METHODS: This is a cross-sectional study within the baseline data from the impact evaluation of the Enhanced Primary Health Care (EnPHC) intervention on 40 public clinics in Malaysia. Patients aged 30 and above, diagnosed with T2D, had a clinic visit for T2D between 01 Nov 2016 and 30 April 2017 and had at least one HbA1c, SBP and LDL-C measurement within 1 year from the date of visit were included for analysis. Multilevel linear regression adjusting for patient and clinic characteristics was used to quantify variation at the clinic and patient levels for each outcome.
RESULTS: Variation in intermediate clinical outcomes in T2D lies predominantly (93% and above) at the patient level. The strongest predictors for poor disease control in T2D were the proxy measures for disease severity including duration of diabetes, presence of microvascular complications, being on insulin therapy and number of antihypertensives. Among the three outcomes, HbA1c and LDL-C results provide greatest opportunity for improvement.
CONCLUSION: Clinic variation in HbA1c, SBP and LDL-C accounts for a small percentage from total variation. Findings from this study suggest that standardised interventions need to be applied across all clinics, with a focus on customizing therapy based on individual patient characteristics.
METHODS: ARISE is a ~26-wk-long, prospective, non-interventional, single-arm study of patients with type 2 diabetes (T2D) initiating IDegAsp treatment. Approximately 1112 patients with T2D aged ≥18 years previously on anti-hyperglycaemic drugs except IDegAsp will be enroled across six countries from 15 Aug 2019 to 12 Nov 2020. IDegAsp treatment will be initiated at the physicians' discretion and as per the local label. Key exclusion criteria include previous participation, or previous IDegAsp treatment. The primary and secondary endpoints are change in HbA1c from baseline (wk 0) to study end (wk 26-36) and the proportion of patients achieving the target HbA1c level of <7% at the study end, respectively. A mixed model for repeated measurements will analyse the primary endpoint.
CONCLUSION: Between-country differences in the prescription patterns of glucose-lowering agents in people with T2D warrant examination of their clinical use in different geographical settings. The ARISE study is designed to assess the clinical use of IDegAsp from real world in six different countries. Findings from the ARISE study will supplement those of previous randomised controlled studies by establishing real-world evidence of IDegAsp use in the participating countries.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04042441. Registered 02 August 2014, https://clinicaltrials.gov/ct2/show/NCT04042441.
RESEARCH DESIGN AND METHODS: Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins.
RESULTS: Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI -0.01, 0.04]; adjusted risk difference -0.003 [95% CI -0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (-0.032 [95% CI -0.064, 0.000]) and after (-0.036 [95% CI -0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA1c during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference -0.181 [95% CI -0.300, -0.062]) and the second trimester (6.1% vs. 6.3% [43 vs. 45 mmol/mol]; -0.139 [95% CI -0.232, -0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference -0.030 [95% CI -0.058, -0.002]), preeclampsia (6.4% vs. 10.0%; -0.036 [95% CI -0.064, -0.007]), and stillbirth (0.4% vs. 1.8%; -0.013 [95% CI -0.024, -0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment.
CONCLUSIONS: Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.
MATERIALS AND METHODS: A single-centered, prospective observational study was conducted among 46 patients with type 2 diabetes mellitus and concomitant chronic kidney disease stage 2 and 3 who were on three different types of basal insulin (Glargine U-100, Levemir, and Insulatard), fasted in Ramadan 2022. All variables were listed as median (IQR). Hypoglycaemia events and glycemic variability obtained from Freestyle Libre continuous glucose monitoring were compared between insulin groups. Changes in glycated haemoglobin, fasting plasma glucose, renal profile, body weight, body mass index, and waist circumference pre and post-Ramadan were evaluated.
RESULTS: The glycaemic variability was found highest in Insulatard with a median (IQR) of 37.2(33)% versus Levemir 34.4(32.4)% versus Glargine U-100 36.8(30.6)%, p = NS. Levemir had reported the lowest median time of below range of 2.5(13)% followed by Glargine 4(25)% and Insulatard 5(8)%; p = NS. The findings of this study indicated that glycated haemoglobin, fasting plasma glucose, renal profile, body weight, body mass index, and waist circumference did not alter statistically between the three groups post-Ramadan. Individually, Insulatard showed a significant reduction in weight and waist circumference (0.9kg, p = 0.026; 0.44 cm, p = 0.008) while Levemir showed a reduction in waist circumference (0.75cm, p = 0.019).
CONCLUSION: This study revealed that Insulatard, Levemir, and Glargine demonstrated similar levels of safety and efficacy among those with diabetic kidney disease who observed fasting during Ramadan.
METHODS: A retrospective cohort of type 2 diabetes (T2D) patients between 2010 and 2019 in Ramathibodi Hospital was created. Complete case analyses were used. Three GVs using HbA1c and fasting plasma glucose (FPG) were considered including CV, SD, and time-varying. Cox proportional hazard regression, ML random survival forest (RSF) and left-truncated, right-censored (LTRC) survival forest were compared in two different data formats (baseline and longitudinal datasets). Adjusted hazard ratios with 95% confidence intervals were used to report the association between three GVs and diabetes complications. Model performance was evaluated using C-statistics along with feature importance in ML models.
RESULTS: A total of 40,662 T2D patients, mostly female (61.7%), with mean age of 57.2 years were included. After adjusting for covariates, HbA1c-CV, HbA1c-SD, FPG-CV and FPG-SD were all associated with CVD, DR and CKD, whereas time-varying HbA1c and FPG were associated with DR and CKD only. The CPH and RSF for DR (C-indices: 0.748-0.758 and 0.774-0.787) and CKD models (C-indices: 0.734-0.750 and 0.724-0.740) had modestly better performance than CVD models (C-indices: 0.703-0.730 and 0.698-0.727). Based on RSF feature importance, FPG GV measures ranked higher than HbA1c GV, and both GVs were the most important for DR prediction. Both traditional and ML models had similar performance.
CONCLUSIONS: We found that GVs based on HbA1c and FPG had comparable performance. Thus, FPG GV may be used as a potential monitoring parameter when HbA1c is unavailable or less accessible.
MATERIALS AND METHODS: A retrospective cohort study was conducted involving 592 prediabetic adults from 28 health clinics in Terengganu between January 2019 and June 2023. Participants were selected based on oral glucose tolerance test (OGTT) results indicating prediabetes. Sociodemographic, medical background, and clinical data, including body mass index (BMI), blood pressure, fasting blood sugar (FBS), and lipid profiles, were extracted from medical records. Glycaemic outcomes were classified into three categories: reversion to normoglyacemia, persistent prediabetes, or progression to DM, based on glycated haemoglobin (HbA1c) levels taken within two years of follow-up. Ordinal logistic regression analysis was used to identify the significant predictors influencing these outcomes.
RESULTS: Analysis showed age, BMI, underlying dyslipidaemia, FBS, and triglyceride levels as significant predictors of glycaemic progression. Specifically, each additional year of age and each one-unit increase in BMI raised the likelihood of progression to DM by 3% and 6%, respectively. Participants with dyslipidaemia were noted to have a 67% higher risk of worsening glycaemic status, while increases in FBS and triglyceride levels were associated with 65% and 34% greater odds of diabetic progression, respectively.
CONCLUSION: This study identifies critical predictors of glycaemic outcomes in prediabetic adults, emphasizing the role of age, BMI, dyslipidaemia, FBS, and triglycerides in the disease progression. These findings support the development of targeted interventions that address these risk factors to curb diabetes progression in high-risk individuals, contributing valuable insights into diabetes prevention strategies tailored for Malaysian populations.
METHODS AND RESULTS: We used 2010 to 2018 ambulatory visit data from children aged 2 to 12 years within CAPRICORN (Chicago Area Patient-Centered Outcomes Research Network), an electronic health record network in Chicago. This study included 87 549 children who attended 197 559 well-child encounters. Across all encounters, children were 51.5% male and mean (SD) age 6.4 (3.3) years. For each child who attended a well-child visit and met age and/or risk-based criteria, receipt of body mass index, blood pressure, lipids, and/or hemoglobin A1c or fasting blood glucose measurements were assessed. We used generalized estimating equations to calculate proportion adherence for each metric overall and stratified by age, sex, race and ethnicity, and insurance status. Universal age-based screening prevalence (95% CI) per 100 eligible visits was 77.1 (76.8-77.3) for body mass index, 33.4 (33.1-33.7) for blood pressure, and 9.6 (9.3-9.9) for lipids. Risk-based screening prevalence (95% CI) per 100 eligible visits was 13.9 (12.2-15.9) for blood pressure, 6.9 (6.4-7.5) for lipids, and 13.3 (12.6-14.1) for blood glucose.
CONCLUSIONS: Early screening of cardiovascular health risk factors could lead to earlier interventions, which could alter cardiovascular health trajectories across the lifetime. Low-to-moderate levels of adherence to universal age-based and risk-based cardiovascular health screening highlight the gap between recommendations and clinical practice, emphasizing the need to understand and address barriers to screening in pediatric populations.