Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals with Type 1 Diabetes on Insulin Pump Therapy.
Launched by MCGILL UNIVERSITY · May 14, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new device called a Continuous Ketone Monitoring (CKM) system to see how well it works for people with type 1 diabetes who use insulin pumps. Over 14 days, participants will wear the CKM system and follow specific diets while the researchers compare its accuracy to the traditional method of checking ketone levels with a fingertip blood test. The main goal is to find out if the CKM system can measure ketones just as accurately as the standard tests.
To be eligible for the trial, participants need to be at least 18 years old and have been diagnosed with type 1 diabetes for at least a year. They should have been using an insulin pump and a continuous glucose monitor for the past month. Participants will need to use a smartphone that meets certain requirements for the study app. While taking part in the trial, participants can expect to follow two special diets and be monitored closely. It's important to know that some individuals, such as those currently on specific medications or with recent serious health issues, may not qualify for the study.
Gender
ALL
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.
Trial Officials
Melissa-Rosina Pasqua, MD
Principal Investigator
Hygea Medical Clinic
About Mcgill University
McGill University, a prestigious research institution located in Montreal, Canada, is committed to advancing medical science through innovative clinical trials. Renowned for its rigorous academic standards and collaborative approach, McGill fosters a dynamic environment that integrates cutting-edge research with clinical practice. With a focus on improving patient outcomes, the university's clinical trials span a wide range of therapeutic areas, leveraging the expertise of its diverse faculty and state-of-the-art facilities. McGill University is dedicated to ethical research practices and the dissemination of knowledge, ensuring that findings contribute meaningfully to the global healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montreal, Quebec, Canada
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0