A cross-sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa (PACT-MEA): Study design and rationale.

AIM: To investigate the epidemiology and clinical management of patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (eASCVD) or high/very high ASCVD risk, defined by the 2021 European Society of Cardiology Guidelines, in seven countries in the Middle East and Africa (PACT-MEA; NCT05317845), and to assess physicians' attitudes and the basis for their decision-making in the management of these patients. MATERIALS AND METHODS: PACT-MEA is a cross-sectional, observational study undertaken in Bahrain, Egypt, Jordan, Kuwait, Qatar, South Africa and the United Arab Emirates based on a medical chart review of approximately 3700 patients with T2D in primary and secondary care settings, and a survey of approximately 400 physicians treating patients with T2D. RESULTS: The primary and secondary objectives are to determine the prevalence of eASCVD and high/very high ASCVD risk in patients with T2D. Current treatment with cardioprotective antidiabetic medication, the proportion of patients meeting the treatment criteria for reimbursement in the study countries where there is an applicable reimbursement guideline, and physician-reported factors in clinical decision-making in T2D management, will also be assessed. CONCLUSIONS: This large cross-sectional study will establish the estimated prevalence and management of eASCVD and high/very high ASCVD risk in patients with type 2 diabetes across the Middle East and Africa.

Mechanisms of action of metformin with special reference to cardiovascular protection.

Management guidelines continue to identify metformin as initial pharmacologic antidiabetic therapy of choice for people with type 2 diabetes without contraindications, despite recent randomized trials that have demonstrated significant improvements in cardiovascular outcomes with newer classes of antidiabetic therapies. The purpose of this review is to summarize the current state of knowledge of metformin's therapeutic actions on blood glucose and cardiovascular clinical evidence and to consider the mechanisms that underlie them. The effects of metformin on glycaemia occur mainly in the liver, but metformin-stimulated glucose disposal by the gut has emerged as an increasingly import site of action of metformin. Additionally, metformin induces increased secretion of GLP-1 from intestinal L-cells. Clinical cardiovascular protection with metformin is supported by three randomized outcomes trials (in newly diagnosed and late stage insulin-treated type 2 diabetes patients) and a wealth of observational data. Initial evidence suggests that cotreatment with metformin may enhance the impact of newer incretin-based therapies on cardiovascular outcomes, an important observation as metformin can be combined with any other antidiabetic agent. Multiple potential mechanisms support the concept of cardiovascular protection with metformin beyond those provided by reduced blood glucose, including weight loss, improvements in haemostatic function, reduced inflammation, and oxidative stress, and inhibition of key steps in the process of atherosclerosis. Accordingly, metformin remains well placed to support improvements in cardiovascular outcomes, from diagnosis and throughout the course of type 2 diabetes, even in this new age of improved outcomes in type 2 diabetes.

Mutations in PYCR2, Encoding Pyrroline-5-Carboxylate Reductase 2, Cause Microcephaly and Hypomyelination.

Despite recent advances in understanding the genetic bases of microcephaly, a large number of cases of microcephaly remain unexplained, suggesting that many microcephaly syndromes and associated genes have yet to be identified. Here, we report mutations in PYCR2, which encodes an enzyme in the proline biosynthesis pathway, as the cause of a unique syndrome characterized by postnatal microcephaly, hypomyelination, and reduced cerebral white-matter volume. Linkage mapping and whole-exome sequencing identified homozygous mutations (c.355C>T [p.Arg119Cys] and c.751C>T [p.Arg251Cys]) in PYCR2 in the affected individuals of two consanguineous families. A lymphoblastoid cell line from one affected individual showed a strong reduction in the amount of PYCR2. When mutant cDNAs were transfected into HEK293FT cells, both variant proteins retained normal mitochondrial localization but had lower amounts than the wild-type protein, suggesting that the variant proteins were less stable. A PYCR2-deficient HEK293FT cell line generated by genome editing with the clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9 system showed that PYCR2 loss of function led to decreased mitochondrial membrane potential and increased susceptibility to apoptosis under oxidative stress. Morpholino-based knockdown of a zebrafish PYCR2 ortholog, pycr1b, recapitulated the human microcephaly phenotype, which was rescued by wild-type human PYCR2 mRNA, but not by mutant mRNAs, further supporting the pathogenicity of the identified variants. Hypomyelination and the absence of lax, wrinkly skin distinguishes this condition from that caused by previously reported mutations in the gene encoding PYCR2's isozyme, PYCR1, suggesting a unique and indispensable role for PYCR2 in the human CNS during development.

The Rate of Insulin use and Suboptimal Glycemic Control among Egyptian Patients with T2DM: Cohort Analysis of Eighth Wave of the International Diabetes Management Practices Study (IDMPS).

AIMS: The International Diabetes Management Practices Study (IDMPS) is an international annual survey aiming to study and characterize the current standards of care for managing DM in developing countries. BACKGROUND: In Egypt, DM represents a substantial burden on the healthcare system, with an estimated 10.9 million patients, ranking it 10th amongst countries with the highest prevalence of DM. Previous studies showed that to maintain safety and achieve treatment goals among diabetic patients, optimal insulin therapy should be selected individually based on the patient's needs. We reported the proportion of Egyptian T2DM patients on insulin therapy who participated in the eighth wave of the IDMPS. METHODS: The 2018 IDMPS wave consisted of cross-sectional and longitudinal phases and aimed to evaluate the proportion of T2DM who were on insulin therapy in 13 countries from four regions. In Egypt, 17 physicians agreed to participate in the present study and were required to include at least one patient. RESULTS: A total of 180 T2DM patients were included in the cross-section phase. At the end of the ninth month of follow-up, data from 170 T2DM patients were available. A total of 39 T2DM patients (21.7%) were on insulin therapy, with a mean duration of 32.4 ± 36.6 months. More than half of the patients (n = 22; 56.4%) were on basal insulin, mainly long-acting (n = 20; 90.9%). The mean basal insulin daily dose was 0.3 ± 0.1 IU/Kg. Notably, 28.2% of the patients received insulin via vials, and 46.2% stated that they were adjusting the insulin dose by themselves. On the other hand, 60.2% of the study population was on oral antidiabetic drugs at the cross-sectional phase. Nearly 17.4% and 27% of the patients in the cross-sectional phase achieved the glycemic target per recommendations of international guidelines and the treating physicians, respectively. At the end of the longitudinal phase, the percentage of T2DM patients who achieved glycemic targets increased to 38.4% and 77.4% as per recommendations of international guidelines and the treating physicians, respectively. Overall, 38.3% of T2DM patients received diabetes education, and 28.9% were involved in an educational program provided by the physician or their clinical staff. Besides, 85.5% of T2DM patients followed their diabetes medication dosage and frequency strictly as prescribed. CONCLUSION: The proportion of insulin use in patients with T2DM aligned with the previous studies from different countries; however, it is still inadequate to achieve the targeted glycemic control. Nearly one-third of Egyptian patients received diabetes education, highlighting the need for adopting a national educational program. Nonetheless, the level of adherence among T2DM from Egypt appears to be high.

Diabetes surpasses obesity as a risk factor for low serum testosterone level.

BACKGROUND: Male obesity is one of the most associated factors with substandard testosterone levels. However, there is growing evidence linking low testosterone levels to insulin resistance and diabetic complications. We aimed to study the impact of diabetes mellitus on testosterone levels and to assess the correlation of various clinical and biochemical factors with hypogonadism. SUBJECTS AND METHODS: This case-control study was conducted on 160 adult males categorized into four equal groups (40 each); Group A: lean men with T2DM, Group B: obese with T2DM, Group C: lean with normal glycemic profile, Group D: obese with normal glycemic profile. Serum total testosterone (TT), SHBG and HbA1c have been measured. Free testosterone (cFT) and HOMA-IR were calculated. RESULTS: A significant negative correlation of serum TT and cFTwith BMI (r -0.16, p 0.04/ r -0.26, p < 0.001, respectively) and with waist circumference (WC) (r -0.23, p 0.003 and r -0.3, p < 0.001, respectively). A significant decrease in TT and cFT in the diabetes group versus the non-diabetes one (p < 0.001 for both). TT level was significantly lower in the diabetic lean group than in the non-diabetic lean (p < 0.001), and even significantly lower than in the non-diabetic obese (p < 0.001). TT level in the diabetic obese group was lower than in the non-diabetic obese (p < 0.001). The same for cFT level, lower in the diabetic lean group than in non-diabetic lean (p < 0.001) and lower in the diabetic obese than in the non-diabetic obese (p < 0.001). Concomitant significant reduction in SHBG in the diabetes group (p < 0.001). Linear regression analysis revealed that TT significantly correlated with HOMA-IR. HOMA-IR with WC, age and the duration of diabetes correlated significantly with cFT. In our model, HOMA-IR and HbA1c accounted for approximately 51.3% of TT variability (adjusted R-squared 0.513). CONCLUSIONS: The impact of T2DM on serum testosterone levels was more significant than that of obesity. Our study showed a decrease in SHBG together with cFT among the diabetes group. Hypogonadism is significantly correlated to insulin resistance and poor glycemic control, which implies another perspective on the impact of suboptimal glycemic control on the development of hypogonadism.

Impact of diabetic peripheral neuropathy on gait abnormalities in patients with type 2 diabetes mellitus.

Background: Many patients with type 2 diabetes (T2DM) suffer from diabetic peripheral neuropathy (DPN) and impaired muscle coordination. These changes may lead to walking instability, and gait abnormalities resulting in increased fall risk and lower limb amputations. The aim of this study was to assess the impact of DPN and patient footwear on the gait in patients with diabetes, in addition to Comparing the peak plantar pressure (PPP) in patients with and without DPN and assessing its association with gait abnormalities. Methodology: This is an observational case-control study. Forty Subjects with T2DM were divided into two age and sex-matched groups, 20 subjects each. Group A: subjects with DPN. Group B: subjects without DPN. All study participants were subjected to a thorough history taking, clinical examinations focusing on detailed foot examination, PPP assessment, and functional gait evaluation. Results: The results obtained in this study showed a median gait assessment score of 21 (17.0-22.5) for group A and 26 (23.5-26.0) for group B which was statistically significant (p < 0.001). There was no statistically significant difference between both groups (p > 0.05) regarding the assessment of footwear appropriateness. Comparing the PPP measurement among both studied groups, the prevalence of an elevated PPP was 80% in group A compared to 65% in group B, which was statistically non-significant, p = 0.288. Conclusions: Gait abnormalities are common among patients with T2DM even in the absence of DPN. However, the presence of DPN was the strongest independent risk factor for gait abnormalities among the studied factors.

Neutrophil-to-Lymphocyte Ratio as a Marker for Cardiac Autonomic Neuropathy in Egyptian Patients With Type 2 Diabetes: A Cross-Sectional Study.

OBJECTIVE: Cardiac autonomic neuropathy (CAN) is one of the most serious complications of diabetes. This study aimed to analyze the correlation between neutrophil-to-lymphocyte ratio (NLR) and CAN in patients with type 2 diabetes (T2D) using 24-hour Holter ECG and to assess the relationship between NLR and severity of diabetic peripheral neuropathy (DPN). SUBJECTS & METHODS:  This cross-sectional study included 90 T2D patients with DPN confirmed by nerve conduction study (NCS). A 24-hour Holter ECG was done to detect the decrease in heart rate variability (HRV). Laboratory parameters, including fasting blood glucose, creatinine, cholesterol, triglyceride, and glycosylated hemoglobin (HbA1c) levels, as well as CBC, neutrophils, lymphocytes, NLR, and platelet-to-lymphocyte ratio (PLR), were calculated accordingly. An albumin-to-creatinine ratio (ACR) test was done and the estimated glomerular filtration rate (eGFR) was calculated. Chronic kidney disease was diagnosed by the presence of albuminuria (≥30 mg/g creatinine) and/or eGFR less than 60. RESULTS: Based on the 24-hour Holter ECG, 25 patients out of 90 (27.7%) had CAN. On comparing both the CAN and non-CAN groups, the CAN group had higher HbA1C (p = 0.005), higher NLR (p = 0.014), and higher neutrophils (p = 0.10). Also, PLR was higher in the CAN group than in the non-CAN group, but this was not statistically significant (p = 0.180). Receiver operator characteristic curve analysis revealed that NLR with a cutoff of 1.7 succeeded in detecting patients with CAN. CONCLUSION: NLR can be used as an inexpensive and accessible marker to detect patients with diabetes at risk for developing CAN.

Results from a cross-specialty consensus on optimal management of patients with chronic kidney disease (CKD): from screening to complications.

BACKGROUND: Chronic kidney disease (CKD) affects around 10% of the global population and has been estimated to affect around 50% of individuals with type 2 diabetes and 50% of those with heart failure. The guideline-recommended approach is to manage with disease-modifying therapies, but real-world data suggest that prescribing rates do not reflect this in practice. OBJECTIVE: To develop a cross-specialty consensus on optimal management of the patient with CKD using a modified Delphi method. DESIGN: An international steering group of experts specialising in internal medicine, endocrinology/diabetology, nephrology and primary care medicine developed 42 statements on aspects of CKD management including identification and screening, risk factors, holistic management, guidelines, cross-specialty alignment and education. Consensus was determined by agreement using an online survey. PARTICIPANTS: The survey was distributed to cardiologists, nephrologists, endocrinologists and primary care physicians across 11 countries. MAIN OUTCOMES AND MEASURES: The threshold for consensus agreement was established a priori by the steering group at 75%. Stopping criteria were defined as a target of 25 responses from each country (N=275), and a 4-week survey period. RESULTS: 274 responses were received in December 2022, 25 responses from Argentina, Australia, Brazil, Guatemala, Mexico, Singapore, South Korea, Taiwan, Thailand, Turkey and 24 responses from Egypt. 53 responses were received from cardiologists, 52 from nephrologists, 55 from endocrinologists and 114 from primary care physicians. 37 statements attained very high agreement (≥90%) and 5 attained high agreement (≥75% and <90%). Strong alignment between roles was seen across the statements, and different levels of experience (2-5 years or 5+ years), some variation was observed between countries. CONCLUSIONS: There is a high degree of consensus regarding aspects of CKD management among healthcare professionals from 11 countries. Based on these strong levels of agreement, the steering group derived 12 key recommendations focused on diagnosis and management of CKD.

Prevalence and Co-prevalence of Comorbidities Among Patients with Type 2 Diabetes Mellitus in the MENA Region: A Systematic Review.

AIM: The management of type 2 diabetes mellitus is affected by the presence of comorbidities. This meta-analysis aimed to determine how likely it is for individuals with type 2 diabetes in the Middle East and North Africa (MENA) to be living with additional chronic health conditions. METHODS: We searched for studies published from January 2010 to December 2020 in PubMed, Ovid MEDLINE®, Cochrane CENTRAL, Scopus, and Web of Science. Studies of adults with type 2 diabetes in the MENA region were included. We performed a random-effects meta-analysis of single proportions to calculate each comorbidity's overall prevalence/co-prevalence. RESULTS: Statistically significant co-prevalence was detected at p < 0.01 for angina (pooled proportion: 0.24, 95% CI: 0.06, 0.49), cerebrovascular accident (pooled proportion: 0.16, 95% CI: 0.08, 0.26), coronary artery disease (pooled proportion: 0.25, 95% CI: 0.16, 0.35), coronary heart disease (pooled proportion: 0.05, 95% CI: 0.01, 0.12), peripheral vascular disease (pooled proportion: 0.19, 95% CI: 0.13, 0.26), hypertension (pooled proportion: 0.56, 95% CI: 0.43, 0.69), renal impairment (pooled proportion: 0.19, 95% CI: 0.10, 0.29), in addition to hyperlipidemia and overweight/obesity. CONCLUSION: There is evidence of co-prevalence of several comorbidities in patients with type 2 diabetes. This highlights the importance of enhancing communication among healthcare professionals to develop the optimal management plan for each patient.

Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Mellitus During the Period of Ramadan in Four Countries (Egypt, Jordan, Lebanon, and Turkey): A Prospective Observational Study.

AIM: This non-interventional observational study aimed to describe the clinical outcomes of patients with T2DM treated with Gla-300 during the period of Ramadan. BACKGROUND: Type 2 diabetes mellitus (T2DM) patients who decide to fast during the holy month of Ramadan face several challenges in achieving glycemic control without increasing the risk of hypoglycemia. Insulin glargine-300 (Gla-300) has well-established safety and efficacy in improving glycemic control in multiple randomized clinical trials (RCTs). However, limited evidence is available regarding its safety and effectiveness during fasting. OBJECTIVE: The objective of this study was to assess the safety and clinical outcomes of insulin glargine-300 (Gla-300) in T2DM patients before, during, and after Ramadan. METHODS: We conducted a prospective, observational, non-comparative, multicenter study on patients with T2DM currently treated with Gla-300 who planned to fast and continue on Gla-300 during Ramadan in four countries (Egypt, Jordan, Lebanon, and Turkey). The study outcomes included the change in glycemic parameters and incidence of hypoglycemia before, during, and after Ramadan. RESULTS: One hundred and forty T2DM patients were included. Nearly 61% of the included patients had a duration of diabetes of <10 years. The mean Gla-300 daily doses during the pre-Ramadan, Ramadan, and post-Ramadan periods were 22.2 ±7.4, 20.4 ±7.5, and 22.5 ±4.7 IU, respectively. The mean change values from pre-Ramadan to Ramadan and post-Ramadan were -1.7 ±6.9 IU and 0.5 ±4.7 IU, respectively, among the included patients. The mean HbA1c decreased during the study period initiating from 7.9 ±1.4% pre-Ramadan to 6.9 ±0.4% post-Ramadan. The overall HBA1c target value was 6.9 ±0.4%, while the HbA1c target was achieved by 29 patients (21.9%). The mean fasting blood glucose (FPG) showed a reduction from baseline value in the post-Ramadan period by -0.9 ±2.3mmol/L. Five patients (3.57%) had symptomatic documented hypoglycemia during Ramadan, and none was considered to have severe hypoglycemia. CONCLUSION: Our study showed that insulin Gla-300 maintained the glycemic control of T2DM patients who decided to fast during the holy month of Ramadan without increasing the risk of hypoglycemia. Regular self-monitoring of blood glucose levels during Ramadan is highly recommended to avoid possible complications.

Technical Note: Bimodal Negative Interference of Biotin in Roche IL-6 Immunoassay.

OBJECTIVE: Interleukin -6 (IL-6) is an important diagnostic test in COVID-19 patients to determine whether to initiate tocilizumab therapy or mechanical ventilation. We investigated potential interference of biotin in Roche IL-6 assay which utilizes biotinylated antibody. METHODS: We prepared three serum pools from left-over specimens which showed IL-6 values over 40 pg/mL. Then aliquots of each serum pool were further supplemented with various amounts of biotin expected in patients taking biotin supplement and then IL-6 values were measured again using Roche IL-6 assay on the Cobas e411 analyzer. RESULTS: We observed negative interference of biotin in IL-6 assay but interference was bimodal as maximum negative interference was observed with 100 ng/mL biotin but not with 1000 ng/mL. However, no interference was observed in the presence of 25 ng/mL biotin. CONCLUSIONS: Biotin showed negative interference with IL-6 assay.

Is There a Rural Penalty in Language Acquisition? Evidence From Germany's Refugee Allocation Policy.

Emerging evidence has highlighted the important role of local contexts for integration trajectories of asylum seekers and refugees. Germany's policy of randomly allocating asylum seekers across Germany may advantage some and disadvantage others in terms of opportunities for equal participation in society. This study explores the question whether asylum seekers that have been allocated to rural areas experience disadvantages in terms of language acquisition compared to those allocated to urban areas. We derive testable assumptions using a Directed Acyclic Graph (DAG) which are then tested using large-N survey data (IAB-BAMF-SOEP refugee survey). We find that living in a rural area has no negative total effect on language skills. Further the findings suggest that the "null effect" is the result of two processes which offset each other: while asylum seekers in rural areas have slightly lower access for formal, federally organized language courses, they have more regular exposure to German speakers.

A Phase II, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients Newly Diagnosed with Type 2 Diabetes Mellitus.

Background: Medicinal plants have long been used for the treatment of type 2 diabetes mellitus (T2DM). This study aimed to investigate the hypoglycemic efficacy and safety of NW Low-Glu® (contents of one capsule are 300 mg Mas Cotek + 100 mg Cinnamomum cassia L. + 250 mg Nigella sativa L. powdered extracts) in treatment-naïve, newly diagnosed T2DM patients. Methods: This was a 12-week, double-blind, double-dummy, randomized, phase 2 clinical trial. A total of 232 male and female patients aged ≥18 and ≤65 years who were newly diagnosed with T2DM and have not received any antidiabetic drugs before and were equally randomized to receive metformin (2000 mg per day), low-dose NW Low-Glu® (content of four capsules per day), or high-dose NW Low-Glu® (content of five capsules per day). Our primary objective was to measure the mean change in HbA1c between each of the experimental arms and the metformin arm. Results: There was a significant reduction in mean HbA1c at 12 weeks compared to baseline in the low-dose (0.6 (1.4)%; p=0.002) and high-dose arms (0.8 (1.7)%; p=0.004). There was also a significant reduction in 2 hr PPG at 12 weeks in the low-dose (35.4 (74.9) mg/dL, p=0.001) and high-dose arms (24.7 (100.8) mg/dL, p=0.04). Weight reduction was significantly higher with both high-dose (1.1 (-1.7) Kg; p=0.005) and low-dose arms (0.9 (-1.5) Kg; p=0.023) compared to metformin (0.8 (-1.8) Kg). No serious AEs or deaths were reported. Conclusions: After 3 months of treatment, NW Low-Glu® was noninferior to metformin in reducing HbA1c and 2 hr PPG, while leading to significantly higher weight reduction in newly diagnosed T2DM patients. It was also safe and well tolerated.

Diabetes and Ramadan: Practical guidelines 2021.

Fasting during Ramadan is one of the five pillars of Islam and is obligatory for all healthy Muslims from the age of puberty. Though individuals with some illness and serious medical conditions, including some people with diabetes, can be exempted from fasting, many will fast anyway. It is of paramount importance that people with diabetes that fast are given the appropriate guidance and receive proper care. The International Diabetes Federation (IDF) and Diabetes and Ramadan (DaR) International Alliance have come together to provide a substantial update to the previous guidelines. This update includes key information on fasting during Ramadan with type 1 diabetes, the management of diabetes in people of elderly ages and pregnant women, the effects of Ramadan on one's mental wellbeing, changes to the risk of macrovascular and microvascular complications, and areas of future research. The IDF-DAR Diabetes and Ramadan Practical Guidelines 2021 seek to improve upon the awareness, knowledge and management of diabetes during Ramadan, and to provide real-world recommendations to health professionals and the people with diabetes who choose to fast.

Registries in rheumatological and musculoskeletal conditions. Paediatric Behçet's disease: an international cohort study of 110 patients. One-year follow-up data.

OBJECTIVE: To set-up an international cohort of patients suspected with Behçet's disease (BD). The cohort is aimed at defining an algorithm for definition of the disease in children. METHODS: International experts have defined the inclusion criteria as follows: recurrent oral aphthosis (ROA) plus one of following-genital ulceration, erythema nodosum, folliculitis, pustulous/acneiform lesions, positive pathergy test, uveitis, venous/arterial thrombosis and family history of BD. Onset of disease is <16 years, disease duration is ≤3 years, future follow-up duration is ≥4 years and informed consent is obtained. The expert committee has classified the included patients into: definite paediatric BD (PED-BD), probable PED-BD and no PED-BD. Statistical analysis is performed to compare the three groups of patients. Centres document their patients into a single database. RESULTS: At January 2010, 110 patients (56 males/54 females) have been included. Mean age at first symptom: 8.1 years (median 8.2 years). At inclusion, 38% had only one symptom associated with ROA, 31% had two and 31% had three or more symptoms. A total of 106 first evaluations have been done. Seventeen patients underwent the first-year evaluation, and 36 had no new symptoms, 12 had one and 9 had two. Experts have examined 48 files and classified 30 as definite and 18 as probable. Twenty-six patients classified as definite fulfilled the International Study Group criteria. Seventeen patients classified as probable did not meet the international criteria. CONCLUSION: The expert committee has classified the majority of patients in the BD group although they presented with few symptoms independently of BD classification criteria.

Effect of Biotin on Cardiac Troponin I and High Sensitivity Cardiac Troponin I Assays on Vista 1500 and ADVIA Centaur Analyzer.

OBJECTIVE: Biotin interferes with biotinylated antibody based immunoassays. We investigated effect of biotin on conventional troponin I and two high sensitivity troponin I assays, all manufactured by Siemens. MATERIALS AND METHODS: One high sensitivity troponin I assay (TNIH-1) was run using ADVIA Centaur analyzer. The second high sensitivity troponin I assay (TNIH-2) as well as conventional troponin I assay (CTNI) were run using Dimension Vista 1500 analyzer. We analyzed 25 specimens using CTNI, TNIH-1 and TNIH-2 assays for comparison of these assays. Moreover, serum pools prepared from additional specimens containing various amounts of troponin I were further supplemented with biotin to achieve biotin concentrations between 50 and 1000 ng/mL followed by reanalysis using CTNI, TNIH-1 and TNIH-2 assays. RESULTS: Although both high sensitivity troponin I assays correlated well, there was a significant positive bias with TNIH-2. We observed no significant negative biotin interference at a level up to 250 ng/mL. Highest observed negative bias was 29.7%. CONCLUSIONS: All three troponin I assays were free from biotin interferences up to a biotin concentration of 250 ng/mL.

Glycemic indices of dates "Ramadan Symbolic Food" in patients with type 2 diabetes using continuous glucose monitoring system.

AIM: The high consumption of dates during Ramadan raises the question about its glycemic index (GI) and its effect on the glycemic control in patients with type 2 diabetes (T2DM). We aimed to determine the GI of varieties of meals containing dates in healthy subjects compared to patients with T2DM and the effect of dates on the postprandial glucose excursions using continuous glucose monitoring system (CGMS). METHOD AND RESULTS: Twenty patients with T2DM and twenty healthy subjects matched for age, sex and body weight participated. Testing was applied on separate days (on 3 occasions) with 50 g of glucose and 50 g equivalent of available carbohydrates from 9 date meals. The GI was calculated as ratios of the incremental areas under the response curves for dates in comparison to glucose. Minimed-530 g-diabetes-system-with-enlite was used for continuous glucose monitoring. There was no significant difference between the mean GI of dates between both study groups. However, there was a significant difference according to the time of peak blood glucose among varieties of meals containing dates in T2DM. CONCLUSION: Studied varieties of dates have low GI. CGMS valued beyond GI calculation to study the postprandial glucose excursions among patients with T2DM.

Individualizing Time-in-Range Goals in Management of Diabetes Mellitus and Role of Insulin: Clinical Insights From a Multinational Panel.

Diabetes mellitus is a global health concern associated with significant morbidity and mortality. Inadequate control of diabetes leads to chronic complications and higher mortality rates, which emphasizes the importance of achieving glycemic targets. Although glycated hemoglobin (HbA1c) is the gold standard for measuring glycemic control, it has several limitations. Therefore, in recent years, along with the emergence of continuous glucose monitoring (CGM) technology, glycemic control modalities have moved beyond HbA1c. They encompass modern glucometrics, such as glycemic variability (GV) and time-in-range (TIR). The key advantage of these newer metrics over HbA1c is that they allow personalized diabetes management with person-centric glycemic control. Basal insulin analogues, especially second-generation basal insulins with properties such as longer duration of action and low risk of hypoglycemia, have demonstrated clinical benefits by reducing GV and improving TIR. Therefore, for more effective and accurate diabetes management, the development of an integrated approach with second-generation basal insulin and glucometrics involving GV and TIR is the need of the hour. With this objective, a multinational group of endocrinologists and diabetologists reviewed the existing recommendations on TIR, provided their clinical insights into the individualization of TIR targets, and elucidated on the role of the second-generation basal insulin analogues in addressing TIR.

Use of SGLT2 inhibitors during Ramadan: An expert panel statement.

Fasting from dawn to sunset, during the holy month of Ramadan, constitutes one of the five main pillars in Islam and is observed by the majority of Muslims. Owing to important physiological changes, Ramadan fasting holds a crucial place in the context of diabetes management. Approximately one-fifth of the world's Muslim population resides in the Middle East and Africa (MEA) region. To discuss the challenges and management of diabetes during Ramadan fasting in the MEA region, a panel of 12 experts in the field of diabetes from across the MEA region attended two expert committee meetings held in Dubai. The key point of discussion was the safety and efficacy of the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) during Ramadan, based on outcomes of the recent clinical trials with SGLT2i. This is the first consensus recommendation on the management of diabetes with SGLT2i across the MEA region during Ramadan. The document summarizes expert views and opinions on the current management of diabetes with SGLT2i during Ramadan and aims to enhance the current knowledge and understanding on the issue of diabetes management during Ramadan. This will aid the physicians of the MEA region with appropriate decision-making for their patients during Ramadan.