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New sensor could replace Finger-Stick ketone tests for diabetes patients

NCT ID NCT06420518

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new continuous ketone monitoring (CKM) system in 16 adults with type 1 diabetes who use insulin pumps. Participants wore the CKM sensor for 14 days and followed special diets with a short insulin stop to see if the device accurately measures ketones compared to standard finger-stick tests. The goal is to make ketone monitoring easier and more continuous for people with diabetes.

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.

Participants

16 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2025

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.

Who is studied

The population of this study are individuals with a type 1 diabetes diagnosis exceeding 1 year, using insulin pump therapy for more than one month. Participant recruitment for the study will predominantly occur through the Hygea Medical Clinic, complemented by outreach to previous study participants who have consented to future contact for research opportunities.

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.

Inclusion Criteria: 1. Adults ≥ 18 years of age. 2. A clinical diagnosis of type 1 diabetes (T1D) for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required). 3. On stable, commercial closed-loop pump therapy for the past 30 days. 4. Stable use of continuous glucose monitor system for the past 30 days. 5. Cellular phone with Android OS operating system 8.1 and above or iOS11 and above operating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app). 6. Able to perform study related tasks. Exclusion Criteria: 1. Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin). 2. Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor. 3. Severe hypoglycemic episode within one month of admission, defined as an event where glucose was \<4 mmol/L resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department. 4. Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month. 5. Planned or ongoing pregnancy or breastfeeding individuals. 6. Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus

As listed by the trial registrant

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

TYPE1DIABETES

Contacts and locations

Locations

  • Hygea Clinic

    Montreal, Quebec, H4A 3T2, Canada

More trials for these conditions

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