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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.
McGill University·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
type1diabetes
Drug/Device/Intervention
Ketogenic diets
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
McGill University
Location
Montreal, Canada
Timeline & enrollment
Phase
N/A
Start date
Apr 30, 2024
End date
Dec 15, 2024
Enrollment
12 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06420518
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.