NCT06420518

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• type1diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-02-18
• Completion: 2025-07-18
• First posted: 2024-05-20
• Last updated: 2025-09-26

Locations

1 site across 1 country: Canada