Patients with prediabetes are at greater risk of developing diabetes 5 months postacute SARS-CoV-2 infection: a retrospective cohort study.

INTRODUCTION: Patients with prediabetes who contract SARS-CoV-2 infection (COVID-19) could be at higher risk of developing frank diabetes compared those who do not. This study aims to investigate the incidence of new-onset diabetes in patients with prediabetes after COVID-19 and if it differs from those not infected. RESEARCH DESIGN AND METHODS: Using electronic medical record data, 42 877 patients with COVID-19, 3102 were identified as having a history of prediabetes in the Montefiore Health System, Bronx, New York. During the same time period, 34 786 individuals without COVID-19 with history of prediabetes were identified and 9306 were propensity matched as controls. SARS-CoV-2 infection status was determined by a real-time PCR test between March 11, 2020 and August 17, 2022. The primary outcomes were new-onset in-hospital diabetes mellitus (I-DM) and new-onset persistent diabetes mellitus (P-DM) at 5 months after SARS-CoV-2 infection. RESULTS: Compared with hospitalized patients without COVID-19 with history of prediabetes, hospitalized patients with COVID-19 with history of prediabetes had a higher incidence of I-DM (21.9% vs 6.02%, p<0.001) and of P-DM 5 months postinfection (14.75% vs 7.51%, p<0.001). Non-hospitalized patients with and without COVID-19 with history of prediabetes had similar incidence of P-DM (4.15% and 4.1%, p>0.05). Critical illness (HR 4.6 (95% CI 3.5 to 6.1), p<0.005), in-hospital steroid treatment (HR 2.88 (95% CI 2.2 to 3.8), p<0.005), SARS-CoV-2 infection status (HR 1.8 (95% CI 1.4 to 2.3), p<0.005), and hemoglobin A1c (HbA1c) (HR 1.7 (95% CI 1.6 to 1.8), p<0.005) were significant predictors of I-DM. I-DM (HR 23.2 (95% CI 16.1 to 33.4), p<0.005), critical illness (HR 2.4 (95% CI 1.6 to 3.8), p<0.005), and HbA1c (HR 1.3 (95% CI 1.1 to 1.4), p<0.005) were significant predictors of P-DM at follow-up. CONCLUSIONS: SARS-CoV-2 infection confers a higher risk for developing persistent diabetes 5 months post-COVID-19 in patients with prediabetes who were hospitalized for COVID-19 compared with COVID-19-negative counterparts with prediabetes. In-hospital diabetes, critical illness, and elevated HbA1c are risk factors for developing persistent diabetes. Patients with prediabetes with severe COVID-19 disease may need more diligent monitoring for developing P-DM postacute SARS-CoV-2 infection.

Health Care Disparities in Outpatient Diabetes Management During the Coronavirus Disease 2019 Pandemic: Where Do We Stand Now?

OBJECTIVE: We examined diabetes outpatient management during the first 2 years of the Coronavirus Disease 2019 pandemic in an endocrinology practice with a focus on health care disparities in outcomes. METHODS: We conducted a retrospective cohort study examining adults with diabetes during 3 time periods: T1 (March 2019-February 2020), T2 (March 2020-February 2021), and T3 (March 2021-February 2022). Clinical outcomes included body mass index (BMI), systolic blood pressure (SBP), Hemoglobin A1c (HgbA1c), low-density lipoprotein cholesterol (LDL), and urine albumin:creatinine ratio. Appointment types (virtual vs in-person) were also collected. RESULTS: Frequencies of HgbA1c, BMI, and SBP measurements reduced by 36.0%, 46.3%, and 48.5% in T2, respectively, and remaining 8.7% (HgbA1c), 13.4% (BMI), and 15.2% (SBP) lower at the end of the study period (P < .001) compared to prepandemic levels. However, the average HgbA1c and LDL slightly improved. Clinic appointments per patient increased during the pandemic, fueled by telehealth utilization. Women had fewer in-person visits during T2, those older than 65 had better HgbA1c, and the most socioeconomically deprived group had the worst HgbA1c during every time period. In addition, black patients had worse HgbA1c, LDL, and SBP values throughout the study, which did not worsen over the pandemic. CONCLUSION: While the frequency of health measurements had not fully recovered 2 years into the pandemic, this did not translate to worse diabetes management or a widening of pre-existing disparities. Our study emphasizes the role of equitable health care in minimizing inequalities in diabetes, particularly during times of crisis.

Effects of COVID-19 pandemic lockdown on the metabolic control of type 2 diabetes mellitus in patients.

Objective: The effects of the COVID-19 pandemic on the control of diabetes mellitus in patients are largely unknown. In this study we aimed to analyze the impact of the pandemic and the ensuing lockdown on the management of type 2 diabetes mellitus. Subjects and methods: A total of 7,321patients with type 2 diabetes mellitus (4,501 from the pre-pandemic period, 2,820 from the post-pandemic period) were studied retrospectively. Results: The admission of patients with diabetes melitus (DM) decreased significantly during the pandemic (4,501 pre-pandemic vs. 2,820 post-pandemic; p < 0.001). The mean age of patients was statistically lower (51.5 ± 14.0 vs. 49.7 ± 14.5 years; p < 0.001), and the mean glycated hemoglobin (A1c) level was significantly higher (7.9% ± 2.4% vs. 7.3% ± 1.7%; p < 0.001) in the post-pandemic period than in the pre-pandemic. The female/male ratio was similar in both periods (59.9%/40.1% for pre-pandemic, 58.6%/41.4% for post-pandemic; p = 0.304). As calculated by month the pre-pandemic rate of women was higher only in January (53.1% vs. 60.6%, p = 0.02). Mean A1c levels were higher in the postpandemic period than in the same month of the previous year, excluding July and October (p = 0.001 for November, p < 0.001 for others). Postpandemic patients admitted to the outpatient clinic were significantly younger than prepandemic visits for July (p = 0.001), August (p < 0.001) and December (p < 0.001). Conclusion: The lockdown had detrimental effects on blood sugar management in patients with DM. Hence, diet and exercise programs should be adapted to home conditions, and social and psychological support should be provided to patients with DM.

SARS-CoV-2 Positive Serology and Islet Autoantibodies in Newly Diagnosed Pediatric Cases of Type 1 Diabetes Mellitus: A Single-Center Cohort Study.

Acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, although presenting less severe forms of the disease in children, seems to play a role in the development of other conditions, including type 1 diabetes mellitus (T1DM). After the beginning of the pandemic, an increase in the number of T1DM pediatric patients was observed in several countries, thus leading to many questions about the complex relationship between SARS-CoV-2 infection and T1DM. Our study aimed to highlight possible correlations between SARS-CoV-2 serology and T1DM onset. Therefore, we performed an observational retrospective cohort study that included 158 children diagnosed with T1DM in the period April 2021-April 2022. The presence or absence of SARS-CoV-2 and T1DM-specific antibodies and other laboratory findings were assessed. In the group of patients with positive SARS-CoV-2 serology, a higher percentage had detectable IA-2A antibodies, more children were positive for all three islet autoantibodies determined (GADA, ICA, and IA-2A), and a higher mean HbA1c value was found. No difference existed between the two groups regarding DKA presence and severity. A lower C-peptide level was found in the patients presenting diabetic ketoacidosis (DKA) at T1DM onset. When compared to a group of patients diagnosed before the pandemic, an increased incidence of both DKA and severe DKA, as well as a higher age at diagnosis and higher levels of HbA1c were present in our study group. These findings have important implications for the ongoing monitoring and management of children with T1DM after the COVID-19 pandemic and highlight the need for further research to better understand the complex relationship between SARS-CoV-2 infection and T1DM.

Intervention effects and long-term changes in physical activity and cardiometabolic outcomes among children at risk of noncommunicable diseases in South Africa: a cluster-randomized controlled trial and follow-up analysis.

Introduction: Risk factors for noncommunicable diseases such as insufficient physical activity (PA), overweight or hypertension are becoming increasingly predominant among children globally. While school-based interventions are promising preventive strategies, evidence of their long-term effectiveness, especially among vulnerable populations, is scarce. We aim to assess the short-term effects of the physical and health KaziKidz intervention on cardiometabolic risk factors and the long-term, pre-and post-COVID-19 pandemic changes thereof in high-risk children from marginalized communities. Methods: The intervention was tested in a cluster-randomized controlled trial between January and October 2019 in eight primary schools near Gqeberha, South Africa. Children with overweight, elevated blood pressure, pre-diabetes, and/or borderline dyslipidemia were identified and re-assessed 2 years post-intervention. Study outcomes included accelerometry-measured PA (MVPA), body mass index (BMI), mean arterial pressure (MAP), glucose (HbA1c), and lipid levels (TC to HDL ratio). We conducted mixed regression analyses to assess intervention effects by cardiometabolic risk profile, and Wilcoxon signed-rank tests to evaluate longitudinal changes in the high-risk subpopulation. Results: We found a significant intervention effect on MVPA during school hours for physically inactive children, and among active as well as inactive girls. In contrast, the intervention lowered HbA1c and TC to HDL ratio only in children with glucose or lipid values within the norm, respectively. At follow-up, the intervention effects were not maintained in at-risk children, who showed a decline in MVPA, and an increase in BMI-for-age, MAP, HbA1c and TC to HDL ratio. Conclusion: We conclude that schools are key settings in which to promote PA and improve health; however, structural changes are necessary to ensure that effective interventions reach marginalized school populations and achieve sustainable impact.

Cross-sectional study to describe the severity, bio-chemical associations, and final outcomes of COVID-19-associated rhino-orbital-cerebral mucormycosis in a tertiary hospital of East India.

Purpose: The second wave of coronavirus disease 2019 (COVID-19) pandemic triggered a mucormycosis epidemic in India. Diabetes mellitus and dysregulated immune response were contributors, and rhino-orbital-cerebral mucormycosis (ROCM) was the most common presentation. It is however not known whether bio-chemical parameters at presentation correlate with stage of ROCM or final outcome in terms of vision or mortality. Methods: This retrospective, hospital-based study included all in-patients of mucormycosis with ophthalmic manifestations at presentation admitted during June 1, 2021 to August 31, 2021. It aimed to evaluate the association between severity of infection, serum levels of HbA1c, ferritin, interleukin-6 (IL-6), C-reactive protein (CRP), and D-dimer levels at presentation and outcome. Results: There were altogether 47 eligible cases having a mean age of 48.8 ± 10.9 years with a male:female ratio of 2.6:1; forty-two (89.4%) had pre-existing diabetes, and five (10.6%) had steroid-induced hyperglycemia. The mean HbA1c among diabetics was 9.7 ± 2.1. HbA1c and serum CRP showed an increase over subsequent stages, which was not statistically significant (P = 0.31). IL-6 values for all stages were similar (P = 0.97). Only serum ferritin levels showed a statistically significant increase over stages (P = 0.04). IL-6 was significantly lower (P = 0.03) in patients who survived, whereas CRP levels were significantly lower in patients who had final visual acuity (VA) better than only perception of light (P = 0.03). Conclusion: Uncontrolled diabetes mellitus is a significant association of ROCM. Serum ferritin levels at presentation best correlate with extent of the disease. CRP levels are best to prognosticate cases that will have sufficient VA to carry on activities of daily living, whereas IL-6 levels are best associated with survival.

A Risk Profile for Disordered Eating Behaviors in Adolescents with Type 1 Diabetes: A Latent Class Analysis Study.

(1) Background: This multi-center study aimed to identify a risk profile for disordered eating behaviors (DEBs) in youth with type 1 diabetes (T1D) based on their dietary intake, lipid profile, body mass index (BMI-SDS), and glycometabolic control. (2) Methods: Adolescents aged 11 to 18 years from five centers across Italy were recruited. Lipid profile, HbA1c, BMI-SDS, and dietary intake data were collected. The risk for developing DEBs was assessed via the Diabetes Eating Problems Survey-R (DEPS-R) questionnaire. A latent class analysis (LCA) was performed using a person-centered approach. (3) Results: Overall, 148 participants aged 11-18 (12.1, ±3.34), 52% males with a mean diabetes duration of 7.2 (±3.4), were enrolled. Based on the results of the DEBS-R score, LCA allowed us to highlight two different classes of patients which were defined as "at-risk" and "not at-risk" for DEB. The risk profile for developing DEBs is characterized by higher BMI-SDS (23.9 vs. 18.6), higher HbA1c (7.9 vs. 7.1%), higher LDL cholesterol (99.9 vs. 88.8 mg/dL), lower HDL cholesterol (57.9 vs. 61.3 mg/dL), higher proteins (18.2 vs. 16.1%), and lower carbohydrates (43.9 vs. 45.3%). Adolescents included in the "at-risk" class were significantly older (p = 0.000), and their parents' SES was significantly lower (p = 0.041). (4) Conclusions: This study allowed us to characterize a risk profile for DEBs based on dietary behavior and clinical parameters. Early identification of the risk for DEBs allows timely intervention and prevention of behavior disorders.

Effect of circulating ceramides on adiposity and insulin resistance in patients with type 2 diabetes: An observational cross-sectional study.

INTRODUCTION: Insulin resistance (IR) is one of the common chronic metabolic disorders in Africa and elsewhere. Accumulation of lipids in the body may be due to an imbalance in the metabolism of lipids, glucose and proteins. Ceramides are a sphingolipid class of lipids that are biologically active and vital in the production of more complex lipids. Circulating ceramides are thought to have a role in the development of obesity-related IR, although the precise involvement remains unclear. AIM: To investigate the impact of circulating ceramide on IR and body adiposity in people with and without type 2 diabetes mellitus (T2DM). METHODOLOGY: The study was observational and cross-sectional. There were a total of 84 volunteers with T2DM and 75 nondiabetics (control). The participants' ages, body mass indexes (BMI), waist circumferences, and blood pressure (BP) were among the clinical parameters assessed. Ceramide levels, fasting plasma glucose (FPG), lipids, basal insulin levels and glycated haemoglobin (HbA1c) were also measured. Additionally, the homeostatic model assessment for IR (HOMA-IR) and beta cell function (HOMA-ß) were computed. RESULTS: T2DM and control participants had different mean values for anthropometric parameters, BP, FPG, HbA1c, lipids, insulin, HOMA-IR, HOMA-ß and ceramide levels (p < .05 for all). HOMA-IR, HOMA-ß and cardiovascular risk were significant correlates with ceramide levels in the T2DM group (r = 0.24; -0.34; 0.24, p < .05, respectively). Further, FPG (OR = 1.83, p = .01) and ceramide (OR = 1.05, p = .01) levels were significant predictors of IR in the case group. CONCLUSION: Patients with T2DM exhibited high ceramide concentrations, which, when combined with high FPG, were associated with IR. The consequences of circulating ceramides in health and disease; however, merit further research.

Interleukin-39 is a novel cytokine associated with type 2 diabetes mellitus and positively correlated with body mass index.

INTRODUCTION: It is suggested that cytokines play a key role in the pathogenesis of type 2 diabetes mellitus (T2DM). Therefore, this study explored two recently discovered cytokines, interleukin (IL)-37 (anti-inflammatory) and IL-39 (pro-inflammatory), in T2DM due to limited data in this context. METHODS: Serum IL-37 and IL-39 levels were determined in 106 T2DM patients and 109 controls using enzyme-linked immunosorbent assay kits. RESULTS: Serum levels (median and interquartile range) of IL-37 (79 [47-102] vs. 60 [46-89] ng/L; probability [p] = .04) and IL-39 (66 [59-69] vs. 31 [19-42] ng/L; p < .001) were significantly elevated in T2DM patients compared to controls. As indicated by the area under the curve (AUC), IL-39 (AUC = 0.973; p < .001) was more predictable for T2DM than IL-37 (AUC = 0.582; p = .039). Elevated levels of IL-39 were significantly associated with T2DM (odds ratio = 1.30; p < .001), while IL-37 did not show this association. Classification of IL-37 and IL-39 levels by demographic and clinical characteristics of patients revealed some significant differences including gender (IL-39), body mass index (BMI; IL-37 and IL-39) and diabetic neuropathy (IL-39). BMI was positively correlated with IL-39 (correlation coefficient [rs ] = 0.27; p = .005) and glycosylated haemoglobin (rs  = 0.31; p = .001), and negatively correlated with age at onset (rs  = -0.24; p = .015). CONCLUSIONS: IL-37 and IL-39 levels were elevated in the serum of T2DM patients. Besides, IL-39 is proposed to be a novel cytokine associated with T2DM and positively correlated with BMI.

Evaluation of the clinical effectiveness of telephone consultation compared to face-to-face consultation in terms of glycaemic control among patients with suboptimally controlled type 2 diabetes: a retrospective cohort study.

OBJECTIVE: With the COVID-19 pandemic, telemedicine has been increasingly deployed in lieu of face-to-face consultations for management of diabetes in primary care. There was a need to evaluate clinical effectiveness of telephone consultations for diabetes management and this study aimed to show whether one-off telephone consultation was inferior or not to face-to-face consultation in terms of glycaemic control among patients with suboptimally controlled type 2 diabetes. DESIGN: Retrospective cohort study. Data of all patients with type 2 diabetes who had a chronic disease consultation during the period 9 April 2020-18 September 2020, and met the study's inclusion and exclusion criteria was obtained from the electronic medical records. SETTING: A primary care clinic in the north-eastern region of Singapore. The clinic's patient population was representative of Singapore's population in terms of gender and age. PARTICIPANTS: 644 patients with type 2 diabetes and glycated haemoglobin (HbA1c) 7.0% and above, aged 21-80 years old. INTERVENTIONS: Participants either underwent telephone or face-to-face consultation for diabetes management. OUTCOME MEASURE: Mean HbA1c change (∆HbA1c) between preintervention and postintervention. RESULTS: Over 4 months, the mean ∆HbA1c was -0.16 percentage points (p.p.) (95% CI -0.26 to -0.07) and -0.11 p.p. (95% CI -0.20 to -0.02) for face-to-face and telephone consultation groups, respectively. The difference in mean ∆HbA1c between the two groups was +0.05 p.p. (95% CI -∞ to 0.16), with the upper limit of the one-sided 95% CI less than the prespecified non-inferiority margin of 0.5 p.p. (p<0.05). In those with HbA1c≥9%, the difference in mean ∆HbA1c was +0.31 p.p. (95% CI -∞ to 0.79), which exceeded the non-inferiority margin. CONCLUSION: For patients with suboptimally controlled type 2 diabetes, one-time telephone consultation was non-inferior to face-to-face consultation in terms of glycaemic control in the short term. However, more studies are required to investigate the long-term effects of telephone consultations and for those with HbA1c≥9%.

Clinical Experience of Using Telemedicine for the Management of Patients Using Continuous Subcutaneous Insulin Infusion in a Highly Complex Latin American Hospital.

INTRODUCTION: Continuous subcutaneous insulin infusion (CSII) has emerged as a potential solution for diabetes management during the pandemic, as it reduces the need for in-person visits and allows for remote monitoring of patients. Telemedicine has also become increasingly important in the management of diabetes during the pandemic, as it allows healthcare providers to provide remote consultations and support. Here, we discuss the implications of this approach for diabetes management beyond the pandemic, including the potential for increased access to care and improved patient outcomes. METHODS: We performed a longitudinal observational study between 1 March 2020 and 31 December 2020 to evaluate glycemic parameters in diabetic patients with CSII in a telehealth service. Glycemic parameters were time in range (TIR), time above range, time below range, mean daily glucose, glucose management indicator (GMI), and glycemic variability control. RESULTS: A total of 36 patients were included in the study, with 29 having type 1 diabetes and 6 having type 2 diabetes. The study found that the proportion of patients achieving target glucose variability and GMI remained unchanged during follow-up. However, in patients with type 2 diabetes, the time in target range increased from 70% to 80%, and the time in hyperglycemia decreased from 2% to 0%. CONCLUSIONS: The results of this study suggest that telemedicine is a strategy for maintaining glycemic control in patients using CSII. However, the lack of access to the internet and adequate telemonitoring devices make it difficult to use on a large scale in emerging countries like ours.

Influence of Nutritional Guidance/Consulting on Glycemic Control during the Coronavirus Disease 2019 Pandemic in Patients with Type 2 Diabetes Mellitus.

Objective The coronavirus disease 2019 (COVID-19) pandemic has led to a global restriction of public behavior due to lockdowns in various major cities. Lifestyle changes and reduced rates of outpatient lifestyle guidance/consulting may have had some impact on glycemic control in patients with type 2 diabetes. This study analyzed the impact of changes in the frequency of nutritional guidance/consulting (NGC) during the COVID-19 pandemic on outpatient care for type 2 diabetes. Methods Among 785 patients, 67 who received regular NGC during the COVID-19 pandemic were assigned to the continuation group (CG), 143 whose NGC was discontinued after the pandemic were assigned to the discontinuation group (DG), and 575 who did not receive regular NGC regardless of the COVID-19 pandemic status were assigned to the irregular NGC group (IGG). The three groups were followed up for two years. Analyses among the three categories were performed using the chi-square test or an analysis of covariance. Results The number of diabetes medications after the declaration of the COVID-19 emergency did not markedly increase in the CG (2.0±1.4 to 2.1±1.5, p>0.05) but significantly increased from 2.2±1.4 to 2.6±1.4 in the DG (p<0.005) and from 2.2±1.4 to 2.4±1.4 in the IGG (p<0.005). The increase in HbA1c adjusted for confounders was unchanged at 0.12±1.06% for the CG and -0.07±1.29% for the IGG but was significantly increased at 0.19±1.49% for the DG (p<0.05). Conclusion In patients with type 2 diabetes mellitus, regular nutritional guidance may be important for maintaining good glycemic control, even during the COVID-19 pandemic.

Ethnic differences in complement system biomarkers and their association with metabolic health in men of Black African and White European ethnicity.

Inflammation plays a fundamental role in the development of several metabolic diseases, including obesity and type 2 diabetes (T2D); the complement system has been implicated in their development. People of Black African (BA) ethnicity are disproportionately affected by T2D and other metabolic diseases but the impact of ethnicity on the complement system has not been explored. We investigated ethnic differences in complement biomarkers and activation status between men of BA and White European (WE) ethnicity and explored their association with parameters of metabolic health. We measured a panel of 15 complement components, regulators, and activation products in fasting plasma from 89 BA and 96 WE men. Ethnic differences were statistically validated. Association of complement biomarkers with metabolic health indices (BMI, waist circumference, insulin resistance, and HbA1c) were assessed in the groups. Plasma levels of the key complement components C3 and C4, the regulators clusterin and properdin and the activation marker iC3b were significantly higher in BA compared to WE men after age adjustment, while FD levels were significantly lower. C3 and C4 levels positively correlated with some or all markers of metabolic dysfunction in both ethnic groups while FD was inversely associated with HbA1c in both groups, and clusterin and properdin were inversely associated with some markers of metabolic dysfunction only in the WE group. Our findings of increased levels of complement components and activation products in BA compared to WE men suggest differences in complement regulation that may impact susceptibility to poor metabolic health.

Use of Telemedicine in Pediatric Services for 4 Representative Clinical Conditions: Scoping Review.

BACKGROUND: Telemedicine is becoming routine in health care. Postpandemic, a universal return to face-to-face consultations may risk a loss of some of the advantages of telemedicine. However, rapid implementation and adoption without robust evaluation of usability, efficacy, and effectiveness could potentially lead to suboptimal health outcomes and downstream challenges to providers. OBJECTIVE: This review assesses telemedicine interventions against international guidance and sufficiency of evidence to support postpandemic utilization in pediatric settings. METHODS: This scoping review was performed following searches on PubMed, Embase, and CINAHL databases on April 15, 2021, and May 31, 2022, and examined studies focused on telemedicine, remote consultation, video call, or remote patient monitoring in children (0-18 years) receiving outpatient care for diabetes, asthma, epilepsy, or renal disease. Exclusion criteria included studies published before 2011 as the technologies used have likely been improved or replaced, studies in adult populations or where it was not possible to disaggregate data for participants younger than 18 years as the focus of the review was on pediatric care, and studies not published in English. Data were extracted by 4 authors, and the data were corroborated by a second reviewer. Studies were examined for feasibility and usability, clinical and process outcomes, and cost-effectiveness. RESULTS: Of the 3158 studies identified, 56 were suitable for final inclusion and analysis. Data on feasibility or usability of interventions (48 studies) were overwhelmingly positive in support of telemedicine interventions, with common themes including convenience, perceived cost savings, and ease of use. However, use in preference to usual care was rarely explored. Clinical and process outcome data (31 studies) were mostly positive. Across all studies, there was limited measurement of standardized clinical outcomes, although these were more commonly reported in asthma (peak flow) and diabetes (glycated hemoglobin [HbA1c]). Implementation science data generally supported cost-effectiveness of telemedicine with a reduction of health care costs. CONCLUSIONS: There is promising evidence supporting telemedicine in pediatric settings. However, there is a lack of evaluation of telemedicine in comparison with usual outpatient care for noninferiority of clinical outcomes, and this review highlights the need for a more standardized approach to evaluation of digital interventions.

High HBV-DNA serum levels are associated with type 2 diabetes in adults with positive HBsAg: An observational study.

Background: The prevalence of diabetes is higher in hepatitis B virus (HBV)-infected population. We aimed to examine the relationship between different serum HBV-DNA levels and type 2 diabetes in adults with positive HBV surface antigen (HBsAg). Methods: We conducted cross-sectional analyses of data obtaining from the Clinical Database System of Wuhan Union Hospital. Diabetes was defined by self-report of type 2 diabetes, fasting plasma glucose (FPG) ≥7mmol/L, or glycated hemoglobin (HbA1c) ≥6.5%. Binary logistic regression analyses were performed to investigate the factors associated with diabetes. Results: Among 12,527 HBsAg-positive adults, 2,144 (17.1%) were diabetic. Patients with serum HBV-DNA <100, 100-2000, 2000-20000 and ≥20000 IU/mL accounted for 42.2% (N=5,285), 22.6% (N=2,826), 13.3% (N=1,665) and 22.0% (N=2,751), respectively. The risk of type 2 diabetes, FPG ≥7mmol/L and HbA1c ≥6.5% in individuals with highly elevated serum HBV-DNA level (≥20000 IU/mL) were 1.38 (95% confidence interval [CI]: 1.16 to 1.65), 1.40 (95% CI: 1.16 to 1.68) and 1.78 (95% CI: 1.31 to 2.42) times relative to those with negative or lowly elevated serum HBV-DNA (<100 IU/mL). However, the analyses showed no association of moderately (2000-20000 IU/mL) to slightly (100-2000 IU/mL) raised serum HBV-DNA levels with type 2 diabetes (OR=0.88, P=0.221; OR=1.08, P=0.323), FPG ≥7mmol/L (OR=1.00, P=0.993; OR=1.11, P=0.250) and HbA1c ≥6.5% (OR=1.24, P=0.239; OR=1.17, P=0.300). Conclusion: In HBsAg-positive adults, highly elevated level rather than moderately to slightly raised levels of serum HBV-DNA is independently associated with an increased risk of type 2 diabetes.

Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial.

Capillary hemoglobin A1c (HbA1c) collection has grown in importance due to its convenience during situations such as the coronavirus disease 2019 (COVID-19) pandemic and virtual visits. The viability of capillary blood samples as an accurate alternative to venous samples has previously only been assessed in smaller sample sizes. In this brief report, 773 paired capillary and venous samples taken from 258 study participants in the Insulin-Only Bionic Pancreas Trial were analyzed at the University of Minnesota Advanced Research and Diagnostic Laboratory and assessed for HbA1c value congruency. Results showed that 97.7% of the capillary samples were within 5% of their respective venous measurement, and R2 between the two HbA1c sources was 0.95. These results are consistent with previous studies that also reported high concordance between capillary and venous HbA1c values using the same laboratory method, providing further evidence that capillary HbA1c measurements are an accurate alternative to venous measurements. Clinical Trial Registration number: NCT04200313.

Changes in Primary Care Quality Associated With Implementation of the Veterans Health Administration Preventive Health Inventory.

Importance: The COVID-19 pandemic caused significant disruptions in primary care delivery. The Veterans Health Administration (VHA) launched the Preventive Health Inventory (PHI) program-a multicomponent care management intervention, including a clinical dashboard and templated electronic health record note-to support primary care in delivering chronic disease care and preventive care that had been delayed by the pandemic. Objectives: To describe patient, clinician, and clinic correlates of PHI use in primary care clinics and to examine associations between PHI adoption and clinical quality measures. Design, Setting, and Participants: This quality improvement study used VHA administrative data from February 1, 2021, through February 28, 2022, from a national cohort of 216 VHA primary care clinics that have implemented the PHI. Participants comprised 829 527 veterans enrolled in primary care in clinics with the highest and lowest decile of PHI use as of February 2021. Exposure: Templated electronic health record note documenting use of the PHI. Main Outcomes and Measures: Diabetes and blood pressure clinical quality measures were the primary outcomes. Interrupted time series models were applied to estimate changes in diabetes and hypertension quality measures associated with PHI implementation. Low vs high PHI use was stratified at the facility level to measure whether systematic differences in uptake were associated with quality. Results: A total of 216 primary clinics caring for 829 527 unique veterans (mean [SD] age, 64.1 [16.9] years; 755 158 of 829 527 [91%] were men) formed the study cohort. Use of the PHI varied considerably across clinics. The clinics in the highest decile of PHI use completed a mean (SD) of 32 997.4 (14 019.3) notes in the electronic health record per 100 000 veterans compared with 56.5 (35.3) notes per 100 000 veterans at the clinics in the lowest decile of use (P < .001). Compared with the clinics with the lowest use of the PHI, clinics with the highest use had a larger mean (SD) clinic size (12 072 [7895] patients vs 5713 [5825] patients; P < .001), were more likely to be urban (91% vs 57%; P < .001), and served more non-Hispanic Black veterans (16% vs 5%; P < .001) and Hispanic veterans (14% vs 4%; P < .001). Staffing did not differ meaningfully between high- and low-use clinics (mean [SD] ratio of full-time equivalent staff to clinician, 3.4 [1.2] vs 3.4 [0.8], respectively; P < .001). After PHI implementation, compared with the clinics with the lowest use, those with the highest use had fewer veterans with a hemoglobin A1c greater than 9% or missing (mean [SD], 6577 [3216] per 100 000 veterans at low-use clinics; 9928 [4236] per 100 000 veterans at high-use clinics), more veterans with an annual hemoglobin A1c measurement (mean [SD], 13 181 [5625] per 100 000 veterans at high-use clinics; 8307 [3539] per 100 000 veterans at low-use clinics), and more veterans with adequate blood pressure control (mean [SD], 20 582 [12 201] per 100 000 veterans at high-use clinics; 12 276 [6850] per 100 000 veterans at low-use clinics). Conclusions and Relevance: This quality improvement study of the implementation of the VHA PHI suggests that higher use of a multicomponent care management intervention was associated with improved quality-of-care metrics. The study also found significant variation in PHI uptake, with higher uptake associated with clinics with more racial and ethnic diversity and larger, urban clinic sites.

Telehealth and Medicare Type 2 Diabetes Care Outcomes: Evidence From Louisiana.

BACKGROUND: At the onset of the COVID-19 pandemic, the Centers for Medicare and Medicaid Services broadened access to telehealth. This provided an opportunity to test whether diabetes, a risk factor for COVID-19 severity, can be managed with telehealth services. OBJECTIVE: The objective of this study was to examine the impacts of telehealth on diabetes control. RESEARCH DESIGN: A doubly robust estimator combined a propensity score-weighting strategy with regression controls for baseline characteristics using electronic medical records data to compare outcomes in patients with and without telehealth care. Matching on preperiod trajectories in outpatient visits and weighting by odds were used to ensure comparability between comparators. SUBJECTS: Medicare patients with type 2 diabetes in Louisiana between March 2018 and February 2021 (9530 patients with a COVID-19 era telehealth visit and 20,666 patients without one). MEASURES: Primary outcomes were glycemic levels and control [ie, hemoglobin A1c (HbA1c) under 7%]. Secondary outcomes included alternative HbA1c measures, emergency department visits, and inpatient admissions. RESULTS: Telehealth was associated with lower pandemic era mean A1c values [estimate=-0.080%, 95% confidence interval (CI): -0.111% to -0.048%], which translated to an increased likelihood of having HbA1c in control (estimate=0.013; 95% CI: 0.002-0.024; P<0.023). Hispanic telehealth users had relatively higher COVID-19 era HbA1c levels (estimate=0.125; 95% CI: 0.044-0.205; P<0.003). Telehealth was not associated with differences in the likelihood of having an emergency department visits (estimate=-0.003; 95% CI: -0.011 to 0.004; P<0.351) but was associated with more the likelihood of having an inpatient admission (estimate=0.024; 95% CI: 0.018-0.031; P<0.001). CONCLUSION: Telehealth use among Medicare patients with type 2 diabetes in Louisiana stemming from the COVID-19 pandemic was associated with relatively improved glycemic control.

Metabolic control of diabetic patients assisted by private and public health care systems during the COVID-19 pandemic: A retrospective cohort study.

AIMS: We sought to analyze the impacts of social restriction measures imposed by the pandemic COVID-19 on the control of metabolic parameters in diabetic patients. METHODS: We accessed the medical records of patients who underwent clinical follow-up in the public and private health systems between July 2019 and June 2021. The sample consisted of 288 patients (111 adults and 177 older individuals). A two-way ANOVA mixed model was used to test the effects of intra- (time: baseline and after 24 months) and inter-subject factors. Linear regression analysis was used to predict the difference in body weight considering age, sex, HbA1c, health care system and insulin use. RESULTS: Among adults, we observed an increase in body weight and LDL-c levels, especially for insulin users (p ≤ 0.05). Adults assisted by the public health care system showed higher HbA1c levels (p = 0.001). Among older individuals using insulin, blood glucose levels decreased (p = 0.019). Body weight decreased in those assisted by the private system (p = 0.005), while glycemia decreased for patients assisted by both health care systems (p = 0.043). The linear regression model confirmed that the increase in body weight was more pronounced in adults than in older individuals. CONCLUSION: The social restriction measures imposed by the pandemic affected the metabolic control of diabetic patients, especially adults assisted by the public health care system.

Effect of a ketogenic diet versus Mediterranean diet on glycated hemoglobin in individuals with prediabetes and type 2 diabetes mellitus: The interventional Keto-Med randomized crossover trial.

BACKGROUND: Consensus has not been reached on what constitutes an optimal diet in individuals with prediabetes and type 2 diabetes mellitus (T2DM), especially between low-carbohydrate options. OBJECTIVES: We compared 2 low-carbohydrate diets with 3 key similarities (incorporating nonstarchy vegetables and avoiding added sugars and refined grains) and 3 key differences (incorporating compared with avoiding legumes, fruits, and whole, intact grains) for their effects on glucose control and cardiometabolic risk factors in individuals with prediabetes and T2DM. METHODS: Keto-Med was a randomized, crossover, interventional trial. Forty participants aged ≥18 years with prediabetes or T2DM followed the well-formulated ketogenic diet (WFKD) and the Mediterranean-plus diet (Med-Plus) for 12 weeks each, in random order. The diets shared the 3 key similarities noted above. The Med-Plus incorporated legumes, fruits, and whole, intact grains, while the WFKD avoided them. The primary outcome was the percentage change in glycated hemoglobin (HbA1c) after 12 weeks on each diet. Secondary and exploratory outcomes included percentage changes in body weight, fasting insulin, glucose, and blood lipids; average glucose from continuous glucose monitor (CGM), and nutrient intake. RESULTS: The primary analysis was of 33 participants with complete data. The HbA1c values did not differ between diets at 12 weeks. Triglycerides decreased more for the WFKD [percentage changes, -16% (SEM, 4%) compared with -5% (SEM, 6%) for the Med-Plus; P = 0.02] and LDL cholesterol was higher for the WFKD [percentage changes, +10% (SEM, 4%) compared with -5% (SEM, 5%) for the Med-Plus; P = 0.01]. Weight decreased 8% (SEM, 1%) compared with 7% (SEM, 1%) and HDL cholesterol increased 11% (SEM, 2%) compared with 7% (SEM, 3%) for the WFKD compared with the Med-Plus, respectively; however, there was a significant interaction of diet × order for both. Participants had lower intakes of fiber and 3 nutrients on the WFKD compared with the Med-Plus. Twelve-week follow-up data suggest the Med-Plus is more sustainable. CONCLUSIONS: HbA1c values were not different between diet phases after 12 weeks, but improved from baseline on both diets, likely due to several shared dietary aspects. The WFKD led to a greater decrease in triglycerides, but also had potential untoward risks from elevated LDL cholesterol and lower nutrient intakes from avoiding legumes, fruits, and whole, intact grains, as well as being less sustainable. This trial was registered at clinicaltrials.gov as NCT03810378.