Testing a home method for glucose tolerance in children with Type 1 Diabetes
A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test
This study tests a new way for kids with Type 1 Diabetes to check their blood sugar at home using a finger prick instead of a needle to see if it's easier and more comfortable.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 4 sites (Cardiff and 3 other locations) |
| Trial ID | NCT06815081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of conducting an oral glucose tolerance test (OGTT) at home using a finger-prick method instead of traditional venous blood draws. Participants will consume a sugary drink and have their glucose levels measured before and two hours after consumption. The study will also explore the use of continuous glucose monitors (CGMs) as an alternative method for glucose monitoring. The goal is to improve the comfort and accessibility of glucose testing for children at risk of or diagnosed with Type 1 Diabetes.
Who should consider this trial
Good fit: Ideal candidates include children under 18 years old who are undergoing an OGTT or have tested positive for islet autoantibodies.
Not a fit: Patients who are over 18 years old or those who cannot consume the oral glucose drink within the required time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could make glucose testing more comfortable and accessible for children, potentially leading to earlier diagnosis and management of Type 1 Diabetes.
How similar studies have performed: While the concept of home glucose monitoring is gaining traction, this specific approach using a finger-prick OGTT is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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 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 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 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
Where this trial is running
Cardiff and 3 other locations
- Noah's Ark Childrens Hospital for Wales — Cardiff, United Kingdom (Recruiting)
- Royal London Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Nottingham Childrens Hospital — Nottingham, United Kingdom (Recruiting)
- John Radcliffe Hospital — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rabbi Swaby, BMBS
- Email: rabbi.swaby@well.ox.ac.uk
- Phone: +44 1865287578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.