Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy. - Trial NCT06420518
Access comprehensive clinical trial information for NCT06420518 through Pure Global AI's free database. This phase not specified trial is sponsored by McGill University and is currently Recruiting. The study focuses on type1diabetes. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
McGill University
Timeline & Enrollment
N/A
Apr 30, 2024
Dec 15, 2024
Primary Outcome
Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 6-hour insulin-suspension study.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06420518
Non-Device Trial