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Study to Evaluate a Prototype Non-Invasive BG Measurement System

NCT05023798 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-08-27

No results posted yet for this study

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:

1. To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system is, as compared to a gold standard invasive method.
2. To chart the Afon device's predicted blood glucose levels over time.
3. 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.
4. The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP.
5. 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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1

Interventions

DEVICE

ATD (device test)

Medical device test (no intervention)

Sponsors & Collaborators

  • Afon Technology

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023798 on ClinicalTrials.gov