Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420518
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
Accuracy of a Continuous Ketone Monitoring CKM System in Individuals With Type 1 Diabetes on Insulin Pump Therapy
Sponsor:
McGill University
Organization:
McGill University
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:
RECRUITING
Status Verified Date:
2024-05
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 01 mmolL
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 01 mmolL
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:
None
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?:
None