Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial.

Importance: Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes. Objective: To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia. Design, Setting, and Participants: This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021. Interventions: A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care. Main Outcomes and Measures: The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight. Results: A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome. Conclusions and Relevance: This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals. Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.

Clinical practice recommendations for the detection and management of hyperglycemia in pregnancy from South Asia, Africa and Mexico during COVID-19 pandemic.

The human coronavirus disease 2019 (COVID-19) pandemic has affected overall healthcare delivery, including prenatal, antenatal and postnatal care. Hyperglycemia in pregnancy (HIP) is the most common medical condition encountered during pregnancy. There is little guidance for primary care physicians for providing delivery of optimal perinatal care while minimizing the risk of COVID-19 infection in pregnant women. This review aims to describe pragmatic modifications in the screening, detection and management of HIP during the COVID- 19 pandemic. In this review, articles published up to June 2021 were searched on multiple databases, including PubMed, Medline, EMBASE and ScienceDirect. Direct online searches were conducted to identify national and international guidelines. Search criteria included terms to extract articles describing HIP with and/or without COVID-19 between 1st March 2020 and 15th June 2021. Fasting plasma glucose, glycosylated hemoglobin (HbA1c) and random plasma glucose could be alternative screening strategies for gestational diabetes mellitus screening (at 24-28 weeks of gestation), instead of the traditional 2 h oral glucose tolerance test. The use of telemedicine for the management of HIP is recommended. Hospital visits should be scheduled to coincide with obstetric and ultrasound visits. COVID-19 infected pregnant women with HIP need enhanced maternal and fetal vigilance, optimal diabetes care and psychological support in addition to supportive measures. This article presents pragmatic options and approaches for primary care physicians, diabetes care providers and obstetricians for GDM screening, diagnosis and management during the pandemic, to be used in conjunction with routine antenatal care.

SARS-CoV-2 Seroprevalence in Individuals With Type 1 and Type 2 Diabetes Compared With Controls.

OBJECTIVE: Data for the association between diabetes and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) susceptibility are conflicting. We aimed to evaluate this association using an analytical cross-sectional study design. METHODS: Study participants were recruited from endocrine clinics of our hospital and belonged to 3 groups: group 1 (type 1 diabetes mellitus [T1DM]), group 2 (type 2 diabetes mellitus [T2DM]), and group 3 (controls). All participants submitted blood samples for SARS-CoV-2 S1/S2 immunoglobulin G antibody test (LIAISON; DiaSorin) and were interviewed for a history of documented infection. RESULTS: We evaluated a total of 643 participants (T1DM, 149; T2DM, 160; control, 334; mean age, 37.9 ± 11.5 years). A total of 324 (50.4%) participants were seropositive for SARS-CoV-2. The seropositivity rate was significantly higher in the T1DM (55.7% vs 44.9%, P = .028) and T2DM (56.9% vs 44.9%, P = .013) groups than in the control group. The antibody levels in seropositive participants with T1DM and T2DM were not significantly different from those in seropositive controls. On multivariable analysis, low education status (odds ratio [OR], 1.41 [95% CI, 1.03-1.94]; P = .035), diabetes (OR, 1.68 [95% CI, 1.20-2.34]; P = .002), and overweight/obesity (OR, 1.52 [95% CI, 1.10-2.10]; P = .012) showed a significant association with SARS-CoV-2 seropositivity. The association between diabetes and SARS-CoV-2 seropositivity was found to further increase in participants with coexisting overweight/obesity (adjusted OR, 2.63 [95% CI, 1.54-4.47]; P < .001). CONCLUSION: SARS-CoV-2 seropositivity, assessed before the onset of the national vaccination program, was significantly higher in participants with T1DM and T2DM than in controls. The antibody response did not differ between seropositive participants with and without diabetes. These findings point toward an increased SARS-CoV-2 susceptibility for patients with diabetes, in general, without any differential effect of the diabetes type.

Impact of SARS-CoV-2 on Progression of Glycemic and Cardiometabolic Variables and Changes in Insulin Indices: A Longitudinal Study.

INTRODUCTION: We aimed to evaluate whether SARS-CoV-2 infection is associated with beta cell dysfunction and progression of glycemic and cardiometabolic variables in an established cohort. METHODS: Study participants (n = 352, 46.9% men) underwent a detailed evaluation at two time points: (a) pre-COVID (2016-19) and (b) peri-COVID (2020-21). At the second visit, SARS-CoV-2 infection was determined on the basis of a quantitative S1/S2 IgG antibody test (DiaSorin Liaison) and/or a documented history of infection. RESULTS: A total of 159 (45.2%) participants were seropositive for SARS-CoV-2, of whom 122 (76.7%) had mild/asymptomatic infection. Progression in body mass index (BMI) category [34 (21.4%) vs. 22 (11.4%), p = 0.011] was seen in a significantly higher proportion of the participants in the infected group compared to the non-infected group. Progression in glycemic and insulin indices [homeostasis model assessment of insulin resistance (HOMA-IR), Matsuda index, and oral disposition index (oDI)] categories was also evident in a larger proportion of participants in the infected group; however, the difference was not statistically significant. On logistic regression analysis, the association between SARS-CoV-2 infection and BMI category progression was statistically significant [fully adjusted OR 2.14 (95% CI, 1.18-3.90; p = 0.013)]. CONCLUSION: In this longitudinal study, predominant mild/asymptomatic SARS-CoV-2 infection was associated with increase in BMI, but not with worsening of beta cell function and insulin resistance, nor glycemic progression.

A practical guidance on the use of intravenous insulin infusion for management of inpatient hyperglycemia: Intravenous Insulin Infusion for Management of Inpatient Hyperglycemia.

BACKGROUND: We aim to provide a practical guidance on the use of intravenous insulin infusion for managing inpatient hyperglycemia. METHODS AND RESULTS: This document was formulated based on the review of available literature and personal experience of authors. We have used various case scenarios to illustrate variables which should be taken into account when deciding adjustments in infusion rate, including but not restricted to ambient blood glucose level and magnitude of blood glucose change in the previous hour. CONCLUSION: The guidance can be generalized to any situation where dedicated protocols are lacking, trained manpower is not available and resource constraints are present.

A guidance on diagnosis and management of hyperglycemia at COVID care facilities in India.

BACKGROUND AND AIMS: Diabetes and coronavirus disease 2019 (COVID-19) share a bidirectional relationship. Hyperglycemia occurring in the setting of either previously diagnosed or undiagnosed diabetes is known to be associated with poor outcomes. Here, we aim to provide a simple and practical guidance on the diagnosis and management of hyperglycemia in admitted patients with COVID-19. METHODS: The guidance is formulated based on experience of authors and relevant literature on the subject searched using Pubmed. RESULTS: Every patient admitted to a COVID care facility should be investigated for hyperglycemia using a combination of tests including capillary blood glucose, fasting plasma glucose and HbA1c. Oral glucose lowering drugs can be considered in patients with mild COVID illness who have mild hyperglycemia [pre-meal blood glucose of <180 mg/dl (10 mmol/L) and post-meal blood glucose of <250 mg/dl (13.9 mmol/L)] and no contraindication to the use of these agents.. All patients with moderate-severe disease and/or hyperglycemia of greater severity should be initiated on insulin therapy. Hyperglycemia should be aggressively screened for and managed in patients receiving systemic glucocorticoids. CONCLUSION: This document provides a broad overview on the diagnosis and management of hyperglycemia at COVID care facilities and should be useful to a wide range of healthcare personnel involved in care of patients with COVID-19.

Basal-Bolus Insulin Regimen for Hospitalised Patients with COVID-19 and Diabetes Mellitus: A Practical Approach.

BACKGROUND AND AIM: The coronavirus disease 2019 (COVID-19) outbreak has rapidly crossed international boundaries and placed increasing demands on healthcare facilities worldwide. Patients with diabetes and uncontrolled blood glucose levels are at increased risk for poor clinical outcomes and in-hospital mortality related to COVID-19. Therefore, achieving good glycaemic control is of paramount importance among hospitalised patients with COVID-19. Basal-bolus insulin therapy is a safe and effective intervention for the management of hyperglycaemia in hospitalised patients. The aim of this article is to provide a practical guidance for the use of the basal-bolus insulin regimen in hospitalised patients with COVID-19 and diabetes mellitus. METHODS: This guidance document was formulated based on the review of available literature and the combined personal experiences of the authors. We provide a comprehensive review on the use of the basal-bolus insulin regimen, including its principles, rationale, indications, prerequisites, initiation, and dose titration, and also suggest targets for blood glucose control and different levels of capillary blood glucose monitoring. Various case scenarios are used to illustrate how optimal glucose control can be achieved, such as through adjustments in doses of prandial and basal insulin, the use of correctional insulin dosing and changes in the timing and content of major and minor meals. CONCLUSION: The practical guidance for the use of the basal-bolus insulin regimen in hospitalised patients with COVID-19 and diabetes mellitus presented here can be used for patients admitted to hospital for indications other than COVID-19 and for those in ambulatory care.

Proposed guidelines for screening of hyperglycemia in patients hospitalized with COVID-19 in low resource settings.

BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic has immensely strained healthcare systems worldwide. Diabetes has emerged as a major comorbidity in a large proportion of patients infected with COVID-19 and is associated with poor health outcomes. We aim to provide a practical guidance on screening of hyperglycemia in persons without known diabetes in low resource settings. METHODS: We reviewed the available guidelines on this subject and proposed an algorithm based on simple measures of blood glucose (BG) which can be implemented by healthcare workers with lesser expertise in low resource settings. RESULTS: We propose that every hospitalized patient with COVID-19 infection undergo a paired capillary BG assessment (pre-meal and 2-h post-meal). Patients with pre-meal BG < 7.8 mmol/L (140 mg/dL) and post-meal BG < 10.0 mmol/L (180 mg/dL) may not merit further monitoring. On the other hand, those with one or more value above these thresholds should undergo capillary BG monitoring (pre-meals and 2 hours after dinner) for the next 24 hours. When two or more (≥50%) such values are significantly elevated [pre-meal ≥8.3 mmol/L (150 mg/dL) and post-meal ≥11.1 mmol/L (200 mg/dL)], pharmacotherapy should be immediately initiated. On the other hand, in patients with modest elevation of one or more values [pre-meal 7.8-8.3 mmol/L (140-150 mg/dL) and post-meal 10.0-11.1 mmol/L (180-200 mg/dL)], dietary modifications should be initiated and pharmacotherapy considered only if BG control remains suboptimal. CONCLUSION: We highlight strategies for screening of hyperglycemia in persons without known diabetes treated for COVID-19 infection in low resource settings. This guidance may well be applied to other settings in the near future.