Capillary OGTT Study

Официальное название

A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test

Обзор

Type 1 diabetes (T1D) is a chronic condition, affecting 1 in 490 children under the age of 15 years. It is caused by the immune system damaging the pancreas, the organ which makes insulin. T1D has recognised stages before symptoms develop, providing an opportunity for early diagnosis, education and treatment which may delay the onset of symptoms. Type 2 diabetes (T2D) is also a chronic condition where the body cannot make enough insulin, or cannot respond to the insulin properly. It is usually related to obesity, rather than an immune problem. It is more common in adults, but the early stages often start in childhood (up to 1 in 4 children in some clinics). Like T1D, early detection can delay onset of T2D, or even prevent it altogether. Early diagnosis of T1D or T2D often relies on a test called the oral glucose tolerance test (OGTT), which is commonly used but not well tolerated, possibly because it requires a drip inserted into the vein, and several blood samples taken over 2-3 hours in a healthcare setting. Our study aims to test whether we can do an OGTT using a finger-prick to test glucose, at home. We call this the 'GTT@home'. The finger-prick creates a drop of blood, which is done before and two hours after drinking a sugary drink. We will also explore whether a continuous glucose monitor (CGM), which reads glucose levels through the skin could be an alternative. We plan to recruit 90 children and young people, across two groups to assess the GTT@home. To understand the experiences of those involved in monitoring, we will invite young people, parents and healthcare workers to take part in an interview, to understand the impact of testing to predict clinical T1D. Group 1 will assess the accuracy of measuring glucose from a finger-prick blood test when compared to a blood test from the vein. We will recruit individuals who are having an OGTT as part of a research study, for clinical care or if they have agreed to have an OGTT for this study. Those with T1D will be invited to wear a CGM to explore its use as an additional, practical alternative. Groups 2 and 3 will assess how well the GTT@home test works when done at home and how acceptable it is. This will only be offered to those known to be at risk of T1D. These studies will help us to understand if the GTT@home can be used in routine care.

Первичные конечные точки

• To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT [Срок оценки: From enrolment to end of study visit on day 1.]
• To assess the feasibility of using the capillary OGTT device in the home environment [Срок оценки: From enrolment to end of study visit on day 1]

Вторичные конечные точки (5)

• To determine the diagnostic accuracy of capillary blood glucose levels at diagnostic thresholds [Срок оценки: From enrolment to end of study visit on day 1.]
• Assess the acceptability of the capillary OGTT device [Срок оценки: From enrolment to end of study visit on day 1.]
• To assess the in-depth experience of participants attending study visits involving a metabolic test or assessment [Срок оценки: From enrolment to end of study visit on day 1]
• To assess the in-depth experience of parents attending study visits with their child involving a metabolic test or assessment [Срок оценки: From enrolment to end of study visit on day 1.]
• To assess the in-depth views of healthcare professionals involved in the delivery of a metabolic test or assessment of a child [Срок оценки: From enrolment to end of study visit on day 1.]

Критерии участия

Критерии включения

Cohort 1

• Willing and able to give informed consent for participation, or assent with parental consent
• Aged < 18 years old
• Able to consume oral glucose drink within 10 minutes
• Undergoing an OGTT, or consent to have one

Cohort 2

• Positive for two or more islet autoantibodies at any time
• Willing and able to give informed consent for participation, or assent with parental consent
• Aged < 18 years old
• Able to consume oral glucose drink within 10 minutes

CGM sub-study

• Willing and able to give informed consent for participation, or assent with parental consent
• Aged < 18 years old
• Able to consume oral glucose drink within 10 minutes
• Confirmed to have stage 1, 2 or 3 T1D
• Participation in Cohort 1

Qualitative sub-study

• Willing and able to give informed consent for participation, or assent with parental consent Then EITHER
• A young person positive for two or more islet autoantibodies (15 years old and above) at any time, or parent of a young person who has experienced a metabolic test e.g. OGTT OR
• A healthcare professional involved in delivering metabolic testing

Cohort 3

• Prediabetes diagnosis as above
• Willing and able to give informed consent for participation, or assent with parental consent
• Aged < 18 years old
• Able to consume oral glucose drink within 10 minutes

Критерии исключения

Cohort 1

• Any known haemoglobinopathy
• Cystic fibrosis related diabetes
• Non-English speaker

Cohort 2

• Any known haemoglobinopathy
• Known clinical diabetes and on treatment
• Non-English speaker
• No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement

CGM sub-study

• Any known haemoglobinopathy
• Cystic fibrosis related diabetes
• Non-English speaker
• Any active skin issue which would prevent the use of a CGM device

Qualitative sub-study

• Non-English speaker

Cohort 3

• Known clinical diabetes and on treatment
• Non-English speaker
• No recent weight available (within 3 months of study visit) and unable to obtain new weight measurement

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Великобритания · 4 центра

• Noah's Ark Childrens Hospital for Wales — Cardiff
• Royal London Barts Health NHS Trust — London
• Nottingham Childrens Hospital — Nottingham
• John Radcliffe Hospital — Oxford

Публикации

• Wilson DM, Pietropaolo SL, Acevedo-Calado M, Huang S, Anyaiwe D, Scheinker D, Steck AK, Vasudevan MM, McKay SV, Sherr JL, Herold KC, Dunne JL, Greenbaum CJ, Lord SM, Haller MJ, Schatz DA, Atkinson MA, Nelson PW, Pietropaolo M; Type 1 Diabetes TrialNet Study Group. CGM Metrics Identify Dysglycemic States in Participants From the TrialNet Pathway to Prevention Study. Diabetes Care. 2023 Mar 1;46(3): PMID 36730530
• Ylescupidez A, Speake C, Pietropaolo SL, Wilson DM, Steck AK, Sherr JL, Gaglia JL, Bender C, Lord S, Greenbaum CJ. OGTT Metrics Surpass Continuous Glucose Monitoring Data for T1D Prediction in Multiple-Autoantibody-Positive Individuals. J Clin Endocrinol Metab. 2023 Dec 21;109(1):57-67. doi: 10.1210/clinem/dgad472. PMID 37572381
• Liu Y, Rafkin LE, Matheson D, Henderson C, Boulware D, Besser REJ, Ferrara C, Yu L, Steck AK, Bingley PJ; Type 1 Diabetes TrialNet Study Group. Use of self-collected capillary blood samples for islet autoantibody screening in relatives: a feasibility and acceptability study. Diabet Med. 2017 Jul;34(7):934-937. doi: 10.1111/dme.13338. Epub 2017 Mar 8. PMID 28226181
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008. PMID 18313558
• Dunseath GJ, Bright D, Luzio SD. Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2019 May;13(3):568-574. doi: 10.1177/1932296818821389. Epub 2019 Jan 9. PMID 30623673
• Ginsberg BH. Factors affecting blood glucose monitoring: sources of errors in measurement. J Diabetes Sci Technol. 2009 Jul 1;3(4):903-13. doi: 10.1177/193229680900300438. PMID 20144340
• Bethel MA, Price HC, Sourij H, White S, Coleman RL, Ring A, Kennedy IE, Tucker L, Holman RR. Evaluation of a self-administered oral glucose tolerance test. Diabetes Care. 2013 Jun;36(6):1483-8. doi: 10.2337/dc12-0643. Epub 2013 Jan 15. PMID 23321216
• Dunseath GJ, Bright D, Jones C, Dowrick S, Cheung WY, Luzio SD. Performance evaluation of a self-administered home oral glucose tolerance test kit in a controlled clinical research setting. Diabet Med. 2019 Jul;36(7):862-867. doi: 10.1111/dme.13961. Epub 2019 Apr 26. PMID 30972793

Идентификаторы

NCT: NCT06815081 · PID16905

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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