Category: Statistics

J Clin Tuberc Other Mycobact Dis. 2021 Jun 22;24:100253. doi: 10.1016/j.jctube.2021.100253. eCollection 2021 Aug.

ABSTRACT

Tuberculosis (TB), which is caused by Mycobacterium tuberculosis (MTB), is a serious infectious disease with high infection and mortality rates and is a public health problem around the world. According to the World Health Organization (WHO) report, one-third of the world’s population is latently infected with MTB, and 5 to 10% of those with latent TB infection (LTBI) have the potential to develop active TB once in their lifetime. Therefore, TB management for promptly distinguishing LTBI from active TB and for proper treatment is important. LTBI is currently diagnosed using the tuberculin skin test (TST) and interferon gamma (IFN-γ) release assay (IGRA). However, this test is substantially limited by its inability to distinguish active TB from LTBI. It is necessary to discover indicators that can be used for effective TB management and to develop diagnostic methods. In the present study, we used IGRA and complete blood count (CBC) analysis for discrimination of active TB, LTBI, and healthy control groups. The results showed that the number of WBC was significantly increased in the group with active TB (p < 0.0100) and level of hemoglobin (Hb) was significantly decreased (p < 0.0010) in the CBC than those of the healthy control and LTBI groups. In the WBC differential count, the number of neutrophils and monocytes were increased (p < 0.0010) in active TB group, where as those of lymphocytes were significantly decreased (p < 0.0100) in active TB group compared healthy control group. Results verified that the levels of total WBC, Hb, neutrophils, lymphocytes and monocytes were statistically significant (p < 0.0500) and the AUC was approximately 0.8613. In addition, receiver operating characteristic (ROC) curve analysis was performed to confirm the clinical usefulness between active TB and healthy control groups. In conclusion, based on these data demonstrated that the usefulness of these potential indicators for differential diagnosis, according to the result can be provided for effective diagnosis and treatment by comparing the expression patterns of the markers in the whole blood of the active TB, LTBI, and healthy control groups. Furthermore, this study needs to investigate a larger number of clinical specimens later to develop biomarkers according to the state of infection with MTB such as LTBI and active TB, as well as after treatment.

PMID:34278005 | PMC:PMC8262775 | DOI:10.1016/j.jctube.2021.100253

Endocrinol Diabetes Metab. 2021 May 29;4(3):e00263. doi: 10.1002/edm2.263. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Type 1 diabetes mellitus (T1DM) is associated with earlier onset of cardiovascular disease. Recent evidence has found hyperglycaemia appears to play a greater role in this association among T1DM compared to T2DM. This study investigates the relationship between glucose and QTc (a key cardiovascular measure) using data from continuous electrocardiogram (ECG) and glucose monitors.

METHODS: Seventeen adults with T1DM were recruited at a clinical facility in Ireland. A continuous glucose monitoring system was fitted to each participant that measured glucose every 5 min for 7 days. The participants simultaneously wore a vest with sensors to measure 12-lead ECG data every 10 min for 7 days. Area under the glucose curve (AUC), proportion of time spent in hypoglycaemia and hyperglycaemia, and mean daily absolute deviation of glucose were calculated. Mixed effects ANOVA and functional regression models were fitted to the data to investigate the aggregate and time-dependent association between glucose and QTc.

RESULTS: All participants were male with an average age of 52.5 (SD 3.8) years. Those with neuropathy had a significantly higher mean QTc compared to their counterparts. Mean QTc was significantly longer during hyperglycaemia. There was a significant positive association between QTc and time spent in hyperglycaemia. A negative association was found between QTc and time spent in hypoglycaemia. A functional model suggested a positive relationship between glucose and QTc at several times during the 7-day follow-up.

CONCLUSION: This study used sensor technology to investigate, with high granularity, the temporal relationship between glucose and ECG data over one week. QTc was found to be longer on average during hyperglycaemia.

PMID:34277986 | PMC:PMC8279601 | DOI:10.1002/edm2.263

Endocrinol Diabetes Metab. 2021 May 7;4(3):e00258. doi: 10.1002/edm2.258. eCollection 2021 Jul.

ABSTRACT

AIMS: This study examined the effect of experimentally-induced hypoglycaemia on measures of myocardial blood flow and myocardial injury in adults with, and without, type 1 diabetes.

METHODS: In a prospective, randomised, open-label, blinded, endpoint cross-over study, 17 young adults with type 1 diabetes with no cardiovascular risk factors, and 10 healthy non-diabetic volunteers, underwent hyperinsulinaemic-euglycaemic (blood glucose 4.5-5.5 mmol/L) and hypoglycaemic (2.2-2.5 mmol/L) clamps. Myocardial blood flow was assessed using transthoracic echocardiography Doppler coronary flow reserve (CFR) and myocardial injury using plasma high-sensitivity cardiac troponin I (hs-cTnI) concentration.

RESULTS: During hypoglycaemia, coronary flow reserve trended non-significantly lower in those with type 1 diabetes than in the non-diabetic participants (3.54 ± 0.47 vs. 3.89 ± 0.89). A generalised linear mixed-model analysis examined diabetes status and euglycaemia or hypoglycaemia as factors affecting CFR. No statistically significant difference in CFR was observed for diabetes status (p = .23) or between euglycaemia and hypoglycaemia (p = .31). No changes in hs-cTnI occurred during hypoglycaemia or in the recovery period (p = .86).

CONCLUSIONS: A small change in CFR was not statistically significant in this study, implying hypoglycaemia may require more than coronary vasomotor dysfunction to cause harm. Further larger studies are required to investigate this putative problem.

PMID:34277982 | PMC:PMC8279606 | DOI:10.1002/edm2.258

Endocrinol Diabetes Metab. 2021 May 15;4(3):e00259. doi: 10.1002/edm2.259. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Cardiovascular (CV) effects of once-weekly subcutaneous (s.c.) semaglutide 0.5 and 1 mg and dulaglutide 1.5 mg are reported in their respective placebo-controlled cardiovascular outcome trials (CVOTs), SUSTAIN 6 and REWIND. There is no head-to-head CVOT comparing these treatments and heterogeneity between their CVOTs renders conventional indirect comparison inappropriate. Therefore, a matching-adjusted indirect comparison (MAIC) was performed to compare the effects of s.c. semaglutide and dulaglutide on major adverse cardiovascular events (MACE) in patients with and without established cardiovascular disease (CVD).

METHODS: Individual patient data from SUSTAIN 6 were matched with aggregate data from REWIND, using a propensity score method to balance baseline effect-modifying patient characteristics. Hazard ratios (HRs) for three-point (3P) MACE (CV death, non-fatal myocardial infarction, non-fatal stroke), anchored via placebo, were then indirectly compared between balanced populations. Sensitivity analyses were performed to test the robustness of the main analysis.

RESULTS: After matching, included effect modifiers were balanced. In the main analysis, s.c. semaglutide was associated with a statistically significant 35% reduction in 3P MACE versus placebo (HR, 0.65 [95% confidence interval [CI]; 0.48, 0.87]) and nonsignificantly greater reduction (26%) versus dulaglutide (HR, 0.74 [95% CI; 0.54, 1.01]). Results were supported by all sensitivity analyses.

CONCLUSIONS: This study demonstrated a statistically significant lower risk of 3P MACE for s.c. semaglutide versus placebo, in a population with lower prevalence of pre-existing CVD than that in the pre-specified primary analysis in SUSTAIN 6. Reduction in 3P MACE with s.c. semaglutide was greater than with dulaglutide, although not statistically significant.

PMID:34277983 | PMC:PMC8279621 | DOI:10.1002/edm2.259

Endocrinol Diabetes Metab. 2021 May 14;4(3):e00260. doi: 10.1002/edm2.260. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Anaemia is common but often overlooked in diabetes mellitus (DM) patients. There is also no official nationwide survey registry that estimated the prevalence of anaemia in DM patients in Ethiopia. Therefore, the main aim of this study is to determine the countrywide pooled prevalence and associated factors of anaemia in DM patients.

METHODS: This systematic review and meta-analysis were conducted as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. STATA 11 software was used for all statistical analysis. Random effects model was used to estimate the pooled prevalence of anaemia and associated factors at a 95% confidence interval (CI) with its respective odds ratio (OR). Subgroup analysis and egger test were used to determine heterogeneity and publication bias, respectively.

RESULTS: Nine articles were included in this systematic review and meta-analysis with a total of 2889 DM patients. The pooled prevalence of anaemia among DM patients in Ethiopia was 22.11% (95% CI: 15.83-28.39) I ² = 94.8%. The prevalence of anaemia in type I and type II DM patients was (16.78% [95% CI: 11.53-22.04]) and (31.12% [95% CI; 9.66-52.58]), respectively. The prevalence of anaemia was higher among male (36.72% [95% CI: 22.58-50.87] I ² = 97.6%) than female (27.51% [95% CI: 16.12-38.90] I ² = 96.3%). Moreover, the odds of anaemia were higher among patients with age ˃ 60 (OR = 2.98; 95% CI: 1.83, 4.87), low estimated glomerular filtration rate (eGFR) (OR = 8.59; 95% CI: 4.76, 15.57), and duration of illness ≥5 years (OR = 2.66; 95%: 1.38, 5.13).

CONCLUSIONS: The result of this review implies that anaemia is a moderate public health problem among DM patients in Ethiopia. Older age, poor glycemic control, low eGFR and longer duration of illness were found to be the contributing factors for the development of anaemia in DM patients. Therefore, by considering the negative impact of anaemia, it is important to include anaemia screening into routine assessment of DM-related complications targeting patients with older age, poor glycemic control, low eGFR, and longer duration of illness to reduce the magnitude of the problem.

PMID:34277984 | PMC:PMC8279623 | DOI:10.1002/edm2.260

Endocrinol Diabetes Metab. 2021 May 26;4(3):e00255. doi: 10.1002/edm2.255. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Late-night salivary cortisol (LSaC) and 24-h urinary free cortisol measurement, and overnight 1-mg dexamethasone suppression test (1 mg-DST) are the first-line screening tests recommended for Cushing’s syndrome. Through elevations in the level of cortisol-binding globulin, oral contraceptive agents lead to increases in the total plasma cortisol concentration, yielding false-positive 1 mg-DST results.

OBJECTIVE: To compare the accuracy of the overnight 1-mg DST and two-day low-dose DST (2d-DST) in female volunteers taking combined oestrogen-progestin oral contraceptives (COCs).

METHODS: This prospective study enrolled 30 healthy participants. Their plasma cortisol response levels were compared after the 1-mg DST and 2d-DST and classified into three categories: normal (≤50 nmol/L), doubtful (51-138 nmol/L) and abnormal (>138 nmol/L). Salivary cortisol was also measured at late night and after the DSTs.

RESULTS: Following the 1-mg DST and 2d-DST, the plasma cortisol concentrations decreased to a median of 69 nmol/L and 37 nmol/L, respectively (p < 0.001). A statistically significant higher proportion of unclear or abnormal results were observed after the 1-mg DST (63%) than after the 2d-DST (27%) (p = 0.004). None of the values were >138 nmol/L after the 2d-DST, while 11% of them were abnormal after the 1-mg DST (p = 0.25). No LSaC value was abnormal.

CONCLUSION: Our results suggest that, when late-night salivary cortisol is not available, the 2d-DST could be a better screening option than the 1-mg DST for women taking oral contraceptive agents who are reluctant to stop them. This finding requires confirmation in those with a suspicion of hypercortisolism.

PMID:34277979 | PMC:PMC8279609 | DOI:10.1002/edm2.255

Endocrinol Diabetes Metab. 2021 May 6;4(3):e00257. doi: 10.1002/edm2.257. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: To assess the effects of alcohol and illicit drug use in young adults (age 18-35) with type 1 diabetes (T1D) on flash glucose monitor sensor glucose (SG) readings.

METHODS: Twenty young adults with T1D were enrolled from a tertiary referral hospital outpatient department in Melbourne, Australia for a 6-week prospective observational study using flash glucose monitoring (FGM). Glucometrics comparing substance using days (SUEDs) to those without substance use (non-SUEDS) were analysed. The primary outcomes were the difference in mean SG values, its standard deviation and minutes/24-h period out of range (SG <3.9 mmol/L or >10.0 mmol/L) between matched SUEDs vs non-SUEDs. An interaction model with the primary effect of HbA1c on SG values was also performed.

RESULTS: There were no differences in the primary outcome measures between SUEDS and non-SUEDs. However, there were differences in the regression coefficients for HbA1c and glucometrics between non-SUEDs and SUEDs for mean SG, time out of range and time with SG > 10 mmol/L. This difference was also identified between non-SUEDS and days of ≥40 g alcohol for mean SG.

CONCLUSIONS: While there was no difference between glucometrics for SUEDs and non-SUEDs on primary outcomes, HbA1C was found to be a less reliable predictor of glucose patterns in the 24-h period following substance use than control days. Young adults with T1D need to monitor and respond to their glucose levels following substance use and engage in harm minimisation practices irrespective of baseline glucose control.

PMID:34277981 | PMC:PMC8279614 | DOI:10.1002/edm2.257

Endocrinol Diabetes Metab. 2021 May 14;4(3):e00252. doi: 10.1002/edm2.252. eCollection 2021 Jul.

ABSTRACT

OBJECTIVE: Diabetes technology is available and its efficacy and safety have been demonstrated; however, there is little evidence as to how this technology is being utilized and its effectiveness in vulnerable populations. This study evaluated differences in outcomes for young adults in the United States (U.S.) from lower socioeconomic (SES) backgrounds with type 1 diabetes (T1D) managed on continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) or fixed-dose insulin (FDI).

RESEARCH DESIGN METHODS AND PARTICIPANTS: Utilizing the Optum® de-identified Electronic Health Record data set between 2008 and 2018 to perform a retrospective, cohort study, we identified 805 subjects with T1D aged 18-30 years with Medicaid. We evaluated median difference in HbA1c between CSII and MDI/FDI users for 24 months. Predictors of diabetic ketoacidosis (DKA)-associated hospitalizations by CSII use were evaluated using logistic regression.

RESULTS: CSII users showed statistically significant lower median HbA1c values at 24 months of follow-up compared to individuals on MDI/FDI. Non-white individuals were at lower odds of receiving treatment with CSII. Subjects on CSII were not more likely to be hospitalized for DKA compared to subjects treated with MDI/FDI. Older subjects were at lower odds of being hospitalized for DKA. Males and subjects followed by Endocrinologists were at higher odds of being hospitalized for DKA.

CONCLUSIONS: Young adults with T1D from lower SES backgrounds show improved glycaemic control when in CSII compared to MDI/FDI without increases in hospitalizations for DKA.

PMID:34277976 | PMC:PMC8279595 | DOI:10.1002/edm2.252

Endocrinol Diabetes Metab. 2021 May 3;4(3):e00251. doi: 10.1002/edm2.251. eCollection 2021 Jul.

ABSTRACT

OBJECTIVES: To investigate whether changes in complete blood count (CBC) in islet autoantibody positive children with increased genetic risk for type 1 diabetes are associated with oral glucose tolerance tests (OGTT) and HbA1c over time.

METHODS: The Environmental Determinants of Diabetes in the Young (TEDDY) study follows children with increased risk for type 1 diabetes in the United States, Germany, Sweden and Finland. In the current study, 89 Swedish TEDDY children (median age 8.8 years) positive for one or multiple islet autoantibodies were followed up to 5 (median 2.3) years for CBC, OGTT and HbA1c. A statistical mixed effect model was used to investigate the association between CBC and OGTT or HbA1c.

RESULTS: HbA1c over time increased by the number of autoantibodies (p < .001). Reduction in mean corpuscular haemoglobin (MCH) and mean cell volume (MCV) was both associated with an increase in HbA1c (p < .001). A reduction in red blood cell (RBC) counts (p = .003), haemoglobin (p = .002) and haematocrit (p = .006) levels was associated with increased fasting glucose. Increased red blood cells, haemoglobin, haematocrit and MCH but decreased levels of red blood cell distribution widths (RDW) were all associated with increased fasting insulin.

CONCLUSIONS: The decrease in RBC indices with increasing HbA1c and the decrease in RBC and its parameters with increasing fasting glucose in seroconverted children may reflect an insidious deterioration in glucose metabolism associated with islet beta-cell autoimmunity.

PMID:34277975 | PMC:PMC8279594 | DOI:10.1002/edm2.251

Endocrinol Diabetes Metab. 2021 Feb 8;4(3):e00231. doi: 10.1002/edm2.231. eCollection 2021 Jul.

ABSTRACT

INTRODUCTION: Longitudinal data on progression, complications, and management of type 2 diabetes mellitus (T2DM) across India are scarce. LANDMARC (CTRI/2017/05/008452), the first pan-India, longitudinal, prospective, observational study, aims to understand the management and real-world outcomes of T2DM over 3 years.

METHODS: Adults (≥25 to ≤60 years old at T2DM diagnosis; diabetes duration ≥2 years at enrollment; controlled/uncontrolled on ≥2 anti-diabetic agents) were enrolled. Baseline characteristics were analyzed using descriptive statistics.

RESULTS: Of the 6279 recruited participants, 6236 were eligible for baseline assessment (56.6% [n/N = 3528/6236] men; mean ± SD age: 52.1 ± 9.2 years, diabetes duration: 8.6 ± 5.6 years). mean ± SD HbA1c, fasting plasma glucose, and postprandial glucose values were 64 ± 17 mmol/mol (8.1 ± 1.6%), 142.8 ± 50.4 mg/dl, and 205.7 ± 72.3 mg/dl, respectively. Only 25.1% (n/N = 1122/6236) participants had controlled glycemia (HbA1c < 53 mmol/mol, <7%). Macrovascular and microvascular complications were prevalent in 2.3% (n/N = 145/6236) and 14.5% (n/N = 902/6236) participants, respectively. Among those with complications, non-fatal myocardial infarction (n/N = 74/145, 51.0%) and neuropathy (n/N = 737/902, 81.7%) were the most reported macrovascular and microvascular complication, respectively. Hypertension (n/N = 2566/3281, 78.2%) and dyslipidemia (n/N = 1635/3281, 49.8%) were the most reported cardiovascular risks. Majority (74.5%; n/N = 4643/6236) were taking oral anti-diabetic drugs (OADs) only, while 24.4% (n/N = 1522/6236) participants were taking OADs+insulin. Biguanides (n/N = 5796/6236, 92.9%) and sulfonylureas (n/N = 4757/6236, 76.3%) were the most reported OADs. Basal (n/N = 837/6236, 13.4%) and premix (n/N = 684/6236, 11.0%) insulins were the most reported insulins.

CONCLUSIONS: Baseline data from LANDMARC help understand the clinical/medical profile of study participants and underscore the extent of suboptimal glycemic control and prevalence of associated complications in a vast majority of Indians with T2DM.

PMID:34277959 | PMC:PMC8279635 | DOI:10.1002/edm2.231