ORIGIN 

People with Type 1 diabetes need insulin to survive, however consistently administering the correct amount of insulin is often challenging and long-term vascular complications and reduced life expectancy are a reality. Closed-loop systems can help. They are designed to maintain glucose levels at a predetermined target by linking continuous glucose monitoring (CGM) information with an insulin dosing algorithm for automated subcutaneous insulin delivery via a pump.

STUDY OVERVIEW

The Adult Hybrid Closed Loop Study (HCL) aimed to evaluate the efficacy and cost-effectiveness of long-term hybrid closed loop (HCL) insulin delivery vs standard therapy (MDI/CSII) to improve glycaemia, psychosocial well-being, sleep quality, cognition, and biochemical markers of vascular risk in people with type 1 diabetes.

A Hybrid Closed Loop Pump rapidly adjusts insulin delivery according to glucose levels measured by a special sensor the patient or carer inserts under the skin each week. It uses a sophisticated algorithm inferring the direction of glucose level change and adjusting the insulin dose accordingly.

The trial was run in seven specialist hospital diabetes clinics in Australia and included 120 adults with Type 1 diabetes. For a six-month test period, half of the subjects were randomised to the world’s most advanced clinically available integrated insulin pump and continuous glucose monitoring system, called a Hybrid Closed Loop (HCL) system, and half continued standard care with multiple daily injections or a less advanced insulin pump without a glucose sensor. Effects on blood glucose, memory, sleep quality and mental well-being were assessed.

FINDINGS

In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose.

For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.

EXPERTISE 

• Trial design  
• Randomization design and program for randomization and statistical guidance 
• Biobank design and management - some biomarker assays e.g., 1,5 AG done in CTC labs

DURATION

2017 - 2019

COLLABORATORS

Collaborative study between the University of Melbourne, St Vincent’s Hospital Melbourne, Deakin University and the University of Sydney. The CTC is responsible for Data Management and Translational Research.

FURTHER READING

First generation “Artificial pancreas” brings hope for people with type 1 diabetes >