NCT06420518Completed
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.
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 16 (actual)
- First submitted
- 14 May 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 18 Feb 2025
- Lead sponsor
- McGill University
- Diseases
- Type 1 diabetes
- NCT number
- NCT06420518
What you commit to
- Study type: Observational
- Participants enrolled: 16
- From 30 Apr 2024 to the primary completion date, 18 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.
Lab values
- Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
- 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.
Other
- Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
- Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
- Planned or ongoing pregnancy or breastfeeding individuals.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hygea Clinic Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
Related publications
- Transient Benign Ketosis Is Common in Type 1 Diabetes During Very-Low Carbohydrate States: Novel Data from Continuous Ketone Sensor.Diabetes Technol Ther · 2026 · PMID 42381172
This page is information, not medical advice. Discuss any trial with your doctor.