Improving T2DM Detection Using Spot cHbA1c Test

NCT06382363 | Completed

• 1 other identifier: UW21-363
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Diabetes Mellitus; Pre-diabetes

Keywords

Hemoglobin-A1c; Screening; Point-of-Care Testing

Outcome Measures

Primary Outcomes (2)

• Proportional difference in detection of T2DM

  The difference in proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (vHbA1c testing)

  36 months

• Uptake rate

  The uptake rate of POC-cHbA1c testing and vHbA1c testing among consented participants

  36 months

Secondary Outcomes (4)

• Proportion of high-risk HbA1c concentration

  36 months

• Difference in uptake rate of OGTT

  36 months

• Number-needed-to-screen to detect one more T2DM case

  36 months

• Proportion of patients who refuse to join the study

  36 months

Study Arms (2)

Control

NO INTERVENTION

Subjects in the control group will be offered a free venous HbA1c test. Consistent with current practice at GOPCs, the venous sampling will be scheduled on a separate clinic visit at a set time within 1-2 weeks of recruitment. Test results will be available within one week. The subject will be informed via phone call regarding his/her DM risk, and if his/her HbA1c≥5.6%, he/she will be scheduled for a confirmatory OGTT within 2-4 weeks, ideally at the same clinic.

Intervention

EXPERIMENTAL

Subjects in the intervention group will be offered a free POC-cHbA1c test to screen for hyperglycemia. The test will be performed on-site (i.e. during the same clinic visit of recruitment). Test results will be available within 10 minutes and the subject will be immediately informed of his/her DM risk, and for those with HbA1c≥5.6%, a confirmatory OGTT will be arranged on-site, scheduled within 2-4 weeks and ideally at the same clinic.

Procedure: POC-cHbA1c testing

Interventions

POC-cHbA1c testing PROCEDURE

The point-of-care HbA1c instrument employed in this study will be the Cobas b 101 (Roche Diagnostics, Switzerland) diagnostic test system. A capillary blood sample will be obtained by dermal puncture of a fingertip using a disposable lancet and resorbed in the specially marked area of the Cobas b 101 test disc. The disc will be inserted in the autoanalyzer. Test results displayed in both % and mmol/l will be available within 10 minutes.

Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (8)

Aberdeen Jockey Club General Out-Patient Clinic

Hong Kong, Hong Kong

Location

Kwun Tong Community Health Centre

Hong Kong, Hong Kong

Location

Lek Yuen General Out-Patient Clinic

Hong Kong, Hong Kong

Location

Li Po Chun General Out-Patient Clinic

Hong Kong, Hong Kong

Location

Ma On Shan Family Medicine Centre

Hong Kong, Hong Kong

Location

Sai Ying Pun Jockey Club General Out-patient Clinic

Hong Kong, Hong Kong

Location

Tseung Kwan O (Po Ning Road) General Out-patient Clinic

Hong Kong, Hong Kong

Location

Yau Ma Tei Jockey Club Specialist Clinic

Hong Kong, Hong Kong

Location

Related Publications (1)

• Chan L, Yu EYT, Wan EYF, Wong SYS, Chao DVK, Ko WWK, Chen CXR, Chan PPL, Bilney EVM, Lee ES, Ng WL, Lam CLK. Improving type 2 diabetes detection among at-risk individuals - comparing the effectiveness of active opportunistic screening using spot capillary-HbA1c testing and venous HbA1c testing: a cluster randomized controlled trial. BMC Med. 2025 Mar 31;23(1):190. doi: 10.1186/s12916-025-04007-z.

  PMID: 40165254 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Linda Chan

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: June 11, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

HK (8)