Cost-utility analysis of Dexcom G6 real-time continuous glucose monitoring versus FreeStyle Libre 1 intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in Belgium.

AIMS/HYPOTHESIS: The aim of this study was to assess the long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring (rtCGM) with alert functionality compared with FreeStyle Libre 1 intermittently scanned continuous glucose monitoring (isCGM) without alerts in adults with type 1 diabetes in Belgium. METHODS: The IQVIA CORE Diabetes Model was used to estimate cost-effectiveness. Input data for the simulated baseline cohort were sourced from the randomised ALERTT1 trial (ClinicalTrials.gov. REGISTRATION NO: NCT03772600). The age of the participants was 42.9 ± 14.1 years (mean ± SD), and the baseline HbA1c was 57.8 ± 9.5 mmol/mol (7.4 ± 0.9%). Participants using rtCGM showed a reduction in HbA1c of 3.6 mmol/mol (0.36 percentage points) based on the 6-month mean between-group difference. In the base case, both rtCGM and isCGM were priced at €3.92/day (excluding value-added tax [VAT]) according to the Belgian reimbursement system. The analysis was performed from a Belgian healthcare payer perspective over a lifetime time horizon. Health outcomes were expressed as quality-adjusted life years. Probabilistic and one-way sensitivity analyses were used to account for parameter uncertainty. RESULTS: In the base case, rtCGM dominated isCGM, resulting in lower diabetes-related complication costs and better health outcomes. The associated main drivers favouring rtCGM were lower HbA1c, fewer severe hypoglycaemic events and reduced fear of hypoglycaemia. The results were robust under a wide range of one-way sensitivity analyses. In models where the price of rtCGM is €5.11/day (a price increase of 30.4%) or €12.34/day (a price increase of 214.8%), rtCGM was cost-neutral or reached an incremental cost-effectiveness ratio of €40,000 per quality-adjusted life year, respectively. CONCLUSIONS/INTERPRETATION: When priced similarly, Dexcom G6 rtCGM with alert functionality has both economic and clinical benefits compared with FreeStyle Libre 1 isCGM without alerts in adults with type 1 diabetes in Belgium, and appears to be a cost-effective glucose monitoring modality. Trial registration ClinicalTrials.gov NCT03772600.

Comparing the glycaemic outcomes between real-time continuous glucose monitoring (rt-CGM) and intermittently scanned continuous glucose monitoring (isCGM) among adults and children with type 1 diabetes: A systematic review and meta-analysis of randomized controlled trials.

AIM: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing the effectiveness of real-time continuous glucose monitoring (rtCGM) versus intermittently scanned continuous glucose monitoring (isCGM) on key glycaemic metrics (co-primary outcomes HbA1c and time-in-range [TIR] 70-180 mg/dL, 3.9-10.0 mmol/L) among people with type 1 diabetes (T1D). METHODS: Medline, PubMed, Scopus, Web of Science and Cochrane Central Register of clinical trials were searched. Inclusion criteria were RCTs; T1D populations of any age and insulin regimen; comparing any type of rtCGM with isCGM (only the first generation had been compared to date); and reporting the glycaemic outcomes. Glycaemic outcomes were extracted post-intervention and expressed as mean differences and 95% CIs between the two comparators. Results were pooled using a random-effect meta-analysis. The risk of bias was assessed using the Cochrane RoB2 tool. The quality of evidence was assessed by the GRADE approach. RESULTS: Five RCTs met the inclusion criteria (4 parallel and 1 crossover design; 4 with CGM use <8 weeks), involving 446 participants (354 adults; 92 children and adolescents). Overall, meta-analysis showed rtCGM compared to isCGM improved absolute TIR by +7.0% (95% CI: 5.8%-8.3%, I2 = 0%, p < 0.01) accompanied by a favorable effect on time-below-range <70 mg/dL (3.9 mmol/L) - 1.7% (95%CI: -3.0% to -0.4%; p = 0.03). No differences were seen regarding HbA1c. CONCLUSIONS: This meta-analysis highlights that for people with T1D, rtCGM confers benefits over isCGM primarily related to increased TIR, with improvements in hypo- and hyperglycaemia.

Real time continuous glucose monitoring in high-risk people with insulin-requiring type 2 diabetes: A randomised controlled trial.

AIMS: To investigate the impact of real-time continuous glucose monitoring (rtCGM) on glycaemia in a predominantly indigenous (Maori) population of adults with insulin-requiring type 2 diabetes (T2D) in New Zealand. METHODS: Twelve-week, multicentre randomised controlled trial (RCT) of adults with T2D using ≥0.2 units/kg/day of insulin and elevated glycated haemoglobin (HbA1c) ≥64 mmol/mol (8.0%). Following a 2-week blinded CGM run-in phase, participants were randomised to rtCGM or control (self-monitoring blood glucose [SMBG]). The primary outcome was time in the target glucose range (3.9-10 mmol/L; TIR) during weeks 10-12, with data collected by blinded rtCGM in the control group. RESULTS: Sixty-seven participants entered the RCT phase (54% Maori, 57% female), median age 53 (range 16-70 years), HbA1c 85 (IQR 74, 94) mmol/mol (9.9 [IQR 8.9, 10.8]%), body mass index (36.7 ± 7.7 kg/m2). Mean (±SD) TIR increased from 37 (24)% to 53 (24)% [Δ 13%; 95% CI 4.2 to 22; P = 0.007] in the rtCGM group but did not change in the SMBG group [45 (21)% to 45 (25)%, Δ 2.5%, 95% CI -6.1 to 11, P = 0.84]. Baseline-adjusted between-group difference in TIR was 10.4% [95% CI -0.9 to 21.7; P = 0.070]. Mean HbA1c (±SD) decreased in both groups from 85 (18) mmol/mol (10.0 [1.7]%) to 64 (16) mmol/mol (8.0 [1.4]%) in the rtCGM arm and from 81 (12) mmol/mol (9.6 [1.1]%) to 65 (13) mmol/mol (8.1 [1.2]%) in the SMBG arm (P < 0.001 for both). There were no severe hypoglycaemic or ketoacidosis events in either group. CONCLUSIONS: Real-time CGM use in a supportive treat-to-target model of care likely improves glycaemia in a population with insulin-treated T2D and elevated HbA1c.

Longitudinal analysis of users transitioning from the Dexcom G5 to the G6 RT-CGM system in Germany, Sweden and the United Kingdom (2018-2020).

AIMS: Regional variations in the adoption of diabetes technology may be reflected in population-level metrics of glycaemic control. In this observational study, we aimed to assess the glycaemic impacts of transitioning from the Dexcom G5 Real-Time Continuous Glucose Monitoring (RT-CGM) System to the Dexcom G6 in three European countries. METHODS: Anonymised RT-CGM data (uploaded to the Dexcom Clarity app) were from users in Germany, Sweden, and the United Kingdom (UK) who transitioned from G5 to G6 between 9-12 months after G6 launched in 2018. Primary endpoints were percent time in hypoglycaemia, percent time in range (TIR), user retention rates, device utilisation, and urgent low soon (ULS) alert utilisation. Metrics were computed for 3-month intervals in the 2-year study window. RESULTS: In all three countries, the transition from G5 to G6 was associated with a clear decrease in hypoglycaemia. In months 0-3 after transitioning, the median percent time 〈3 mmol/L (54 mg/dL) and 〈3.9 mmol/L (70 mg/dL) decreased by [0.12-0.28] and [0.40-0.43] percentage points, respectively, with another [0.11-0.21] and [0.34-0.65] percentage point decrease in months 3-6 in the three countries analysed. TIR and CGM utilisation were sustained or improved slightly across all countries. At the end of the study window, the retention rate was [88.8-94.8%] and ULS utilization was [83.9-86.9%] in the three countries analysed. CONCLUSIONS: Similar RT-CGM trends were observed across Germany, Sweden, and the UK. Improvements in hypoglycaemia occurred in all countries. The high retention of users may lead to sustained glycaemic benefits associated with RT-CGM use.

Assessment of factors associated with improved glycemic control after switching from intermittently scanned to real-time continuous glucose monitoring in Japanese patients with type 1 diabetes.

The advantages of real-time continuous glucose monitoring (rtCGM) over intermittently scanned CGM (isCGM) reportedly include lower glycated hemoglobin (HbA1c) levels as well as reduced glycemic variability. However, there have been few studies of the effect of switching from isCGM to rtCGM on glycemic control, as well as the specific factors underlying any observed improvements. To that end, all patients with type 1 diabetes mellitus who used the DEXCOM rtCGM device (Terumo Corporation, Tokyo, Japan) at our institution were reviewed, and 16 individuals with type 1 diabetes who switched from isCGM to rtCGM were investigated. The patients' HbA1c decreased in 75% of the cases (p = 0.02). On the other hand, GMI increased in 75% of the cases (p = 0.01). Intriguingly, the percentage of time below range and coefficient of variation were significantly improved with rtCGM compared to isCGM (2.9% vs. 7.6%, p = 0.016 and 35% vs. 40%, p = 0.0019, respectively). We also found that the discrepancy between HbA1c and GMI among users of isCGM was a key indicator that improved when switching to rtCGM. If discrepancies are observed between HbA1c and GMI when using isCGM, switching to rtCGM should be considered for improving glycemic control.

Trends of glucose, lactate and ketones during anaerobic and aerobic exercise in subjects with type 1 diabetes: The ACTION-1 study.

BACKGROUND: Exercise is part of type 1 diabetes (T1D) management due to its cardiovascular and metabolic benefits. However, despite using continuous glucose monitoring, many patients are reluctant to exercise because of fear for hypoglycaemia. AIMS: We assessed trends in glucose, lactate and ketones during anaerobic and aerobic exercise in people with T1D and compared incremental area under the curve (AUC) between both exercises. METHODS: Twenty-one men with T1D (median [IQR]: age 29 years [28-38], body mass index (BMI) 24.4 kg/m2 [22.3-24.9], HbA1c 7.2% [6.7-7.8]), completed a cardiopulmonary exercise test (CPET) and a 60-min aerobic exercise (AEX) at 60% VO2 peak on an ergometer bicycle within a 6-week period. Subjects consumed a standardised breakfast (6 kcal/kg, 20.2 g CHO/100 ml) before exercise without pre-meal insulin and basal insulin for pump users. RESULTS: During CPET, glucose levels increased, peaking at 331 mg/dl [257-392] 1-3 h after exercise and reaching a nadir 6 h after exercise at 176 mg/dl [118-217]. Lactate levels peaked at 6.0 mmol/L [5.0-6.6] (max 13.5 mmol/L). During AEX, glucose levels also increased, peaking at 305 mg/dl [245-336] 80 min after exercise and reaching a nadir 6 h after exercise at 211 mg/dl [116-222]. Lactate levels rose quickly to a median of 4.3 mmol/L [2.7-6.7] after 10 min. Ketone levels were low during both tests (median ≤ 0.2 mmol/L). Lactate, but not glucose or ketone AUC, was significantly higher in CPET compared to AEX (p = 0.04). CONCLUSIONS: Omitting pre-meal insulin and also basal insulin in pump users, did prevent hypoglycaemia but induced hyperglycaemia due to a too high carbohydrate ingestion. No ketosis was recorded during or after the exercises. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT05097339.

Long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring system in people with type 1 diabetes in Australia.

INTRODUCTION: Real-time continuous glucose monitoring (rt-CGM) allows patients with diabetes to adjust insulin dosing, potentially improving glucose control. This study aimed to compare the long-term cost-effectiveness of the Dexcom G6 rt-CGM device versus self-monitoring of blood glucose (SMBG) and flash glucose monitoring (FGM) in Australia in people with type 1 diabetes (T1D). METHODS: Long-term costs and clinical outcomes were estimated using the CORE Diabetes Model. Clinical input data for the analysis of rt-CGM versus SMBG and FGM were sourced from the DIAMOND study and a network meta-analysis, respectively. Rt-CGM and FGM were associated with quality of life (QoL) benefits due to reduced fear of hypoglycaemia (FoH) and fingerstick testing. Analyses were performed over a lifetime time horizon from an Australian healthcare payer perspective, including direct costs from published data. Future costs and clinical outcomes were discounted at 5% per annum. RESULTS: Rt-CGM was associated with an increased quality-adjusted life expectancy of 1.199 quality-adjusted life years (QALYs), increased mean total lifetime costs of AUD 21,596 and an incremental cost-effectiveness ratio (ICER) of AUD 18,020 per QALY gained compared with SMBG. Compared with FGM, rt-CGM was associated with an increased quality-adjusted life expectancy of 0.569 QALYs, increased mean total lifetime costs of AUD 11,064 and an ICER of AUD 19,455 per QALY gained. Key drivers of outcomes included HbA1c benefits and QoL benefits associated with reduced FoH and fingerstick testing. CONCLUSIONS: Due to improved clinical outcomes and QoL gains rt-CGM is highly cost-effective compared with SMBG and FGM in people with T1D in Australia.

Benefits of a Switch from Intermittently Scanned Continuous Glucose Monitoring (isCGM) to Real-Time (rt) CGM in Diabetes Type 1 Suboptimal Controlled Patients in Real-Life: A One-Year Prospective Study §.

The switch from intermittently scanned continuous glucose monitoring (isCGM) to real-time (rt) CGM could improve glycemic management in suboptimal controlled type 1 diabetes patients, but long-term study is lacking. We evaluated retrospectively the ambulatory glucose profile (AGP) in such patients after switching from Free Style Libre 1 (FSL1) to Dexcom G4 (DG4) biosensors over 1 year. Patients (n = 21, 43 ± 15 years, BMI 25 ± 5, HbA1c 8.1 ± 1.0%) had severe hypoglycemia and/or HbA1c ≥ 8%. AGP metrics (time-in-range (TIR) 70-180 mg/dL, time-below-range (TBR) <70 mg/dL or <54 mg/dL, glucose coefficient of variation (%CV), time-above-range (TAR) >180 mg/dL or >250 mg/dL, glucose management indicator (GMI), average glucose) were collected the last 3 months of FSL1 use (M0) and of DG4 for 3, 6 (M6) and 12 (M12) months of use. Values were means ± standard deviation or medians [Q1;Q3]. At M12 versus M0, the higher TIR (50 ± 17 vs. 45 ± 16, p = 0.036), and lower TBR < 70 mg/dL (2.5 [1.6;5.5] vs. 7.0 [4.5;12.5], p = 0.0007), TBR < 54 mg/dL (0.7 [0.4;0.8] vs. 2.3 [0.8;7.0], p = 0.007) and %CV (39 ± 5 vs. 45 ± 8, p = 0.0009), evidenced a long-term effectiveness of the switch. Compared to M6, TBR < 70 mg/dL decreased, %CV remained stable, while the improvement on hyperglycemia exposure decreased (higher GMI, TAR and average glucose). This switch was a relevant therapeutic option, though a loss of benefit on hyperglycemia stressed the need for optimized management of threshold alarms. Nevertheless, few patients attained the recommended values for AGP metrics, and the reasons why some patients are "responders" vs. "non-responders" warrant to be investigated.

The use of real time continuous glucose monitoring or flash glucose monitoring in the management of diabetes: A consensus view of Italian diabetes experts using the Delphi method.

Until recently, in Italy, the use of continuous glucose monitoring (CGM) systems has been limited, but is now rapidly increasing, including the so-called real-time CGM (rtCGM) and the intermittently viewed CGM (iCGM), also called Flash Glucose Monitoring (FGM). These technologies overcome many of the limitations of self-monitoring of blood glucose (SMBG) by fingerprick and allow to go beyond HbA1c to check glucose control in diabetes. However, standardized protocols for applying and interpreting rtCGM and FGM data are lacking. In this paper, we delineate a consensus amongst Italian diabetes physicians on the attributes of rtCGM and FGM technologies, and introduce a consistent approach for their use by Italian healthcare professionals. Most experts consider rtCGM and FGM as two separate categories of interstitial subcutaneous fluid (ISF) sensing technologies, and see them as superior to SMBG. Furthermore, there is strong consensus that rtCGM and FGM reduce hypoglycemia risk, increase the amount of time in the target glucose range and augment treatment satisfaction. However, there is still no agreement on the indication of the FGM for subjects who suffer asymptomatic hypoglycemia. Consensus on the role of education in initiating and optimizing use of rtCGM/FGM and about the interpretation of glucose trends was near unanimous, whereas no consensus was reached on the statement that there are no disadvantages/risks of rtCGM/FGM. Some issues remain in rtCGM/FGM management: a) risk of excessive correction of high or low glucose; b) risk of alert fatigue leading to alert silencing or rtCGM termination; c) allergic reaction to the adhesive keeping rtCGM or FGM sensors in place. The panel almost unanimously agreed that sensor accuracy depends on multiple variables, that alarm setting should be individualized, and that global glycemic profile represent an useful tool in interpreting glucose data. More clinical studies and a wider use of these devices will increase the efficacy and effectiveness of continuous glucose monitoring in Italy.

Comparison between preprandial vs. postprandial insulin aspart in patients with type 1 diabetes on insulin pump and real-time continuous glucose monitoring.

BACKGROUND: The objective was to compare glycemic control between preprandial and postprandial bolus administration (15 min before [PRE] or immediately after the meal [POST]) in patients with type 1 diabetes using insulin pump and real-time continuous glucose monitoring. METHODS: Between September 2015 and February 2016, a single-centre, open randomized, 2-way crossover study of patients on bolus insulin aspart administration was conducted during two 14-day periods and according to 2 administration regimen schedules (PRE/POST or POST/PRE). Inclusion criteria were as follows: patients with type 1 diabetes, ≥18 and ≤ 65 years old, treated with insulin aspart using a Medtronic® insulin pump and trained on functional insulin therapy. Patients were randomly assigned to either regimen schedule. At the beginning of each period, each patient was provided with a standardized high fat meal. Primary outcome was the area under the curve for interstitial glucose above 140 mg/dL per minute (AUC > 140 mg/dL/min) during each period. Secondary outcomes were time spent in hypo/eu/hyperglycemia, glycemic variability indices, and AUC during 4 hours after high fat meal calculated with continuous glucose monitoring data. RESULTS: Twenty-two patients were included. Mean AUC > 140 mg/dL/min was statistically higher in patients on POST (43.70 mg/dL/min; 95%CI: 34.08 to 53.31) versus PRE insulin aspart regimen (37.24 mg/dL/min 95%CI: 27.63 to 46.85) (P = 0.03). Mean interstitial glycemia and glycemic variability indices were also increased (P < 0.05) on POST regimen. The mean AUC 4 hours after the high fat meal was higher on POST regimen but not statistically different (P = 0.06). CONCLUSIONS: In our study, postprandial administration of insulin aspart appears to mildly increase glycemic excursion and glycemic variability.

Higher rate of hyperglycemia than hypoglycemia during Ramadan fasting in patients with uncontrolled type 1 diabetes: Insight from continuous glucose monitoring system.

BACKGROUND: Patients with uncontrolled type 1 diabetes mellitus (T1DM) are at a high risk for Ramadan fasting and are exempt from fasting; however, most still insist on fasting. The aim of this study was to examine glucose level fluctuations in those patients during Ramadan fasting using a real-time continuous glucose monitoring system (RT-CGMS). METHODS: This pilot study involved adult patients with uncontrolled T1DM (HbA1c > 7%) who insisted on fasting during Ramadan in 2014 from Maternity and Children's Hospital, Medina, Saudi Arabia. A Medtronic RT-CGMS was used to monitor the participants' glucose levels for 3 consecutive days during fasting. RESULTS: The study included 22 patients (mean age 22 ±â€¯6 years, duration of diabetes 10.9 ±â€¯7.2 years, HbA1c level 9.3 ±â€¯1.2). All participants were using the basal-bolus insulin regimen, except for one patient who was on an insulin pump. Sensor glucose (SG) profiles typically followed a pattern that was characterized by an exaggerated increase after iftar, which was sustained overnight, and a second rapid rise after suhoor, with a prolonged glucose decay over the daylight hours. The average SG was 199 ±â€¯104.1 mg/dl, which was lower during fasting 188.4 ±â€¯103.41 mg/dl than during the eating hours 212.5 ±â€¯103.51 mg/dl (P = 0.00). There was a higher rate of hyperglycemia (48%) than hypoglycemia (10%). CONCLUSIONS: Patients with uncontrolled T1DM who fasted during Ramadan experienced a wide fluctuation of glucose levels between fasting and eating hours, exhibiting a greater tendency toward hyperglycemia. The long-term effects for this finding are not known and warrant further investigation.

[Design and implementation of real-time continuous glucose monitoring instrument].

Real-time continuous glucose monitoring can help diabetics to control blood sugar levels within the normal range. However, in the process of practical monitoring, the output of real-time continuous glucose monitoring system is susceptible to glucose sensor and environment noise, which will influence the measurement accuracy of the system. Aiming at this problem, a dual-calibration algorithm for the moving-window double-layer filtering algorithm combined with real-time self-compensation calibration algorithm is proposed in this paper, which can realize the signal drift compensation for current data. And a real-time continuous glucose monitoring instrument based on this study was designed. This real-time continuous glucose monitoring instrument consisted of an adjustable excitation voltage module, a current-voltage converter module, a microprocessor and a wireless transceiver module. For portability, the size of the device was only 40 mm × 30 mm × 5 mm and its weight was only 30 g. In addition, a communication command code algorithm was designed to ensure the security and integrity of data transmission in this study. Results of experiments in vitro showed that current detection of the device worked effectively. A 5-hour monitoring of blood glucose level in vivo showed that the device could continuously monitor blood glucose in real time. The relative error of monitoring results of the designed device ranged from 2.22% to 7.17% when comparing to a portable blood meter.

Real-time continuous glucose monitoring-guided glucose management in inpatients with diabetes receiving short-term continuous subcutaneous insulin infusion: a randomized clinical trial.

Background: The use of real-time continuous glucose monitoring (rtCGM) technology remains largely investigational in the hospital setting. The current study aimed to evaluate the effectiveness of rtCGM in inpatients with diabetes who were treated with short-term continuous subcutaneous insulin infusion (CSII). Methods: In this randomized, parallel controlled trial conducted on the endocrinology wards in a tertiary hospital located in Shanghai, adults with type 1 and type 2 diabetes who required short-term CSII during hospitalization were randomly assigned (1:1) to receive either rtCGM-based glucose monitoring and management program or point-of-care (POC) standard of care (8 times/day) with blinded CGM. Primary outcome measure was the difference in the percentage of time within the target glucose range of 3.9-10 mmol/L (TIR, %). This study was registered at www.chictr.org.cn (ChiCTR2300068933). Findings: Among the 475 randomized participants (237 in the rtCGM group and 238 in the POC group), the mean age of was 60 ± 13 years, and the mean baseline glycated hemoglobin level was 9.4 ± 1.8%. The CGM-recorded mean TIR was 71.1 ± 15.8% in the rtCGM group and 62.9 ± 18.9% in the POC group, with a mean difference of 8.2% (95% confidence interval [CI]: 5.1-11.4%, P < 0.001). The mean time above range >10 mmol/L was significantly lower in the rtCGM group than in the POC group (28.3 ± 15.8% vs. 36.6 ± 19.0%, P < 0.001), whereas there was no significant between-group difference in the time below range <3.9 mmol/L (P = 0.11). Moreover, the time to reach target glucose was significantly shorter in the rtCGM group than in the POC group (2.0 [1.0-4.0] days vs. 4.0 [2.0-5.0] days, P < 0.001). There were no serious adverse events in both groups. Interpretation: In patients with diabetes who received short-term CSII during hospitalization, the rtCGM program resulted in better glucose control than the POC standard of care, without increasing the risk of hypoglycemia. Funding: The Program of Shanghai Academic Research Leader (22XD1402300), Shanghai Oriental Talent Program (Youth Project) (No. NA), the Shanghai "Rising Stars of Medical Talent" Youth Development Program-Outstanding Youth Medical Talents (SHWSRS(2021)_099), and the Shanghai Research Center for Endocrine and Metabolic Diseases (2022ZZ01002).

Acceptability and experiences of real-time continuous glucose monitoring in adults with type 2 diabetes using insulin: a qualitative study.

Aims: To explore the lived experiences of initiating real-time continuous glucose monitoring (rt-CGM) use in individuals with type 2 diabetes using insulin. Methods: Twelve semi-structured interviews were conducted amongst individuals with type 2 diabetes taking insulin who were enrolled in the 2GO-CGM randomised controlled trial and had completed 3 months of rtCGM. Interviews were transcribed verbatim and analysed to identify common themes regarding their experiences. Results: The interviews revealed three key themes: i) rtCGM as a facilitator of improved health behaviours; ii) the acceptability of rtCGM systems compared to capillary blood glucose testing; and iii) barriers to the continual usage of rtCGM technology - including: connection difficulties, longevity of the sensors, and local cutaneous reactions to the sensor adhesive. Conclusion: Adults on insulin with type 2 diabetes find rtCGM systems widely acceptable, and easier to engage with than traditional self-monitoring of capillary blood glucose. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01403-9.

Real-World Continuous Glucose Monitoring Data from a Population with Type 1 Diabetes in South Korea: Nationwide Single-System Analysis.

Background: We used continuous glucose monitoring (CGM) data to investigate glycemic outcomes in a real-world population with type 1 diabetes (T1D) from South Korea, where the widespread use of CGM and the nationwide education program began almost simultaneously. Methods: Data from Dexcom G6 users with T1D in South Korea were collected between January 2019 and January 2023. Users were included if they provided at least 90 days of glucose data and used CGM at least 70% of the days in the investigational period. The relationship between CGM utilization and glycemic metrics, including the percentage of time in range (TIR), time below range (TBR), and time above range (TAR), was assessed. The study was approved by the Institutional Review Board of Samsung Medical Center (SMC 2023-05-030). Results: A total of 2288 users were included. Mean age was 41.5 years (57% female), with average uploads of 428 days. Mean TIR was 62.4% ± 18.5%, mean TBR <70 mg/dL was 2.6% ± 2.8%, mean TAR >180 mg/dL was 35.0% ± 19.3%, mean glucose was 168.1 ± 35.8 mg/dL, mean glucose management indicator was 7.2% ± 0.9%, and mean coefficient of variation was 36.7% ± 6.0%. Users with higher CGM utilization had higher TIR (67.8% vs. 52.7%), and lower TBR <70 mg/dL (2.3% vs. 4.7%) and TAR >180 mg/dL (30.0% vs. 42.6%) than those with low CGM utilization (P < 0.001 for all). Users whose data were shared with others had higher TIR than those who did not (63.3% vs. 60.8%, P = 0.001). Conclusions: In this South Korean population, higher CGM utilization was associated with a favorably higher mean TIR, which was close to the internationally recommended target. Using its remote data-sharing feature showed beneficial impact on TIR.

Reduction in Diabetes-Related Hospitalizations and Medical Costs After Dexcom G6 Continuous Glucose Monitor Initiation in People with Type 2 Diabetes Using Intensive Insulin Therapy.

INTRODUCTION: Some people with type 2 diabetes (T2D) require intensive insulin therapy to manage their diabetes. This can increase the risk of diabetes-related hospitalizations. We hypothesize that initiation of real-time continuous glucose monitoring (RT-CGM), which continuously measures a user's glucose values and provides threshold- and trend-based alerts, will reduce diabetes-related emergency department (ED) and inpatient hospitalizations and concomitant costs. METHODS: A retrospective analysis of US healthcare claims data using Optum's de-identified Clinformatics® Data Mart database was performed. The cohort consisted of commercially insured, CGM-naïve individuals with T2D who initiated Dexcom G6 RT-CGM system between August 1, 2018, and March 31, 2021. Twelve months of continuous health plan enrollment before and after RT-CGM initiation was required to capture baseline and follow-up rates of diabetes-related hospitalizations and associated healthcare resource utilization (HCRU) costs. Analyses were performed for claims with a diabetes-related diagnosis code in either (1) any position or (2) first or second position on the claim. RESULTS: A total of 790 individuals met the inclusion criteria. The average age was 52.8 (10.5) [mean (SD)], 53.3% were male, and 76.3% were white. For claims with a diabetes-related diagnosis code in any position, the number of individuals with ≥ 1 ED visit decreased by 30.0% (p = 0.01) and with ≥ 1 inpatient visit decreased by 41.5% (p < 0.0001). The number of diabetes-related visits and average number of visits per person similarly decreased by at least 31.4%. Larger relative decreases were observed for claims with a diabetes-related diagnosis code in the first or second position on the claim. Total diabetes-related costs expressed as per-person-per-month (PPPM) decreased by $341 PPPM for any position and $330 PPPM for first or second position. CONCLUSION: Initiation of Dexcom G6 among people with T2D using intensive insulin therapy was associated with a significant reduction in diabetes-related ED and inpatient visits and related HCRU costs. Expanded use of RT-CGM could augment these benefits and result in further cost reductions.

Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose in people with insulin-treated Type II diabetes in France.

Aim: Clinical trials and real-world data for Type II diabetes both show that glycated hemoglobin (HbA1c) levels and hypoglycemia occurrence can be reduced by real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG). The present cost-utility study investigated the long-term health economic outcomes associated with using rt-CGM versus SMBG in people with insulin-treated Type II diabetes in France. Materials & methods: Effectiveness data were obtained from a real-world study, which showed rt-CGM reduced HbA1c by 0.56% (6.1 mmol/mol) versus sustained SMBG. Analyses were conducted using the IQVIA Core Diabetes Model. A French payer perspective was adopted over a lifetime horizon for a cohort aged 64.5 years with baseline HbA1c of 8.3% (67 mmol/mol). A willingness-to-pay threshold of €147,093 was used, and future costs and outcomes were discounted at 4% annually. Results: The analysis projected quality-adjusted life expectancy was 8.50 quality-adjusted life years (QALYs) for rt-CGM versus 8.03 QALYs for SMBG (difference: 0.47 QALYs), while total mean lifetime costs were €93,978 for rt-CGM versus €82,834 for SMBG (difference: €11,144). This yielded an incremental cost-utility ratio (ICUR) of €23,772 per QALY gained for rt-CGM versus SMBG. Results were particularly sensitive to changes in the treatment effect (i.e., change in HbA1c), annual price and quality of life benefit associated with rt-CGM, SMBG frequency, baseline patient age and complication costs. Conclusion: The use of rt-CGM is likely to be cost-effective versus SMBG for people with insulin-treated Type II diabetes in France.

Changes in glucometric parameters in people living with diabetes users of the free-style libre 2 system before and after the update possibility to real-time glucose readings in real world practice.

In Spain, from October 10th, 2023, the FreeStyle Libre 2 system offers the possibility to automatically changed from isCGM to rtCGM with a system update. Our study aimed to evaluate the glucometric before and after that date. We didn't find significant changes in TIR, however time of use increased and TBR decreased.

Clinical application of real-time continuous glucose monitoring system during postoperative enteral nutrition therapy in esophageal cancer patients.

BACKGROUND: Enteral nutrition (EN) support therapy increases the risk of abnormal blood glucose (BG). The aim of this study is to evaluate the clinical value of a real-time continuous glucose monitoring (rt-CGM) system in BG monitoring during postoperative EN support therapy in patients with esophageal cancer. METHODS: Patients without diabetes mellitus (DM) with esophageal cancer who planned to receive postoperative EN were enrolled. With the self-monitoring of BG value as the reference BG, the accuracy of rt-CGM was evaluated by the mean absolute relative difference (MARD) value, correlation efficient, agreement analysis, and Parkes and Clarke error grid plot. Finally, paired t tests were used to compare the differences in glucose fluctuations between EN and non-EN days and slow and fast days. RESULTS: The total MARD value of the rt-CGM system was 13.53%. There was a high correlation between interstitial glucose and fingertip capillary BG (consistency correlation efficient = 0.884 [95% confidence interval, 0.874-0.894]). Results of 15/15%, 20/20%, 30/30% agreement analysis were 58.51%, 84.71%, and 99.65%, respectively. The Parkes and Clarke error grid showed that the proportion of the A and B regions were 100% and 99.94%, respectively. The glucose fluctuations on EN days vs non-EN days and on fast days vs slow days were large, and the difference was statistically significant (P < 0.001). CONCLUSION: The rt-CGM system achieved clinical accuracy and can be used as a new option for glucose monitoring during postoperative EN therapy. The magnitude of glucose fluctuation during EN therapy remains large, even in the postoperative population without DM.

Analysis of "Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes".

In an article in the Journal of Diabetes Science and Technology, Laffell et al examined the accuracy and performance of a seventh-generation "G7" continuous glucose monitor (CGM) system in participants with type 1 diabetes aged 2 to 17 years. The study had notable points which increase the generalizability of the authors' findings to usual clinical practice, such as accuracy assessment across a wide range of glycemia in the arm and abdominal area, at variable rates of change and time periods (beginning and end of sensor wear). However, accuracy measurements in the younger cohort (2-6 years old) were relatively few. Overall and per-sensor accuracy assessments using standard accuracy metrics were consistently high. The authors also highlighted the enhanced features of the G7 system compared to earlier generation systems, which support better usability.