Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial.

Background: Nutrition education and counselling are considered a cornerstone for the management of type 2 diabetes (T2D). However, there is limited research related to the management of T2D through dietary approach, particularly in low-income and middle-income countries (LMICs) like Nepal. This study assessed the effectiveness of a dietician-led dietary intervention in reducing glycated haemoglobin (HbA1c) levels among people with T2D. Methods: An open-label, two-armed, hospital-based, randomised controlled trial was conducted at Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Participants were randomly assigned to either dietician-led dietary intervention group (n = 78) or usual care control group (n = 78). People with type 2 diabetes with HbA1c >6.5% and aged 24-64 years were included in the study. The primary outcome was a change in HbA1c level over six months, and secondary outcomes included changes in biochemical and clinical parameters, Problem Areas in Diabetes (PAID) score, diabetic knowledge, dietary adherence, and macronutrient intake level. Data were analysed using an intention-to-treat approach. This trial is registered with ClinicalTrials.gov, NCT04267367. Findings: Between August 15, 2021 and February 25, 2022, 156 people with type 2 diabetes were recruited for the study, of which 136 participants completed the trial. At six months of follow-up, compared to baseline values, the mean HbA1c (%) level decreased in the intervention group by 0.48 (95% CI: -0.80 to -0.16), while it increased in the control group by 0.22 (95% CI: -0.21 to 0.66). In an adjusted model, the reduction in HbA1c (%) levels for the intervention was 0.61 (95% CI: -1.04 to -0.17; p = 0.006). In addition, fasting blood glucose was decreased by 18.96 mg/dL (95% CI: -36.12 to -1.81; p = 0.031) after the intervention. The intervention resulted in the reduction of BMI, waist and hip circumference, PAID score, dietary adherence, and macronutrient intake in the intervention group compared to the control group. Interpretation: The dietician-led intervention improved glycaemic control, improved macronutrient intake, and clinical outcomes among people with type 2 diabetes. The dietician-led intervention may be considered for diabetes management in LMICs. Funding: The research was funded by the University Grants Commission (UGC), Nepal.

Assessment of four in vitro phenotypic biofilm detection methods in relation to antimicrobial resistance in aerobic clinical bacterial isolates.

INTRODUCTION: The lack of standardized methods for detecting biofilms continues to pose a challenge to microbiological diagnostics since biofilm-mediated infections induce persistent and recurrent infections in humans that often defy treatment with common antibiotics. This study aimed to evaluate diagnostic parameters of four in vitro phenotypic biofilm detection assays in relation to antimicrobial resistance in aerobic clinical bacterial isolates. METHODS: In this cross-sectional study, bacterial strains from clinical samples were isolated and identified following the standard microbiological guidelines. The antibiotic resistance profile was assessed through the Kirby-Bauer disc diffusion method. Biofilm formation was detected by gold standard tissue culture plate method (TCPM), tube method (TM), Congo red agar (CRA), and modified Congo red agar (MCRA). Statistical analyses were performed using SPSS version 17.0, with a significant association considered at p<0.05. RESULT: Among the total isolates (n = 226), TCPM detected 140 (61.95%) biofilm producers, with CoNS (9/9) (p<0.001) as the predominant biofilm former. When compared to TCPM, TM (n = 119) (p<0.001) showed 90.8% sensitivity and 70.1% specificity, CRA (n = 88) (p = 0.123) showed 68.2% sensitivity and 42% specificity, and MCRA (n = 86) (p = 0.442) showed 65.1% sensitivity and 40% specificity. Juxtaposed to CRA, colonies formed on MCRA developed more intense black pigmentation from 24 to 96 hours. There were 77 multi-drug-resistant (MDR)-biofilm formers and 39 extensively drug-resistant (XDR)-biofilm formers, with 100% resistance to ampicillin and ceftazidime, respectively. CONCLUSION: It is suggested that TM be used for biofilm detection, after TCPM. Unlike MCRA, black pigmentation in colonies formed on CRA declined with time. MDR- and XDR-biofilm formers were frequent among the clinical isolates.

Trimethoprim-sulfamethoxazole Versus Azithromycin for the Treatment of Undifferentiated Febrile Illness in Nepal: A Double-blind, Randomized, Placebo-controlled Trial.

BACKGROUND: Azithromycin and trimethoprim-sulfamethoxazole (SXT) are widely used to treat undifferentiated febrile illness (UFI). We hypothesized that azithromycin is superior to SXT for UFI treatment, but the drugs are noninferior to each other for culture-confirmed enteric fever treatment. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of azithromycin (20 mg/kg/day) or SXT (trimethoprim 10 mg/kg/day plus sulfamethoxazole 50 mg/kg/day) orally for 7 days for UFI treatment in Nepal. We enrolled patients >2 years and <65 years of age presenting to 2 Kathmandu hospitals with temperature ≥38.0°C for ≥4 days without localizing signs. The primary endpoint was fever clearance time (FCT); secondary endpoints were treatment failure and adverse events. RESULTS: From June 2016 to May 2019, we randomized 326 participants (163 in each arm); 87 (26.7%) had blood culture-confirmed enteric fever. In all participants, the median FCT was 2.7 days (95% confidence interval [CI], 2.6-3.3 days) in the SXT arm and 2.1 days (95% CI, 1.6-3.2 days) in the azithromycin arm (hazard ratio [HR], 1.25 [95% CI, .99-1.58]; P = .059). The HR of treatment failures by 28 days between azithromycin and SXT was 0.62 (95% CI, .37-1.05; P = .073). Planned subgroup analysis showed that azithromycin resulted in faster FCT in those with sterile blood cultures and fewer relapses in culture-confirmed enteric fever. Nausea, vomiting, constipation, and headache were more common in the SXT arm. CONCLUSIONS: Despite similar FCT and treatment failure in the 2 arms, significantly fewer complications and relapses make azithromycin a better choice for empirical treatment of UFI in Nepal. CLINICAL TRIALS REGISTRATION: NCT02773407.

BE-SMART (Basal Early Strategies to Maximize HbA1c Reduction with Oral Therapy): Expert Opinion.

The past three decades have seen a quadruple rise in the number of people affected by diabetes mellitus worldwide, with the disease being the ninth major cause of mortality. Type 2 diabetes mellitus (T2DM) often remains undiagnosed for several years due to its asymptomatic nature during the initial stages. In India, 70% of diagnosed diabetes cases remain uncontrolled. Current guidelines endorse the initiation of insulin early in the course of the disease, specifically in patients with HbA1c > 10%, as the use of oral agents alone is unlikely to achieve glycemic targets. Early insulin initiation and optimization of glycemic control using insulin titration algorithms and patient empowerment can facilitate the effective management of uncontrolled diabetes. Early glucose control has sustained benefits in people with diabetes. However, insulin initiation, dose adjustment, and the need to repeatedly assess blood glucose levels are often perplexing for both physicians and patients, and there are misconceptions and concerns regarding its use. Hence, an early transition to insulin and ideal intensification of treatment may aid in delaying the onset of diabetes complications. This opinion statement was formulated by an expert panel on the basis of existing guidelines, clinical experience, and economic and cultural contexts. The statement stresses the timely and appropriate use of basal insulin in T2DM. It focuses on the seven vital Ts-treatment initiation, timing of administration, transportation and storage, technique of administration, targets for titration, tablets, and tools for monitoring.Funding: Sanofi.