Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a simple alarm prevent a deadly complication in type 1 diabetes?

NCT ID NCT07225465

Disease control Sponsor: St Vincent's Hospital Melbourne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a continuous ketone monitor with a lower alarm threshold (1.0 vs 1.5 mmol/L) can reduce the risk of diabetic ketoacidosis in people with type 1 diabetes who take dapagliflozin, a drug typically used for type 2 diabetes. 115 adults will wear a dual glucose/ketone monitor and take dapagliflozin for 12 weeks. The goal is to find the safest way to use this drug in type 1 diabetes by catching rising ketones early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dapagliflozin (Forxiga)
What this could lead to
If successful, this study could help establish safe guidelines for using SGLT2 inhibitors in type 1 diabetes, potentially improving blood sugar control and reducing complications.
What could go wrong
This is a small, early-phase trial (115 participants) and does not yet prove safety or effectiveness. The risk of diabetic ketoacidosis remains a serious concern, and the optimal ketone threshold is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 115 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Type 1 diabetes mellitus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Ketosis type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004, Australia

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.