Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06420518
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2024-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy.
Sponsor:
McGill University
Organization:
Study Overview
Official 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.
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CKM 1
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.
\- 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: