Project description:The ambulatory glucose profile (AGP) lacks sufficient statistical metrics and insightful graphs; indeed, it is missing important information on the temporal patterns of glucose variations. The AGP graph is difficult to interpret due to the overlapping metrics and fluctuations in glucose levels over 14 days. The objective of this proposed work is to overcome these challenges, specifically the lack of insightful information and difficulty in interpreting AGP graphs, to create a platform for decision assistance. The present work proposes 20 findings built from decision rules that were developed from a combination of AGP metrics and additional statistical metrics, which have the potential to identify patterns and insightful information on hyperglycemia and hypoglycemia. The "CGM Trace" webpage was developed, in which insightful metrics and graphical representations can be used to make inferences regarding the glucose data of any user. However, doctors (endocrinologists) can access the "Findings" tab for a summarized presentation of their patients' glycemic control. The findings were implemented for 67 patients' data, in which the data of 15 patients were collected from a clinical study and the data of 52 patients were gathered from a public dataset. The findings were validated by means of MANOVA (multivariate analysis of variance), wherein a p value of < 0.05 was obtained, depicting a strong significant correlation between the findings and the metrics. The proposed work from "CGM Trace" offers a deeper understanding of the CGM data, enhancing AGP reports for doctors to make treatment adjustments based on insightful information and hidden patterns for better diabetic management.
Project description:BackgroundTreatment indexes using continuous glucose monitoring (CGM) have become standardized internationally, and the use of ambulatory glucose profile (AGP) is currently recommended. However, the relationship between AGP indexes and standardized CGM metrics has not been investigated. Using flash glucose monitoring (FGM), this retrospective study served to evaluate the association of the inter-quartile range (IQR) of AGP with standardized CGM metrics.MethodsThe study subjects were 30 patients with type 2 diabetes mellitus (T2DM) and 23 non-diabetic patients (control group). We evaluated average IQR (AIQR) and standardized CGM metrics. The primary endpoint was the relationship between AIQR and Time in range (TIR) in a 24-h period.ResultsIn the T2DM group, the AIQR was notably high and correlated negatively with TIR, and positively with Time above range, average interstitial glucose level, standard deviation of interstitial glucose, coefficient of variation of interstitial glucose, and mean of daily difference in blood glucose (MODD). For the T2DM group, the AIQR was notably lower in patients who achieved TIR > 70%, compared to those who did not. The AIQR cutoff value, as determined by ROC analysis, was 28.3 mg/dl for those who achieved TIR > 70%. No association was detected between the presence of hypoglycemia and AIQR.ConclusionsOur study is the first to provide the AIQR cutoff value for achieving the TIR target value. The range of interstitial glucose variability in AGP was associated with indexes of intra- and interday variations and hyperglycemia. Our results provide new perspectives in the yet-to-be established methods for evaluation of AGP in practical clinical settings.
Project description:BackgroundAutonomic neuropathy commonly occurs as a long-term complication of diabetes mellitus (DM) and can be diagnosed based on heart rate variability (HRV), calculated from electrocardiogram (ECG) recordings. There are limited data on HRV using real-time ECG and ambulatory glucose monitoring in patients with DM. The aim of this study was to investigate real-time HRV according to ambulatory glucose levels in patients with DM.MethodsA total of 43 patients (66.3 ± 7.5 years) with DM underwent continuous real-time ECG monitoring (225.7 ± 107.3 h) for HRV and ambulatory glucose monitoring using a remote monitoring system. We compared the HRV according to the ambulatory glucose profile. Data were analyzed according to the target in glucose range (TIR).ResultsThere were no significant differences in the baseline characteristics of the patients according to the TIR. During monitoring, we checked ECG and ambulatory glucose levels (a total of 15,090 times) simultaneously for all patients. Both time- and frequency-domain HRVs were lower when the patients had poorly controlled glucose levels (TIR < 70%) compared with well controlled glucose levels (TIR > 70%). In addition, heart and respiratory rates increased with real-time glucose levels (P < 0.001).ConclusionsPoorly controlled glucose levels were independently associated with lower HRV in patients with DM. This was further substantiated by the independent continuous association between real-time measurements of hyperglycemia and lower HRV. These data strongly suggest that cardiac autonomic dysfunction is caused by elevated blood sugar levels.
Project description:BackgroundIn 2014, an innovative blinded continuous glucose monitoring system was introduced with automated ambulatory glucose profile (AGP) reporting. The clinical use and interpretation of this new technology has not previously been described. Therefore we wanted to understand its use in characterizing key factors related to glycemic control: glucose exposure, variability, and stability, and risk of hypoglycemia in clinical practice.MethodsClinicians representing affiliated diabetes centers throughout South Africa were trained and subsequently were given flash glucose monitoring readers and 2-week glucose sensors to use at their discretion. After patient use, sensor data were collected and uploaded for AGP reporting.ResultsComplete data (sensor AGP with corresponding clinical information) were obtained for 50 patients with type 1 (70%) and type 2 diabetes (30%), irrespective of therapy. Aggregated analysis of AGP data comparing patients with type 1 versus type 2 diabetes, revealed that despite similar HbA1c values between both groups (8.4 ± 2 vs 8.6 ± 1.7%, respectively), those with type 2 diabetes had lower mean glucose levels (9.2 ± 3 vs 10.3 mmol/l [166 ± 54 vs 185 mg/dl]) and lower indices of glucose variability (3.0 ± 1.5 vs 5.0 ± 1.9 mmol/l [54 ± 27 vs 90 ± 34.2 mg/dl]). This highlights key areas for future focus.ConclusionsUsing AGP, the characteristics of glucose exposure, variability, stability, and hypoglycemia risk and occurrence were obtained within a short time and with minimal provider and patient input. In a survey at the time of the follow-up visit, clinicians indicated that aggregated AGP data analysis provided important new clinical information and insights.
Project description:The ambulatory glucose profile (AGP) is now established as the standardised, practical one-page report for graphically presenting a summary of glycaemic control status in patients with diabetes who use continuous glucose monitoring (CGM) systems as part of their daily diabetes care. The AGP report provides both a visual and a statistical summary of the glucose metrics that, as agreed in the 2019 international consensus for assessing glycaemic control, should be analysed in all people with diabetes who are using CGM systems. The AGP report can be analysed in a systematic fashion to understand current glycaemic control and to monitor, in real time, the impact of adjustments to therapy in both type 1 diabetes and type 2 diabetes. Here we provide a practical guide to the glycaemic measures that are summarised in the AGP Report and illustrate the essential components of an AGP review in a series of hypothetical, real-world, patient-centred case studies (see Supplementary Materials).
Project description:BackgroundMeasuring function with valid and responsive tools in patients with cancer is essential for driving clinical decision-making and for the end points of clinical trials. Current patient-reported outcome measurements of function fall short for many reasons. This study evaluates the responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile, a novel measure of function across multiple domains.MethodsTwo hundred nine participants across five geographically distinct tertiary care centers completed the assessment and pain rating at two outpatient cancer rehabilitation clinic visits. Patients and providers completed a global rating of change measure at the second visit to indicate whether the patient was improving or worsening in function. Multiple response indices and linear models measured whether the measure was responsive to self-reported and clinician-rated changes over time. Correlations between changes in function and changes in anchors (pain rating and performance status) were also calculated.ResultsFunction as measured by the PROMIS Cancer Function Brief 3D Profile changed appropriately as both patients and clinicians rated change. Small to moderate effect sizes supported the tool's responsiveness. Function was moderately correlated with pain and more strongly correlated with performance status, and changes in function corresponded with changes in anchor variables. No floor/ceiling effect was found.ConclusionsThe PROMIS Cancer Function Brief 3D Profile is sensitive to changes over time in patients with cancer. The measure may be useful in clinical practice and as an end point in clinical trials.Lay summaryWe gave patients a questionnaire by which they told their physicians how well they were functioning, including how fatigued they were. This study tested that questionnaire to see whether the scores would change if patients got better or worse.
Project description:BackgroundHypertension affects about 36 million Brazilians. It is estimated that 10%-20% of these have resistant hypertension. These patients are at an increased risk of early target organ damage, as well as cardiovascular and renal events.ObjectiveTo estimate the prevalence of resistant hypertension in a specialized outpatient clinic, to describe the sociodemographic and clinical characteristics of these patients, and to identify possible factors associated with resistant hypertension.MethodsData collection from medical records of hypertensive patients treated using oral antihypertensive drugs in optimized doses at a specialized university clinic from March 2014 to December 2014, after ethical approval statement. All patients were using appropriate antihypertensive drugs in optimized doses and assisted at a teaching-assistance clinic of internal medicine of the Bahiana School of Medicine and Public Health in Brazil.ResultsA total of 104 patients were enrolled and 31.7% (n = 33) had criteria for resistant hypertension. Of the total participants, 75.7% were female and 54.8% were black or brown. The average age was 61.7 years (SD ± 10.1). In the resistant hypertension group, 63.6% had diabetes, compared to 32.4% in the hypertension group. Among resistant hypertensive patients, 51.5% had dyslipidemia. Regarding drug treatment, 75.8% of the resistant hypertension group and 51.4% of the hypertension group used statins. Among patients with resistant hypertension, 90.9% used angiotensin II receptor blockers and 66.7%, dihydropyridine calcium channel blockers. In the resistant hypertension group, 75.8% used beta-blockers, against 25.4% in the hypertension group.ConclusionThe prevalence of hypertension was higher than that described in the global literature, which may be associated with the high percentage of black and brown ("pardos") patients in the population studied, and also because the study was performed in a specialized outpatient clinic.
Project description:Glucose-6-phosphate dehydrogenase (G6PD) deficiency affects over 500 million individuals who can experience anemia in response to oxidative stressors such as certain foods and drugs. Recently, the World Health Organization (WHO) called for revisiting G6PD variant classification as a priority to implement genetic medicine in low- and middle-income countries. Toward this goal, we sought to collect reports of G6PD variants and provide interpretations. We identified 1,341 G6PD variants in population and clinical databases. Using the ACMG standards and guidelines for the interpretation of sequence variants, we provided interpretations for 268 variants, including 186 variants that were not reported or of uncertain significance in ClinVar, bringing the total number of variants with non-conflicting interpretations to 400. For 414 variants with functional or clinical data, we analyzed associations between activity, stability, and current classification systems, including the new 2022 WHO classification. We corroborated known challenges with classification systems, including phenotypic variation, emphasizing the importance of comparing variant effects across individuals and studies. Biobank data made available by All of Us illustrate the benefit of large-scale sequencing and phenotyping by adding additional support connecting variants to G6PD-deficient anemia. By leveraging available data and interpretation guidelines, we created a repository for information on G6PD variants and nearly doubled the number of variants with clinical interpretations. These tools enable better interpretation of G6PD variants for the implementation of genetic medicine.
Project description:BackgroundClinical interpretation of continuous glucose monitoring (CGM) data for people without diabetes has not been well established. This study aimed to investigate concordance among CGM experts in recommending clinical follow-up for individuals without diabetes, based upon their independent review of CGM data.MethodsWe sent a survey out to expert clinicians (n = 18) and asked them to evaluate 20 potentially challenging Dexcom G6 Pro CGM reports (and hemoglobin A1c [HbA1c] and fasting venous blood glucose levels) from individuals without diabetes. Clinicians reported whether they would recommend follow-up and the reasoning for their decision. We performed Fleiss Kappa interrater reliability to determine agreement among clinicians.ResultsMore than half of expert clinicians (56-100%, but no clear consensus) recommended follow-up to individuals who spent >2% time above range (>180 mg/dL), even if HbA1c <5.7% and fasting glucose <100 mg/dL. There were no observed trends for recommending follow-up based on mean glucose or glucose management indicator. Overall, we observed poor agreement in recommendations for who should receive follow-up based on their CGM report (Fleiss Kappa = 0.36).ConclusionsHigh discordance among expert clinicians when interpreting potentially challenging CGM reports for people without diabetes highlights the need for more research in developing normative data for people without diabetes. Future work is required to develop CGM criteria for identifying potentially high-risk individuals who may progress to prediabetes or type 2 diabetes.