life. Recent advances in technology have made it possible to assess the efficacy of T1D therapies using a broader set of outcomes; however, definitions for other outcomes have not been standardised which causes inconsistency in the definitions used in different research studies. This hinders the development process for new clinical therapies including the reimbursement and regulatory approval process.
In order to change this, the Type 1 Diabetes Outcome Program was launched to develop consensus definitions for outcomes of T1D. The report was compiled by a Steering Committee comprised of representatives from the 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 Paediatric Endocrine Society, and the T1D Exchange.
The group developed definitions for measures beyond HbA1c, such as hypoglycemia, hyperglycemia, time in range, and diabetic ketoacidosis (DKA). The deﬁnitions reﬂect their assessment of the outcome’s short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were also identiﬁed. The report with full definitions is published in Diabetes Care.
The use of these standardised outcomes are recommended for use in research, development and evaluation of type 1 diabetes therapies to assess their effectiveness in improving clinically meaningful outcomes in people with type 1 diabetes.
Here is Australia, this is extremely relevant for the Type 1 Diabetes Clinical Network’s (T1DCRN) research initiatives, such as the national T1D database ADDN, and clinical trials testing therapies and technology such as a hybrid closed loop system.
The Australasian Diabetes Data Network (ADDN) is Australia’s first centralised database gathering clinical information from people with T1D. The data from ADDN will help researchers to answer questions such as which treatments and therapies best improve outcomes for people with T1D, and we now have a wider, more clinically meaningful, range of standardised measures to better assess this. Click here to learn more about ADDN.
The hybrid closed loop studies are assessing the effectiveness of a device to manage blood glucose levels on a day to day basis. Part of what they are assessing is whether this technology will actually improve quality of life overall, and if it will be accessible to people with T1D. These standardised measures will better indicate whether the device actually improves quality of life on a day to day basis which cannot be measured by HbA1c alone, helping researchers to determine whether it is better than standard therapy. This also has potential to help regulatory bodies make more informed decisions on new technology and therapies in the future.
This consensus is a positive step towards accelerating research towards improving quality of life for people with T1D.