Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Accuracy of GTT@Home
研究概览
简要总结
This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D) (carriers of at least one islet autoantibody) or with new onset Stage 3 T1D within 100 days from the diagnosis.
详细描述
Investigators will conduct an observational longitudinal study that will include one home-based unsupervised GTT@Home test, a standard OGTT at a research facility and a supervised GTT@Home. Additionally, participants will have up to10-day blinded-CGM data collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight ≥43 kg
- •Presence of at least one islet autoantibody and/or≥ diagnosis of clinical T1D within 100 days.
- •Documentation of the presence at least 1 islet autoantibody
- •If participants meet ADA diagnostic criteria for Stage 3 type 1 diabetes, they will be eligible if the enrollment occurs within 100 days from the diagnosis and are at least 12 years old.
- •Participants must be in good general health without other acute (e.g. infectious disease) febrile or chronic illnesses (e.g. uncontrolled asthma requiring high steroid doses, chronic arthritis) that in the judgment of the investigator could jeopardize participant safety or interfere with the study,
- •Ability to give consent/assent
- •Able to understand written and spoken English
排除标准
- •Currently pregnant or becomes pregnant during the study
- •Participants on sodium glucose cotransporter inhibitors (SGLTi).
- •Donated blood in the past 8 weeks.
研究组 & 干预措施
Recently diagnosed with diabetes
Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis
干预措施: GTT@Home (Diagnostic Test)
Single islet autoantibody
Participants with single islet autoantibody
干预措施: GTT@Home (Diagnostic Test)
2 or more positive islet antibodies
Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia
干预措施: GTT@Home (Diagnostic Test)
结局指标
主要结局
Accuracy of GTT@Home
时间窗: up to 4 weeks from enrollment
The accuracy will be quantified by correlation between GTT@Home and OGTT glucose measures as well as by the mean absolute relative difference between the two measures.
次要结局
未报告次要终点