Investigators: Dr Mary Abraham, Professor Tim Jones, Ms Nirubasini Paramalingam, Professor Liz Davis
Subcutaneous insulin therapy in the form of insulin injections or insulin pump therapy has been the cornerstone of insulin delivery for people with Type 1 diabetes (T1D). Despite advancements in monitoring and improved delivery systems, most people with T1D are not able to achieve optimal glycaemic control. This raises the need to look for alternative modes of insulin delivery which are non-invasive, likely to be less challenging and more acceptable in long-term. Apart from the mode of administration, oral insulin has the added advantage of replicating a near-physiological state with reduced levels of insulin in systemic circulation and thereby confers a ‘lower risk of hypoglycaemia’. This exciting dimension highlights the necessity to evaluate this therapy further. Many oral insulin preparations have been trialled, especially in the last two decades, although with limited success, especially due to the challenges in absorption of the oral medications. Improved oral drug delivery systems designed to address these barriers have provided a new horizon to explore this avenue further.
A multicentre 12-week clinical trial using oral insulin has recently demonstrated efficacy in adults with early-stage of Type 2 diabetes. Oral insulin caused a clinically meaningful reduction in glucose levels without hypoglycaemia. This opens up exciting avenues to explore its potential in T1D. This proposed pilot study is designed as the first step to explore the possibility of oral insulin in T1D as an adjunct to current management. It has the potential to reduce the dose of insulin administered subcutaneously, thereby reducing the complications of hypoglycaemia and weight gain.
Oral insulin therapy, if found effective, has the immense ability to reform the current management with use of a non-invasive approach of insulin delivery and its implication in reducing the burden of disease over the life-span.
The benefits to the participants are that they may achieve better glycaemic control with a reduction in sub-cutaneous insulin requirements. They may also benefit from better metabolic outcomes in their lipid profile. If this study shows that oral insulin is beneficial to those on hybrid closed loop systems and also find the use of oral insulin acceptable, we will then investigate the use of oral insulin in a larger group of those with T1D. We will investigate if those with T1D, irrespective of their insulin therapy, will have improvements in their blood glucose control as compared to those without. We will also investigate further the other benefits to the use of oral insulin.
The outcomes of this research will be submitted for publication in peer reviewed journals and for presentation at scientific meetings. The project results will be disseminated to patients and families through the bi-monthly newsletter and parent evenings, and to the clinicians at the departmental meeting.
- Dr Radhika James, Perth Children’s Hospital
- Perth Children’s Hospital
- Funding being sought – Diabetes Australia and Diabetes Research WA