Scholarlink

Background <p>Prolonged instability in blood glucose, indicated by glycated haemoglobin (HbA1c), is a key factor in the development of microvascular complications.</p> Objective <p>The study aimed to develop and validate the disease progression model of HbA1c&#xa0;among Malaysian type 2 diabetes mellitus (T2DM) patients, with and without diabetic nephropathy.</p> Methods <p>Retrospective data were obtained from medical records of 251 T2DM patients over a seven-year period from a Malaysian tertiary care hospital via purposive sampling method. NONMEM software was used for the model development. Baseline HbA1c status, representing the natural disease progression (DP) was determined, without covariate effects. Linear and non-linear DP models were evaluated. The best base model was further developed with the inclusion of covariates, using forward addition (<i>p</i> &lt; 0.05) and backward elimination (<i>p</i> &lt; 0.01). Final model selection was based on the lowest objective function value (OFV), visual predictive check (VPC) with 1000 simulations, relative standard error (RSE), and scientific plausibility. External validation was performed with a dataset of 109 T2DM patients.</p> Results <p>Baseline HbA1c was 10.1%, with a gradual decline by 0.0074% per year. Every unit rise in fasting blood glucose (FBS) above 7.4&#xa0;mmol/L was associated with a 0.06% incline in HbA1c/year, while each year of age above the median age of 47.5&#xa0;years was associated with an increase in HbA1c by 0.03%/year. Body mass index (BMI) has the highest impact, raising HbA1C by 0.12%/year. The between-subject variability (BSV) was 108.2% for the rate of disease progression while 14.8% for baseline disease status.</p> Conclusions <p>HbA1c progression was significantly influenced by FBS, age, and BMI, highlighting the need for tailored treatment strategies in the management of T2DM and its complications.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Pharmacometrics disease progression modelling of glycated haemoglobin (HbA1c) among type 2 diabetes mellitus patients, with and without diabetic nephropathy

  • 期刊论文

  • 发表日期：

    2025年9月12日

查看全文
  • Sohail Aziz,
  • Sabariah Noor Harun,
  • Siti Maisharah Sheikh Ghadzi

摘要

Background

Prolonged instability in blood glucose, indicated by glycated haemoglobin (HbA1c), is a key factor in the development of microvascular complications.

Objective

The study aimed to develop and validate the disease progression model of HbA1c among Malaysian type 2 diabetes mellitus (T2DM) patients, with and without diabetic nephropathy.

Methods

Retrospective data were obtained from medical records of 251 T2DM patients over a seven-year period from a Malaysian tertiary care hospital via purposive sampling method. NONMEM software was used for the model development. Baseline HbA1c status, representing the natural disease progression (DP) was determined, without covariate effects. Linear and non-linear DP models were evaluated. The best base model was further developed with the inclusion of covariates, using forward addition (p < 0.05) and backward elimination (p < 0.01). Final model selection was based on the lowest objective function value (OFV), visual predictive check (VPC) with 1000 simulations, relative standard error (RSE), and scientific plausibility. External validation was performed with a dataset of 109 T2DM patients.

Results

Baseline HbA1c was 10.1%, with a gradual decline by 0.0074% per year. Every unit rise in fasting blood glucose (FBS) above 7.4 mmol/L was associated with a 0.06% incline in HbA1c/year, while each year of age above the median age of 47.5 years was associated with an increase in HbA1c by 0.03%/year. Body mass index (BMI) has the highest impact, raising HbA1C by 0.12%/year. The between-subject variability (BSV) was 108.2% for the rate of disease progression while 14.8% for baseline disease status.

Conclusions

HbA1c progression was significantly influenced by FBS, age, and BMI, highlighting the need for tailored treatment strategies in the management of T2DM and its complications.