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Can Real-Time ketone tracking make a diabetes drug safer?

NCT ID NCT06753994

Disease control Sponsor: McGill University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers at McGill University are studying whether continuous ketone monitoring can track ketone levels in adults with type 1 diabetes who take empagliflozin, an SGLT2 inhibitor. Empagliflozin lowers blood sugar but can raise ketone levels, increasing the risk of diabetic ketoacidosis. The trial enrolls 24 adults with type 1 diabetes who use intensive insulin therapy. Participants wear a continuous ketone monitor for four weeks, then take empagliflozin at 2.5 mg for four weeks and 10 mg for nine weeks. Some participants also do exercise and low-carbohydrate diet tests to see how ketones change.

What this could mean

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

Active substance
empagliflozin, an SGLT2 inhibitor drug
What this could lead to
If it works, this could give doctors a real-time way to watch ketone levels and help people with type 1 diabetes use empagliflozin more safely.
What could go wrong
This is a small, early-stage study with 24 participants and no control group. The findings may not apply to everyone with type 1 diabetes, and continuous ketone monitoring is still an experimental approach.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

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

18 years and older

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.

Adults ≥ 18 years old. * A T1D diagnosis for at least one year, as per their treating physician in agreement with the investigator's judgment (confirmatory C-peptide and antibodies will not be required). * HbA1c level of \< 11% within the last six months. * Current use of intensive insulin therapy, either multi-daily injection or closed-loop insulin pump therapy, with no plan to change during the study. * Current use of CGM, either real-time or intermittent. * Active avoidance of pregnancy during the trial, which includes effective contraception for any individuals of childbearing potential, who are sexually active. * Ability to consume an average of more than 50 g of carbohydrates per day. * Use of a compatible phone to allow for download of the CKM sensor application. Exclusion Criteria: * DKA or severe hypoglycemia within the last six months. * Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others). * Current or ≤ one-month use of supraphysiological doses of glucocorticoids. * Body mass index \< 20 kg/m2. * Glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last two months.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Motor Activity type 1 diabetes mellitus diabetic ketoacidosis prevention target

As listed by the trial registrant

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

Diabetes T1D TYPE1DIABETES

Contacts and locations

Locations

  • Hygea Medical Clinic

    Montreal, Quebec, H4A 3J1, Canada

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