From Lab to Clinic: Automated Insulin Delivery
Most people living with T1D do not reach accepted glycaemic goals placing them at risk of long-term diabetes complications. In addition, many remain at risk of severe hypoglycaemia and experience psychological distress resulting from the burden of T1D and its treatment. Feedback control of insulin delivery has long been proposed as an effective approach to achieving glycaemia closer to levels seen in those without T1D but the technology to enable this was not available until recently.
The availability of insulin pumps that can deliver precise doses of insulin along with the development of accurate wearable glucose sensors (CGM) that can measure ambient glucose levels continuously led to efforts to achieve feedback control. The addition of the third essential component, mathematical control algorithms, led to production of effective insulin delivery systems that were tested initially in silico and then in humans firstly in clinic and eventually in a free-living situation.
The first commercially available product was released in 2017 and since then a range of devices have rapidly become available. All currently available systems require a meal bolus and are designated as Hybrid Closed Loop (HCL). Multiple RCTs and a large body of real-world data have demonstrated significant improvements in glycaemia and hypoglycaemia rates along with improved quality of life in users of automated insulin delivery systems. Health economic analyses have confirmed cost effectiveness.
Challenges and improvements remain. A key challenge in Australia is ensuring equity of access, outside of philanthropy access to insulin pumps requires an individual to have top level private health insurance which is limiting access for the disadvantaged.
Further enhancements under investigation include the development of fully closed loop systems that do not require meal bolusing. Personalization of devices with learning algorithms and AI is likely in the future. Systems aimed at special groups (the elderly, pregnancy) are under development and their use in T2D is under trial. Overall automated insulin delivery has been a major transformative innovation that is now the recommended means of insulin delivery in T1D in many jurisdictions.