Capillary OGTT Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorUniversity of Oxford

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Any known haemoglobinopathy

Cystic fibrosis related diabetes

Non-English speaker

Any known haemoglobinopathy

Trial population

Cohort 1 - Children \< 18 years of age. 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.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. Cohort 3 - Children \< 18 years of age, who are identified as having pre-T2D. 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

135 Participants
are grouped into 5 trial groups
Group A: Cohort 1 (Simultaneous venous and capillary OGTT)
Group B: Cohort 2 (Capillary OGTT at home)
Group C: Cohort 1 (CGM sub-study)
Group D: Qualitative sub-study
Group E: Cohort 3 (Pre-clinical type 2 diabetes)

Trial outcomes

Primary outcomes

1

To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT

Agreement between capillary and blood glucose measures.

Time frame
From enrolment to end of study visit on day 1.
2

To assess the feasibility of using the capillary OGTT device in the home environment

1. Proportion of successful glucose readings at 0, 120 minutes 2. Proportion of errors/missing glucose readings 3. Proportion of adverse events

Time frame
From enrolment to end of study visit on day 1

Secondary outcomes

1

To determine the diagnostic accuracy of capillary blood glucose levels at diagnostic thresholds

Sensitivity and specificity of capillary glucose at 5.6mmol/L, 7.0mmol/L (fasting), 11.1 mmol/L (60 min), and 7.8mmol/L and 11.1mmol/L (120 min).

Time frame
From enrolment to end of study visit on day 1.
2

Assess the acceptability of the capillary OGTT device

Acceptability by questionnaire (Parent +/- child), using either a standard 7-point Likert scale (1 - not painful at all, 7 - very painful) for participants aged 16 and above, or Wong Baker Faces pain scale (0 - no hurt, 10 - hurts worst) for participants aged under 16.

Time frame
From enrolment to end of study visit on day 1.
3

To assess the in-depth experience of participants attending study visits involving a metabolic test or assessment

Analysis of qualitative interviews from young people.

Time frame
From enrolment to end of study visit on day 1
4

To assess the in-depth experience of parents attending study visits with their child involving a metabolic test or assessment

Analysis of qualitative interviews from parents.

Time frame
From enrolment to end of study visit on day 1.

Other outcomes

1

To explore the diagnostic accuracy of CGM to define T1D stages during a standard OGTT

Sensitivity/specificity of sensor glucose levels at diagnostic thresholds.

Time frame
From enrolment to end of study visit at day 10.
2

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

Sensor glucose variability (coefficient of variation (%CV)), during home meals, across different T1D stages.

Time frame
From enrolment to end of study visit on day 10.
3

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

Sensor glucose variability (mean amplitude of glycaemic excursion (MAGE) mmol/L)), during home meals, across different T1D stages.

Time frame
From enrolment to end of study visit on day 10.
4

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

Sensor glucose variability (low blood glucose index (LBGI)), during home meals, across different T1D stages.

Time frame
From enrolment to end of study visit on day 10.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

University of Bristol

Collaborator

Yale University

Collaborator

Oxford University Hospitals NHS Trust

Collaborator

Nottingham University Hospitals NHS Trust

Collaborator

Cardiff and Vale University Health Board

Collaborator

Royal London Hospital, Barts Health NHS Trust

Collaborator