A global committee of leading diabetes organisations has for the first time issued a consensus statement identifying and defining meaningful health outcome measures for people with type 1 diabetes (T1D). These outcomes can be used to measure the effectiveness of a treatment or therapy for T1D.
The need for a consensus
In both clinical and research settings, diabetes management is assessed based on a measurement called HbA1C, which provides the average blood glucose over a three-month period. Despite the importance of this measure in clinical management, there are limitations on what HbA1c tells individuals and doctors about their T1D. Given that T1D is a chronic condition that people manage every day, much of what people with T1D experience, like the number of extreme high and low blood glucose events, are not captured within this single measure. Outcomes such as time in range, and number of hypoglycaemiac episodes are extremely relevant to whether new treatments will actually improve quality of life.
Progress through technology
Recent advances in technology have made it possible to assess how well new T1D therapies work, using a broader set of outcomes. However, definitions for outcomes have not been standardised which causes inconsistency in different research studies. This hinders the development process for new clinical therapies including the reimbursement and regulatory approval process.
A team efforts sparks a breakthrough
In order to change this, the Type 1 Diabetes Outcome Program launched to develop consensus definitions for outcomes of T1D. The report, which is published in Diabetes Care, was put together by a Steering Committee made up 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 other measures, 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 T1D. The group also identified knowledge gaps to be addressed by future research.
These standardised outcomes are recommended for use in research, development and evaluation of therapies, to assess their effectiveness in improving clinically meaningful outcomes in people with T1D.
Closer to home
Here in Australia, this is extremely relevant for the Type 1 Diabetes Clinical Network’s (T1DCRN) research initiatives, such as the national T1D database – ADDN (Australasian Diabetes Data Network) – and clinical trials testing therapies and technology, like the hybrid closed-loop system.
ADDN is Australia’s first database gathering medical information from people with T1D in one space. The data from ADDN will help researchers to answer questions such as which treatments and therapies best improve outcomes for people with T1D. Thanks to the work of the Type 1 Diabetes Outcome Program, we now have a wider, more clinically meaningful, range of standardised measures to better assess this. 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, which cannot be measured by HbA1c alone. This will help 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.