Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on In… (NCT06420518) | Clinical Trial Compass
CompletedNot Applicable
Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy.
Canada16 participantsStarted 2024-04-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults ≥ 18 years of age.
✓. A clinical diagnosis of type 1 diabetes (T1D) for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required).
✓. On stable, commercial closed-loop pump therapy for the past 30 days.
✓. Stable use of continuous glucose monitor system for the past 30 days.
✓. Cellular phone with Android OS operating system 8.1 and above or iOS11 and above operating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app).
✓. Able to perform study related tasks.
Exclusion criteria
✕. Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
✕. Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
✕
What they're measuring
1
Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 8-hour insulin-suspension study.
. Severe hypoglycemic episode within one month of admission, defined as an event where glucose was \<4 mmol/L resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department.
✕. Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
✕. Planned or ongoing pregnancy or breastfeeding individuals.
✕. Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.