ATD
Development Study to Undertake a Comprehensive Performance Evaluation of Prototype Non-Invasive Blood Glucose Measurement Systems Compared to a Standard (Invasive) Measurement Method of Blood Glucose
Sponsor study identifier
observational
50
1 country
1
Study Start
September 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 9, 2021
Actual (reported)August 27, 2021
Actual (reported)September 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Exploratory Efficacy Objective 1
To estimate real-time serial blood glucose levels from the device measurements using a gold standard methodology for blood glucose measurement as control. A comparison addressing the potential differences of MARDs and PARDs respectively will be done for the Afon system tested and assessed using mixed effect linear models with the BG as the fixed effect and subjects as random effects. Within the model the least square means, the differences between least square means of MARD of the Afon system and corresponding two-sided 95% parametric confidence interval will be calculated.
Up to 4 hours per test session.
Exploratory Efficacy Objective 2
To chart patient-specific predicted vs actual blood glucose levels over time, including before and after glucose challenge. The type I error is set at 5% two-sided.
Up to 4 hours per test session.
Safety Objective 1
To examine the safety and tolerability of the prototype sensors. Number of participants with no device-related SAE = 0.
Up to 4 hours per test session.
The first iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
Medical device test (no intervention)
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Trial participants will be patients who have agreed to help with the development of a non-invasive glucometer. Between thirty and fifty patients will be enrolled in this pilot study of prototype sensors. If any prototype sensor is of interest and promise, the number of patients exposed to it may be increased. Subjects who withdraw from the study will be replaced.
JCRF
Swansea, SA2 8PP, United Kingdom
Handy C, Chaudhry MS, Qureshi MRA, Love B, Shillingford J, Plum-Morschel L, Zijlstra E. Noninvasive Continuous Glucose Monitoring With a Novel Wearable Dial Resonating Sensor: A Clinical Proof-of-Concept Study. J Diabetes Sci Technol. 2024 Nov;18(6):1408-1415. doi: 10.1177/19322968231170242. Epub 2023 Apr 27.
First Submitted
August 9, 2021
First Posted
August 27, 2021
Study Start
September 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 30, 2022
Estimated (date passed)A Study of Glucose Control in Participants With Type 1 and Type 2 Diabetes
Exploratory Usability Objective
To obtain patient input for wearable device design by means of a usability questionnaire1 answered questionnaire per participant.
25 minutes - 1 hour during a test session.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
The next iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. The prototype will be tested on a cohort of 3-5 patients.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 27, 2021
Record last verified: 2021-08
No data will be shared.
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Source: ClinicalTrials.gov.
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