Diabetes Mellitus, Type 2ATDNCT05023798
Study to Evaluate a Prototype Non-Invasive BG Measurement System
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Afon Technology at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- ATD (device test)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2021to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Patient who has a documented Type 1 diagnosis (diagnosed under age 29), or Type 2 diabetes for more than one year (with negative GAD antibody test results) and who are willing and able to give informed consent for participation in the study Male or female patient Patient aged 18 to 80 years Patients with a BMI 18-35 kg/m2.
Who cannot join
- The patient may not enter the study if ANY of the following apply:
- Type 1 patients diagnosed after age 29 Type 2 patients with positive GAD antibody test results Patient with other active implantable medical devices, such as pacemakers Patient who is currently participating in another clinical trial for a pharmaceutical product Patient with a history of allergy to any materials used in the prototype sensors or materials used to stabilise the devices or cabling including Rocktape, double-sided tape and prosthetic adhesive Female patient who is pregnant or lactating
- Patient with any injury or infection of the wrist
- Patient who is unwilling or unable to attend each visit fasting from midnight (water is permitted freely) or fasting for a minimum of 3 hours (for an afternoon session)
- Patient who takes paracetamol or aspirin in the 24 hours preceding each visit
- Patient with clinically significant abnormal values in clinical chemistry, as judged by the PI
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- Concurrent illness or a condition that may interfere with blood glucose levels (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy)
- Patient who is incapable of giving informed legal consent
- Recent (1 month) episode of DKA, HONK or severe hypoglycaemia
- Patient on pramlintide (Symlin/Tripro-Amylin)
- Patient who attends the visit under the influence of alcohol or recreational drugs
- Patient with severe macrovascular disease - stroke, CVD, CKD stage IV -V Patient who fails screening for alcohol and recreational drugs use.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
JCRF
Swansea, SA2 8PP
Steve Luzio, +44 (0)1792 295078, S.Luzio@Swansea.ac.uk
Stephen C Bain, MD
About this study
Official title: 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
- 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.
- The main objectives of the research are:
- To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system is, as compared to a gold standard invasive method.
- To chart the Afon device's predicted blood glucose levels over time.
- 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.
- The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP.
- 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.
Read the detailed description
Diabetes is a chronic disease currently affecting more than 425 million people worldwide. 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).By the end of this year, 4 million deaths will happen worldwide as a result of diabetes and its complications. These complications include renal failure, blindness, and amputation. It is well established clinically that good glycaemic control minimises the risk of long-term complications and improves morbidity and mortality. Current problems with frequent blood glucose testing are mainly due to patient intolerability. Many patients find finger prick testing for blood glucose levels to be painful, dislike using sharp objects and seeing their own blood. There is also a risk of infection, and in the long term, this practice can result in damage to the finger tissue. This is because the fingers have a high concentration of sensory nerve endings. Additionally, the current invasive blood glucose monitoring systems suffer limitations in terms of the requirement for continuous calibration and susceptibility to contamination by the growth of various living organisms.
The Afon technology device would be a gamechanger in terms of improving the quality of life of millions of patients and improve their chances to manage the condition without severe complications.
- Being tested
- ATD (device test)
- Keywords
- diabetes, non-invasive, BG sensor
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATD (device test)Device
Medical device test (no intervention)
| Study group | Role | What they receive |
|---|---|---|
| ATD Cohort 1 | The first iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. Receives: Device: ATD (device test) | |
| ATD Cohort 2 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 3 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 4 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 5 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 6 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 7 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 8 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 9 | 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. Receives: Device: ATD (device test) | |
| ATD Cohort 10 | 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. Receives: Device: ATD (device test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 25 minutes - 1 hour during a test session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start15 Sep 2021 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afon Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023798
- Sponsor's protocol ID
- 04-001
- Acronym
- ATD
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared.
Publications
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.
PubMed 37102600
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05023798
- Acronym / sponsor ID
- ATD / 04-001
- Keywords
- diabetes, non-invasive, BG sensor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Afon TechnologyIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- The main objectives of the research are:
- To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system is, as compared to a gold standard invasive method.
- To chart the Afon device's predicted blood glucose levels over time.
- 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.
- The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP.
- 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.
Detailed description
Diabetes is a chronic disease currently affecting more than 425 million people worldwide. 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).By the end of this year, 4 million deaths will happen worldwide as a result of diabetes and its complications. These complications include renal failure, blindness, and amputation. It is well established clinically that good glycaemic control minimises the risk of long-term complications and improves morbidity and mortality. Current problems with frequent blood glucose testing are mainly due to patient intolerability. Many patients find finger prick testing for blood glucose levels to be painful, dislike using sharp objects and seeing their own blood. There is also a risk of infection, and in the long term, this practice can result in damage to the finger tissue. This is because the fingers have a high concentration of sensory nerve endings. Additionally, the current invasive blood glucose monitoring systems suffer limitations in terms of the requirement for continuous calibration and susceptibility to contamination by the growth of various living organisms.
The Afon technology device would be a gamechanger in terms of improving the quality of life of millions of patients and improve their chances to manage the condition without severe complications.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| ATD Cohort 1 | – | Device: ATD (device test)The first iteration of the sensor will be tested and results compared to the gold-standard laboratory measuring equipment. |
| ATD Cohort 2 | – | Device: ATD (device test)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. |
| ATD Cohort 3 | – | Device: ATD (device test)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. |
| ATD Cohort 4 | – | Device: ATD (device test)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. |
| ATD Cohort 5 | – | Device: ATD (device test)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. |
| ATD Cohort 6 | – | Device: ATD (device test)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. |
| ATD Cohort 7 | – | Device: ATD (device test)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. |
| ATD Cohort 8 | – | Device: ATD (device test)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. |
| ATD Cohort 9 | – | Device: ATD (device test)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. |
| ATD Cohort 10 | – | Device: ATD (device test)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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patient who has a documented Type 1 diagnosis (diagnosed under age 29), or Type 2 diabetes for more than one year (with negative GAD antibody test results) and who are willing and able to give informed consent for participation in the study Male or female patient Patient aged 18 to 80 years Patients with a BMI 18-35 kg/m2.
Key exclusion criteria (12 listed)
- Type 1 patients diagnosed after age 29 Type 2 patients with positive GAD antibody test results Patient with other active implantable medical devices, such as pacemakers Patient who is currently participating in another clinical trial for a pharmaceutical product Patient with a history of allergy to any materials used in the prototype sensors or materials used to stabilise the devices or cabling including Rocktape, double-sided tape and prosthetic adhesive Female patient who is pregnant or lactating
- Patient with any injury or infection of the wrist
- Patient who is unwilling or unable to attend each visit fasting from midnight (water is permitted freely) or fasting for a minimum of 3 hours (for an afternoon session)
- Patient who takes paracetamol or aspirin in the 24 hours preceding each visit
- Patient with clinically significant abnormal values in clinical chemistry, as judged by the PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATD (device test)Medical device test (no intervention) | Device | ATD Cohort 1, ATD Cohort 10, ATD Cohort 2, ATD Cohort 3, ATD Cohort 4, ATD Cohort 5, ATD Cohort 6, ATD Cohort 7, ATD Cohort 8, ATD Cohort 9 |
Primary outcome
Exploratory Efficacy Objective 1
Time frame: Up to 4 hours per test session.
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.
Exploratory Efficacy Objective 2
Time frame: Up to 4 hours per test session.
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.
Safety Objective 1
Time frame: Up to 4 hours per test session.
To examine the safety and tolerability of the prototype sensors. Number of participants with no device-related SAE = 0.
Exploratory Usability Objective
Time frame: 25 minutes - 1 hour during a test session.
To obtain patient input for wearable device design by means of a usability questionnaire1 answered questionnaire per participant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Derived from this study: PubMed 37102600Handy 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.
- Individual participant dataSharing planned: No. No data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Afon Technology at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Luzio (+44 (0)1792 295078, S.Luzio@swansea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory Efficacy Objective 1 (time frame: Up to 4 hours per test session.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05023798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.