Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382363
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-04-19
Brief Title:
Improving T2DM Detection Using Spot cHbA1c Test
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Improving T2DM Detection Among At-Risk Individuals - Effectiveness of Active Opportunistic Screening Using Spot Capillary-HbA1c Test - a Cluster Randomized Controlled Trial DM-REACH
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DM-REACH
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 n4 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 ie HbA1c56 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
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 n4 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 ie HbA1c56 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
Detailed Description:
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
1 To determine the difference in the proportion of T2DM detected between the intervention group POC-cHbA1c testing and control group conventional vHbA1c testing
2 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
Secondary Objectives
1 To determine the proportion of subjects with high-risk HbA1c concentration ie HbA1c56 among the studied at-risk group
2 To compare the difference in uptake rate of confirmatory OGTT test between intervention and control groups
3 To calculate the number-needed-to-screen to detect one more case with T2DM using POC-cHbA1c testing compared to vHbA1c testing
4 The proportion of patients who refuse to join the study among all eligible subjects
Hypotheses
1 A greater proportion of T2DM patients will be detected in the intervention group POC-cHbA1c testing than in the control group vHbA1c
2 Uptake rate of POC-cHbA1c testing will be higher than vHbA1c testing among the studied population
3 Uptake rate of confirmatory OGTT among screened positive patients ie HbA1c 56 in the intervention group will be higher than for those in the control group
Data analysis
Descriptive statistics will be used to summarize patients characteristics in the intervention POC-cHbA1c testing group and control vHbA1c testing group The difference in characteristics between groups will be assessed by independent t-tests for continuous variables or Chi-square tests for categorical variables The uptake rate of POC-cHbA1c testing and vHbA1c testing will be reported The difference in the proportion of T2DM detected between groups will also be compared using a Chi-squared test The number-needed-to-screen to identify one additional patient with DM will be calculated To take cluster effect into account a mixed effect logistic model will be used to evaluate the effect of the intervention on the uptake rate by treating the clinic as a random effect and adjusting for the patients characteristics All statistical analyses will be performed using Stata All significance tests will be two-tailed and findings with a p-value less than 005 will be considered statistically significant
Potential problem
Missing data will be handled by using multiple imputation The chained equation method will be used to impute each missing value five times adjusted for all baseline covariates and outcomes The same analysis method will be adopted for each of the five imputed datasets and the results will be pooled using Rubins rule Complete case analysis will also be conducted to confirm the results by multiple imputation analysis
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
1 To determine the difference in the proportion of T2DM detected between the intervention group POC-cHbA1c testing and control group conventional vHbA1c testing
2 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
Secondary Objectives
1 To determine the proportion of subjects with high-risk HbA1c concentration ie HbA1c56 among the studied at-risk group
2 To compare the difference in uptake rate of confirmatory OGTT test between intervention and control groups
3 To calculate the number-needed-to-screen to detect one more case with T2DM using POC-cHbA1c testing compared to vHbA1c testing
4 The proportion of patients who refuse to join the study among all eligible subjects
Hypotheses
1 A greater proportion of T2DM patients will be detected in the intervention group POC-cHbA1c testing than in the control group vHbA1c
2 Uptake rate of POC-cHbA1c testing will be higher than vHbA1c testing among the studied population
3 Uptake rate of confirmatory OGTT among screened positive patients ie HbA1c 56 in the intervention group will be higher than for those in the control group
Data analysis
Descriptive statistics will be used to summarize patients characteristics in the intervention POC-cHbA1c testing group and control vHbA1c testing group The difference in characteristics between groups will be assessed by independent t-tests for continuous variables or Chi-square tests for categorical variables The uptake rate of POC-cHbA1c testing and vHbA1c testing will be reported The difference in the proportion of T2DM detected between groups will also be compared using a Chi-squared test The number-needed-to-screen to identify one additional patient with DM will be calculated To take cluster effect into account a mixed effect logistic model will be used to evaluate the effect of the intervention on the uptake rate by treating the clinic as a random effect and adjusting for the patients characteristics All statistical analyses will be performed using Stata All significance tests will be two-tailed and findings with a p-value less than 005 will be considered statistically significant
Potential problem
Missing data will be handled by using multiple imputation The chained equation method will be used to impute each missing value five times adjusted for all baseline covariates and outcomes The same analysis method will be adopted for each of the five imputed datasets and the results will be pooled using Rubins rule Complete case analysis will also be conducted to confirm the results by multiple imputation analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None