Brief Summary

1.Diabetes mellitus is a chronic disease currently affecting more than 425 million people, of which one-third are people older than 65 years. In the UK, the number of people currently diagnosed with diabetes surpassed 3.8 million in 2019, with someone being diagnosed with the illness every two minutes (Diabetes.org figures). The prototype device being tested is a non-invasive blood glucose measurement system worn on the wrist. This would help people with diabetes manage their condition better and help prevent complications.
2.The main objectives of the research are:
3.To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system is, as compared to a gold standard invasive method.
4.To chart the Afon device's predicted blood glucose levels over time.
5.The study will be done with 30-50 patients. Eligible patients will have been diagnosed with diabetes (type 1 or 2) at least one year prior, be between 18 and 80 years old, and with a BMI between 18-35 kg/m2. For details of the full list of inclusion and exclusion criteria, see accompanying documentation.
6.The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP.
7.Participants will attend the site for a total of 5 visits, one for screening, and four study visits, no more than 7 days apart. The study will run for one year.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

12 months study duration

First Submitted

Initial submission to the registry

August 9, 2021

Completed

18 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed

19 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed

Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 9, 2021

Last Update Submit

August 20, 2021

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Keywords

diabetesnon-invasiveBG sensor

Outcome Measures

Primary Outcomes (4)

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.
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.

Study Arms (10)

ATD Cohort 1

The first iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment.

Device: ATD (device test)