Ongoing study to review effectiveness of at-home testing for type 1 diabetes
US researchers to assess how home testing is working to diagnose and monitor early type 1 diabetes.
Researchers at Yale School of Medicine, New Haven, Connecticut in the US are evaluating a new finger-prick, at-home glucose tolerance test, to monitor early-stage type 1 diabetes in people with type 1 diabetes autoantibodies.
The GTT@home test offers a simpler, less invasive alternative to clinic-based Oral Glucose Tolerance Tests (OGTTs).
The study aims to assess its accuracy, usability, and acceptance, potentially paving the way for wider use in early type 1 diabetes detection and monitoring.
Researchers have begun an evaluation of the new at-home tests to diagnose and monitor early stages of type 1 diabetes, based on blood glucose levels.
The test would be used in individuals who have already tested positive for type 1 diabetes autoantibodies to identify where they may be in their early-stage type 1 diabetes progression.
GTT@home is an OGTT developed by British diabetes home-testing company Digostics that uses finger-prick blood samples to measure how well the body processes glucose.
For this study, researchers found the tests to be as accurate as lab-based OGTTs when used in adults with glucose intolerance, type 2 diabetes, or in pregnant women to diagnose gestational diabetes. The GTT@home test has successfully been implemented in several UK NHS Trusts to screen for gestational diabetes in pregnancy.
Dr. Jennifer Sherr, Professor of Paediatric Endocrinology and the Medical Director of Paediatric Diabetes at Yale School of Medicine and co-lead principal investigator of the trial, said: “As the presence of diabetes autoantibodies foretells an eventual diagnosis of type 1 diabetes, it is critical to conduct an OGTT to stage the disease, which helps predict the risk of progression over time.
“Yet, in the current paradigm this requires coming to a clinical centre or laboratory and getting venous blood draws. Despite knowing there is an increased risk of diabetes many individuals struggle to undergo an OGTT for staging or repeat the test to permit ongoing monitoring.
“An at-home OGTT would alleviate this barrier. The ability to have those at risk use a product that is simple, requires finger-pricks instead of venous draws, and can be done within a person’s own home at a date and time that is convenient for them would be a fantastic step forward for both patients and providers.”
T1D can be diagnosed at any age, and it is the most common childhood autoimmune disease, affecting around one in 350 children. In type 1 diabetes the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, resulting in elevated blood glucose levels.
Type 1 diabetes affects every aspect of health and wellbeing and results in lifelong insulin dependence and an increased risk of major health problems such as heart disease, blindness, and kidney failure. In 40% or more of children the diagnosis of type 1 diabetes is not made until the child has become severely unwell and presents with metabolic decompensation, which is known as diabetic ketoacidosis (DKA), a life-threatening diabetes complication.
Study lead Dr Alfonso Galderisi, Associate Professor of Paediatrics at Yale School of Medicine, confirmed that the study will recruit 60 patients aged eight and over: “To understand the ease of conducting the test, participants will complete an unsupervised GTT@home test. Five to seven days later, participants will come to our research unit, and we will conduct the standard of care OGTT alongside a supervised GTT@home, with the results of the two tests compared to assess accuracy. We will also be interviewing participants to assess their perception of the two methods used to conduct OGTTs.”
Glucose tolerance tests are performed in the morning after an overnight fast. The GTT@home test kit contains the test device, finger prickers for blood sample collection, a preformulated glucose drink, and detailed instructions. The process begins with an initial finger prick blood sample, followed by the consumption of the glucose drink. Two hours later, a second blood sample is taken. With standard clinic-based OGTTs, individuals need to travel to a clinic early in the morning and then undergo the two blood draws two hours apart and have an IV inserted.
The GTT@home device analyses blood samples shortly after completion of the test and shares results in a timely manner directly with the study teams or clinician. Expedited analysis of samples eliminates the risk of sample degradation that can affect hospital-based OGTTs when samples are not sent to the lab immediately, improving diagnostic reliability.
The results of the trial will inform future regulatory submissions for GTT@home use in type 1 diabetes, which already has regulatory approval in the UK, Europe and other regions for other types of diabetes.
As we recently reported the GTT@home test has already been implemented at NHS trusts in South East England, with more than 2,500 women screened for gestational diabetes in pregnancy since its recent launch. This first study in children began earlier this year by researchers at the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Centre.
Read more At home testing to help women at risk of developing gestational diabetes
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