Phase 2 study for people with Type 1 Diabetes
Not yet recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| St Vincent's Hospital Melbourne | Fitzroy | VIC | Status not stated |
| Austin Health | Heidelberg | VIC | Status not stated |
| Baker Heart and Diabetes Institute | Melbourne | VIC | Status not stated |
| The Royal Melbourne Hospital | Parkville | VIC | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Aged between 24 and 85 years of age inclusive (66% 24Y to 65Y; and 33% \>65Y to 85Y)
* Diagnosed with T1D (made on clinical criteria) for at least 1 year
* Insulin regimen either on MDI or insulin pump with at least 40% in one mode
* Minimum total daily insulin dose 0.4 Units per kg / day (can be on insulin pump or MDI);
* HbA1c \<10% (86mmol/ mol)
* Minimum daily carbohydrate intake of 100g
* Willing to adhere to the study protocol
* Ability to perform high-intensity exercise (specific to the exercise sub-study)
Exclusion Criteria:
* Pregnancy or planned pregnancy
* eGFR \<30ml/min/1.73m2
* History of DKA in the last 12 months
* Use of low carbohydrate diet (\<100g/day)
* Diabetic gastroparesis
* Tape allergy
* Heavy alcohol use (15 standard drinks per week or binge drinking)
* Use of SGLT inhibitor in the last month
* Medications increasing the risk of DKA e.g. steroids, anorectic agents (eg phentermine, naltrexone HCl/bupropion HCl, and GLP 1 agonists).
* Major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 6 November 2025.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.