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

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.

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.

Study Overview

• Status: Completed
• Conditions: type1diabetes
• Intervention / Treatment: Other: Ketogenic diets; Other: 8-hour insulin-suspension period

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3T2
      • Hygea Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continuous ketone monitoring (CKM) system; All study participants will wear the CKM system for the 2-week study duration. This timeframe is overlapped with both the outpatient phase (sequential ketogenic diets) and, inpatient phase (insulin-suspension period) of the study. The accuracy of the ketone values from the CKM will be assessed using standard point-of-care capillary ketone measurements as reference (control).	Other: Ketogenic diets; 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.; Other: 8-hour insulin-suspension period; 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.
Standard point-of-care capillary ketone meter; All study participants will be asked to measure their ketone levels with a standard point-of-care capillary ketone meter once upon waking, before a meal and, 2-hours post-meal for the entire 2-week study duration. These ketone measurements will be used as reference values (control) for comparison with the readings from the CKM.	Other: Ketogenic diets; 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.; Other: 8-hour insulin-suspension period; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 8-hour insulin-suspension study.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mean absolute difference (MAD) of ketone CKM (active device) concentration compared to ketone capillary-measurements at home (control).		2 weeks
MD of ketone CKM concentration compared to ketone capillary-measurements at home.		2 weeks
MAD & MD according to duration during outpatient period:	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	2 weeks
MAD & MD across ketone levels during insulin-suspension visit:	i) ≥1.0, ii) ≥0.6, iii) ≤0.6	2 weeks
Number of participants experiencing ketones by both the CKM and capillary-ketone meter.	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	2 weeks
Glycemic and insulin outcomes will be compared between the very low-carbohydrate diet and the intermittent fasting diet.	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	2 weeks
Mean difference (MD) of ketone CKM concentration compared to ketone capillary-measurements during the 8h insulin-suspension study.		2 weeks

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Melissa-Rosina Pasqua, MD, Hygea Medical Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): February 18, 2025
• Study Completion (Actual): July 18, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; Continuous ketone monitoring system; Ketone monitoring; Diabetes ketoacidosis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Carbohydrate-Restricted; Diet, Ketogenic
• Other Study ID Numbers: 2024-10140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No