Evaluating a continuous ketone monitoring system for type 1 diabetes management

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.

This study is testing a new continuous ketone monitoring system to see if it works as well as regular ketone tests for people with type 1 diabetes using insulin pumps.

Quick facts

• Study type: Observational
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06420518 on ClinicalTrials.gov

What this trial studies

This observational pilot trial aims to assess the accuracy of a continuous ketone monitoring (CKM) system in individuals with type 1 diabetes who are using insulin pump therapy. Over a 14-day period, participants will wear the CKM system while undergoing two sequential ketogenic diets, interspersed with an inpatient insulin-suspension phase. The study will compare the CKM system's performance against standard point-of-care capillary ketone monitors to determine if the CKM can provide equivalent accuracy in ketone monitoring. Participants will be required to collect multiple ketone measurements throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of type 1 diabetes who are on stable insulin pump therapy and continuous glucose monitoring.

Not a fit: Patients currently using SGLT2 inhibitors or those with recent severe hypoglycemic episodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring of ketone levels in patients with type 1 diabetes, potentially reducing the risk of diabetic ketoacidosis.

How similar studies have performed: While the approach of continuous ketone monitoring is gaining interest, this specific CKM system's accuracy has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥ 18 years of age.
2. 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).
3. On stable, commercial closed-loop pump therapy for the past 30 days.
4. Stable use of continuous glucose monitor system for the past 30 days.
5. 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).
6. Able to perform study related tasks.

Exclusion Criteria:

1. Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
2. Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
3. 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.
4. Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
5. Planned or ongoing pregnancy or breastfeeding individuals.
6. Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.

Where this trial is running

Montreal, Quebec

• Hygea Clinic — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Melissa-Rosina Pasqua, MD — Hygea Medical Clinic
• Study coordinator: Nicholas Sabelli, B.Sc (Hons.)

Conditions type1diabetes; Continuous ketone monitoring system; Ketone monitoring; Diabetes ketoacidosis; diabetes