A Seven Day Study in Persons with Type 1 Diabetes

Aim of study

This research project is examining a new device (SynerG™) that combines glucose monitoring and insulin delivery. The aim of this study is to demonstrate accuracy and performance of the SynerG™ device over 7 days.

Importance of research

A single device that combines glucose monitoring and insulin delivery can reduce the burden of wearing multiple devices for people living with type 1 diabetes.

Who can be involved in this study?

Participants must meet the following requirements:

• Type 1 diabetes (of at least 6 months duration).
• Age 18 to 75 years (inclusive).
• Insulin pump usage at the time of screening and for at least 3 months prior to screening.
• HbA1c between 5.8 and 10% (inclusive).
• Willingness and ability to follow all study procedures and to attend all clinic visits. 

Participants are required to wear the SynerG™ device, a Dexcom G6 and study provided insulin pump (Tandem t:slim X2™ or Medtronic MiniMed™ 780G) for 7 days. During this time, you will participate in 3 meal challenge tests at St Vincent’s Hospital (Fitzroy) lasting 6 to 7 hours each.

Participants are required to attend St Vincent’s Hospital on five occasions over approximately 14 days. This will involve a screening visit, a device training visit and 3 meal challenge tests.

This project has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) HREC Reference: 189/23.

The Diabetes Technology Research Group

For further information about the study can be found here.