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

type1diabetes Clinical Trial

— CKM 1  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420518
• Other study ID #: 2024-10140
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: McGill University
• Contact: Nicholas Sabelli, B.Sc (Hons.)
• Phone: (514) 377-9455
• Email: nicholas.sabelli[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In this study, all study participants will wear the CKM system and collect multiple standard point-of-care capillary ketone measurements. Therefore, there will be two groups in terms of measurements methods, one acting as an active comparator (the CKM system) and, the other serving as a control (point-of-care capillary ketone measurements). Both groups of measurement methods will be assessed in all study participants for both the outpatient phase (sequential ketogenic diets) and, the inpatient phase (insulin-suspension period) of the study to evaluate the accuracy of the CKM system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 15, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults = 18 years of age.

2. A clinical diagnosis of 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 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Intervention

Other:
• Ketogenic diets
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.
• 6-hour insulin-suspension period
Interspaced between both ketogenic diets, on day 8 of the study, participants will have their insulin pumps suspended for 6 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.

Locations

Country	Name	City	State
Canada	Hygea Clinic	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 6-hour insulin-suspension study.		2 weeks
Secondary	Overall mean absolute difference (MAD) of ketone CKM (active device) concentration compared to ketone capillary-measurements at home (control).		2 weeks
Secondary	Mean difference (MD) of ketone CKM concentration compared to ketone capillary-measurements during the 6h insulin-suspension study.		2 weeks
Secondary	MD of ketone CKM concentration compared to ketone capillary-measurements at home.		2 weeks
Secondary	MAD & MD according to duration during outpatient period:	i)During the overall study period, ii) In the first 2 days of sensor life, iii)In the 13-14 days (last 2 days) of sensor life	2 weeks
Secondary	MAD & MD across ketone levels during insulin-suspension visit:	i) =1.0, ii) =0.6, iii) =0.6	2 weeks
Secondary	Number of participants experiencing ketones by both the CKM and capillary-ketone meter.	i) =0.6 during overall study period, inpatient period, outpatient period, ii) =1.0 during overall study period, inpatient period, outpatient period, iii) =1.5 mmol/L during overall study period, inpatient period, outpatient period	2 weeks
Secondary	Glycemic and insulin outcomes will be compared between the very low-carbohydrate diet and the intermittent fasting diet.	i) Between 3.9 and 7.8 mmol/L, ii) Below 3.9 mmol/L and 3.0 mmol/L, iii) Above 10.0 mmol/L and 13.9 mmol/L	2 weeks