Improving T2DM Detection Among At-Risk Individuals - Effectiveness of Active Opportunistic Screening Using Spot Capillary-HbA1c Test - a Cluster Randomized Controlled Trial (DM-REACH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 852
- 试验地点
- 8
- 主要终点
- Proportional difference in detection of T2DM
研究概览
简要总结
Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients.
Design: Pragmatic cluster randomized controlled trial.
Setting: 8 public primary care clinics in Hong Kong.
Participants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months.
Intervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive.
Main outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups.
Secondary outcomes include number-needed-to-screen to detect one more T2DM case.
Data analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated.
Expected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population.
详细描述
Aim:
This pragmatic cluster randomized controlled trial aims to determine the effectiveness of active opportunistic screening using point-of-care capillary HbA1c (POC-cHbA1c) testing compared to venous HbA1c (vHbA1c) testing in improving T2DM detection among at-risk public primary care patients, to estimate the impact of such a screening strategy in the real-world setting. The ultimate goal would be to fill the current preventive care gap and reduce the burden of undiagnosed T2DM in Hong Kong.
Objectives:
Primary Objectives
- To determine the difference in the proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (conventional vHbA1c testing).
- To evaluate the uptake rate of the POC-cHbA1c test relative to the vHbA1c test among at-risk public primary care patients in Hong Kong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-diabetic patient;
- •Aged ≥ 45 years;
- •Family history of DM in a first-degree relative;
- •History of Gestational DM;
- •Hypertension (i.e. Systolic Blood Pressure (BP) ≥140mmHg, Diastolic BP ≥90mmHg or on therapy for hypertension);
- •History of pre-diabetes (i.e. impaired fasting glucose with fasting glucose concentration between 5.6-6.9 mmol/L, impaired glucose tolerance with 2-hour post challenge plasma glucose concentration between 7.8-11.0 mmol/L or HbA1c between 5.6-6.4%);
- •Hyperlipidemia (i.e. total cholesterol ≥ 5.2 mmol/L, triglycerides ≥ 1.7 mmol/L or on therapy);
- •Obesity (i.e. for Chinese subjects, body mass index (BMI) ≥ 25 kg/m2).
排除标准
- •Known history of T2DM or on hypoglycaemic treatment;
- •Received T2DM screening within 12-months;
- •Women who are pregnant or breast-feeding at recruitment;
- •Active thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment;
- •History of blood donation or blood transfusion within 3 months prior to recruitment;
- •Patients who are taking systemic steroid therapy or iron supplement at recruitment.
结局指标
主要结局
Proportional difference in detection of T2DM
时间窗: 36 months
The difference in proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (vHbA1c testing)
Uptake rate
时间窗: 36 months
The uptake rate of POC-cHbA1c testing and vHbA1c testing among consented participants
次要结局
- Proportion of high-risk HbA1c concentration(36 months)
- Difference in uptake rate of OGTT(36 months)
- Proportion of patients who refuse to join the study(36 months)
- Number-needed-to-screen to detect one more T2DM case(36 months)
研究者
Dr. Linda Chan
Clinical Assistant Professor
The University of Hong Kong