Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy.

NCT06420518 | Completed

• 1 other identifier: 2024-10140
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

type1diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 8-hour insulin-suspension study.

  2 weeks

Secondary Outcomes (7)

• Overall mean absolute difference (MAD) of ketone CKM (active device) concentration compared to ketone capillary-measurements at home (control).

  2 weeks

• Mean difference (MD) of ketone CKM concentration compared to ketone capillary-measurements during the 8h insulin-suspension study.

  2 weeks

• MD of ketone CKM concentration compared to ketone capillary-measurements at home.

  2 weeks

• MAD & MD according to duration during outpatient period:

  2 weeks

• MAD & MD across ketone levels during insulin-suspension visit:

  2 weeks

Study Arms (2)

Continuous ketone monitoring (CKM) system

All study participants will wear the CKM system for the 2-week study duration. This timeframe is overlapped with both the outpatient phase (sequential ketogenic diets) and, inpatient phase (insulin-suspension period) of the study. The accuracy of the ketone values from the CKM will be assessed using standard point-of-care capillary ketone measurements as reference (control).

Other: Ketogenic diets; Other: 8-hour insulin-suspension period

Standard point-of-care capillary ketone meter

All study participants will be asked to measure their ketone levels with a standard point-of-care capillary ketone meter once upon waking, before a meal and, 2-hours post-meal for the entire 2-week study duration. These ketone measurements will be used as reference values (control) for comparison with the readings from the CKM.

Other: Ketogenic diets; Other: 8-hour insulin-suspension period

Interventions

Ketogenic diets OTHER

During the outpatient phase of the study, all participants will undergo a very low-carbohydrate diet (less than 50grams/day) and, a fasting diet (12 hours) in a randomized order. Both diets are 6 days in duration and, will be interspaced by an inpatient insulin-suspension period. These ketogenic diets are implemented to drive higher ketone levels, within a safe threshold, to assess the accuracy of the CKM sensor. All the while, study participants will be wearing the CKM and, taking multiple daily ketone measurements with a standard point-of-cate ketone meter.

Continuous ketone monitoring (CKM) system; Standard point-of-care capillary ketone meter

8-hour insulin-suspension period OTHER

Interspaced between both ketogenic diets, on day 8 of the study, participants will have their insulin pumps suspended for 8 hours; therefore, participants will not receive any basal or bolus insulin. Ketone levels will be monitored on-site every 30 minutes with standard point-of-care capillary ketone meters and, if ketones measurements exceed the safety threshold, participants will be treated accordingly. Clearly defined stopping criteria and corrective treatments have been outlined in the study protocol to ensure participants safety.

Continuous ketone monitoring (CKM) system; Standard point-of-care capillary ketone meter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of this study are individuals with a type 1 diabetes diagnosis exceeding 1 year, using insulin pump therapy for more than one month. Participant recruitment for the study will predominantly occur through the Hygea Medical Clinic, complemented by outreach to previous study participants who have consented to future contact for research opportunities.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Hygea Clinic

Montreal, Quebec, H4A 3T2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Melissa-Rosina Pasqua, MD

  Hygea Medical Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, McGill University Health Centre, Hygea Clinic

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: April 30, 2024
• Primary Completion: February 18, 2025
• Study Completion: July 18, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CA (1)