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Completed

NCT Number: NCT06420518

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

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.

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Key information

Conditions

Type1diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hygea Clinic

Montreal, Quebec, H4A 3T2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥ 18 years of age.
  • 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).
  • On stable, commercial closed-loop pump therapy for the past 30 days.
  • Stable use of continuous glucose monitor system for the past 30 days.
  • 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).
  • Able to perform study related tasks.

Exclusion criteria

  • Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
  • Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
  • 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.
  • Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
  • Planned or ongoing pregnancy or breastfeeding individuals.
  • Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.

Treatment and study plan

Ketogenic diets

Other

During the outpatient phase of the study, all participants will undergo a very low-carbohydrate diet (less than 50grams/day) and, a fasting diet (12 hours) in a randomized order. Both diets are 6 days in duration and, will be interspaced by an inpatient insulin-suspension period. These ketogenic diets are implemented to drive higher ketone levels, within a safe threshold, to assess the accuracy of the CKM sensor. All the while, study participants will be wearing the CKM and, taking multiple daily ketone measurements with a standard point-of-cate ketone meter.

8-hour insulin-suspension period

Other

Interspaced between both ketogenic diets, on day 8 of the study, participants will have their insulin pumps suspended for 8 hours; therefore, participants will not receive any basal or bolus insulin. Ketone levels will be monitored on-site every 30 minutes with standard point-of-care capillary ketone meters and, if ketones measurements exceed the safety threshold, participants will be treated accordingly. Clearly defined stopping criteria and corrective treatments have been outlined in the study protocol to ensure participants safety.

Primary outcomes

  1. Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 8-hour insulin-suspension study.

    Time frame: 2 weeks

Secondary outcomes

  1. Overall mean absolute difference (MAD) of ketone CKM (active device) concentration compared to ketone capillary-measurements at home (control).

    Time frame: 2 weeks

  2. Mean difference (MD) of ketone CKM concentration compared to ketone capillary-measurements during the 8h insulin-suspension study.

    Time frame: 2 weeks

  3. MD of ketone CKM concentration compared to ketone capillary-measurements at home.

    Time frame: 2 weeks

  4. MAD & MD according to duration during outpatient period:

    Time frame: 2 weeks

    i)During the overall study period, ii) In the first 2 days of sensor life, iii)In the 13-14 days (last 2 days) of sensor life

  5. MAD & MD across ketone levels during insulin-suspension visit:

    Time frame: 2 weeks

    i) ≥1.0, ii) ≥0.6, iii) ≤0.6

  6. Number of participants experiencing ketones by both the CKM and capillary-ketone meter.

    Time frame: 2 weeks

    i) ≥0.6 during overall study period, inpatient period, outpatient period, ii) ≥1.0 during overall study period, inpatient period, outpatient period, iii) ≥1.5 mmol/L during overall study period, inpatient period, outpatient period

  7. Glycemic and insulin outcomes will be compared between the very low-carbohydrate diet and the intermittent fasting diet.

    Time frame: 2 weeks

    i) Between 3.9 and 7.8 mmol/L, ii) Below 3.9 mmol/L and 3.0 mmol/L, iii) Above 10.0 mmol/L and 13.9 mmol/L

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

A Phase I Clinical Trial Testing the Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy.

Acronym: CKM 1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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