CompletedNot Applicable

Improving T2DM Detection Using Spot cHbA1c Test

Hong Kong852 participantsStarted 2022-06-11

Plain-language summary

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.

Who can participate

Age range45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

What they're measuring

Proportional difference in detection of T2DM

Timeframe: 36 months

Uptake rate

Timeframe: 36 months

Trial details

NCT IDNCT06382363

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-12