Dynamics of glucose levels after Billroth I versus Roux-en-Y reconstruction in patients who undergo distal gastrectomy.

PURPOSE: Recent studies have highlighted the importance of understanding trends in blood glucose levels. We examined the differences in blood glucose fluctuations according to the reconstruction method used after distal gastrectomy (DG) in patients with non-diabetic gastric cancer (GC). METHODS: Sixty-one patients who underwent DG followed by either Billroth 1 (B1) or Roux-en-Y (R-Y) reconstruction were enrolled in this study. We used flash continuous glucose monitoring (CGM), a new technique for assessing glycemic control, to document the post-gastrectomy glycemic profile. Immediately before discharge, a CGM sensor was placed subcutaneously to evaluate blood glucose trends for 2 weeks. RESULTS: The coefficient of variation of glucose levels was significantly higher in the Roux-en-Y (R-Y) group than in the Billroth I (B-I) group (p = 0.0260). The time below range (TBR, glucose levels of < 70 mg/dL) was also significantly higher in the R-Y group (p = 0.0115). Logistic regression analysis revealed that preoperative casual glucose levels of < 100 mg/dL and R-Y reconstruction were independently correlated with risk factors for a postoperative nocturnal TBR of > 30% (p = 0.006 and 0.042, respectively). CONCLUSION: Our findings provide new insights into the post-DG reconstruction method selected for patients with non-diabetic gastric cancer by assessing postoperative blood glucose fluctuations using flash CGM.

Type 2 diabetes in latin America: recommendations on the flash glucose monitoring system.

OBJECTIVE: To establish recommendations through the consensus of a Latin American experts panel on the use of the flash glucose monitoring system (fCGM) in people living with type 2 diabetes mellitus (T2DM) regarding the benefits and challenges of using the fCGM. METHODS: An executive committee of experts was created, comprised by a panel of fifteen physicians, including endocrinologists and internal medicine physicians, with expertise in management of adult patients with T2DM. The experts were from various countries: Colombia, Chile, Peru, Mexico, Argentina, and Brazil. The modified Delphi method was used, considering a consensus level of at least 80% of the participants. A seventeen-item instrument was developed to establish recommendations on the use of fCGM in patients with T2DM in Latin American. RESULTS: The number of glucose scans recommended per day with the fCGM for patients managed with oral antidiabetic drugs or basal insulin was a median of 6 scans per day, and for those managed with multiple insulin doses, a median of 10 scans per day was recommended. Additionally, a holistic and individualized management approach was recommended, taking into account new treatment directions and identifying patients who would benefit from the use of the fCGM. CONCLUSION: Continuous use of the fCGM is recommended for people living with T2DM, regardless of their type of treatment. These metrics must be evaluated individually for each patient profile.

Recommendations on the use of the flash continuous glucose monitoring system in hospitalized patients with diabetes in Latin America.

BACKGROUND: Continuous glucose monitoring can improve glycemic control for hospitalized patients with diabetes, according to current evidence. However, there is a lack of consensus-established recommendations for the management of hospitalized patients with diabetes using flash continuous glucose monitoring system (fCGM) in Latin America. Therefore, this expert consensus exercise aimed to establish guidelines on the implementation of fCGM in the management of hospitalized patients with diabetes in Latin America. METHODS: The modified Delphi method was applied on a panel of nine specialists, establishing consensus at 80%. A twenty-two-question instrument was developed to establish recommendations on the use of fCGM in hospitalized patients living with diabetes. RESULTS: Based on consensus, experts recommend the use of fCGM in hospitalized patients with diabetes starting at admission or whenever hyperglycemia (> 180 mg/dl) is confirmed and continue monitoring throughout the entire hospital stay. The recommended frequency of fCGM scans varies depending on the patient's age and diabetes type: ten scans per day for pediatric patients with type 1 and 2 diabetes, adult patients with type 1 diabetes and pregnant patients, and seven scans for adult patients with type 2 diabetes. Different hospital services can benefit from fCGM, including the emergency room, internal medicine departments, intensive care units, surgery rooms, and surgery wards. CONCLUSIONS: The use of fCGM is recommended for patients with diabetes starting at the time of admission in hospitals in Latin America, whenever the necessary resources (devices, education, personnel) are available.

Diabetes Complications and Related Comorbidities Impair the Accuracy of FreeStyle Libre, a Flash Continuous Glucose Monitoring System, in Patients with Type 2 Diabetes.

Background: Although flash continuous glucose monitoring systems (FCGM) accuracy has been extensively studied in diabetes, its accuracy is still not fully evaluated in type 2 diabetes (T2D) patients in real-world settings. In the present study, we aim to assess the effects of diabetes complications and related comorbidities on FCGM accuracy in T2D patients with diabetes complications and related comorbidities in the real world. Methods: FCGM data were collected at eight-time points daily (3 AM, 7 AM, 9 AM, 11 AM, 1 PM, 5 PM, 7 PM, and 9 PM) from 742 patients with T2D and compared with simultaneous fingertip capillary blood glucose (reference blood glucose, REF), and the difference was evaluated using Parkes error grid (PEG), surveillance error grid (SEG), and logistic regression analysis. Results: In total, 25,579 FCGM/REF data pairs were included in the study. The FCGM values were lower than the paired REF values in 75% of the pairs. The maximum bias (-23.0%) and maximum mean absolute relative difference (24.5%) were observed at 3 AM among eight-time points. SEG analysis also demonstrated the highest percentage of paired readings in moderate and great risk zone (C and D) at 3 AM than PEG analysis (7.33% vs 0.43%, P<0.001). According to the SEG classification, hypoglycemia, infection, diabetic foot, diabetic ketoacidosis, and hypertension were independent risk factors that impaired FCGM accuracy in patients. Conclusion: FCGM commonly underestimates blood glucose levels. Compared with PEG, SEG analysis seems more conducive to the analysis of FCGM performance. The present data highlights the impairment of diabetes complications and related comorbidities on the FCGM accuracy in T2D patients.

Association between Changes in the Systolic Blood Pressure from Evening to the Next Morning and Night Glucose Variability in Heart Disease Patients.

Objectve To assess the impact of glycemic variability on blood pressure in hospitalized patients with cardiac disease. Methods In 40 patients with cardiovascular disease, the glucose levels were monitored by flash continuous glucose monitoring (FGM; Free-Style Libre™ or Free-Style Libre Pro; Abbott, Witney, UK) and self-monitoring blood glucose (SMBG) for 14 days. Blood pressure measurements were performed twice daily (morning and evening) at the same time as the glucose level measurement using SMBG. Results The detection rate of hypoglycemia using the FGM method was significantly higher than that with the 5-point SMBG method (77.5% vs. 5.0%, p<0.001). Changes in the systolic blood pressure from evening to the next morning [morning - evening (ME) difference] were significantly correlated with night glucose variability (r=0.63, P<0.001). A multiple regression analysis showed that night glucose variability using FGM was more closely correlated with the ME difference [r=0.62 (95% confidence interval, 0.019-0.051); p<0.001] than with the age, body mass index, or smoking history. Night glucose variability was also more closely associated with the ME difference in patients with unstable angina pectoris (UAP) than in those with acute myocardial infarction (AMI) or heart failure (HF) (r=0.83, p=0.058). Conclusion Night glucose variability is associated with the ME blood pressure difference, and FGM is more accurate than the 5-point SMBG approach for detecting such variability.

Clinical interpretation of the flash continuous glucose monitoring data out of range in type 2 diabetes: A real-world study.

AIMS: Flash continuous glucose monitoring system (FCGM) reports nocturnal hypoglycemia with low accuracy in low blood glucose. In our study, we aimed to evaluate the accuracy and clinic profile of FCGM data out of range in T2DM. METHODS: FCGM data out of range were measured in T2DM patients at eight-time points of a day and compared with fingertip capillary blood glucose levels (REFs) as reference values. RESULTS: A total of 307 out-of-range cases from 25,886 paired FCGM/REF data from 742 T2DM patients were evaluated. The distribution of "LO" and "HI" cases displayed the significant difference between eight-time points (P < 0.001) with the highest frequency (6.52%) of the "LO" value at 3 AM. The consistency rate between FCGM "LO" readings and REF < 40 mg/dl was far lower than that of FCGM "HI" readings with REF > 500 mg/dl (0.84% vs. 52.2%). In addition, the frequency of some clinical characteristics, including diabetes duration, hypoglycemia, hypertension, HbA1c, and Hb, were higher in patients with FCGM "LO" readings compared to those with "HI" readings. CONCLUSIONS: These findings suggest the results and treatment regarding FCGM "LO" data should be interpreted with strong caution in the light of the emerging possible adverse measurement in patients.

Cost-Effectiveness of the FreeStyle Libre® System Versus Blood Glucose Self-Monitoring in Individuals with Type 2 Diabetes on Insulin Treatment in Sweden.

INTRODUCTION: Frequent glucose monitoring is essential to obtain glucose control. This is done by periodic self-monitoring of blood glucose (SMBG) using finger-prick testing, or by using continuous glucose monitoring devices, wherein a sensor records interstitial glucose data automatically. This study assessed the cost-effectiveness of using the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) compared to SMBG in individuals with type 2 diabetes (T2D) treated with insulin from a Swedish societal perspective. METHODS: Cost-effectiveness analysis was conducted using the IQVIA Core Diabetes model v9.5, with demographic and clinical inputs from a real-world study using Swedish National Diabetes Register data. Two cohorts of individuals with T2D were considered based on baseline HbA1C (HbA1c: 8-9% [64-75 mmol/mol]; HbA1c: 9-12% [75-108 mmol/mol]). HbA1c reductions with FSL were - 0.41% (- 4 mmol/mol; SD: 0.94%-10 mmol/mol) and - 1.30% (- 14 mmol/mol; SD: 1.40%-15 mmol/mol) for the two cohorts, respectively. Utilities, treatment costs and diabetes-related complication costs were obtained from published sources. Analyses were conducted over a lifetime horizon, applying annual discounting of 3% on costs and effects. Scenario analyses and probabilistic sensitivity analyses were performed. RESULTS: Individuals with T2D who had a baseline HbA1c of 8-9% (64-75 mmol/mol) and 9-12% (75-108 mmol/mol) and used FSL gained 0.50 and 0.57 quality-adjusted life-years (QALYs), respectively, at an incremental cost of SEK109,957 and SEK82,170 compared to SMBG, generating an incremental cost-utility ratio of SEK219,127 and SEK144,412 per QALY gained. Assuming a willingness-to-pay threshold of SEK300,000 per QALY gained, FSL use was considered cost-effective compared to SMBG for the majority of the individuals in both the lower and higher HbA1c cohorts. The key driver identified was the additional quality-of-life benefit that applied to FSL use. CONCLUSION: The FreeStyle Libre Flash Continuous Glucose Monitoring System is a cost-effective glucose monitoring alternative to SMBG for individuals with T2D in Sweden who are treated with insulin but are not reaching their glycaemic goals.

The road from intermittently scanned continuous glucose monitoring to hybrid closed-loop systems. Part B: results from randomized controlled trials.

BACKGROUND: Advances in diabetes technology have been exponential in the last few decades. With evolution in continuous glucose monitoring (CGM) systems and its progressive automation in control of insulin delivery, these advances have changed type 1 diabetes mellitus (T1DM) management. These novel technologies have the potential to improve glycated haemoglobin (HbA1c), reduce hypoglycaemic events, increase time spent in range and improve quality of life (QoL). Our aim was to evaluate the sustained effects in free-living unsupervised conditions of CGM systems (intermittently scanned and real time) and insulin delivery [from multiple daily injections, via sensor-augmented pump therapy and (predictive) low-glucose insulin suspension to hybrid closed-loop systems] on glucose control and QoL in adults and children with T1DM. METHODS: We performed a systematic review of randomized controlled trials (RCTs), using PubMed and the Cochrane library up to 30 May 2019. Inclusion of RCTs was based on type of intervention (comparing glucose-monitoring devices and insulin-delivery devices), population (nonpregnant adults and children with T1DM), follow-up (outpatient setting for at least 8 weeks) and relevant outcomes [HbA1c, time in range (TIR), time in target, time in hypoglycaemia and QoL]. Exclusion of RCTs was based on intervention (exercise, only overnight use). The Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were used to score the quality of the papers and for the final selection of the articles. RESULTS: Our search resulted in 214 articles, of which 19 were eligible. Studies on advanced use in adults and children with T1DM reported increased TIR (all 9 studies); decreased time in hypoglycaemia (13 out of 15 studies); lowered HbA1c levels (5 out of 15 studies); improved QoL (10 of 16 studies) and treatment satisfaction (7 studies). CONCLUSIONS: Recent technologies have dramatically changed the course of T1DM. They are proving useful in controlling glycaemia in patients with T1DM, without increasing the treatment burden.

Metrics Beyond Hemoglobin A1C in Diabetes Management: Time in Range, Hypoglycemia, and Other Parameters.

We review clinical instances in which A1C should not be used and reflect on the use of other glucose metrics that can be used, in substitution of or in combination with A1C and SMBG, to tailor an individualized approach that will result in better outcomes and patient empowerment.

Professional flash continuous glucose monitoring as a supplement to A1C in primary care.

Decreasing glycated hemoglobin (A1C) is the primary goal of current diabetes management due to intervention studies in type 1 and type 2 diabetes associating levels <7.0% (53 mmol/mol) with lower complication risk. Strategic self-monitoring of blood glucose (SMBG) is also recommended to achieve greater time in range, with fewer extremes of hypo- or hyperglycemia. Unlike A1C, SMBG can distinguish among fasting, prandial, and postprandial hyperglycemia; uncover glycemic variability, including potentially dangerous hypoglycemia; and provide feedback to patients about the effects of behavior and medication on glycemic control. However, it has the drawback of capturing only static glucose readings and users are often dependent on time-pressed clinicians to interpret numerous data points. A novel flash continuous glucose monitoring (FCGM) device used for a single 2-week period with a readily interpretable data report know as the ambulatory glucose profile (AGP) has the potential to overcome limitations of conventional technologies, with less cost and greater convenience. This review summarizes the rationale for using intermittent FCGM as a supplement to A1C in primary care, and provides a stepwise approach to interpreting the AGP visual display for efficient individualized therapy.

How Can We Realize the Clinical Benefits of Continuous Glucose Monitoring?

Controlling glycemia in diabetes remains key to prevent complications in this condition. However, glucose levels can undergo large fluctuations secondary to daily activities, consequently creating management difficulties. The current review summarizes the basics of glucose management in diabetes by addressing the main glycemic parameters. The advantages and limitation of HbA1c, the gold standard measure of glucose control, are discussed together with the clinical importance of hypoglycemia and glycemic variability. The review subsequently moves focus to glucose monitoring techniques in diabetes, assessing advantages and limitations. Monitoring glucose levels is crucial for effective and safe adjustment of hypoglycemic therapy, particularly in insulin users. Self-monitoring of blood glucose (SMBG), based on capillary glucose testing, remains one of the most widely used methods to monitor glucose levels, given the relative accuracy, familiarity, and manageable costs. However, patient inconvenience and the sporadic nature of SMBG limit clinical effectiveness of this approach. In contrast, continuous glucose monitoring (CGM) provides a more comprehensive picture of glucose levels, but these systems are expensive and require constant calibration which, together with concerns over accuracy of earlier devices, restrict CGM use to special groups of patients. The newer flash continuous glucose monitoring (FCGM) system, which is more affordable than conventional CGM devices and does not require calibration, offers an alternative glucose monitoring strategy that comprehensively analyzes glucose profile while sparing patients the inconvenience of capillary glucose testing for therapy adjustment or CGM calibration. The fast development of new CGM devices will gradually displace SMBG as the main glucose testing method. Avoiding the inconvenience of SMBG and optimizing glycemia through alternative glucose testing strategies will help to reduce the risk of complications and improve quality of life in patients with diabetes.