Preserving pancreas function can make glucose control easier and reduce the need to use injected insulin
About the study
When Type 1 diabetes is first diagnosed, the pancreas is still able to make small amounts of insulin, which helps control glucose levels. Preserving pancreas function can make glucose control easier and reduce the need to use injected insulin. This study investigates whether the combination of two immune therapies called abatacept and nasal insulin can preserve pancreas function in recently diagnosed type 1 diabetes.
Anticipated date enrolment will close: March 2026
Who can take part
You may be eligible to participate in this study if you have recently diagnosed Type 1 diabetes. To be eligible for inclusion you must:
- be between 6 and 21 years and weigh more than 20kg
- have diabetes mellitus diagnosed within past 100 days
- have presence of at least one islet autoantibody
- be willing to use continuous glucose monitoring (CGM) for the duration of the study
- demonstrate ability to record home insulin doses
- be willing to forego other forms of experimental treatment during the study
- be up to date with vaccinations against Covid-19, up to date with other recommended vaccinations; willing to postpone live vaccine immunisations for 3 months after end of treatment
What's involved
- 17 visits across 2 years including: a screening visit (to determine eligibility); 48-week treatment period with 13 visits; and a 48-week follow-up period with 3 visits.
- Study drug treatment will be administered by participant/carer at home
- Abatacept will be injected under the skin using a syringe once per week
- Insulin or placebo will be taken via nasal spray every day for 10 days initially and twice per week thereafter
- In addition to standard health assessments (vital signs, physical exam, side effects), the following tests will be performed
- Urine and blood samples
- Fasting Mixed Meal test every 6 months
- Continuous glucose monitoring
- Questionnaires to assess quality of life
- Completion of a diary to record insulin doses and study drug administration
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.