Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment.
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ABSTRACT:
SUBMITTER: Ontario Health (Quality)
PROVIDER: S-EPMC6939983 | biostudies-literature | 2019
REPOSITORIES: biostudies-literature
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Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment.
Ontario health technology assessment series 20191212 8
<h4>Background</h4>People with diabetes manage their condition by monitoring the amount of glucose (a type of sugar) in their blood, typically using a method called self-monitoring of blood glucose. Flash glucose monitoring is another method of assessing glucose levels; it uses a sensor placed under the skin and a separate touchscreen reader device. We conducted a health technology assessment of flash glucose monitoring for people with type 1 or type 2 diabetes, which included an evaluation of e ...[more]
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Project description:AimsFor people with type 2 diabetes (T2D) on intensive insulin therapy, the use of flash continuous glucose monitoring ("flash monitoring") is associated with improved average glucose control and/or reduced hypoglycemic exposure. This study assessed the cost-effectiveness of flash monitoring versus traditional blood glucose monitoring (BGM) in people with T2D using intensive insulin in the United Kingdom (UK).MethodsThe IQVIA CORE Diabetes Model (IQVIA CDM; v9.0) was used to analyze the impact of flash monitoring versus BGM over a 40-year time horizon from the UK payer perspective. Model inputs included baseline characteristics, intervention effects, resource utilization, costs, and utilities, based on recently published literature and national databases. UK National Health Service reimbursed costs of flash monitoring and BGM were used. An intervention-related health utility was obtained from a time trade-off study. Alternative scenarios were explored to assess the impact of key assumptions on base case results.ResultsIn base-case analysis, flash monitoring compared with BGM resulted in an incremental cost of £5781 and an additional 0.47 quality-adjusted life years (QALYs). This provides an incremental cost-effectiveness ratio (ICER) of £12,309/QALY. HbA1c and the intervention-related health utility were the key drivers of differentiation. All scenario analyses, including different discount rates, time horizons, effects on HbA1c and on the intervention-related health utility, as well as glycemic emergencies, generated ICERs of less than £20,000 per QALY.ConclusionsThe consistent results across base case and a range of scenario analyses indicate that long-term flash glucose monitoring use is cost-effective compared with BGM in a UK population of T2D on intensive insulin therapy based on updated clinical effects and a cost-effectiveness threshold of £20,000-30,000 per QALY.
| S-EPMC9607728 | biostudies-literature
Project description:IntroductionThis study aims to estimate the budget impact of increased uptake of the FreeStyle Libre Flash Glucose Monitoring system in people with type 1 diabetes mellitus (T1DM) in the UK.Research design and methodsA budget impact model was developed, applying real-world data collected in the Association of British Clinical Diabetologists (ABCD) FreeStyle Libre Nationwide Audit. Costs of diabetes glucose monitoring in a T1DM population (n=1790) using self-monitoring of blood glucose (SMBG) or the FreeStyle Libre system were compared with a scenario with increased use of the FreeStyle Libre system.ResultsThe ABCD audit demonstrates FreeStyle Libre system use reduces diabetes-related resource utilization. The cost analysis found that higher acquisition costs are offset by healthcare costs avoided (difference £168 per patient per year (PPPY)). Total costs were £1116 PPPY with FreeStyle Libre system compared with £948 PPPY with SMBG. In an average-sized UK local health economy, increasing FreeStyle Libre system uptake from 30% to 50% increased costs by 3.4% (£1 787 345-£1 847 618) and when increased to 70% increased by a further 3.3%.ConclusionIncreased uptake of the FreeStyle Libre system in the T1DM population marginally increases the cost to UK health economies and offers many system benefits.
| S-EPMC8961112 | biostudies-literature
Project description:BackgroundType 2 diabetes has a growing prevalence and confers significant cost burden to the health care system, raising the urgent need for cost-effective and easily accessible solutions. The management of type 2 diabetes requires significant commitment from the patient, caregivers, and the treating team to optimize clinical outcomes and prevent complications. Technology and its implications for the management of type 2 diabetes is a nascent area of research. The impact of some of the more recent technological innovations in this space, such as continuous glucose monitoring, flash glucose monitoring, web-based applications, as well as smartphone- and smart watch-based interactive apps has received limited attention in the research literature.ObjectiveThis scoping review aims to explore the literature available on type 2 diabetes, flash glucose monitoring, and digital health technology to improve diabetic clinical outcomes and inform future research in this area.MethodsA scoping review was undertaken by searching Ovid MEDLINE and CINAHL databases. A second search using all identified keywords and index terms was performed on Ovid MEDLINE (January 1966 to July 2021), EMBASE (January 1980 to July 2021), Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, latest issue), CINAHL (from 1982), IEEE Xplore, ACM Digital Libraries, and Web of Science databases.ResultsThere were very few studies that have explored the use of mobile health and flash glucose monitoring in type 2 diabetes. These studies have explored somewhat disparate and limited areas of research, and there is a distinct lack of methodological rigor in this area of research. The 3 studies that met the inclusion criteria have addressed aspects of the proposed research question.ConclusionsThis scoping review has highlighted the lack of research in this area, raising the opportunity for further research in this area, focusing on the clinical impact and feasibility of the use of multiple technologies, including flash glucose monitoring in the management of patients with type 2 diabetes.
| S-EPMC10131890 | biostudies-literature
Project description:AimHypoglycaemia in Type 1 diabetes is associated with mortality and morbidity, especially where awareness of hypoglycaemia is impaired. Clinical pathways for access to continuous glucose monitoring (CGM) and flash glucose monitoring technologies are unclear. We assessed the impact of CGM and flash glucose monitoring in a high-risk group of people with Type 1 diabetes.MethodsA randomized, non-masked parallel group study was undertaken. Adults with Type 1 diabetes using a multiple-dose insulin-injection regimen with a Gold score of ≥ 4 or recent severe hypoglycaemia were recruited. Following 2 weeks of blinded CGM, they were randomly assigned to CGM (Dexcom G5) or flash glucose monitoring (Abbott Freestyle Libre) for 8 weeks. The primary outcome was the difference in time spent in hypoglycaemia (below 3.3 mmol/l) from baseline to endpoint with CGM versus flash glucose monitoring.ResultsSome 40 participants were randomized to CGM (n = 20) or flash glucose monitoring (n = 20). The participants (24 men, 16 women) had a median (IQR) age of 49.6 (37.5-63.5) years, duration of diabetes of 30.0 (21.0-36.5) years and HbA1c of 56 (48-63) mmol/mol [7.3 (6.5-7.8)%]. The baseline median percentage time < 3.3 mmol/l was 4.5% in the CGM group and 6.7% in the flash glucose monitoring. At the end-point the percentage time < 3.3 mmol/l was 2.4%, and 6.8% respectively (median between group difference -4.3%, P = 0.006). Time spent in hypoglycaemia at all thresholds, and hypoglycaemia fear, were different between groups, favouring CGM.ConclusionCGM more effectively reduces time spent in hypoglycaemia in people with Type 1 diabetes and impaired awareness of hypoglycaemia compared with flash glucose monitoring. (Clinical Trial Registry No: NCT03028220).
| S-EPMC5888121 | biostudies-literature
Project description:IntroductionPublished evaluations of sensor glucose monitoring use in insulin treated type 2 diabetes are limited. The aim of this study was to assess the impact of flash glucose-sensing technology as a replacement for self-monitoring of blood glucose (SMBG) over a 12-month period in participants with type 2 diabetes who were on intensive insulin therapy.MethodsAn open-label, randomized, controlled study in adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers aimed at assessing flash glucose sensing technology was conducted. Participants (N = 224) were randomized (1:2 respectively) to a control group (n = 75) that used SMBG (FreeStyle Lite™) or to an intervention group (n = 149) which used sensor glucose data (FreeStyle Libre™ Flash Glucose Monitoring System) for self-management over 6 months. All intervention group participants who completed the 6-month treatment phase continued into an additional 6-month open-access phase.ResultsA total of 139 intervention participants completed the 6-month treatment phase and continued into the open-access phase. At 12 months (end of open-access period), time in hypoglycemia [sensor glucose <3.9 mmol/L (70 mg/dL)] was reduced by 50% compared to baseline [-0.70 ± 1.85/24 h (mean ± standard deviation); p = 0.0002]. Nocturnal hypoglycemia [2300 to 0600 hours, <3.9 mmol/L (70 mg/dL)] was reduced by 52%; p = 0.0002. There was no change in time in range [sensor glucose 3.9-10.0 mmol/L (70-180 mg/dL)]. SMBG testing fell from a mean of 3.9 (median 3.9) times/day at baseline to 0.2 (0.0), with an average frequency of sensor scanning of 7.1 (5.7) times/day at 12 months, and mean sensor utilization was 83.6 ± 13.8% (median 88.3%) during the open-access phase. During this 6-month extension period no device-related serious adverse events were reported. Nine participants reported 16 instances of device-related adverse events (e.g. infection, allergy) and 28 participants (20.1%) experienced 134 occurrences of anticipated skin symptoms/sensor-insertion events expected with device use (e.g. erythema, itching and rash).ConclusionThe use of flash glucose-sensing technology for glycemic management in individuals with type 2 diabetes treated by intensive insulin therapy over 12 months was associated with a sustained reduction in hypoglycemia and safely and effectively replaced SMBG.Trial registrationClinicalTrials.gov identifier, NCT02082184.
| S-EPMC5446381 | biostudies-literature
Project description:Aims/hypothesisMinimal evidence supports the efficacy of flash monitoring in lowering HbA1c. We sought to assess the impact of introducing flash monitoring in our centre.MethodsWe undertook a prospective observational study to assess change in HbA1c in 900 individuals with type 1 diabetes following flash monitoring (comparator group of 518 with no flash monitoring). Secondary outcomes included changes in hypoglycaemia, quality of life, flash monitoring data and hospital admissions.ResultsThose with baseline HbA1c ≥58 mmol/mol (7.5%) achieved a median -7 mmol/mol (interquartile range [IQR] -13 to -1) (0.6% [-1.2 to -0.1]%) change in HbA1c (p < 0.001). The percentage achieving HbA1c <58 mmol/mol rose from 34.2% to 50.9% (p < 0.001). Median follow-up was 245 days (IQR 182 to 330). Individuals not using flash monitoring experienced no change in HbA1c across a similar timescale (p = 0.508). Higher HbA1c (p < 0.001), younger age at diagnosis (p = 0.003) and lower social deprivation (p = 0.024) were independently associated with an HbA1c fall of ≥5 mmol/mol (0.5%). More symptomatic (OR 1.9, p < 0.001) and asymptomatic (OR 1.4, p < 0.001) hypoglycaemia was reported after flash monitoring. Following flash monitoring, regimen-related and emotional components of the diabetes distress scale improved although the proportion with elevated anxiety (OR 1.2, p = 0.028) and depression (OR 2.0, p < 0.001) scores increased. Blood glucose test strip use fell from 3.8 to 0.6 per day (p < 0.001). Diabetic ketoacidosis admissions fell significantly following flash monitoring (p = 0.043).Conclusions/interpretationFlash monitoring is associated with significant improvements in HbA1c and fewer diabetic ketoacidosis admissions. Higher rates of hypoglycaemia may relate to greater recognition of hitherto unrecognised events. Impact upon quality of life parameters was mixed but overall treatment satisfaction was overwhelmingly positive.
| S-EPMC6647076 | biostudies-literature
Project description:ObjectivesFlash glucose monitoring for patients with T1 diabetes avoids frequent painful finger-prick testing, thus potentially improving frequency of glucose self-monitoring. Our study aimed to explore experiences of young people using Freestyle Libre sensors and their parents, and to identify benefits and challenges to National Health Service (NHS) staff of its adoption in their care provision.ParticipantsYoung people with T1 diabetes, their parents and healthcare professionals were interviewed between February and December 2021. Participants were recruited via social media and through NHS diabetes clinic staff.DesignSemistructured interviews were conducted online and analysed using thematic methods. Staff themes were mapped onto normalisation process theory (NPT) constructs.ResultsThirty-four participants were interviewed: 10 young people, 14 parents and 10 healthcare professionals. Young people reported that life was much easier since changing to flash glucose monitoring, increasing confidence and independence to manage their condition. Parents' quality of life improved and they appreciated access to real-time data. Using the NPT concepts to understand how technology was integrated into routine care proved useful; health professionals were very enthusiastic about flash glucose monitoring and coped with the extra data load to facilitate more tailored patient support within and between clinic visits.ConclusionThis technology empowers young people and their parents to understand their diabetes adherence more completely; to feel more confident about adjusting their own care between clinic appointments; and provides an improved interactive experience in clinic. Healthcare teams appear committed to delivering improving technologies, acknowledging the challenge for them to assimilate new information required to provide expert advice.
| S-EPMC10124239 | biostudies-literature
Project description:BackgroundThis study aimed to investigate the characteristics and extent of glycometabolism impairment in patients with adrenal diseases, including Cushing syndrome, primary aldosteronism, pheochromocytoma, and nonfunctional adrenal incidentaloma.MethodsThis study enrolled thirty-two patients with adrenal diseases as adrenal disease groups and eight healthy individuals as healthy controls. Blood glucose levels were indicated by glucose concentration in interstitial fluid, which was documented using flash glucose monitoring system. According to flash glucose monitoring system data, parameters representing general blood glucose alterations, within-day and day-to-day glucose variability, and glucose-target-rate were calculated. Furthermore, blood glucose levels at nocturnal, fasting, and postprandial periods were analyzed. Besides, islet β-cell function and insulin resistance were assessed.ResultsAnalysis of flash glucose monitoring system-related parameters indicated impaired glycometabolism in patients with adrenal diseases compared with that of healthy controls at general blood glucose, within-day and day-to-day glucose variability, and glucose-target-rate levels. Furthermore, the dynamic glucose monitoring data revealed that significantly affected blood glucose levels compared with that of healthy controls were observed at postprandial periods in the Cushing syndrome and primary aldosteronism groups; at nocturnal, fasting and postprandial periods in the pheochromocytoma group. Significant insulin resistance and abnormal β-cell function were observed in the Cushing syndrome group compared with that in healthy controls.ConclusionAdrenal diseases can negatively affect glucose metabolism. Patients diagnosed with adrenal diseases should receive timely and appropriate treatment to avoid adverse cardiovascular events linked to hyperglycemia and insulin resistance.
| S-EPMC7546367 | biostudies-literature
Project description:Flash glucose monitoring system (FGMS) is an improved subset of continuous glucose monitoring with a recognized effectiveness on glycemic control, though validation in patients with Liver Cirrhosis (LC) is lacking. To evaluate the accuracy of FGMS in patients with Type 2 Diabetes Mellitus (DM) and LC, a prospective, case-control study was performed in 61 ambulatory patients with LC and DM (LC group, n?=?31) or DM (Control group, n?=?30). During 14 days, patients performed 4 assessments per day of self-monitoring of blood glucose (SMBG, reference value) followed by FGMS scanning. There were 2567 paired SMBG and FGMS values used in the accuracy analysis, with an overall mean absolute relative difference (MARD) of 12.68% in the LC group and 10.55% in the control group (p?<?0,001). In patients with LC, the percentage of readings within Consensus Consensus Error Grid analysis Zone A and A?+?B were 80.36% and 99,26%, respectively. Sensor clinical accuracy was not affected by factors such as body mass index, age, gender, Child-Pugh score or edematoascitic decompensation. This is the first study to approach FGMS clinical accuracy in LC, revealing a potential usability of this system to monitor glycemic control in this population.
| S-EPMC7198519 | biostudies-literature
Project description:AimsDiscrepancy between HbA1c and glucose exposure may have significant clinical implications. We sought to assess predictors of disparity between HbA1c and flash monitoring metrics and how these relate to microvascular complications.MethodsWe conducted a cross-sectional study of adults with type 1 diabetes (n = 518). We assessed the relationship between clinic HbA1c and flash monitoring metrics, predictors of discrepancy between these measurements, and whether discrepancy was associated with microvascular complications.ResultsActual HbA1c and estimated HbA1c were strongly correlated (r = .779, P < .001). The likelihood of having a higher actual HbA1c than estimated HbA1c was greater with increasing age (OR = 1.055 per year, P < .001) and lower in men (OR = .208, P < .001). HbA1c was significantly lower in men (58 mmol/mol [51-67]) (7.5% [6.8-8.3]) compared to women (61 mmol/mol [54-70], P = .021) (7.7% [7.1-8.6]), despite no significant differences in any flash monitoring metrics. Whereas HbA1c was not different between younger (≤39 years) and older individuals (>39 years) despite significantly higher glucose exposure, in younger people, based on multiple flash monitoring metrics. Having a lower estimated than actual HbA1c was independently associated with a lower prevalence of retinopathy (OR = .55, P = .004).ConclusionsHbA1c appears to overestimate glucose exposure in women and older people with type 1 diabetes. This has potentially important clinical implications, as is hinted at by the independent relationship with retinopathy prevalence. It may also be of relevance when considering the use of HbA1c for the diagnosis of diabetes.
| S-EPMC8861792 | biostudies-literature