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1,730 result(s) for "Continuous Glucose Monitoring"
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A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes
In this randomized, controlled trial involving adults with insulin-treated type 2 diabetes, automated insulin delivery resulted in lower glycated hemoglobin levels than continuous glucose monitoring alone.
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 HbA 1c was 57.8 ± 9.5 mmol/mol (7.4 ± 0.9%). Participants using rtCGM showed a reduction in HbA 1c 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 HbA 1c , 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 Graphical Abstract
Impact of COVID-19 lockdowns on glycemic control across age groups based on a retrospective isCGM analysis from Poland 2020–2021
Most European countries experienced three COVID-19 waves in 2020–2021. In Poland, Wave 1 (March-July 2020) was associated with a severe lockdown prohibiting external social activities beyond every-day necessities. During Waves 2 and 3 some restrictions were reimplemented, however, impacted everyday life less. The study aimed to analyze the individual as well as long-term impacts of COVID-19 pandemic lockdowns on glycemic control in different age groups of people with diabetes using intermittently scanned continuous glucose monitoring (isCGM), in Poland. We analyzed retrospective data from isCGM users during the COVID-19 pandemic (from January 2020 to September 2021), describing glucometrics according to the International Consensus on time in range (TIR). Longitudinal data were analyzed from 680 Polish patients with diabetes, comprising 470 adults aged 18–64, 66 adults aged 65+, and 144 children and adolescents. The most evident improvement in glycemic indices was observed during the first, most severe lockdown, especially in adults (TIR 68.2 vs. 65.6%). For seniors, most indices were stable during the pandemic, with only small improvement in time below range (TBR) (TBR70 1.9 vs. 2.6%). The comparison of the pre-pandemic and post-lockdown periods showed that most glycemic indices returned to similar levels, however, in children and adolescents, some deterioration was seen. Changes in glycemic indices during the COVID-19 pandemic in 2020–2021 in patients using isCGM differed between the 3 lockdown events and between age groups. Results demonstrate an age dependency in users’ response to the COVID-19 lockdowns in Poland and suggest that behavior changes brought on by dramatic lifestyle changes associated with COVID lockdowns were not sustained following the pandemic.
Effect of switching from intermittently scanned continuous glucose monitoring to FreeStyle Libre 2 with real‐time continuous glucose monitoring and alert functionality
Aims/Introduction This study aimed to assess the impact of switching from FreeStyle Libre (FSL) to FreeStyle Libre 2 (FSL2) with real‐time continuous glucose monitoring (rtCGM) functionality. Materials and Methods We retrospectively assessed 58 patients who transitioned from FSL to FSL2 with rtCGM functionality. Results Switching from FSL to FSL2 significantly increased the valid data acquisition rate (76.8% ± 21.6% vs 90.4% ± 18.0%, P < 0.001). Time in range (TIR) improved from 57.7% ± 18.1% to 61.7% ± 17.1% (P = 0.023); time in tight range improved from 33.3% ± 15.4% to 38.6% ± 16.9% (P = 0.006), and glycated hemoglobin decreased from 7.6% ± 1.1% to 7.4% ± 1.0% (P = 0.009). TIR improvement was immediate in Type 1 diabetes but gradual after an initial decline in Type 2 diabetes. Logistic regression identified younger age as a predictor of TIR improvement (odds ratio: 0.95, 95% confidence interval: 0.90–0.99, P = 0.034). Conclusions Transitioning from FSL to FSL2 with rtCGM functionality improved valid data acquisition rate and glycemic control, particularly in patients with Type 1 diabetes. The duration required for improvement in continuous glucose monitoring‐related parameters varied by diabetes type, with early improvements observed in Type 1 diabetes and gradual improvements in Type 2 diabetes. Transitioning from FSL to FSL2 with rtCGM function improved sensor usage and glycemic control, particularly in patients with Type 1 diabetes. The duration required for improvement in continuous glucose monitoring‐related parameters varied by diabetes type, with early improvements observed in Type 1 diabetes and gradual improvements in Type 2 diabetes.
The benefits and accuracy of real‐time continuous glucose monitoring in children and adolescents with type 1 diabetes attending a summer camp
Aims/Introduction This study evaluated the usability, satisfaction, and accuracy of a real‐time continuous glucose monitoring (rt‐CGM) in children and adolescents with type 1 diabetes (T1D) attending a summer camp. Materials and Methods Seven children and adolescents with T1D (camper) and 31 of healthcare providers (HCPs) participating in a 2‐day summer camp in Kumamoto, Japan were enrolled. The usability and satisfaction were evaluated by tailored questionnaire. The accuracy of rt‐CGM was evaluated using self‐monitoring of blood glucose (BG) and sensor glucose (SG) values before or after (off camp) and during (on camp) the camp. Results The score of the usefulness of rt‐CGM showed 3.29 ± 0.90 in campers and 4.23 ± 0.87 in HCPs (P = 0.017). The degree of recommendation score for rt‐CGM was 3.29 ± 1.11 in campers and 4.23 ± 0.79 in HCPs (P = 0.013). Time in range (TIR) off camp was 45.9% and that on camp was 57.0%. Time above range (TAR) off camp was 53.4% and that on camp was 42.4%. The mean absolute relative difference (MARD) off camp was 19.7% ± 25.2%, whereas that on camp was 16.0% ± 14.8% (P = 0.367). Clinically acceptable zones of the error grid analyses were approximately 96% in total. Conclusions Rt‐CGM exhibited higher usability and recommendation scores in HCPs than those in campers. This may be related to relatively lower accuracy in rt‐CGM. Overall usability and recommendation are clinically satisfactory, but due to relatively low accuracy, no decision should be made based on a single, non‐verified SG value alone. This study assessed rt‐CGM in children with type 1 diabetes at a summer camp. Seven campers and 31 HCPs were enrolled. HCPs rated rt‐CGM higher in usability and recommendation. While TIR improved during camp, accuracy was relatively low, cautioning against decisions based solely on single, non‐verified sensor glucose values.
Cost-Effectiveness of the FreeStyle Libre® System Versus Blood Glucose Self-Monitoring in Individuals with Type 2 Diabetes on Insulin Treatment in Sweden
Introduction Frequent glucose monitoring is essential to obtain glucose control. This is done by periodic self-monitoring of blood glucose (SMBG) using finger-prick testing, or by using continuous glucose monitoring devices, wherein a sensor records interstitial glucose data automatically. This study assessed the cost-effectiveness of using the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) compared to SMBG in individuals with type 2 diabetes (T2D) treated with insulin from a Swedish societal perspective. Methods Cost-effectiveness analysis was conducted using the IQVIA Core Diabetes model v9.5, with demographic and clinical inputs from a real-world study using Swedish National Diabetes Register data. Two cohorts of individuals with T2D were considered based on baseline HbA1C (HbA1c: 8–9% [64–75 mmol/mol]; HbA1c: 9–12% [75–108 mmol/mol]). HbA1c reductions with FSL were − 0.41% (− 4 mmol/mol; SD: 0.94%-10 mmol/mol) and − 1.30% (− 14 mmol/mol; SD: 1.40%-15 mmol/mol) for the two cohorts, respectively. Utilities, treatment costs and diabetes-related complication costs were obtained from published sources. Analyses were conducted over a lifetime horizon, applying annual discounting of 3% on costs and effects. Scenario analyses and probabilistic sensitivity analyses were performed. Results Individuals with T2D who had a baseline HbA1c of 8–9% (64–75 mmol/mol) and 9–12% (75–108 mmol/mol) and used FSL gained 0.50 and 0.57 quality-adjusted life-years (QALYs), respectively, at an incremental cost of SEK109,957 and SEK82,170 compared to SMBG, generating an incremental cost-utility ratio of SEK219,127 and SEK144,412 per QALY gained. Assuming a willingness-to-pay threshold of SEK300,000 per QALY gained, FSL use was considered cost-effective compared to SMBG for the majority of the individuals in both the lower and higher HbA1c cohorts. The key driver identified was the additional quality-of-life benefit that applied to FSL use. Conclusion The FreeStyle Libre Flash Continuous Glucose Monitoring System is a cost-effective glucose monitoring alternative to SMBG for individuals with T2D in Sweden who are treated with insulin but are not reaching their glycaemic goals.
Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya
Background Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. Methods This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). Discussion This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. Trial registration NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.
Perspectives on Continuous Glucose Monitoring Among Adults with Type 2 Diabetes in the United Kingdom: Cross-Sectional Survey
Type 2 diabetes (T2D) is one of the most common noncommunicable diseases, requiring ongoing lifestyle changes and continuous glucose management through medication, diet, and physical activity. Traditional self-monitoring of blood glucose can be burdensome, especially with frequent finger pricks. As continuous glucose monitoring (CGM) becomes more affordable and accessible, it offers benefits such as increased glucose awareness, behavioral modifications, and reduced anxiety. However, challenges remain, including cost, discomfort, skin reactions, and privacy concerns. In the United Kingdom, perceptions of CGM among people with T2D, including both users and nonusers, are not well understood, limiting insight into factors influencing adoption and sustained use. This study aims to explore how adults with T2D perceive the benefits and challenges of using CGM, including both current users and nonusers. This study used a cross-sectional, online survey using YouGov's nationally representative panel to explore experiences of CGM among adults with T2D in the United Kingdom. A total of 531 participants were recruited from November to December 2024. Thematic analysis of responses to 2 open-ended questions identified key perceived benefits and challenges associated with CGM use. A total of 531 adults with T2D completed the YouGov online survey. Over half were male (297/531, 55.9%) and aged 65 years and older (281/531, 52.9%). Two-thirds (347/531, 65.3%) had lived with T2D for more than 5 years, and 9.6% (51/531) use or had previously used a CGM. Overall, 50.8% (270/531) responded to at least one free-text question, with 49% (260/531) commenting on benefits and 33.1% (176/531) on challenges. Thematic analysis identified five key benefit themes: (1) reduced monitoring burden, described as eliminating frequent finger prick testing and simplifying daily routines; (2) lifestyle feedback, enabling participants to better understand how diet and physical activity influence glucose levels; (3) greater control, by supporting more informed decision-making and increasing confidence in self-management; (4) feeling safer, through alerts for hypo- and hyperglycemia; and (5) sharing data with clinicians, which facilitated communication and more collaborative care. The main challenges were (1) access barriers, including restrictive eligibility criteria and the high cost of self-funding; (2) device issues, such as discomfort, inconvenience, and practical difficulties wearing the sensor; (3) technology reliance, with concerns about depending on devices rather than listening to bodily cues; (4) emotional strain, including anxiety, over-monitoring, and increased preoccupation with glucose levels; and (5) data concerns, particularly regarding accuracy, interpretation, and privacy. Adults with T2D, including both users and nonusers, described CGM as a practical and empowering tool that improves understanding, safety, and collaboration with health care providers. Nevertheless, access barriers, usability issues, and emotional and data-related burdens remain major obstacles to equitable adoption. Addressing these through improved affordability, digital literacy support, and customized clinical guidance may support ongoing and inclusive CGM use in routine care.
Diabetes Therapy Podcast: Real-World Data for Glucose Sensing Technologies in Type 1 Diabetes
For people living with type 1 diabetes (T1D), home glucose monitoring has evolved from occasional qualitative urine tests to frequently sampled continuous data providing hundreds of data points per day to inform optimal self-management. Continuous glucose monitoring technologies have a robust evidence base derived from randomized controlled trials (RCTs) over the last 20 years, and are now implemented in routine clinical practice, reflecting their clinical and cost effectiveness. However, while randomized studies are the gold standard, they can be slow to set-up, unrepresentative and do not provide data for efficacy in large, unselected populations. Real-world data can be responsive to rapid product cycles in technologies, provide a large, representative population, and have a lower regulatory burden. In this podcast we discuss the advantages and pitfalls of using real-world data to assess the efficacy of continuous glucose sensing technologies in people with T1D, with reference to examples of real-world data for real-time and intermittently scanned continuous glucose monitoring. Large datasets confirm the RCT data for real-time technologies and additionally provide data for work absenteeism and hospital admissions, as well as showing the impact of advanced technology features that can be difficult to assess in randomized studies. Real-world data for intermittently scanned monitoring also confirm the randomized controlled trial data, provide additional insights not shown in controlled study environments and highlight the importance of health equality. A mature real-world dataset for automated insulin delivery systems is now available and the future of glucose sensing is also discussed.
Comparison of continuous glucose monitoring with self-monitoring of blood glucose in type 1 diabetes in the changing atmospheric pressures in aviation: a hypobaric flight simulation
Aim/hypothesis Pilots with type 1 diabetes are required to perform capillary glucose monitoring regularly during flights. Continuous glucose monitoring (CGM) may be an effective and more practical alternative. This study aimed to assess the accuracy of CGM systems against self-monitoring of blood glucose (SMBG) during a hypobaric flight simulation. Methods Twelve insulin pump users with type 1 diabetes were studied using two simulation protocols. Protocol A consisted of a ground phase, ascent, a 190 min cruise with ingestion of a liquid meal, descent and then ground. Protocol B consisted of a ground phase, ascent, a 60 min cruise while fasting, descent, a 20 min ground phase, ascent, a second flight of 120 min with ingestion of a meal, followed by descent and ground. Insulin was administered with or before the meal according to the participants’ carbohydrate-counting regimen during both protocols. In Protocol A, capillary, interstitial and plasma glucose were measured during flight and at ground, while in Protocol B, glucose and oxygen were measured. Measurements from three CGM brands and two SMBG devices were recorded during the flight simulations. Findings at cabin pressures during flight (550 mmHg) and ground (750 mmHg) were compared. Fasted and postprandial glucose measurements were analysed using Spearman’s correlations and mean absolute relative differences (MARDs). Results Eleven men and one woman ( n =6 men in Protocol A; n =5 men and n =1 woman in Protocol B) were studied. A total of 1533 data points were recorded. During flight vs ground level, Spearman’s correlations for CGM system- and SMBG-derived glucose values were very strong in both Protocol A ( r =0.96 during flight vs r =0.94 at ground) and Protocol B ( r =0.85 during flight vs r =0.69 at ground). The differences in aggregated CGM MARDs during flight vs ground level were minimal across Protocol A (11.85%; 95% CI [9.78, 13.92] vs 9.08%; 95% CI [7.02, 11.14]) and Protocol B (12.01%; 95% CI [3.34, 20.69] vs 12.97%; 95% CI [4.30, 21.65]). Conclusions/interpretation The performance of CGM systems and SMBG are comparable during flight-associated atmospheric pressure changes. All tested measurement devices for CGM and SMBG were suitable for diabetes-care-based decisions during flight simulation. Graphical Abstract