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Type 1 Diabetes (T1D)CapOGTTNCT06815081

Capillary OGTT Study

An observational study of Type 1 Diabetes (T1D) and Type 2 Diabetes, run by University of Oxford at 4 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 17 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes (T1D), Type 2 Diabetes
How many people
135 participants
Where
4 sitesUnited Kingdom
Study dates
29 Feb 2024to 31 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study 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.

Who may be able to join

  • 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
Show all 25Show fewer
  • 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

Who cannot join

  • Cohort 1
  • Any known haemoglobinopathy
  • Cystic fibrosis related diabetes
  • Non-English speaker
  • Cohort 2
  • Any known haemoglobinopathy
Show all 20Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rabbi Swaby, BMBS contact

+44 1865287578

rabbi.swaby@well.ox.ac.uk

Claire Scudder contact

+44 (0)7765 932065

capogtt@ndm.ox.ac.uk

United Kingdom4 sites, 4 recruiting

  • Noah's Ark Childrens Hospital for Wales

    Cardiff, CF14 4XW

    Anna de Carteret, +44 2921847816, Anna.deCarteret@wales.nhs.uk

    Ambika Shetty

    Recruiting

  • Royal London Barts Health NHS Trust

    London, E1 1FR

    Kevin Samuels, +44 203 594 1551 ext. 1455, kevin.samuels@nhs.net

    Ruben Willemsen

    Recruiting

  • Nottingham Childrens Hospital

    Nottingham, NG7 2UH

    Binta Barra, +44 115 9249924 ext. 80680, binta.barra@nhs.net

    Rachel Williams

    Recruiting

  • John Radcliffe Hospital

    Oxford, OX3 9DU

    Rabbi Swaby, BMBS, +44 1865 231729, rabbi.swaby@well.ox.ac.uk

    Rachel Besser, PhD, rachel.besser@ouh.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read more

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.

Keywords
Capillary, Glucose, Oral glucose tolerance test, Method Comparison, Feasibility, Acceptability, Type 1 diabetes, Monitoring, Follow-up, Screening, Type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06815081
Study groupRoleWhat they receive
Cohort 1 (Simultaneous venous and capillary OGTT)To assess the ability of the capillary OGTT to be a reliable and acceptable alternative to the standard venous OGTT in children, investigators will aim to capture a spread of glucose values across the whole diagnostic range. This will be undertaken in clinical and research settings, led by either a healthcare professional or research nurse. Children undergoing a standard venous OGTT will be invited to complete a capillary OGTT. Both venous and capillary samples will be collected at the same time. Investigators will also invite children with stage 3 (clinical) T1D to capture glucose levels in the hyperglycaemic range. These participants will receive a smaller glucose dose for their OGTT (1g/kg, max dose 75g), to attenuate their glucose rise and allow the comparison of clinically meaningful glucose values. Participants will be asked to complete a questionnaire following the OGTT to obtain information about acceptability.
Cohort 2 (Capillary OGTT at home)In this cohort (running concurrently alongside cohort 1) investigators aim to assess the acceptability and feasibility of a capillary OGTT device in children and young people with early-stage (known stage 1 or 2) T1D. This will take place in the home of participants, with written and video instructions provided. Children known to be positive for ≥ 2 IAb will be invited to take part and will be sent a capillary OGTT test kit which will include a glucose drink, lancets and instructions (written and video). They will fast overnight (from midnight the night before, for a minimum of 8 hours) before completing a 2-hour OGTT using the test kit and instructions provided. Glucose samples will be collected at 0 and 120 minutes. Participants will be asked to complete a questionnaire following completion of the OGTT, to obtain information about acceptability.
Cohort 1 (CGM sub-study)In this sub-study investigators aim to explore the ability of CGM to be an alternative to the standard venous OGTT. A subgroup of participants in cohort 1 with known T1D (stage 1, 2 or 3) will be invited to wear a CGM sensor for up to 10 days, which will be worn during their OGTT, at home during a standard mixed meal and free-living. Whilst wearing the CGM at home, participants will be asked to consume a liquid mixed meal (Ensure Plus, 6ml/kg maximum 360ml, preceded by an 8-hour fast) and complete a 3-day food diary, by photographing the largest meal of the day to allow estimation of carbohydrate intake (not the same day as the OGTT or liquid mixed meal). Participants will then be asked to complete a questionnaire to obtain information about acceptability.
Qualitative sub-studyTo understand the factors that contribute to uptake of monitoring offered to children at risk of type 1 diabetes, investigators will invite a small number of young people (aged 15-18) and parents to take part in a semi-structured interview. Investigators will also invite healthcare professionals involved in delivering metabolic testing as part of follow-up to take part in semi-structured interviews, to understand their views on the factors which may influence future implementation into clinical care.
Cohort 3 (Pre-clinical type 2 diabetes)In this cohort (running concurrently alongside cohort 1) we aim to assess the acceptability and feasibility of a capillary OGTT device in children with pre-clinical T2D at home. This will take place in the home of participants, with written or video instructions provided. For cohort 3, children with raised BMI (≥91st centile) and any marker of insulin resistance: HbA1c 39-47mmol, or known impaired fasting glucose (5.6 - 6.9 mmol/L), or impaired glucose tolerance (7.8 - 11.0 mmol/L), will be invited to take part. They will fast overnight (from midnight the night before, for a minimum of 8 hours) before completing a 2-hour OGTT using the test kit and instructions provided. Participants will be asked to complete a questionnaire following completion of the OGTT, to obtain information about acceptability.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: From enrolment to end of study visit on day 1

Secondary outcomes (5)

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From enrolment to end of study visit on day 1.

  5. To assess the in-depth views of healthcare professionals involved in the delivery of a metabolic test or assessment of a child

    Analysis of qualitative interviews from healthcare professionals.

    Measured: From enrolment to end of study visit on day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2025
  2. Study start29 Feb 2024
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06815081
Sponsor's protocol ID
PID16905
Acronym
CapOGTT
Status last verified
Mar 2026
First submitted
27 Jan 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Dates of birth will not be shared, but ages (possibly grouped) will be provided.

Publications

  • 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):526-534. doi: 10.2337/dc22-1297.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 30972793

  • Bruns DE, Metzger BE, Sacks DB. Diagnosis of Gestational Diabetes Mellitus Will Be Flawed until We Can Measure Glucose. Clin Chem. 2020 Feb 1;66(2):265-267. doi: 10.1093/clinchem/hvz027. No abstract available.

    PubMed 32040567

  • Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem. 2010 Mar;47(Pt 2):101-10. doi: 10.1258/acb.2009.009222. Epub 2009 Dec 1.

    PubMed 19952034

  • Bogdanet D, O'Shea P, Lyons C, Shafat A, Dunne F. The Oral Glucose Tolerance Test-Is It Time for a Change?-A Literature Review with an Emphasis on Pregnancy. J Clin Med. 2020 Oct 27;9(11):3451. doi: 10.3390/jcm9113451.

    PubMed 33121014

  • Sosenko JM, Skyler JS, DiMeglio LA, Beam CA, Krischer JP, Greenbaum CJ, Boulware D, Rafkin LE, Matheson D, Herold KC, Mahon J, Palmer JP; Type 1 Diabetes TrialNet Study Group; Diabetes Prevention Trial-Type 1 Study Group. A new approach for diagnosing type 1 diabetes in autoantibody-positive individuals based on prediction and natural history. Diabetes Care. 2015 Feb;38(2):271-6. doi: 10.2337/dc14-1813. Epub 2014 Dec 17.

    PubMed 25519451

  • Simmons KM, Sosenko JM, Warnock M, Geyer S, Ismail HM, Elding Larsson H, Steck AK. One-Hour Oral Glucose Tolerance Tests for the Prediction and Diagnostic Surveillance of Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Nov 1;105(11):e4094-101. doi: 10.1210/clinem/dgaa592.

    PubMed 32844178

  • Sosenko JM, Skyler JS, Palmer JP; Diabetes Type 1 TrialNet and Diabetes Prevention Trial-Type 1 Study Groups. The development, validation, and utility of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS). Curr Diab Rep. 2015 Aug;15(8):49. doi: 10.1007/s11892-015-0626-1.

    PubMed 26077017

  • Sosenko JM, Skyler JS, Mahon J, Krischer JP, Greenbaum CJ, Rafkin LE, Beam CA, Boulware DC, Matheson D, Cuthbertson D, Herold KC, Eisenbarth G, Palmer JP; Type 1 Diabetes TrialNet and Diabetes Prevention Trial-Type 1 Study Groups. Use of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS) for improving the accuracy of the risk classification of type 1 diabetes. Diabetes Care. 2014 Apr;37(4):979-84. doi: 10.2337/dc13-2359. Epub 2014 Feb 18.

    PubMed 24550217

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes (T1D) and Type 2 Diabetes, run by University of Oxford at 4 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rabbi Swaby, BMBS (+44 1865287578, rabbi.swaby@well.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT (time frame: From enrolment to end of study visit on day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06815081, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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