Oral Glucose Tolerance Test at Home With Continuous Glucose Monitoring vs Standard Clinic-based Testing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
研究概览
简要总结
This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Participants with prediabetes will undergo both home-based and clinic-based OGTTs, with glucose levels measured via CGM and venous plasma glucose. The primary outcome is the correlation between CGM-based glucose values and standard OGTT results. Secondary outcomes include diagnostic agreement, metabolic hormone associations, and feasibility of home-based testing as a diagnostic tool for dysglycemia.
详细描述
This study aims to evaluate the feasibility, accuracy, and diagnostic utility of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT.
Study Design Type: Randomized, crossover study Participants: 70 adults with prediabetes Intervention: Each participant will complete both a home-based OGTT with CGM and a clinic-based OGTT with venous plasma glucose measurement.
Primary Objective To evaluate the diagnostic accuracy and agreement of the 2-hour CGM glucose value from a home OGTT compared with the 2-hour venous plasma glucose value from a clinic OGTT.
Secondary Objectives To evaluate the lag-adjusted CGM timing and reproducibility across 2 home OGTTs.
Methods Participants will be randomized into two groups: one starting with a clinic-based OGTT, the other with a home-based OGTT, followed by a crossover period. CGM will continuously monitor glucose responses, and standard venous plasma glucose measurements will serve as the reference method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetes indicated by any of the following values:
- •- Fasting venous plasma glucose ≥5.6 but <7.0 mmol/L
- •- HbA1c ≥39 but <48 mmol/mol
- •Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity
- •Ability to read and respond to online instructions and questionnaires in Swedish.
排除标准
- •T2D indicated by ≥2 of the following values, measured at different occasions or through different analyses:
- •- Fasting venous plasma glucose ≥7.0 mmol/L
- •- Non-fasting venous plasma glucose value ≥11.1 mmol/L
- •- HbA1c ≥48 mmol/mol
- •Previous bariatric surgery e.g., gastric by-pass or gastric sleeve surgery
- •Body mass index <20 kg/m2
- •Body weight <43 kg
- •Current pregnancy
- •Need of regular use of GLP-1 receptor agonists, SGLT-2 inhibitors, acetaminophen or ascorbic acid supplements during the study period
- •Fear of needle sticks
- •Shift work during the study period
- •Involvement in the study design, data collection, analysis, or participant recruitment.
研究组 & 干预措施
OGTT at the clinic then at home
OGTT at the clinic then at home
干预措施: OGTT at the clinic (Diagnostic Test)
OGTT at home then at the clinic
OGTT at home then at the clinic
干预措施: OGTT at home using CGM (Diagnostic Test)
OGTT at home then at the clinic
OGTT at home then at the clinic
干预措施: OGTT at the clinic (Diagnostic Test)
OGTT at the clinic then at home
OGTT at the clinic then at home
干预措施: OGTT at home using CGM (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
时间窗: 2 hours after the start of the OGTT
The diagnostic accuracy of the 2-hour interstitial glucose measured by CGM during a home-based oral glucose tolerance test (OGTT) will be evaluated against the 2-hour venous plasma glucose obtained during a clinic-based OGTT (reference standard) for the classification of normoglycemia, prediabetes, and diabetes. The 2-hour CGM value will be defined as the first CGM recording at or within 5 minutes after the 2-hour timepoint (i.e., between 120 and 125 minutes). Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's kappa coefficient for overall classification agreement, each reported with 95% CIs. Systematic bias and limits of agreement between the two continuous glucose measurements will further be assessed using Bland-Altman analysis.
次要结局
- Diagnostic accuracy of the lag-adjusted 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT(0-20 minutes after the 2-hour timepoint of the OGTT (lag-adjusted))
- Reproducibility of home-based OGTT using CGM(2 hours and 2 hours plus 0-20 minutes lag-adjustment after the start of the OGTT)
研究者
Peder af Geijerstam
Principal Investigator
Linkoeping University