A Study to Determine a Capillary Alternative to the Gold Standard Oral Glucose Tolerance Test
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 8
- 主要终点
- To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •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
排除标准
- •Any known haemoglobinopathy
- •Cystic fibrosis related diabetes
- •Non-English speaker
- •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
- •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
研究组 & 干预措施
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.
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.
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.
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.
结局指标
主要结局
To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT
时间窗: From enrolment to end of study visit on day 1.
Agreement between capillary and blood glucose measures.
To assess the feasibility of using the capillary OGTT device in the home environment
时间窗: From enrolment to end of study visit on day 1
1. Proportion of successful glucose readings at 0, 120 minutes 2. Proportion of errors/missing glucose readings 3. Proportion of adverse events
次要结局
- To determine the diagnostic accuracy of capillary blood glucose levels at diagnostic thresholds(From enrolment to end of study visit on day 1.)
- Assess the acceptability of the capillary OGTT device(From enrolment to end of study visit on day 1.)
- To assess the in-depth experience of participants attending study visits involving a metabolic test or assessment(From enrolment to end of study visit on day 1)
- To assess the in-depth experience of parents attending study visits with their child involving a metabolic test or assessment(From enrolment to end of study visit on day 1.)
- To assess the in-depth views of healthcare professionals involved in the delivery of a metabolic test or assessment of a child(From enrolment to end of study visit on day 1.)