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

Recruiting

• Conditions: type1diabetes
• Interventions: Other: Ketogenic diets; Other: 6-hour insulin-suspension period

• Registration Number: NCT06420518
• Lead Sponsor: McGill University

Brief 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.

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 Timeline

• Study Start: 2024-04-30
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard point-of-care capillary ketone meter	Ketogenic diets	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.
Continuous ketone monitoring (CKM) system	Ketogenic diets	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).
Continuous ketone monitoring (CKM) system	6-hour insulin-suspension period	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).
Standard point-of-care capillary ketone meter	6-hour insulin-suspension period	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Hygea Clinic; 🇨🇦 Montreal, Quebec, Canada