Evaluating the Safety and Utility of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes Undergoing Haemodialysis

What This Trial Is About

Diabetes is the leading cause of kidney failure in the UK, and managing diabetes in people with advanced kidney disease is especially challenging due to fluctuating glucose levels and higher risk of unsafe low glucose readings. This trial investigates whether automated insulin delivery AID systems can improve glucose control and quality of life for people with type 2 diabetes who are treated with multiple insulin injections and undergoing regular haemodialysis. The study is conducted across four UK centers with a parallel design involving about 84 participants. Participants will wear a glucose sensor at the start and will be randomly assigned to one of two groups one group will use the Omnipod 5 automated insulin delivery system, while the other will continue with usual care augmented by continuous glucose monitoring. Each treatment stage lasts 12 weeks, with the entire study lasting about 18 weeks per participant. Researchers will compare glucose levels between the two groups and collect feedback through questionnaires and interviews. During the study, participants will be closely monitored for safety and their glucose levels will be tracked using continuous sensors. Various questionnaires will assess treatment satisfaction, quality of life, and diabetes-related distress. The main outcome measured is the time glucose levels remain in the target range between 3.9 and 10 mmolL over 12 weeks. Secondary measures include time spent below target glucose levels, episodes of severe hypoglycemia, ketosis events, and several quality of life assessments. This comprehensive monitoring aims to understand the impact of automated insulin delivery in this population.

A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis