Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy.

Last updated: May 5, 2025
Sponsor: McGill University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Diabetes And Hypertension

Treatment

8-hour insulin-suspension period

Ketogenic diets

6-hour insulin-suspension period

Clinical Study ID

NCT06420518
2024-10140
  • Ages > 18
  • All Genders

Study Summary

The goal of this 14-day randomized pilot trial is to assess the accuracy of a continuous ketone monitoring (CKM) system when compared to standard point-of-care capillary ketone monitors in individuals with type 1 diabetes on insulin pump therapy. The main question it aims to answer is:

  • Can a CKM system demonstrate equivalent ketone monitoring compared to a capillary ketone monitor with accuracy within a mean absolute difference of no more than ± 0.1 mmol/L.

Participants will be asked to wear the SiBio KS1 CKM system for 14-days while undergoing two sequential ketogenic diets which are interspaced by an inpatient insulin-suspension period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥ 18 years of age.

  2. A clinical diagnosis of type 1 diabetes (T1D) for at least one year, as per theirtreating diabetes physician in agreement with the primary investigator's clinicaljudgment (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 aboveoperating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app).

  6. Able to perform study related tasks.

Exclusion

Exclusion Criteria:

  1. Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitormedication (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 whereglucose was <4 mmol/L resulting in seizure, loss of consciousness, needing thirdparty assistance, or need to present to the emergency department.

  4. Diabetic ketoacidosis episode requiring medical attention or intravenous insulinwithin one month.

  5. Planned or ongoing pregnancy or breastfeeding individuals.

  6. Any serious medical or psychiatric illness likely to interfere with ability tocomplete the trial, as per judgement of investigators.

Study Design

Total Participants: 16
Treatment Group(s): 3
Primary Treatment: 8-hour insulin-suspension period
Phase:
Study Start date:
April 30, 2024
Estimated Completion Date:
July 01, 2025

Study Description

In this study, all study participants will wear the CKM system and collect multiple standard point-of-care capillary ketone measurements. Therefore, there will be two groups in terms of measurements methods, one acting as an active comparator (the CKM system) and, the other serving as a control (point-of-care capillary ketone measurements). Both groups of measurement methods will be assessed in all study participants for both the outpatient phase (sequential ketogenic diets) and, the inpatient phase (insulin-suspension period) of the study to evaluate the accuracy of the CKM system.

Connect with a study center

  • Hygea Clinic

    Montreal, Quebec H4A 3T2
    Canada

    Active - Recruiting

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