Flash Continuous Glucose Monitoring Research Articles

Time in Range, Time in Tight Range, and Average Glucose Relationships Are Modulated by Glycemic Variability: Identification of a Glucose Distribution Model Connecting Glycemic Parameters Using Real-World Data.

Background: Time in range (TIR), time in tight range (TITR), and average glucose (AG) are used to adjust glycemic therapies in diabetes. However, TIR/TITR and AG can show a disconnect, which may create management difficulties. We aimed to understand the factors influencing the relationships between these glycemic markers. Materials and Methods: Real-world glucose data were collected from self-identified diabetes type 1 and type 2 diabetes (T1D and T2D) individuals using flash continuous glucose monitoring (FCGM). The effects of glycemic variability, assessed as glucose coefficient of variation (CV), on the relationship between AG and TIR/TITR were investigated together with the best-fit glucose distribution model that addresses these relationships. Results: Of 29,164 FCGM users (16,367 T1D, 11,061 T2D, and 1736 others), 38,259 glucose readings/individual were available. Comparing low and high CV tertiles, TIR at AG of 150 mg/dL varied from 80% ± 5.6% to 62% ± 6.8%, respectively (P < 0.001), while TITR at AG of 130 mg/dL varied from 65% ± 7.5% to 49% ± 7.0%, respectively (P < 0.001). In contrast, higher CV was associated with increased TIR and TITR at AG levels outside the upper limit of these ranges. Gamma distribution was superior to six other models at explaining AG and TIR/TITR interactions and demonstrated nonlinear interplay between these metrics. Conclusions: The gamma model accurately predicts interactions between CGM-derived glycemic metrics and reveals that glycemic variability can significantly influence the relationship between AG and TIR with opposing effects according to AG levels. Our findings potentially help with clinical diabetes management, particularly when AG and TIR appear mismatched.

The Performance of Freestyle Libre Pro Flash Continuous Glucose Monitoring in Hospitalized Patients Treated with an Intravenous Insulin Infusion for Acute Prednisolone-Induced Hyperglycemia.

Few studies have evaluated the performance of flash glucose monitoring in hospitalized patients requiring intravenous insulin therapy. In this prospective study, an intravenous insulin infusion was adjusted hourly using flash glucose monitoring in hospitalized adults with prednisolone-associated hyperglycemia. The difference in paired point of care (POC) and flash glucose measurements and risk of severe hyper- or hypoglycemia (assessed by Clarke error grid analysis) were assessed. Glucose concentration measured by flash glucose monitoring was lower than POC glucose (mean difference 1.5 mmol/L [27 mg/dL], p < 0.001); however, mean POC glucose was within the target range (9.1 ± 4.1 mmol/L [164 ± 72 mg/dL]) and 97.8% of glucose measurements were within Zone A and B on error grid analysis. Flash glucose monitoring could be used in combination with POC glucose monitoring to minimize the frequency of finger prick blood glucose levels in hospitalized patients prescribed an intravenous insulin infusion.

Use of continuous glucose monitoring in insulin-treated older adults with type 2 diabetes

BackgroundFew studies have reported the adherence to and efficacy of continuous glucose monitoring (CGM) for improving diabetes management in insulin-treated older adults with type 2 diabetes mellitus (T2DM).MethodsProspective observational cohort study using FreeStyle Libre Flash CGM in insulin-treated adults > 65 years with T2DM and HbA1c between 7% and 9%. The participants wore the CGM during the 6-weeks study period. The primary outcome was time in range (TIR) between 70 and 180 mg/dL. Secondary outcomes included time below range (TBR), glycemic variability (GV), adherence, and use of glucose data for self-insulin adjustment. Linear regressions with random effects verified the changes in TBR, TIR, time above range (TAR), GV, and GMI across the three visits using CGM (baseline, 4 weeks and 6 weeks), controlled for sex, age, educational level, and health system (private or public).ResultsA total of 66 participants completed the six weeks of CGM (age 72·8 ± 5·3 years; BMI 27·8 ± 3·6 kg/m2), HbA1c: 8·0 ± 0·6%, with an overall sensor utilization of 93·1 ± 6·0%. We observed a stability in TIR (baseline: 63.5 ± 18.9% vs. endpoint: 65.5 ± 18.8%; β = 1,0, p = 0.190). Despite the low TBR at the baseline, we observed statistically significant reduction over the study period (baseline: 5.8 ± 7.0% vs. endpoint: 3.8 ± 4.7%; (β=-1.00, p = 0.008). Glucose variability also reduced from the baseline (34.9 ± 7.2%) to the endpoint (33.0 ± 6.8%) (β=-0.99, p = < 0.001).ConclusionFreeStyle Libre Flash CGM is well accepted by older adults with T2DM and allows participants to make therapeutic decisions to reduce TBR and glycemic variability.

A Pilot Trial of Continuous Glucose Monitoring Upon Emergency Department Discharge Among People With Diabetes Mellitus

ObjectivePeople with diabetes mellitus, particularly those with limited access to longitudinal care, frequently present to the emergency department (ED). Continuous glucose monitoring (CGM) has been shown to improve outcomes in ambulatory settings, so we hypothesized that it would be beneficial if initiated upon ED discharge. MethodsWe randomized adults with diabetes who were seen in the ED for hypo- or hyperglycemia to either 14 days of flash CGM or care coordination alone. All participants were scheduled to follow up in our diabetes specialty clinic. Outcomes included clinic attendance, the 3-month change in hemoglobin A1c, and repeat ED utilization. ResultsWe recruited 30 participants, including 13 with newly diagnosed diabetes. All but one (97%) had type 2 diabetes. We found no significant difference between the CGM (n = 16) and control (n = 14) groups in terms of clinic attendance (75 vs 64%, P = .61) or repeat ED utilization (31 vs 50%, P = .35), although our power was low. The absolute reduction in A1c was greater in the CGM group (5.2 vs 2.4%, P = .08). Among newly diagnosed participants for whom we had data, 7 out of 7 in the CGM group had a follow-up A1c under 7% compared to 1 out of 3 in the control group (P = .03). Over 90% of patients and providers found the CGM useful. ConclusionsOur data demonstrate the feasibility of starting CGM in the ED, a valuable setting for engaging difficult-to-reach patients. Our pilot study was limited by its small sample size, however, as recruitment in the ED can be challenging.

157-LB: A Randomized Trial of Continuous Glucose Monitoring upon Emergency Department Discharge

Background: People with type 2 diabetes (T2D), particularly those with limited access to longitudinal care, frequently present to the emergency department (ED), leading to increased hospital utilization and disjointed care. Continuous glucose monitoring (CGM) has been shown to improve patient engagement and glycemic outcomes in outpatients, so we hypothesized that it would be beneficial if initiated upon ED discharge. Methods: We randomized adults with T2D who were seen in the ED for hypo- or hyperglycemia to either flash CGM or care coordination alone. All participants were scheduled to follow up in our diabetes specialty clinic within two or three weeks. Outcomes included clinic attendance, patient-reported diabetes-related distress, satisfaction with CGM, and follow-up hemoglobin A1c. Results: We recruited 30 participants, including 13 with newly diagnosed T2D. We found no significant difference between the CGM (n=16) and control (n=14) groups in terms of clinic attendance (75 versus 64%, P=0.69) or the change in diabetes-related distress as measured via the Diabetes Distress Scale. Among participants in the CGM group who returned for follow up, 83% found CGM helpful, as did 90% of their providers. The mean A1c reduction after approximately 3 months was greater in the CGM group (5.2 versus 1.9%, P=0.051), although the groups were not balanced in terms of diabetes duration. Among participants with newly diagnosed T2D, excluding those missing data, five out of five in the CGM group had a follow-up A1c under 7% (from a mean baseline of 12.9%) compared to zero out of two in the control group (P=0.048). Discussion: Our study demonstrates the feasibility of starting CGM in the ED, an important setting for engaging difficult-to-reach patients. We did not see an effect of CGM on follow-up clinic attendance or diabetes-related distress, but there was a trend towards improved A1c at 3 months in the CGM group. Our study was limited by its small sample size, however, as recruitment in the ED can be challenging. Disclosure M. J. O'connor: None. X. Ding: None. C. Hernandez: None. L. M. Hubacz: None. R. J. Church: None. L. O'connor: None. Funding Herman G. Berkman Diabetes Clinical Innovation Fund

Relationship between key continuous glucose monitoring-derived metrics and specific cognitive domains in patients with type 2 diabetes mellitus

BackgroundContinuous glucose monitoring (CGM)-derived time in range (TIR) is closely associated with micro- and macrovascular complications in type 2 diabetes mellitus (T2DM). This study was performed to investigate the relationship between key CGM-derived metrics and specific cognitive domains in patients with T2DM.MethodsOutpatients with T2DM who were otherwise healthy were recruited for this study. A battery of neuropsychological tests was performed to evaluate cognitive function, including memory, executive functioning, visuospatial ability, attention, and language. Participants wore a blinded flash continuous glucose monitoring (FGM) system for 72 h. The key FGM-derived metrics were calculated, including TIR, time below range (TBR), time above range (TAR), glucose coefficient of variation (CV), and mean amplitude of glycemic excursions (MAGE). Furthermore, the glycemia risk index (GRI) was also calculated by the GRI formula. Binary logistic regression was used to assess risk factors for TBR, and we further analysed the associations between neuropsychological test results and key FGM-derived metrics with multiple linear regressions.ResultsA total of 96 outpatients with T2DM were recruited for this study, with 45.8% experiencing hypoglycemia (TBR< 3.9 mmol/L). Spearman analysis results revealed that a higher TBR< 3.9 mmol/L was correlated with worse performance on the Trail Making Test A (TMTA), Clock Drawing Test (CDT), and cued recall scores (P < 0.05). Logistic regression analysis results indicated that the TMTA (OR = 1.010, P = 0.036) and CDT (OR = 0.429, P = 0.016) scores were significant factors influencing the occurrence of TBR< 3.9 mmol/L. Multiple linear regressions further demonstrated that TBR< 3.9 mmol/L (β = -0.214, P = 0.033), TAR> 13.9 mmol/L (β = -0.216, P = 0.030) and TAR10.1–13.9 mmol/L (β = 0.206, P = 0.042) were significantly correlated with cued recall scores after adjusting for confounding factors. However, TIR, GRI, CV and MAGE showed no significant correlation with the results of neuropsychological tests (P > 0.05).ConclusionsA higher TBR< 3.9 mmol/L and TAR> 13.9 mmol/L were associated with worse cognitive functions (memory, visuospatial ability, and executive functioning). Conversely, a higher TAR of 10.1–13.9 mmol/L was associated with better memory performance in memory tasks.

Budget Impact Analysis of the FreeStyle Libre Flash Continuous Glucose Monitoring System® in Patients with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus with Multiple Daily Insulin Injections in Argentina.

To estimate the budget impact of the potential coverage of FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for glycemia monitoring in all type 1 diabetes mellitus (T1DM) patients and in those with type 2 diabetes mellitus (T2DM) with multiple daily insulin injections, from the social security and the private third-party payer's perspective in Argentina. A budget impact model was developed to estimate the cost difference between the self-monitoring of blood glucose (standard of care) and FSL over 5years. Input parameters were retrieved from local literature complemented by expert opinion. Health care costs were estimated by a micro-costing approach and reported in USD as of April 2022 (1 USD = 113.34 Argentine pesos). One-way sensitivity and scenario analyses were conducted. From a social security third-party payer perspective, the incorporation of FSL was associated with net savings per member per month (PMPM) of $0.026 (Year 1) to $0.097 (Year 5) and net savings PMPM of $0.002 (Year 1) to $0.008 (Year 5) for T1DM and T2DM patients, respectively. Similar findings are reported from the private third-party payer perspective. The budget impact results were more sensitive to the acquisition costs of the FSL and test strips. The potential coverage of FSL in patients with T1DM and T2DM with multiple daily insulin injections could be associated with small financial savings considering current technology acquisition costs (FSL and test strips) for social security and the private sector third-party payers in Argentina.

Budget impact analysis of the freestyle libre flash continuous glucose monitoring system® in patients with diabetes mellitus type 1 in Chile

ABSTRACT Objective To estimate the budget impact of covering the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for type 1 Diabetes Mellitus patients (T1DM), compared to self-monitoring of blood glucose (SMBG), from the perspective of public and private third-party payers in Chile. Methods A budget impact model was developed to estimate the cost difference between SMBG and FSL over five years. Two FSL coverage schemes were assessed. Input parameters were retrieved from the literature review and complemented by expert opinion. Healthcare costs were estimated by a micro-costing approach and reported in USD. Results For a public sector third-party payer, incorporating FSL implied a cost increase up to USD 0.013 per member per month (PMPM) for the fifth year under the broad coverage scheme and a net saving of 0.0001 PMPM (all years) under the restricted coverage scheme. From a private sector third-party payer, incorporating FSL implied savings up to USD 0.028 PMPM (fifth year) for the broad coverage scheme and up to USD 0.012 PMPM (fifth year) for the restricted scheme. Conclusion Incorporating the FSL for T1DM patients was associated with a marginal incremental cost for the public sector third-party payer and cost savings in Chile’s private healthcare sector.

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

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. 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. 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. 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.

Cost-Effectiveness Analysis of Flash Glucose Monitoring System for People with Type 2 Diabetes Receiving Intensive Insulin Treatment.

AimsFor people with type 2 diabetes (T2D) on intensive insulin therapy, the use of flash continuous glucose monitoring (“flash monitoring”) is associated with improved average glucose control and/or reduced hypoglycemic exposure. This study assessed the cost-effectiveness of flash monitoring versus traditional blood glucose monitoring (BGM) in people with T2D using intensive insulin in the United Kingdom (UK).MethodsThe IQVIA CORE Diabetes Model (IQVIA CDM; v9.0) was used to analyze the impact of flash monitoring versus BGM over a 40-year time horizon from the UK payer perspective. Model inputs included baseline characteristics, intervention effects, resource utilization, costs, and utilities, based on recently published literature and national databases. UK National Health Service reimbursed costs of flash monitoring and BGM were used. An intervention-related health utility was obtained from a time trade-off study. Alternative scenarios were explored to assess the impact of key assumptions on base case results.ResultsIn base-case analysis, flash monitoring compared with BGM resulted in an incremental cost of £5781 and an additional 0.47 quality-adjusted life years (QALYs). This provides an incremental cost-effectiveness ratio (ICER) of £12,309/QALY. HbA1c and the intervention-related health utility were the key drivers of differentiation. All scenario analyses, including different discount rates, time horizons, effects on HbA1c and on the intervention-related health utility, as well as glycemic emergencies, generated ICERs of less than £20,000 per QALY.ConclusionsThe consistent results across base case and a range of scenario analyses indicate that long-term flash glucose monitoring use is cost-effective compared with BGM in a UK population of T2D on intensive insulin therapy based on updated clinical effects and a cost-effectiveness threshold of £20,000–30,000 per QALY. Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01325-w.

Key updates to the management of type 2 diabetes in adults: how to embrace and embed the new NICE guidance

Key updates to the management of type 2 diabetes in adults: how to embrace and embed the new <scp>NICE</scp> guidance

679-P: Costs and Cost-Effectiveness of the FreeStyle Libre System vs. Blood Glucose Self-Monitoring in Patients with Type 2 on MDI Insulin Treatment in Israel

Introduction: Frequent glucose monitoring is essential to obtaining glucose control. We assessed the costs and cost-effectiveness of using the FreeStyle Libre® Flash Continuous Glucose Monitoring system (FSL) compared to self-monitoring of blood glucose (SMBG) in people with type 2 diabetes treated with multiple daily insulin injections (T2D MDI) from a healthcare payer perspective in Israel. Methods: We calculated the incremental cost per quality adjusted life year (QALY) gained. Glucose monitoring costs are based on actual costs of FreeStyle Libre®, strips and lancets, assuming full adherence to monitoring. Severe hypoglycemic events (SHE) and diabetic ketoacidosis (DKA) costs are based on real-world data from Israel and the Israeli Ministry of Health list price. Costs are presented in Israeli Shekel (ILS) and $US. The incidence rates of SHE and DKA are based on real-world data from a large cohort of patients in France. Due to the short time horizon of this analysis, we assumed no mortality differences between the two monitoring alternatives. Utility increments for the use of CGM vs. SMBG, decrease in HbA1C and disutility for SHE and DKA events are based on estimates from the literature. The analysis was conducted over a 5-year time horizon, applying an annual discount rate of 3% on costs and outcomes. One way sensitivity analyses were performed on difference in costs. Results: FreeStyle Libre® use is associated with a cost increase of ILS 27,021 ($US 8,444) and an increase of 0.26 QALYs, generating an incremental cost-effectiveness ratio of ILS 103,977 ($US 32,493) per QALY gained. These results are highly sensitive to changes in costs of glucose monitoring. Conclusion: Assuming a willingness to pay threshold of $US 43,600 per QALY gained (GDP per capita in Israel in 2020) , the FreeStyle Libre® system is a highly cost-effective glucose monitoring alternative to SMBG for T2D MDI patients in Israel. Disclosure D.Greenberg: Advisory Panel; Abbott Diabetes, Consultant; Geffen Medical, Israel.

704-P: Time in Range and Time Below Range in Insulin-Treated Older Adults with Type 2 Diabetes

Hypoglycemia is the key limiting step for optimizing glycemic control in older adults. Continuous glucose monitoring (CGM) technology has not been well-evaluated in insulin treated older patients with type 2 diabetes (T2D) . Methods: This prospective observational cohort study assessed of glycemic control using the FreeStyle Libre Flash CGM in insulin treated older adult patients with T2D. Subjects &amp;gt;65 years with T2DM on insulin therapy and HbA1c between 7% and 9%, with or without oral agents, were identified from a public hospital and a private diabetes clinic and invited by phone to participate (n= 462) . Patients treated with GLP1 agonists; eGFR &amp;lt;30 ml/min; Hb &amp;lt;11g/dL; ALT&amp;gt; 3x ULN; glucocorticoid use in the previous 3 months, and active malignancy were excluded. Participants worn the CGM continuously during a 6-weeks study period. They returned to clinic every 2 weeks for CGM data downloaded and new CGM placement, assessment of glycemic control and hypoglycemia. The investigators adjusted insulin treatment at each visit as needed. The first 2 weeks of CGM was considered baseline point and the last 2 weeks was the endpoint. The differences on time in range (TIR 70-180, mg/dl) and time below range (TBR, &amp;lt; 70 mg/dl) was tested using the Wilcoxon Signed-rank test with p &amp;lt;0.05. Results: A total of 125 patients were randomized and 49 patients completed the 6 weeks follow-up (women=53.9%; age=72.8 ± 5.0 years; BMI=28.3±3.6 Kg/m2; eGFR=62.4 ± 16.6; ml/min A1c=8.0 ± 0.57%; GMI=7.1 ± 0.8%. The patients had a median TIR of 65% (min= 7%, max= 94%) at the baseline and 68% (min= 4%; max= 97%) at the endpoint. The median TBR was 3% (min= 0%, max= 23%) at the baseline and 2% (min= 0%; max= 18%) at the end of study. The TBR was significantly reduced after 6 weeks of CGM (p&amp;lt;0.01) . Conclusions: An individualized approach may be possible using FreeStyle Libre Flash CGM to avoid overtreatment and undertreatment of older adults with T2D. CGM is a useful tool to reduce hypoglycemia in insulin older adults with T2D. Disclosure S.A.O.Leite: None. M.Silva: None. A.C.R.Lavalle: None. M.Bastos: None. M.C.Bertogy: None. S.C.Vieira: None. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. Funding Abbott DiabetesCare (ADC-OUS-IIS-19-47)

Spanish Consensus on the Use of Intermittently Scanned Continuous Glucose Monitoring in the Management of Patients With Insulin Therapy: The MONITOR Project.

Continuous glucose monitoring (CGM) systems are increasingly being adopted as an alternative or adjunct to self-monitoring of blood glucose (SMBG) by patients receiving insulin therapy. However, the available evidence on the role of intermittently scanned CGM or flash CGM (isCGM) remains limited. This consensus aims to evaluate the degree of agreement among Spanish experts on the role of isCGM in the evaluation of glycemic variability, reduction of glycosylated hemoglobin (HbA1c) levels, and selection and adjustment of insulin therapy. Delphi methodology was used to achieve consensus in two survey rounds. A total of 431 Spanish endocrinologists participated in the first round of a 34-item questionnaire survey on isCGM and 427 participated in the second round. Any disagreement was resolved in round 2. Consensus was reached for 32 statements, and four items were ultimately agreed upon SMBG after round 2. There was a high degree of consensus that isCGM helps to evaluate glycemic variability, improves HbA1c levels, and can guide therapeutic changes in type 1 diabetes patients. However, there was no consensus on the routine use of the interquartile range to evaluate glycemic variability or the selection of HbA1c as the main parameter for monitoring glycemic control. Most Spanish experts believe that the isCGM system is appropriate for: (1) identifying glycemic variability and facilitating its management, (2) evaluating hyperglycemia as a complement of HbA1c levels, and (3) guiding therapeutic decisions on insulin selection and dosing. The isCGM system is a useful tool for patients and health care professionals to improve glycemic control in insulin-dependent diabetes.

Remote Pharmacist-Assisted Flash Continuous Glucose Monitoring Improves Glycemic Outcomes in Patients With Poorly Controlled Diabetes: A Retrospective Case Series.

This article reports on a retrospective case series evaluating glycemic outcomes using a flash continuous glucose monitoring (CGM) system in pharmacist-managed diabetes cases. The flash CGM system was used during initial assessment of patients' diabetes control and then continued throughout the intervention to ensure the safety and efficacy of the glycemic interventions. The Cloud-based CGM software was used to monitor patients remotely and assess their glycemic metrics. Action plans were created to address areas of most pressing concern, ensuring reduction or elimination of hypoglycemia, correction of hyperglycemia, and minimization of glycemic variability. In these complex cases, use of the flash CGM system in conjunction with lifestyle and medication interventions safely and effectively improved diabetes management and achieved targeted glucose outcomes.

Comparing clinical outcomes between two continuous glucose monitors: similar diabetes-related events, all-cause hospitalizations and HbA1c reductions in type 1 and type 2 diabetes

ObjectivesWe compared clinical outcomes after acquiring a FreeStyle Libre© Flash Continuous Glucose Monitoring System (FSL) or Dexcom (DEX) continuous glucose monitoring (CGM) device in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) treated with intensive insulin therapy. Design and MethodsThis retrospective analysis of the IBM® MarketScan® Research Databases and IBM® Explorys® Electronic Health Records Database assessed differences in acute diabetes-related events (ADE), all-cause hospitalizations (ACH) and glycated hemoglobin (HbA1c) in T1D and T2D populations 6 months post CGM acquisition. Analyses were conducted in two study cohorts (Cohort 1, n = 7,494; Cohort 2, n = 678). Participants were T1D or T2D, age ≥ 18 years, treated with short or rapid-acting insulin and naïve to CGM, who acquired a CGM system. Users were propensity score matched on demographics and clinical factors. ResultsCohort 1: Post-CGM ADE-free rates at 6 months ranged from 94.8 to 96.7% and ACH-free rates ranged from 90.4 to 95.4%, for both T1D and T2D groups, with no significant differences between CGM systems. Cohort 2: Significant HbA1c reductions were associated with use of the DEX and FSL devices in the T1D (-0.35% and -0.37%, respectively) and T2D (-0.73% and -0.79%, respectively) cohorts, both p < 0.001, with no significant differences in the magnitude of reduction between systems (T1D p = 0.99 and T2D p = 0.84). ConclusionsAcquisition of the FSL and DEX systems was associated with similar rates of acute diabetes-related events and all-cause hospitalizations and similar HbA1c reductions in adults with T1D and T2D.

Where can you wear your Libre? Using the FreeStyle Libre continuous glucose monitor on alternative sites.

To investigate the accuracy and acceptability of the FreeStyle Libre Flash continuous glucose monitoring system (FSL-CGM) at alternative sites during free living and under experimental conditions. Participants with type 1 diabetes were provided with three FSL-CGM sensors applied to the upper arm, the lower back, and the anterior chest. On day 2 or 3, FSL-CGM sensor glucose was compared with venous glucose following a standard meal, during and after an exercise test, and after skin cooling. Participants completed 14-day use of the sensors with concomitant sensor scanning at all sites and capillary glucose tests. The primary outcome was accuracy between sensor sites of 14-day mean glucose. Clarke's error grids, precision absolute relative deviation, and mean absolute relative deviation were calculated. In the 20 participants, compared with the arm sensor, the accuracy of the back sensor and the chest sensor was 97.9% and 98%, respectively. Under experimental conditions, the arm sensor was more accurate than that of the back and chest. All the sensors recorded higher glucose concentration than venous samples during exercise. The arm and chest sites were most preferred, with the greatest sensor failures from the back. The FSL-CGM is clinically accurate when the sensors are applied to alternate chest or back sites. Greater variability occurs during rapid changes in glucose concentration with all sensor sites compared with venous glucose. Understanding these variabilities allows appropriate use of an economically viable continuous glucose monitor.

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

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). 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 2weeks. 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 < 70mg/dL) was also significantly higher in the R-Y group (p = 0.0115). Logistic regression analysis revealed that preoperative casual glucose levels of < 100mg/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). 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.

Flash CGM associated with event reduction in nonintensive diabetes therapy.

We evaluated the effects of acquiring a flash continuous glucose monitoring (CGM) system in the population with type 2 diabetes (T2D) treated with basal or noninsulin therapy. This was a retrospective database analysis of the IBM MarketScan Commercial Claims and Medicare Supplemental databases that assessed rates of acute diabetes-related events (ADEs) and all-cause inpatient hospitalizations (ACHs) in a large population with T2D treated with basal insulin therapy or noninsulin medications. ADE and ACH rates 6 months prior to and 6 months post CGM acquisition were compared. Inclusion criteria for analysis were diagnosis of T2D; age 18 years or older; treatment with long-acting, neutral protamine Hagedorn, or premixed insulin or noninsulin therapy; naïve to CGM; and acquisition of their flash CGM system between October 2017 and March 2019. Patients served as their own controls. Event rates were compared using weighted Cox regression with Andersen-Gill extension for repeat events. A cohort of 10,282 adults with T2D (mean [SD] age, 53.1 [9.6] years; 51.9% male) who met inclusion criteria were assessed. ADE rates decreased from 0.076 to 0.052 events per patient-year (HR, 0.68; 95% CI, 0.58-0.80; P < .001). ACH rates decreased from 0.177 to 0.151 events per patient-year (HR, 0.85; 95% CI, 0.77-0.94; P = .002). Acquisition of the flash CGM system was associated with significant reductions in outpatient and inpatient ADEs and ACHs. These findings provide compelling evidence that use of flash CGM in patients with T2D treated with basal insulin therapy or noninsulin therapy improves clinical outcomes and potentially reduces costs.

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

IntroductionFrequent 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.MethodsCost-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.ResultsIndividuals 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.ConclusionThe 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.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01172-1.