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OBJECTIVE: Real-time continuous glucose monitoring (CGM) is effective for diabetes management in cases of type 1 diabetes and adults with type 2 diabetes (T2D) but has not been assessed in adolescents and young adults (AYAs) with T2D. The objective of this pilot interventional study was to assess the feasibility and acceptability of real-time CGM use in AYAs with T2D. METHODS: Adolescents and young adults (13-21 years old) with T2D for six months or more and hemoglobin A1c (A1c) greater than 7%, on any Food and Drug Administration-approved treatment regimen, were included. After a blinded run-in period, participants were given access to a real-time CGM system for 12 weeks. The use and acceptability of the real-time CGM were evaluated by sensor usage, surveys, and focus group qualitative data. RESULTS: Participants (n = 9) median age was 19.1 (interquartile range [IQR] 16.8-20.5) years, 78% were female, 100% were people of color, and 67% were publicly insured. Baseline A1c was 11.9% (standard deviation ±2.8%), with median diabetes duration of 2.5 (IQR 1.4-6) years, and 67% were using insulin. Seven participants completed the study and demonstrated statistically significant improvement in diabetes-related quality of life, with the mean Pediatric Quality of Life inventory (PedsQL) diabetes score increasing from 70 to 75 after using CGM (P = .026). Focus group results supported survey results that CGM use among AYAs with T2D is feasible, can improve quality of life, and has the potential to modify behavior. CONCLUSION: Real-time CGM is feasible and acceptable for AYAs with T2D and may improve the quality of life of patients with diabetes. Larger randomized controlled trials are needed to assess the effects on glycemic control and healthy lifestyle changes.

OBJECTIVE: Glycemia management in critical care is posing a challenge in frequent measuring and adequate insulin dose adjustment. In recent years, continuous glucose measurement has gained accuracy and reliability in outpatient and inpatient settings. The aim of this study was to assess the feasibility and accuracy of real-time continuous glucose monitoring (CGM) in ICU patients after major abdominal surgery. RESEARCH DESIGN AND METHODS: We included patients undergoing pancreatic surgery and solid organ transplantation (liver, pancreas, islets of Langerhans, kidney) requiring an ICU stay after surgery. We used a Dexcom G6 sensor, placed in the infraclavicular region, for real-time CGM. Arterial blood glucose measured by the amperometric principle (ABL 800; Radiometer, Copenhagen, Denmark) served as a reference value and for calibration. Blood glucose was also routinely monitored by a StatStrip bedside glucose meter. Sensor accuracy was assessed by mean absolute relative difference (MARD), bias, modified Bland-Altman plot, and surveillance error grid for paired samples of glucose values from CGM and acid-base analyzer (ABL). RESULTS: We analyzed data from 61 patients and obtained 1,546 paired glucose values from CGM and ABL. Active sensor use was 95.1%. MARD was 9.4%, relative bias was 1.4%, and 92.8% of values fell in zone A, 6.1% fell in zone B, and 1.2% fell in zone C of the surveillance error grid. Median time in range was 78%, with minimum (

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC) that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing. Specifically, it is proposed that at least 7.5% of comparator BG concentrations are 300 mg/dL (16.7 mmol/L), respectively, and that at least 7.5% of BG-RoC combinations indicate fast BG changes with impending hypo- or hyperglycemia, respectively. These proposed characteristics of the comparator data can facilitate the harmonization of testing conditions across different studies and CGM systems and ensure that the most relevant scenarios representing real-life situations are established during performance testing. In addition, a study protocol and testing procedure for the manipulation of glucose levels are suggested that enable the collection of comparator data with these characteristics. This work is an important step toward establishing a future standard for the performance evaluation of CGM systems.

Post-transplantation diabetes mellitus (PTDM) negatively affects graft and patient survival after kidney transplantation (KT). This prospective study used continuous glucose monitoring (CGM) to evaluate perioperative blood glucose dynamics, identify PTDM risk factors, and compare predictive accuracy with capillary blood glucose monitoring (CBGM) in 60 non-diabetic living-donor KT recipients. Patients underwent 2-week pre- and postoperative CGM, including routine CBGM during their in-hospital stays. PTDM-related risk factors and glucose profiles were analyzed with postoperative CGM and CBG. PTDM developed in 14 (23.3%) patients and was associated with older age, male sex, higher baseline HbA1c, high-density lipoprotein cholesterol, and 3-month cumulative tacrolimus exposure levels. Male sex and postoperative time above the range (TAR) of 180 mg/dL by CGM were PTDM-related risk factors in the multivariate analysis. For predictive power, the CGM model with postoperative glucose profiles exhibited higher accuracy compared with the CBGM model (areas under the curves of 0.916, and 0.865, respectively). Therefore, we found that male patients with a higher postoperative TAR of 180 mg/dL have an increased risk of PTDM. Postoperative CGM provides detailed glucose dynamics and demonstrates superior predictive potential for PTDM than CBGM. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusions The real‐world benefits of continuous glucose monitoring (CGM) in the broad type 2 diabetes (T2D) population are not well studied. Our study evaluated the impact of CGM use on health care resource utilization over 12 months in adults with T2D.This retrospective cohort analysis used Optum's de‐identified Market Clarity data of >79 million people to evaluate CGM use in people with T2D who were treated with non‐insulin (NIT), basal insulin (BIT) and prandial insulin therapy (PIT). The primary outcomes were changes in all‐cause hospitalizations, acute diabetes‐related hospitalizations and acute diabetes‐related emergency room visits during the 6‐ and 12‐month post‐index period following transition from blood glucose monitoring to CGM. A pre‐specified subgroup analysis assessed glucose control and medication changes among people with T2D over 1 year.The analysis included 74 679 adults with T2D (NIT; n = 25 269), (BIT; n = 16 264) and (PIT; n = 33 146). Significant reductions in all‐cause hospitalizations, acute diabetes‐related hospitalizations and acute diabetes‐related emergency room visits were observed in the 6‐month post‐index period that were sustained during the 6–12 month post‐index period (NIT, −10.1%, −31.0%, −30.7%; BIT, −13.9%, −47.6%, −28.2%; and PIT, −22.6%, −52.7%, −36.6%, respectively). A subgroup analysis of 6030 people showed mean glycated haemoglobin reductions at approximately 3 months, which were also sustained throughout the post‐index period: NIT, −1.1 (0.05)%; BIT, −1.1 (0.06)%; and PIT, −0.9 (0.04)%, p < 0.0001.CGM use in real‐life across different therapeutic regimens in adults with T2D was associated with reductions in health care resource utilization with improved glucose control over 1 year. [ABSTRACT FROM AUTHOR]

Background/objectives: Insulin resistance (IR)-related disorders and cognitive impairment lead to reduced quality of life and cause a significant strain on individuals and the public health system. Thus, we investigated the effects of insulin resistance (IR), and blood glucose fluctuations on cognitive function under laboratory and free-living conditions, using ecological momentary assessment (EMA). Subjects/methods: Baseline assessments included neuropsychological tests and blood analysis. Individuals were classified as either insulin-sensitive (<2) or insulin-resistant (≥2), based on their Homeostatic Model Assessment (HOMA-IR) values. Continuous glucose monitoring (CGM) using a percutaneous sensor was performed for 1 week. Using multiple linear regression, we examined the effects of HOMA-IR and CGM metrics on cognitive domains. Working memory (WM) performance, which was assessed using EMA, 4 times a day for 3 consecutive days, was matched to short-term pre-task CGM metrics. Multilevel analysis was used to map the within-day associations of HOMA-IR, short-term CGM metrics, and WM. Results: Analyses included 110 individuals (mean age 48.7 ± 14.3 years, 59% female, n = 53 insulin-resistant). IR was associated with lower global cognitive function (b = −0.267, P = 0.027), and WM (b = −0.316; P = 0.029), but not with executive function (b = −0.216; P = 0.154) during baseline. EMA showed that higher HOMA-IR was associated with lower within-day WM performance (β = −0.20, 95% CI −0.40 to −0.00). CGM metrics were not associated with cognitive performance. Conclusions: The results confirm the association between IR and decrements in global cognitive functioning and WM, while no effects of CGM metrics were observed, making IR a crucial time point for intervention. Targeting underlying mechanisms (e.g., inflammation) in addition to glycemia could be promising to minimize adverse cognitive effects. Registered under https://drks.de/register/de identifier no. DRKS00022774. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusions To map the glycaemic variabilities and insulin requirements across different phases of the menstrual cycle and assess the efficacy and performance of the MiniMed 780G system on mitigating glycaemic variabilities during phases of the menstrual cycle.A pilot study recruiting 15 adolescent and young adult females with type 1 diabetes was conducted. Only females with regular spontaneous menstruation were enrolled in the current study. Phases of each menstrual cycle were determined as either follicular phase or luteal phase. The study analysed continuous glucose monitoring metrics during two study periods: the open loop period (OLP) and the advanced hybrid closed‐loop (AHCL) period; each period lasted 3 consecutive months.During the OLP, the mean time in range (TIR) significantly decreased during the luteal phase compared with the follicular phase (65.13% ± 3.07% vs. 70.73% ± 2.05%) (P < .01). The mean time above range significantly increased from 21.07% ± 2.58% during the follicular phase to 24.87% ± 2.97% during the luteal phase (P < .01). After initiating the AHCL period, TIR was comparable during both phases of the menstrual cycle (P = .72), without increasing the time spent below 70 mg/dL (P > .05). Regarding insulin delivery during the AHCL period, the percentage of Auto basal and Auto correction delivered by the algorithm increased by 13.55% and 30.6%, respectively (P < .01), during the luteal phase.The fully automated adaptive algorithm of the MiniMed 780G system mitigated menstrual cycle‐dependent glycaemic variability, successfully attaining the recommended glycaemic outcomes with a TIR greater than 70% throughout the entire menstrual cycle. [ABSTRACT FROM AUTHOR]

Effective continuous glucose monitoring solutions require consistent sensor performance over the lifetime of the device, a manageable variance between devices, and the capability of high volume, low cost production. Here we present a novel and microfabrication-compatible method of depositing and stabilizing enzyme layers on top of planar electrodes that can aid in the mass production of sensors while also improving their consistency. This work is focused on the fragile biorecognition layer as that has been a critical difficulty in the development of microfabricated sensors. We test this approach with glucose oxidase (GOx) and evaluate the sensor performance with amperometric measurements of in vitro glucose concentrations. Spincoating was used to deposit a uniform enzyme layer across a wafer, which was subsequently immobilized via glutaraldehyde vapor crosslinking and patterned via liftoff. This yielded an approximately 300 nm thick sensing layer which was applied to arrays of microfabricated platinum electrodes built on blank wafers. Taking advantage of their planar array format, measurements were then performed in high-throughput parallel instrumentation. Due to their thin structure, the coated electrodes exhibited subsecond stabilization times after the bias potential was applied. The deposited enzyme layers were measured to provide a sensitivity of 2.3 ± 0.2 μA mM−1 mm−2 with suitable saturation behavior and minimal performance shift observed over extended use. The same methodology was then demonstrated directly on top of wireless CMOS potentiostats to build a monolithic sensor with similar measured performance. This work demonstrates the effectiveness of the combination of spincoating and vapor stabilization processes for wafer scale enzymatic sensor functionalization and the potential for scalable fabrication of monolithic sensor-on-CMOS devices. [ABSTRACT FROM AUTHOR]

Background: Effective glycemic control is crucial for hospitalized patients, leading to benefits such as shorter hospital stays and reduced postoperative infection rates. While previous studies have emphasized the effectiveness of multidisciplinary collaborative stewardship for hospital‐wide hyperglycemia management, patient perspectives and preferences have not been adequately considered. Objective: To identify factors influencing treatment preferences of Chinese hospitalized diabetes patients using discrete choice experiments (DCEs) and provide practical insights for the construction of a hospital‐wide glycemic control programme. Methods: A face‐to‐face survey was conducted among diabetes patients admitted to nonendocrine departments in a tertiary hospital in Nanjing, China. The attributes and levels were determined based on DCE principles, and a conditional logit model was used to quantify patients' preferences. Results: A total of 157 respondents were analyzed. Antihyperglycemic effectiveness, healthcare providers, treatment regimen, monitoring frequency, and adverse reactions were the five attributes that significantly influenced patient preference (p < 0.05). Notably, an 80% glycemic control rate (β = 2.009) and a multidisciplinary management team involving clinical pharmacists (β = 1.346) had the greatest impact. Negative effects were observed for hypoglycemia (β = −1.008), insulin pump use (β = −0.746), and frequent glucose monitoring (β = −0.523). Female patients exhibited higher concern for healthcare providers (β = 1.172) compared to males. Younger and shorter‐course patients prioritized antihyperglycemic effectiveness (β = 3.330, β = 1.510), while older patients preferred multidisciplinary management (β = 1.186) and opposed increased monitoring frequency (β = −0.703). Patients with higher educational backgrounds showed greater acceptance of continuous glucose monitoring (β = 1.983), and those with higher annual income placed more emphasis on glycemic control rate. Conclusion: Treatment preferences of hospitalized diabetes patients are mainly influenced by antihyperglycemic effectiveness, adverse reactions, healthcare providers, and individual characteristics. Comprehensive consideration and an individualized therapy strategy should be given when constructing a hospital‐wide glycemic control programme. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion To establish trust in real‐world evidence (RWE) derived from CareLink Personal (CP), Medtronic's data management system for MiniMed system users, we show that this database and its analyses strictly adhere to the principles of RWE.The methodology is applicable to all MiniMed iterations. We described every step from raw data to predefined outcomes. In addition, we showed CP's fitness‐for‐research by the below metrics (using last year's MiniMed 780G system data as a case study): representative population, relevant endpoints, appropriate granularity, high data completeness, high data representativity and consistency in results.The process from raw data to outcomes has been validated, and metrics/logics adhere to established definitions. Over 95% of users have a CP account; with 96% providing consent, this allows the use of >91% of the census population. There is no rationale for an over‐representation of a specific phenotype among users not included. CP includes >50 endpoints, including ‘International Consensus on Time in Range’ based metrics. Data are recorded at 5‐min intervals (maximum 288 per day), and on average there were 263 data points per person per day. Ninety‐nine per cent of uploads were automated. For the last year, only 1 in 6 users had a data gap >1 day, and 1 in 50 had a gap >1 week. The time in range from in‐silico studies was similar to that of real‐world studies from different geographies and with ever growing populations.RWE from CP adheres to the principles of RWE and can serve as robust evidence on the performance and safety of MiniMed systems. [ABSTRACT FROM AUTHOR]

Continuous glucose monitoring (CGM) is a promising, minimally invasive alternative to plasma glucose measurements for calibrating physiology-based mathematical models of insulin-regulated glucose metabolism, reducing the reliance on in-clinic measurements. However, the use of CGM glucose, particularly in combination with insulin measurements, to develop personalized models of glucose regulation remains unexplored. Here, we simultaneously measured interstitial glucose concentrations using CGM as well as plasma glucose and insulin concentrations during an oral glucose tolerance test (OGTT) in individuals with overweight or obesity to calibrate personalized models of glucose-insulin dynamics. We compared the use of interstitial glucose with plasma glucose in model calibration, and evaluated the effects on model fit, identifiability, and model parameters' association with clinically relevant metabolic indicators. Models calibrated on both plasma and interstitial glucose resulted in good model fit, and the parameter estimates associated with metabolic indicators such as insulin sensitivity measures in both cases. Moreover, practical identifiability of model parameters was improved in models estimated on CGM glucose compared to plasma glucose. Together these results suggest that CGM glucose may be considered as a minimally invasive alternative to plasma glucose measurements in model calibration to quantify the dynamics of glucose regulation. [ABSTRACT FROM AUTHOR]

Aims/Introduction Materials and Methods Results Conclusions Coefficient of variation (CV) is an indicator for glucose variability in continuous glucose monitoring (CGM), and the target threshold of %CV in type 1 diabetes is proposed to be ≤36%. This study aimed to evaluate the clinical significance of CV in children and adolescents with type 1 diabetes.Participants included 66 children with type 1 diabetes. A total of 48 participants were treated with multiple daily injections of insulin, and 18 with continues subcutaneous insulin infusion, using intermittently scanned CGM. The frequencies of the CGM metrics and glycosylated hemoglobin values were examined, and the significance of a threshold %CV of 36% was evaluated.The mean frequencies in time in range (TIR), time below range, %CV and the mean glycosylated hemoglobin value were 59.3 ± 16.1, 4.0 ± 3.5, 39.3 ± 6.2 and 7.3 ± 0.8%, respectively. The frequencies of participants who achieved a TIR >70% and a %CV of ≤36% were 24.1 and 27.3%, respectively. A total of 18 participants with a %CV of ≤36% had significantly higher TIR, lower time below range and lower glycosylated hemoglobin than the 48 with a %CV of >36% (72.6 ± 12.6 vs 52.4 ± 13.6, 2.4 ± 1.9 vs 4.6 ± 3.6, 6.9 ± 0.8 vs 7.4 ± 0.7%, respectively).Children and adolescents with type 1 diabetes using intermittently scanned CGM had difficulties in achieving the recommended targets of TIR and CV. However, the target %CV of ≤36% seems to be an appropriate indicator for assessing glycemic control and risk of hypoglycemia in pediatric patients with type 1 diabetes with any treatment. [ABSTRACT FROM AUTHOR]

Objective: Diabetes-related care makes up approximately 24% of outpatient clinic visits. Therefore, confidence and understanding of diabetes management is necessary for family medicine residents. Methods: We developed a combined lecture and simulation lab curriculum utilizing a registered nurse and pharmacist to deliver education to 20 family medicine learners. Pre and post surveys of the educational material were completed in 2 sections including one gauging medical knowledge and a second part gauging level of comfort. Results: Of the learners who participated, fourteen completed the pre-post surveys. Most (53%) respondents improved their scores, while 20% scored the same 27% scored worse. The overall average score increased 57% to 70% and improvement was statistically significant (P <.05). All learners improved confidence by at least 1 point. Conclusion: An interprofessional team utilizing a lecture curriculum focusing on providing education on effective prescribing, medication safety profiles, and resource availability, showed improvement in confidence but mixed knowledge benefit. Further modifications to the curriculum may yield further educational gains. [ABSTRACT FROM AUTHOR]

Background/Objectives: Obesity and overweight have become increasingly prevalent in different populations of people with type 1 diabetes (PwT1D). This study aimed to assess the effect of body weight on glycaemic indices in PwT1D. Methods: Adult PwT1D using continuous glucose monitoring (CGM) and followed up at a regional academic diabetes centre were included. Body weight, body mass index (BMI), waist circumference, glycated haemoglobin (HbA1c), and standard CGM glycaemic indices were recorded. Glycaemic indices were compared according to BMI, and correlation and linear regression analysis were performed to estimate the association between measures of adiposity and glycaemic indices. Results: A total of 73 PwT1D were included (48% normal weight, 33% overweight, and 19% obese). HbA1c was 7.2% (5.6–10), glucose management indicator (GMI) 6.9% (5.7–8.9), coefficient of variation (CV) for glucose 39.5% ± 6.4, mean glucose 148 (101–235) mg/dL, TIR (time in range, glucose 70–180 mg/dL) 66% (25–94), TBR70 (time below range, 54–69 mg/dL) 4% (0–16), TBR54 (<54 mg/dL) 1% (0–11), TAR180 (time above range, 181–250 mg/dL) 20% ± 7, and TAR250 (>250 mg/dL) 6% (0–40). Glycaemic indices and achievement (%) of optimal glycaemic targets were similar between normal weight, overweight, and obese patients. BMI was associated negatively with GMI, mean glucose, TAR180, and TAR250 and positively with TIR; waist circumference was negatively associated with TAR250. Conclusions: CGM-derived glycaemic indices were similar in overweight/obese and normal weight PwT1D. Body weight and BMI were positively associated with better glycaemic control. PwT1D should receive appropriate ongoing support to achieve optimal glycaemic targets whilst maintaining a healthy body weight. [ABSTRACT FROM AUTHOR]

Background: Acute coronary syndrome encompasses a range of clinical conditions resulting from sudden reduction in blood flow to the heart muscle, primarily due to the rupture of atherosclerotic plaques and subsequent thrombosis. It is an important global cause of death and also the major cause of morbidity and mortality in India. Abnormal glucose metabolism, significantly impacts cardiovascular health, exacerbating outcomes in acute coronary syndrome. The GRACE risk score, a tool for predicting ACS outcomes, may benefit from integrating continuous glucose monitoring (CGM) data. Aim: To investigate the relationship between glucose fluctuations and the GRACE risk score in ACS patients with abnormal glucose metabolism using continuous glucose monitoring Materials & Methods: In this observational study, 100 patients with ACS and abnormal glucose metabolism were monitored using CGM systems for 24 hours. The GRACE risk score was calculated for each patient. Correlations between the GRACE score, mean blood glucose levels, and glucose variability were analyzed. Results: A total of 100 participants were included in the study. The mean Grace risk score and mean 24 Hours Mean Blood Glucose (mmol/l) were 123 ± 28 and 7.8 ± 2.1. Majority of the participants were belonged to the intermidiate-risk group with 45%. Conclusion: The GRACE risk score is associated with glucose fluctuations in ACS patients with abnormal glucose metabolism. These findings suggest that glucose monitoring may enhance risk assessment and management strategies in this patient population. [ABSTRACT FROM AUTHOR]

Background Diabetes technology, especially advanced hybrid closed-loop (AHCL) systems, is rapidly advancing, offering improved glycemic control, reduced hypoglycemia, and reduced treatment burden for patients with type 1 diabetes (T1D). This study aimed to evaluate the clinical efficiency of an AHCL system—the Medtronic MiniMed 780G insulin pump combined with continuous glucose monitoring—among individuals with T1D in real-world clinical settings. Methods In an observational retrospective study, we identified a cohort of 41 patients (mean age, 47.1 ± 13.7 years; T1D duration, 23.6 ± 13 years; 73.2% female) previously using an insulin pump or those on multiple daily insulin injections, currently using the AHCL system for at least 6 months. Primary outcomes were the changes of the following parameters, before AHCL initiation and at 6 months after treatment; (1) time in range (TIR): time with glucose levels in the range of 70 to 180 mg/dL, (2) time below range (TBR): time with glucose levels below 70 mg/dL, and (3) time above range (TAR): time with glucose levels above 180 mg/dL. Results Data analysis from 41 patients showed a significant 16.5% ± 13.8% increase in TIR (from 56.6 ± 17.9 to 73.1 ± 10.6%, p < 0.001). Both TBR and TAR decreased by 2.9 ± 4.8% (p = 0.004) and 13.6 ± 16.4% (p < 0.001), respectively. Mean glucose concentration, coefficient of variation, and glucose management indicator significantly improved. Conclusion The AHCL system effectively improved glucose control regarding TIR, TBR, and TAR. Enhanced glycemic control metrics highlight the potential for wider adoption of AHCL technology. [ABSTRACT FROM AUTHOR]

Aims: To assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life. Methods: Four hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events. Results: 82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35–16.85) in group A and 10.14 (95% CI: 4.08–20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life. Conclusion: This study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals. Trial registration: ClinicalTrials.gov registration no. NCT04060732. [ABSTRACT FROM AUTHOR]

OBJECTIVE To determine the accuracy of a continuous glucose monitoring system (CGMS) device by comparing glucose concentrations measured over time as determined by the CGMS to those of the chemistry analyzer (reference method). ANIMALS 7 healthy goats and 7 dairy calves. METHODS A randomized, crossover design with 3 treatments: control, hypoglycemia, and hyperglycemia. The CGMS device was applied to the neck. Hypoglycemia and hyperglycemia were induced by insulin and xylazine, respectively. Glucose concentrations were measured by the chemistry analyzer CGMS, point-of-care glucometer, and intensive care unit machine at 0 (before treatment), 2, 4, 6, 8, 10, and 12 hours. Agreement between the CGMS and the chemistry analyzer was determined by Bland-Altman plots. The analytical and clinical accuracy of the CGMS was determined using the International Organization for Standardization (ISO) 15197:2013 criteria and the Parkes error grid analysis. RESULTS In goats, the CGMS overestimated glucose concentrations during the hypoglycemic, normoglycemia, and hyperglycemia treatments. In calves, the CGMS underestimated glucose concentrations during the hypoglycemic treatment but overestimated glucose concentrations in normoglycemia and hyperglycemic treatments. The CGMS met the ISO clinical accuracy criteria for goats and calves, with > 99% of the glucose measurements in zones A and B of the Parkes grid. However, the CGMS did not meet the ISO 15197:2013 criteria for analytical accuracy. CLINICAL RELEVANCE The CGMS evaluated in our study only met the ISO 15197:2013 clinical accuracy criteria, not the analytical accuracy. Therefore, the device might be considered for clinical use. [ABSTRACT FROM AUTHOR]

Objective: Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. Research Design and Methods: We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. Results: Assessment of samples from 75 subjects (type 2 diabetes, n = 6; type 1 diabetes, n = 28; nondiabetic pregnant subjects, n = 10; and nondiabetic, n = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors (R2 = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. Conclusion: Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology. [ABSTRACT FROM AUTHOR]

Objective: Continuous glucose monitoring (CGM) devices are integral in the outpatient care of people with type 1 diabetes, although they lack inpatient labeling. Food and Drug Administration began allowing inpatient use during the coronavirus disease 2019 (COVID-19) pandemic, with some accuracy data now available, primarily from adult hospitals. Pediatric inpatient data remain limited, particularly during diabetic ketoacidosis (DKA) admissions and for patients receiving intravenous (IV) insulin. Design and Methods: This retrospective chart review compared point-of-care glucose values to personal Dexcom G6 sensor data during pediatric hospitalizations. Accuracy was assessed using mean absolute relative difference (MARD), Clarke Error Grids, and the percentage of values within 15/20/30% if glucose value >100 mg/dL and 15/20/30 mg/dL if glucose value ≤100 mg/dL. Results: Matched paired glucose values (N = 612) from 36 patients (median age 14 years, 58.3% non-Hispanic White, 47.2% male) and 42 inpatient encounters were included in this subanalysis of DKA admissions. The MARDs for DKA and non-DKA admissions (N = 503) were 11.8% and 11.7%, with 97.6% and 98.6% of pairs falling within A and B zones of the Clarke Error Grid, respectively. Severe DKA admissions (pH <7.15 and/or bicarbonate <5 mmol/L) had a MARD of 8.9% compared to 14.3% for nonsevere DKA admissions. The MARD during administration of IV insulin (N = 266) was 13.4%. Conclusions: CGM accuracy is similar between DKA and non-DKA admissions and is maintained in severe DKA and during IV insulin administration, suggesting potential usability in pediatric hospitalizations. Further study on the feasibility of implementation of CGM in the hospital is needed. [ABSTRACT FROM AUTHOR]

Aim: To assess the long‐term glycaemic outcomes, with additional metrics, in adults with type 1 diabetes (T1D) using the Tandem t:slim X2 with Control‐IQ technology advanced hybrid closed‐loop (AHCL) system. Methods: This was a single‐centre, retrospective study involving 56 T1D patients who transitioned to the Tandem t:slim X2 with Control‐IQ system. The primary and secondary endpoints consisted of variations in time in tight range (TiTR; 70‐140 mg/dL) and the glycaemia risk index (GRI), respectively. Additional standardized continuous glucose monitoring (CGM) metrics, mean sensor glucose, coefficient of variation, the glucose management indicator (GMI), HbA1c and insulin daily dose, were also evaluated. Variables were measured at baseline and at 15 days, 3 months, 6 months and 1 year after Tandem t:slim X2 Control‐IQ initiation. Glucose outcomes are expressed as mean (standard deviation). Results: Use of Tandem t:slim X2 with Control‐IQ over 1 year was associated with an increase in mean TiTR, from 38.11% (17.05%) to 43.10% (13.20%) (P =.059), and with a decline in the GRI, from 41.03 (25.48) to 28.55 (16.27) (P =.008). CGM metrics, including time in range and time above range, showed consistent improvements. Mean sensor glucose, the GMI and HbA1c decreased significantly over time. After an initial increase, insulin daily dose remained stable throughout the 12 months. Conclusions: The results highlight the sustained effectiveness of Tandem t:slim X2 with Control‐IQ in improving glycaemic outcomes over 1 year and support the use of this technology for the management of T1D. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the real‐world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D). Materials and Methods: PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for studies published up until 2 March 2024. We included pragmatic randomized controlled trials (RCTs), cohort studies, and before–after studies that compared AID systems with conventional insulin therapy in real‐world settings and reported continuous glucose monitoring outcomes. Percent time in range (TIR; 3.9–10 mmol/L), time below range (TBR; <3.9 mmol/L), time above range (TAR; >10 mmol/L), and glycated haemoglobin (HbA1c) level were extracted. Data were summarized as mean differences (MDs) with 95% confidence interval. Results: A total of 23 before–after studies (101 704 participants) were included in the meta‐analysis. AID systems were associated with an increased percentage of TIR (11.61%, 10.47 to 12.76; p < 0.001). The favourable effect of AID systems was consistently observed when used continuously for 6 (11.76%) or 12 months (11.33%), and in both children (12.16%) and adults (11.04%). AID systems also showed favourable effects on TBR (−0.53%, −0.63 to −0.42), TAR (−9.65%, −10.63 to −8.67) and HbA1c level (−0.42%, −0.47 to −0.37) when compared with previous treatments. Conclusions: Similar improvements in glycaemic parameters were observed in real‐world settings in RCTs using AID systems in T1D. AID systems benefit both children and adults by increasing TIR for both short‐ and long‐term interventions. [ABSTRACT FROM AUTHOR]

Aim: To perform a participant‐level post hoc meta‐analysis of Phase 3a trials in type 2 diabetes (T2D) to characterize the hypoglycaemia safety and glycaemic efficacy of once‐weekly insulin icodec (icodec). Materials and Methods: All ONWARDS 1–5 randomized participants were pooled as overall T2D, insulin‐naive, an insulin‐experienced subgroups, and by once‐daily trial comparator (degludec or glargine U100). The main outcomes included incidence and rates of clinically significant and severe hypoglycaemia. Additional endpoints included change in glycated haemoglobin (HbA1c) from baseline and HbA1c target achievement without clinically significant or severe hypoglycaemia. Results: The meta‐analysis comprised 3765 participants (1882 icodec vs. 1883 comparators). In the overall T2D pool, clinically significant hypoglycaemia incidence was similar in the icodec group versus the comparator group (17.9% vs. 16.2%, odds ratio [OR] 1.14, 95% confidence interval [CI] 0.94, 1.38); however, rates were low but significantly higher in the icodec group (1.15 vs. 1.00 episodes/participant‐year of exposure, estimated rate ratio 1.51 [95% CI 1.24, 1.85]). Fewer severe hypoglycaemic episodes occurred with icodec than with comparators (8 vs. 18). A greater reduction in HbA1c occurred with icodec versus comparators, irrespective of subgroup (estimated treatment difference range [−0.10 to −0.29%]; all p < 0.05). Across subgroups, except for the insulin‐experienced subgroup, the odds of achieving HbA1c <53 mmol/mol (7.0%) without clinically significant or severe hypoglycaemia were greater with icodec than with comparators (OR range 1.30–1.55; all p < 0.05). Conclusions: Icodec was associated with a similar incidence but higher rates of clinically significant hypoglycaemia (equating to one additional hypoglycaemic episode every 6 years) and fewer severe hypoglycaemic episodes versus comparators. Our findings also confirmed the greater efficacy of icodec that was demonstrated in the ONWARDS trial programme. [ABSTRACT FROM AUTHOR]

Aim: To investigate the relationship between continuous glucose monitoring (CGM)‐derived glucometrics and metabolic dysfunction‐associated steatotic liver disease (MASLD) in type 1 diabetes (T1D). Methods: A cross‐sectional study collecting data on anthropometrics, glucometrics and MASLD in adults with T1D using a CGM device was conducted. MASLD was assessed by abdominal ultrasound and the presence of at least one cardiometabolic criterion. Backward multivariable logistic regression models were applied to define variables independently associated with MASLD. Results: A total of 302 consecutive participants were included (median age 49 [34‐61] years, male sex 58%, median diabetes duration 29 [17‐38] years, mean time in range [TIR] 55% ± 16%). MASLD was present in 17% of cases, and 32% had metabolic syndrome (MetS). MetS was significantly more prevalent in the MASLD group (65% vs. 25%, P <.0001). TIR (P =.038) and time below range (TBR) (P =.032) were lower and time above range (TAR) was higher (P =.006), whereas HbA1c did not reach significance (P =.068). No differences were found for the glycaemia risk index. TIR (P =.028), TAR (P =.007), TBR (P =.036), waist circumference (P <.001) and systolic blood pressure (P =.029) were independently associated with MASLD, while sex, age, aspartate aminotransferase/alanine aminotransferase ratio, gamma‐glutamyl transferase, high‐density lipoprotein cholesterol and triglycerides were not. Conclusions: TIR, TAR, TBR, waist circumference and systolic blood pressure were independently associated with MASLD. [ABSTRACT FROM AUTHOR]

This article discusses the accuracy of the professional flash glucose monitoring system FreeStyle Libre Pro (FLP) in hospitalized individuals with type 2 diabetes mellitus who are receiving standardized basal-bolus insulin therapy. The study found that the FLP system exhibited an overall median absolute relative difference (MARD) of 8.4% and showed slightly less accuracy during hypoglycemia. The FLP system measured lower glucose levels compared to the point-of-care (POC) device, resulting in more hypoglycemic episodes being detected. The study concludes that the FLP sensor demonstrated good accuracy in hospitalized patients, but further research is needed to support the use of continuous glucose monitoring sensors during acute illness in the hospital setting. [Extracted from the article]

Aim: We investigated the relationship between the complexity of the glucose time series index (CGI) during pregnancy and adverse pregnancy outcomes in women with gestational diabetes mellitus (GDM). Materials and Methods: In this retrospective cohort study, 388 singleton pregnant women with GDM underwent continuous glucose monitoring (CGM) at a median of 26.86 gestational weeks. CGI was calculated using refined composite multiscale entropy based on CGM data. The participants were categorized into tertiles according to their baseline CGI (CGI <2.32, 2.32‐3.10, ≥3.10). Logistic regression was used to assess the association between CGI and composite adverse outcomes or large for gestational age (LGA). The discrimination performance of CGI was estimated using receiver operating characteristic analysis. Results: Of the 388 participants, 71 (18.3%) had LGA infants and 63 (16.2%) had composite adverse outcomes. After adjustments were made for confounders, compared with those with a high CGI (CGI ≥3.10), participants with a low CGI (CGI <2.32) had a higher risk of composite adverse outcomes (odds ratio: 12.10, 95% confidence interval: 4.41‐33.18) and LGA (odds ratio: 12.68, 95% confidence interval: 4.04‐39.75). According to the receiver operating characteristic analysis, CGI was significantly better than glycated haemoglobin and conventional CGM indicators for the prediction of adverse pregnancy outcomes (all p <.05). Conclusion: A lower CGI during pregnancy was associated with composite adverse outcomes and LGA. CGI, a novel glucose homeostasis predictor, seems to be superior to conventional glucose indicators for the prediction of adverse pregnancy outcomes in women with GDM. [ABSTRACT FROM AUTHOR]

Aim: To determine whether recent repeated exposure to real‐life hypoglycaemia affects the pro‐inflammatory response during a hypoglycemia episode. Materials and Methods: This was a post hoc analysis of a hyperinsulinaemic normoglycaemic‐hypoglycaemic clamp study, involving 40 participants with type 1 diabetes. Glucose levels 1 week before the clamp were monitored using a Freestyle Libre 1. Blood was drawn during normoglycaemia and hypoglycaemia, and 24 hours after resolution of hypoglycaemia for measurements of inflammatory responses and counterregulatory hormone levels. We determined the relationship between the frequency and duration of spontaneous hypoglycaemia, and time below range (TBR) and the inflammatory response to experimental hypoglycaemia. Results: On average, participants experienced 0.79 (0.43, 1.14) hypoglycaemia episodes per day, with a duration of 78 (47, 110) minutes and TBR of 5.5% (2.8%, 8.5%). TBR and hypoglycaemia frequency were inversely associated with the increase in circulating granulocyte and lymphocyte counts during experimental hypoglycaemia (P <.05 for all). A protein network consisting of DNER, IF‐R, uPA, Flt3L, FGF‐5 and TWEAK was negatively associated with hypoglycaemia frequency (P <.05), but not with the adrenaline response. Neither other counterregulatory hormones, nor hypoglycaemia awareness status, was associated with any of the inflammatory parameters markers. Conclusions: Repeated exposure to spontaneous hypoglycaemia is associated with blunted effects of subsequent experimental hypoglycaemia on circulating immune cells and the number of inflammatory proteins. [ABSTRACT FROM AUTHOR]

This article discusses a study comparing the effectiveness of advanced hybrid closed-loop (AHCL) pump therapy and multiple daily injection therapy (MDI) in children with newly diagnosed type 1 diabetes. The study found that AHCL systems had positive effects on glucose control and psychological outcomes, achieving recommended glycemic outcomes and reducing the frequency of hypoglycemia. The research was conducted in a real-world setting and included data on glucose metrics, glycated hemoglobin (HbA1c), and quality of life. The results suggest that AHCL systems may be a beneficial treatment option for pediatric type 1 diabetes. Another study mentioned in the text examined glucose management in individuals with type 1 diabetes. The study showed improvements in glucose management over time, with participants experiencing lower average glucose levels and spending more time in the target range. However, there were also increases in time above range and time below range at certain time intervals. The study concludes that AHCL therapy is a better option for pediatric patients with newly diagnosed type 1 diabetes, leading to better glucose control and improved quality of life. [Extracted from the article]

Aims: To assess the cost–utility of the FreeStyle Libre flash continuous glucose monitoring (CGM) system from an Italian healthcare system perspective, when compared with self‐monitoring of blood glucose (SMBG) in people living with type 2 diabetes mellitus (T2DM) receiving basal insulin. Materials and Methods: A patient‐level microsimulation model was run using Microsoft Excel for 10 000 patients over a lifetime horizon, with 3.0% discounting for costs and utilities. Inputs were based on clinical trials and real‐world evidence, with patient characteristics reflecting Italian population data. The effect of flash CGM was modelled as a persistent 0.8% reduction in glycated haemoglobin versus SMBG. Costs (€ 2023) and disutilities were applied to glucose monitoring, diabetes complications, severe hypoglycaemia, and diabetic ketoacidosis. The health outcome was measured as quality‐adjusted life‐years (QALYs). Results: Direct costs were €5338 higher with flash CGM than with SMBG. Flash CGM was associated with 0.51 more QALYs than SMBG, giving an incremental cost‐effectiveness ratio (ICER) of €10 556/QALY. Scenario analysis ICERs ranged from €3825/QALY to €26 737/QALY. In probabilistic analysis, flash CGM was 100% likely to be cost effective at willingness‐to‐pay thresholds > €20 000/QALY. Conclusions: From an Italian healthcare system perspective, flash CGM is cost effective compared with SMBG for people living with T2DM on basal insulin. [ABSTRACT FROM AUTHOR]

Objective: We aimed to compare glycemic variability (GV) parameters using both a flash glucose monitoring (FGM) system and cardiometabolic risk parameters in hospitalized patients with type 2 diabetes mellitus (T2DM) between cohorts receiving short-term intensive insulin infusion (STII) plus empagliflozin (EMPA) combination therapy vs. STII therapy alone. Methods: In a 2-week, open-label, randomized, parallel-group clinical trial, newly diagnosed patients with T2DM [fasting plasma glucose (FPG) > 11.1 mmol/L or hemoglobin A1c (HbA1c) > 9.0%] or patients with poor glycemic control (HbA1c > 7.0%) on oral antidiabetic drugs (OAD) received either STII+EMPA therapy (n = 30) or STII therapy alone (n = 30). FGM was carried over 14 days, and the data were used to calculate time in range (TIR [3.9–10 mmol/L]) and compare GV parameters. 1,5-Anhydroglucitol (1,5-AG) and cardiometabolic indicators of oxidative stress, inflammation, and vascular endothelial function were also compared. Results: After treatment, the TIR percentage was significantly higher (p < 0.05), and the time below range (TBR; < 3.9 mmol/L) was significantly lower (p < 0.05) in the STII+EMPA group than that in the STII group. The various measured glycemic parameters were significantly lower, and the average daily dose of insulin was also significantly lower in patients with STII+EMPA treatment (all p < 0.05). Plasma 1,5-AG levels were significantly higher (p < 0.05) in the STII+EMPA group than that in the control group. Conclusions: Newly diagnosed patients with T2DM or with poor glycemic control on OAD attained greater benefit and lower GV from STII+EMPA treatment than that for STII treatment alone. The 1,5-AG marker is a good indicator of the effects of short-term glycemic control. [ABSTRACT FROM AUTHOR]

The article discusses the Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC). It explains how the DCCT demonstrated that intensive treatment of type 1 diabetes reduced the risk of microvascular complications, such as retinopathy, neuropathy, and albuminuria. However, it also found that intensive treatment had adverse effects, including an increase in severe hypoglycemia. The EDIC study showed that the benefits of intensive treatment persisted over time, leading to reductions in severe complications and mortality. The findings of these studies have greatly influenced diabetes treatment guidelines and improved outcomes for people with type 1 diabetes. [Extracted from the article]

OBJECTIVE: To evaluate the impact of prolonged hybrid closed loop (HCL) use in children with type 1 diabetes (T1D) on glucose control and BMI throughout pubertal progression. RESEARCH DESIGN AND METHODS: We used a prospective multicenter extension study following the Free-Life Kid AP (FLKAP) HCL trial. The 9-month previously reported FLKAP trial included 119 prepubertal children (aged 6–12 years). During the extension study, participants could continue to use HCL for 30 months (M9 to M39). HbA1c values were collected every 3 months up to M39, while continuous glucose monitoring metrics, BMI z scores, and Tanner stages were collected up to M24. Noninferiority tests were performed to assess parameter sustainability over time. RESULTS: One hundred seventeen children completed the extension study, with mean age 10.1 years (minimum to maximum, 6.8–14.0) at the beginning. Improvement of HbA1c obtained in the FLKAP trial was significantly sustained during extension (median [interquartile range], M9 7.0% [6.8–7.4], and M39 7.0% [6.6–7.4], P < 0.0001 for noninferiority test) and did not differ between children who entered puberty at M24 (Tanner stage ≥2; 54% of the patients) and patients who remained prepubertal. BMI z score also remained stable (M9 0.41 [−0.29 to 1.13] and M24 0.48 [−0.11 to 1.13], P < 0.0001, for noninferiority test). No severe hypoglycemia and one ketoacidosis episode not related to the HCL system occurred. CONCLUSIONS: Prolonged use of HCL can safely and effectively mitigate impairment of glucose control usually associated with pubertal progression without impact on BMI in children with T1D. [ABSTRACT FROM AUTHOR]

Aim: To conduct a discursive review on continuous glucose monitoring use among Black older adults and to address the issue of racial disparities in diabetes management and outcomes. Type 2 diabetes mellitus is a global health concern with significant complications and mortality rates. Black older adults are disproportionately affected. Initially designed for type 1 diabetes, continuous glucose monitoring has emerged as an innovative tool for type 2 diabetes mellitus management. Despite its potential, there are challenges related to adherence and digital literacy among Black older adults for managing Diabetes. Design: A discursive review. Methods: Searching literature in PubMed, Scopus, and Google Scholar for papers published from 2017 to 2023, we explored the use of continuous glucose monitoring in Black older adults with type 2 diabetes mellitus, examining barriers, facilitators and challenges. Discussion: We highlight recommendations from the literature which included barriers, facilitators, and cultural factors associated with continuous glucose monitoring use. Findings underscore the importance of addressing these challenges to reduce racial–ethnic disparities in type 2 diabetes mellitus management among Black older adults. Nurses and advanced practice registered nurses are at the forefront and can play a pivotal role in exploring and implementing interventions to promote access and proper use of continuous glucose monitoring among Black older adult patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

This article explores the topic of glucose control in critically ill patients, focusing on the influential Leuven study from Belgium. While the study initially showed improved outcomes with tight blood glucose control, subsequent research has yielded mixed results and highlighted the risk of severe hypoglycemia. Observational studies suggest that preadmission glycemic status may play a role in outcomes. The concept of relative hypoglycemia and relative hyperglycemia is introduced, which can independently increase mortality risk. A study by Okazaki et al. supports these findings and suggests that managing blood glucose levels based on preadmission glycemia may be appropriate, but caution is needed when interpreting the results due to differences in medical practice and patient populations. Another document discusses the use of transesophageal echocardiography (TEE) as a monitoring tool during CPR. TEE allows for continuous imaging during CPR, improving the acquisition of cardiac images and enabling the detection of markers of CPR quality. However, there is limited evidence on the impact of TEE on patient outcomes, such as mortality. Further research is necessary to determine the effectiveness of TEE in improving CPR quality and outcomes. [Extracted from the article]

Aims: In tackling rising diabetes‐related emergencies, the need to understand and address emergency service usage by people with type 1 diabetes is vital. This review aimed to quantify current trends in presentations for type 1 diabetes‐related emergencies and identify public health strategies that reduce the frequency of diabetes‐related emergencies and improve glycaemic management. Methods: Medline (OVID), Cochrane and CINAHL were searched for studies published between 2000 and 2023, focusing on people with type 1 diabetes, severe hypoglycaemia and/or diabetic ketoacidosis, and ambulance and/or emergency department usage. There were 1313 papers identified, with 37 publications meeting review criteria. Results: The incidence of type 1 diabetes‐related emergencies varied from 2.4 to 14.6% over one year for hypoglycaemic episodes, and between 0.07 and 11.8 events per 100 person‐years for hyperglycaemic episodes. Notably, our findings revealed that ongoing diabetes education and the integration of diabetes technology, such as continuous glucose monitoring and insulin pump therapy, significantly reduced the incidence of these emergencies. However, socio‐economic disparities posed barriers to accessing these technologies, subsequently shifting the cost to emergency healthcare and highlighting the need for governments to consider subsidising these technologies as part of preventative measures. Conclusions: Improving access to continuous glucose monitoring and insulin pump therapy, in combination with ongoing diabetes education focusing on symptom recognition and early management, will reduce the incidence of diabetes‐related emergencies. Concurrent research assessing emergency healthcare usage patterns during the implementation of such measures is essential to ensure these are cost‐effective. [ABSTRACT FROM AUTHOR]

Introduction: This review presents a critical appraisal of differences in the methodologies and quality of model-based and empirical data-based cost-utility studies on continuous glucose monitoring (CGM) in type 1 diabetes (T1D) populations. It identifies key limitations and challenges in health economic evaluations on CGM and opportunities for their improvement. Methods: The review and its documentation adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews. Searches for articles published between January 2000 and January 2023 were conducted using the MEDLINE, Embase, Web of Science, Cochrane Library, and Econlit databases. Published studies using models and empirical data to evaluate the cost utility of all CGM devices used by T1D patients were included in the search. Two authors independently extracted data on interventions, populations, model settings (e.g., perspectives and time horizons), model types and structures, clinical outcomes used to populate the model, validation, and uncertainty analyses. They subsequently met to confirm consensus. Quality was assessed using the Philips checklist for model-based studies and the Consensus Health Economic Criteria (CHEC) checklist for empirical studies. Model validation was assessed using the Assessment of the Validation Status of Health-Economic decision models (AdViSHE) checklist. The extracted data were used to generate summary tables and figures. The study protocol is registered with PROSPERO (CRD42023391284). Results: In total, 34 studies satisfied the selection criteria, two of which only used empirical data. The remaining 32 studies applied 10 different models, with a substantial majority adopting the CORE Diabetes Model. Model-based studies often lacked transparency, as their assumptions regarding the extrapolation of treatment effects beyond available evidence from clinical studies and the selection and processing of the input data were not explicitly stated. Initial scores for disagreements concerning checklists were relatively high, especially for the Philips checklist. Following their resolution, overall quality scores were moderate at 56%, whereas model validation scores were mixed. Strikingly, costing approaches differed widely across studies, resulting in little consistency in the elements included in intervention costs. Discussion and Conclusion: The overall quality of studies evaluating CGM was moderate. Potential areas of improvement include developing systematic approaches for data selection, improving uncertainty analyses, clearer reporting, and explaining choices for particular modeling approaches. Few studies provided the assurance that all relevant and feasible options had been compared, which is required by decision makers, especially for rapidly evolving technologies such as CGM and insulin administration. High scores for disagreements indicated that several checklists contained questions that were difficult to interpret consistently for quality assessment. Therefore, simpler but comprehensive quality checklists may be needed for model-based health economic evaluation studies. [ABSTRACT FROM AUTHOR]

Introduction: There is a growing body of evidence demonstrating the benefit of flash glucose monitoring in people living with type 2 diabetes mellitus (T2DM). This real-world study aimed to evaluate the effect of initiating flash glucose monitoring on change in HbA1c after 3–6 months in adults living with T2DM treated with multiple daily injections of insulin. Methods: A retrospective observational study using data from ten clinical centres in the UK for adults with T2DM treated with multiple daily injections of insulin for at least 1 year was conducted. Patients who had been using the FreeStyle Libre/Libre 2 Flash Glucose Monitoring System for at least 3 months with baseline HbA1c 64–108 mmol/mol (8.0–12.0%) recorded up to 3 months prior to system use were included. Pregnant patients and those on dialysis were excluded. Patients with an HbA1c value measured 3–6 months after commencing flash glucose monitoring were included in the final analysis for evaluation of change. Results: In total, 87 patients were included in the final analysis (mean age, 60.0 ± 11.8 years, 60.9% male, mean body mass index (BMI), 31.6 ± 5.4 [mean ± SD]). From a mean baseline HbA1c of 80 ± 11 mmol/mol (9.5% ± 1.0%), HbA1c lowered by 11 ± 14 mmol/mol (1.0% ± 1.3%) at 3–6 months (p < 0.0001). A decrease was observed independent of age, baseline HbA1c, sex, duration of insulin use and BMI subgroups. Conclusions: Initiation of flash glucose monitoring was associated with a clinically and statistically significant improvement in HbA1c in a real-world setting at 3–6 months. [ABSTRACT FROM AUTHOR]

Introduction: Both glucagon-like peptide-1 receptor agonists (GLP-1 RA) and continuous glucose monitoring (CGM) improve glycemia in patients with type 2 diabetes (T2D). However, it is unknown whether adding CGM to GLP-1 RA therapy further improves A1c. We evaluated changes in A1c levels 6 months after initiation of FreeStyle Libre (FSL) in adults with sub-optimally controlled T2D already on GLP-1 RA therapy. Methods: This retrospective, observational study used Optum's de-identified Market Clarity Data, a linked electronic health record-claims database to assess changes in A1c after FSL acquisition. Inclusion criteria were T2D diagnosis, ≥ 18 years, baseline A1c ≥ 8%, with the first FSL acquisition between 2018 and 2022. Patients were required to be on GLP-1 RA prior to FSL with at least one GLP-1 RA prescription within 90 days of FSL acquisition. GLP-1 RA initiation was defined as the earliest GLP-1 RA prescription from 2017 onwards. Paired changes in A1c were assessed at 6 months after initial FSL acquisition. Results: The study cohort included 1454 adults with T2D (age 55 ± 10 years, 52% male, 38% with intensive insulin therapy, median 471 days from GLP-1 RA initiation to FSL, and baseline A1c 9.8 ± 1.5%). After FSL acquisition, patients experienced an A1c decrease of 1.5 ± 1.9% (p < 0.001). Patients with a baseline A1c > 10% had the largest reduction (n = 497, − 2.7 ± 2.2%, p < 0.001). Significant improvements were observed in subgroups based on insulin therapy and GLP-1 RA formulation. Those initiating GLP-1 RA therapy > 24 months before FSL acquisition also showed improvements in A1c (n = 478; − 1.3 ± 1.7%, p < 0.001). Conclusions : In a large, real-world study of adults with T2D, those on prior GLP-1 RA therapy experienced significant A1c improvements after acquiring FSL, irrespective of GLP-1 RA duration, GLP-1 RA formulation, or insulin therapy type. These findings support the use of FSL in adults with T2D treated with GLP-1 RA. [ABSTRACT FROM AUTHOR]

The objectives of the current research were to evaluate the accuracy and reliability of continuous glucose monitoring (CGM) in patients undergoing cardiac surgery and assess the impact of preoperative liraglutide administration on perioperative glucose control as captured by CGM. This was a prospective, single-center, prespecified analysis of the GLOBE trial, a randomized controlled trial comparing preoperative liraglutide treatment to placebo in patients undergoing cardiac surgery. The work took place at a single-center academic hospital in the Netherlands. Twenty-five patients undergoing cardiac surgery were recruited from the hospital's cardiac surgery department. Participants received the Dexcom G5 CGM system from the day before surgery until discharge from the intensive care unit after surgery. Additionally, participants were randomized to receive either preoperative liraglutide or placebo. Arterial blood gas (ABG) glucose measurements were collected as a reference and matched to CGM readings to assess accuracy and reliability. In 240 paired CGM–ABG glucose measurements, the mean absolute relative difference was 14.4 ± 12.5%. Temporary sensor interruption occurred mainly intraoperatively (92% of patients). The median duration of intraoperative sensor interruption was 65 (48-95) minutes. Liraglutide increased glycemic time in range 72% versus 47% in the control group (absolute difference 25%, 95% confidence interval –41.4 to –8.9, p =.004). Despite intraoperative sensor interruption, CGM seems an accurate method for semi-invasive, real-time assessment of blood glucose levels. CGM can provide a detailed observation of the pre- and postoperative glycemic trajectory, demonstrating increased time in range following perioperative liraglutide treatment compared with placebo. [ABSTRACT FROM AUTHOR]

Context Adults with type 1 diabetes (T1D) face the necessity of balancing the benefits of exercise with the potential hazards of hypoglycemia. Objective This work aimed to assess whether impaired awareness of hypoglycemia (IAH) affects exercise-associated hypoglycemia in adults with T1D. Methods We compared continuous glucose monitoring (CGM)-measured glucose during exercise and for 24 hours following exercise from 95 adults with T1D and IAH (Clarke score ≥4 or ≥1 severe hypoglycemic event within the past year) to 95 "aware" adults (Clarke score ≤2 and no severe hypoglycemic event within the past year) matched on sex, age, insulin delivery modality, and glycated hemoglobin A1c. A total of 4236 exercise sessions, and 1794 exercise days and 839 sedentary days, defined as 24 hours following exercise or a day without exercise, respectively, were available for analysis. Results Participants with IAH exhibited a nonsignificant trend toward greater decline in glucose during exercise compared to "aware" (−21 ± 44 vs −19 ± 43 mg/dL [−1.17 ± 2.44 vs −1.05 ± 2.39 mmol/L], adjusted group difference of −4.2 [95% CI, −8.4 to 0.05] mg/dL [−0.23 95% CI, −.47 to 0.003 mmol/L]; P =.051). Individuals with IAH had a higher proportion of days with hypoglycemic events below 70 mg/dL [3.89 mmol/L] (≥15 minutes <70 mg/dL [<3.89 mmol/L]) both on exercise days (51% vs 43%; P =.006) and sedentary days (48% vs 30%; P =.001). The increased odds of experiencing a hypoglycemic event below 70 mg/dL (<3.89 mmol/L) for individuals with IAH compared to "aware" did not differ significantly between exercise and sedentary days (interaction P =.36). Conclusion Individuals with IAH have a higher underlying risk of hypoglycemia than "aware" individuals. Exercise does not appear to differentially increase risk for hypoglycemia during the activity, or in the subsequent 24 hours for IAH compared to aware individuals with T1D. [ABSTRACT FROM AUTHOR]