Clinical trial NCT06815081: Capillary OGTT Study
Official title: A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes (T1D)
Keywords: Capillary
Glucose
Oral glucose tolerance test
Method Comparison
Feasibility
Acceptability
Type 1 diabetes
Monitoring
Follow-up
Screening
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University of Bristol
name: Yale University
name: Oxford University Hospitals NHS Trust
name: Nottingham University Hospitals NHS Trust
name: Cardiff and Vale University Health Board
name: Royal London Hospital, Barts Health NHS Trust
First posted: 2025-02-07
Enrollment: 90
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1 - Children \< 18 years of age, across a range of ages, will be invited to take part. To get a spread of glucose values, we will aim to recruit approximately equal numbers of participants with normoglycaemia, dysglycaemia and hyperglycaemia.

Cohort 1 CGM sub-study - Children \< 18 years of age, who have T1D stage 1, 2 or 3 and undergoing an OGTT in cohort 1 will be invited to take part.This sub-study will be additional and optional to cohort 1.

Cohort 2 - Children \< 18 years of age, who are identified as having stage 1, 2 or 3 T1D will be invited to take part in an OGTT at home.

Qualitative sub-study - Young people ≥ 15 years old with T1D stage 1, 2 or recent stage 3 (up to 12 months), who have been involved in metabolic follow-up, will be invited to take part. Parents of a child (of any age) with T1D stage 1, 2 or recent stage 3 will also be invited. Healthcare professionals involved in delivering metabolic follow-up for children with diabetes antibodies will also be invited.

Brief summary: 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. Early diagnosis 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.

This study aims to test whether an OGTT using a finger-prick to test glucose, can be done at home. This is the 'GTT@home'. The finger-prick creates a drop of blood, which is done before and two hours after drinking a sugary drink. Investigators will also explore whether a continuous glucose monitor (CGM), which reads glucose levels through the skin could be an alternative. The investigators 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, the investigators 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. The investigators will recruit individuals who are having an OGTT as part of a research study, for clinical care, or if individuals 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.

Group 2 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 investigators to understand if the GTT@home can be used in routine care.


Eligibility criteria: Inclusion criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT
timeFrame: From enrolment to end of study visit on day 1.
measure: To assess the feasibility of using the capillary OGTT device in the home environment
timeFrame: From enrolment to end of study visit on day 1
Secondary outcomes:
measure: To determine the diagnostic accuracy of capillary blood glucose levels at diagnostic thresholds
timeFrame: From enrolment to end of study visit on day 1.
measure: Assess the acceptability of the capillary OGTT device
timeFrame: From enrolment to end of study visit on day 1.
measure: To assess the in-depth experience of participants attending study visits involving a metabolic test or assessment
timeFrame: From enrolment to end of study visit on day 1
measure: To assess the in-depth experience of parents attending study visits with their child involving a metabolic test or assessment
timeFrame: From enrolment to end of study visit on day 1.
measure: To assess the in-depth views of healthcare professionals involved in the delivery of a metabolic test or assessment of a child
timeFrame: From enrolment to end of study visit on day 1.
Other outcomes:
measure: To explore the diagnostic accuracy of CGM to define T1D stages during a standard OGTT
timeFrame: From enrolment to end of study visit at day 10.
measure: To explore CGM values at fasting and 120-minutes and its relation to OGTT measures of glucose, during a) standard liquid mixed meal, and b) free-living
timeFrame: From enrolment to end of study visit on day 10.
measure: To explore CGM values at fasting and 120-minutes and its relation to OGTT measures of glucose, during a) standard liquid mixed meal, and b) free-living
timeFrame: From enrolment to end of study visit on day 10.
measure: To explore CGM values at fasting and 120-minutes and its relation to OGTT measures of glucose, during a) standard liquid mixed meal, and b) free-living
timeFrame: From enrolment to end of study visit on day 10.
measure: To explore CGM values at fasting and 120-minutes and its relation to OGTT measures of glucose, during a) standard liquid mixed meal, and b) free-living
timeFrame: From enrolment to end of study visit on day 10.
measure: To explore CGM values at fasting and 120-minutes and its relation to OGTT measures of glucose, during a) standard liquid mixed meal, and b) free-living
timeFrame: From enrolment to end of study visit on day 10.
Locations:
city: Cardiff
country: United Kingdom
facility: Noah's Ark Childrens Hospital for Wales
city: London
country: United Kingdom
facility: Royal London Barts Health NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham Childrens Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
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