Study Results
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Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-02-29
2025-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Qualitative sub-study
To 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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
Yes
Sponsors
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University of Bristol
OTHER
Yale University
OTHER
Oxford University Hospitals NHS Trust
OTHER
Nottingham University Hospitals NHS Trust
OTHER
Cardiff and Vale University Health Board
OTHER_GOV
Royal London Hospital, Barts Health NHS Trust
UNKNOWN
University of Oxford
OTHER
Responsible Party
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Locations
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Noah's Ark Childrens Hospital for Wales
Cardiff, , United Kingdom
Royal London Barts Health NHS Trust
London, , United Kingdom
Nottingham Childrens Hospital
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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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.
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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.
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.
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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.
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.
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.
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.
Bediaga NG, Li-Wai-Suen CSN, Haller MJ, Gitelman SE, Evans-Molina C, Gottlieb PA, Hippich M, Ziegler AG, Lernmark A, DiMeglio LA, Wherrett DK, Colman PG, Harrison LC, Wentworth JM. Simplifying prediction of disease progression in pre-symptomatic type 1 diabetes using a single blood sample. Diabetologia. 2021 Nov;64(11):2432-2444. doi: 10.1007/s00125-021-05523-2. Epub 2021 Aug 2.
Weiss A, Zapardiel-Gonzalo J, Voss F, Jolink M, Stock J, Haupt F, Kick K, Welzhofer T, Heublein A, Winkler C, Achenbach P, Ziegler AG, Bonifacio E; Fr1da-study group. Progression likelihood score identifies substages of presymptomatic type 1 diabetes in childhood public health screening. Diabetologia. 2022 Dec;65(12):2121-2131. doi: 10.1007/s00125-022-05780-9. Epub 2022 Aug 27.
Driscoll KA, Tamura R, Johnson SB, Gesualdo P, Clasen J, Smith L, Jacobsen L, Elding Larsson H, Haller MJ; TEDDY Study Group. Adherence to oral glucose tolerance testing in children in stage 1 of type 1 diabetes: The TEDDY study. Pediatr Diabetes. 2021 Mar;22(2):360-368. doi: 10.1111/pedi.13149. Epub 2021 Jan 6.
Sims EK, Geyer S, Johnson SB, Libman I, Jacobsen LM, Boulware D, Rafkin LE, Matheson D, Atkinson MA, Rodriguez H, Spall M, Elding Larsson H, Wherrett DK, Greenbaum CJ, Krischer J, DiMeglio LA; Type 1 Diabetes TrialNet Study Group. Who Is Enrolling? The Path to Monitoring in Type 1 Diabetes TrialNet's Pathway to Prevention. Diabetes Care. 2019 Dec;42(12):2228-2236. doi: 10.2337/dc19-0593. Epub 2019 Sep 26.
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Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ; Type 1 Diabetes TrialNet Study Group. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613. doi: 10.1056/NEJMoa1902226. Epub 2019 Jun 9.
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Besser REJ, Bell KJ, Couper JJ, Ziegler AG, Wherrett DK, Knip M, Speake C, Casteels K, Driscoll KA, Jacobsen L, Craig ME, Haller MJ. ISPAD Clinical Practice Consensus Guidelines 2022: Stages of type 1 diabetes in children and adolescents. Pediatr Diabetes. 2022 Dec;23(8):1175-1187. doi: 10.1111/pedi.13410. Epub 2022 Sep 30. No abstract available.
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Related Links
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Published protocol
Other Identifiers
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PID16905
Identifier Type: -
Identifier Source: org_study_id
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