Incidence of Referable Retinal Disease in Diabetic Patients at a Primary Care Practice

Purpose: This work tests the feasibility of remote ophthalmic imaging to identify referable retinal abnormalities and assesses the effectiveness of color fundus photography (CFP) vs optical coherence tomography (OCT) for this purpose. Methods: This prospective, nonrandomized study included 633 patients with diabetes at Duke Primary Care. Undilated patients underwent screening with CFP and OCT camera (MaestroCare, Topcon). Images were graded independently for interpretability and the presence of predetermined retinal disease. Retinal disease was classified as diabetic retinopathy (DR) referable to a retina specialist or incidental findings referable to either a retina specialist or a general ophthalmologist, depending on severity. Results: Mean (SD) age of screened patients was 66 (13) years, and 49% were women. The average glycated hemoglobin A1c level was 7.6 % (SD, 1.7%), and 30% of the patients were on insulin. The average duration of diabetes was 5.9 (SD, 7.3) years. Remote images from OCT were significantly more interpretable than CFP (98% vs 83%, respectively; P < .001). Referral rates were 9% for DR and 28% for incidental findings. Among patients with DR, OCT and CFP were helpful in 58% and 87% of cases, respectively ( P < .001). Conclusions: Remote diagnosis of ophthalmic imaging at the point of service may allow for early identification of retinal disease and timely referral and treatment. Our approach showed that OCT had significantly better interpretability, while CFP was more helpful in identifying DR. These findings may be important when choosing the screening device in a specific context.

Recommendations for proficiency testing criteria for hemoglobin A1c based on the Shanghai Center for Clinical Laboratory’s study

Objectives The US Centers for Medicare & Medicaid Services proposed in 2019 that glycated hemoglobin A1c (HbA1c) be a CLIA′88 regulated analyte. People who commented expressed concerns that the proposed acceptance limit (AL, HbA1c in NGSP unit) ±10% for proficiency testing (PT) would be unable to maintain already improved analytical performance and guarantee the clinical utility of HbA1c testing. Assessing impact of various ALs on PT performance is needed to provide scientific evidence for adopting an appropriate AL. Methods Ten patient EDTA-whole blood specimens were distributed to 318 and 336 laboratories in the 2018 and 2019 PT events organized by Shanghai Center for Clinical Laboratory (SCCL). HbA1c concentrations were measured by participants using various methodologies commonly used in the USA and China. Targets were determined using secondary reference measurement procedures (SRM) at SCCL. “Failed Results” were those outside the SRM-defined target ± AL (5% through 10%). Laboratories with Failed Results ≥2 out of five samples per PT event obtained Event Unsatisfactory Status. Results HbA1c target values ranged 33.3 mmol/mol (5.2 NGSP%) −102.2 mmol/mol (11.5 NGSP%) for 2018 event, and 33.3 mmol/mol (5.2 NGSP%) −84.7 mmol/mol (9.9 NGSP%) for 2019 event. Overall Laboratory Event Unsatisfactory Rates were 11.3–12.2%, 4.8–5.3%, 0.9–3.1%, 0.6–2.2%, 0.6–1.4% and 0.6–1.4%, at AL of ±5, ±6, ±7, ±8, ±9 and ±10%, respectively. Conclusions The AL (in NGSP unit) of ±6% or ±7% for PT evaluation of HbA1c results would be appropriate, with satisfactory event scores for about 95% of participant laboratories in a PT event.

A Carbon-Based Antifouling Nano-Biosensing Interface for Label-Free POCT of HbA1c

Electrochemical biosensing relies on electron transport on electrode surfaces. However, electrode inactivation and biofouling caused by a complex biological sample severely decrease the efficiency of electron transfer and the specificity of biosensing. Here, we designed a three-dimensional antifouling nano-biosensing interface to improve the efficiency of electron transfer by a layer of bovine serum albumin (BSA) and multi-walled carbon nanotubes (MWCNTs) cross-linked with glutaraldehyde (GA). The electrochemical properties of the BSA/MWCNTs/GA layer were investigated using both cyclic voltammetry and electrochemical impedance to demonstrate its high-efficiency antifouling nano-biosensing interface. The BSA/MWCNTs/GA layer kept 92% of the original signal in 1% BSA and 88% of that in unprocessed human serum after a 1-month exposure, respectively. Importantly, we functionalized the BSA/MWCNTs/GA layer with HbA1c antibody (anti-HbA1c) and 3-aminophenylboronic acid (APBA) for sensitive detection of glycated hemoglobin A (HbA1c). The label-free direct electrocatalytic oxidation of HbA1c was investigated by cyclic voltammetry (CV). The linear dynamic range of 2 to 15% of blood glycated hemoglobin A (HbA1c) in non-glycated hemoglobin (HbAo) was determined. The detection limit was 0.4%. This high degree of differentiation would facilitate a label-free POCT detection of HbA1c.

HemoDownloader: Open source software utility to extract data from HemoCue HbA1c 501 devices in epidemiological studies of diabetes mellitus

Diabetes mellitus is a serious disease with increasing global prevalence. Point-of-care analysis of glycated hemoglobin A (HbA1c) holds promise as a diagnostic test for diabetes mellitus in epidemiological studies in challenging environments with limited access to centralized biochemical labs. The HemoCue HbA1c 501 device can be used for point-of-care determination of HbA1c, but its usability in epidemiological studies is limited by its inability to export results in digital format. We have developed the open source HemoDownloader software to overcome this limitation of the device. HemoDownloader has an easy-to-use graphical user interface and can export data from HemoCue HbA1c 501 to standard spreadsheet file formats. The program has the potential to improve data collection and management in epidemiological studies of diabetes mellitus.

Effects of Telemetric Interventions on Maternal and Fetal or Neonatal Outcomes in Gestational Diabetes: Systematic Meta-Review (Preprint)

BACKGROUND In 2019, 1 of 6 births was affected by gestational diabetes mellitus (GDM) globally. GDM results in adverse maternal, fetal, and neonatal outcomes in the short and long term, such as pregnancy and birth complications, type 2 diabetes, metabolic syndrome, and cardiovascular disease. In the context of “transgenerational programming,” diabetes mellitus during pregnancy can contribute to “programming” errors and long-term consequences for the child. Therefore, early therapy strategies are required to improve the clinical management of GDM. The interest in digital therapy approaches, such as telemetry, has increased because they are promising, innovative, and sustainable. OBJECTIVE This study aimed to assess the current evidence regarding the clinical effectiveness of telemetric interventions in the management of GDM, addressing maternal glycemic control, scheduled and unscheduled visits, satisfaction, diabetes self-efficacy, compliance, maternal complications in pregnancy and childbirth, as well as fetal and neonatal outcomes. METHODS Medline via PubMed, Web of Science Core Collection, Embase, Cochrane Library, and CINAHL databases were systematically searched from January 2008 to April 2020. We included randomized controlled trials, systematic reviews, meta-analyses, and clinical trials in English and German. Study quality was assessed using “A MeaSurement Tool to Assess systematic Reviews” and “Effective Public Health Practice Project.” RESULTS Our search identified 1116 unique studies. Finally, we included 11 suitable studies (including a total of 563 patients and 2779 patient cases): 4 systematic reviews or meta-analyses (1 of high quality and 3 of moderate quality), 6 randomized controlled trials (2 of high quality and 4 of moderate quality), and 1 low-quality nonrandomized controlled trial. We classified 4 “asynchronous interventions” and 3 “asynchronous and real-time interventions.” Our findings indicate that telemetric therapy clearly improves glycemic control and effectively reduces glycated hemoglobin A_1c levels. Furthermore, in 1 study, telemetry proved to be a significant predictor for a better glycemic control (hazard ratio=1.71, 95% CI 1.11-2.65; <i>P</i>=.02), significantly fewer insulin titrations were required (<i>P</i>=.04), and glycemic control was achieved earlier. Telemetric therapy significantly reduced scheduled and unscheduled clinic visits effectively, and women were highly satisfied with the treatment (<i>P</i>&lt;.05). From fetal and neonatal short-term outcomes, some improving tendencies in favor of telemetry were determined. No long-term outcomes were detected. CONCLUSIONS Telemetric interventions clearly improved glycemic control, notably glycated hemoglobin A_1c levels, and reduced scheduled and unscheduled clinic visits effectively, which reinforces this digital approach in the treatment of GDM.

Effects of periodontal therapy with topical antibiotics in the glycemic control of diabetic patients: systematic review.

Background: Periodontal disease is considered as a diabetes complication and has been suggested that periodontal treatment plus antibiotics should reduce glycated hemoglobin A, by reducing local production of pro inflammatory substances. Objective: To evaluate diabetic patients with periodontal disease under periodontal treatment plus topical antibiotics and reduction of HbA1c, compared to diabetic patients under periodontal treatment without antibiotics. Materials and Methods: Using PUBMED, SCOPUS, WEB OF SCIENCE, EMBASE and Google Scholar data bases, were screened documents from 2008 to 2018. The documents included were the clinical studies, which included non-surgical periodontal treatment plus topical antibiotics, whose outcomes included the HbA1c report. Two independent researchers evaluate title; abstract and bias risk with Downs Black scale and Cochrane tool. Documents with a score higher than 15 on average by the two evaluators were included. Results: Five articles, which find inclusion criteria, were identified. Two documents failed to demonstrate statistically significant effect when compared to non-surgical periodontal therapy alone. Conclusion: In general a modest reduction of HbA1c was identified when using antibiotic therapy.

The Association between Helicobacter pylori Infection and Glycated Hemoglobin A in Diabetes: A Meta-Analysis

Background.The association between Helicobacter pylori infection and glycated hemoglobin A has been confirmed in many studies, but these conclusions are still contradictory and controversial. Therefore, we conducted a meta-analysis to resolve the problem of inconsistent results in diabetes.Methods. A comprehensive search was conducted on related researches published in PubMed, Embase, and China Academic Journal Full-text Database (CNKI) from the inception of each database to April 2019. Fixed or random effects model was used to pool the weighted mean difference with 95% confidence interval from individual studies. Subgroup and sensitivity analyses were also performed. Publication bias was estimated by funnel plot, Egger’s test, and fail-safe numbers.Results. 35 studies with 4,401 participants with diabetes were included in the meta-analysis. Glycated hemoglobin A levels were elevated in patients with Helicobacter pylori infection compared with patients without Helicobacter pylori infection (WMD=0.50, 95% CI: 0.28-0.72,p<0.001). In subgroup analysis by the subtype of diabetes, there was a correlation between Helicobacter pylori infection and elevated glycated hemoglobin A in type 1 diabetes (I2=74%,p<0.001,WMD=0.46, 95% CI: 0.12-0.80), and in type 2 diabetes (I2=90%,p<0.001,WMD=0.59, 95% CI: 0.28-0.90,p<0.001). In subgroup analysis by the study design, there was a correlation in cross-sectional study (I2=89%,p<0.001,WMD=0.42, 95% CI: 0.16-0.69,p≤0.003) and in case-control study (I2=83%,p<0.001,WMD=0.39, 95% CI: 0.14-0.64,p≤0.003). By different methods for detecting Helicobacter pylori, there was a correlation in the biopsy group (I2=83%,p<0.001,WMD=0.6, 95% CI: 0.11-1.09,p≤0.03) and in other groups of test methods (I2=87%,p<0.001,WMD=0.37, 95% CI: 0.17-0.56,p<0.001). Sensitivity analysis showed that our results were reliable, and no evidence of substantial publication bias was detected.Conclusion. The meta-analysis might indicate a correlation between Helicobacter pylori infection and glycated hemoglobin A levels in diabetes.