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Could FreeStyle Libre™ sensor glucose data support decisions for safe driving?

ABSTRACT: AIM:Many countries require individuals with diabetes to adhere to standards regarding blood glucose testing in order to be granted or retain a driving licence. Currently, interstitial glucose results may not be used. The aim of this study was to determine whether interstitial glucose measurements using flash glucose-sensing technology can provide additional information to augment safe driving. METHODS:Sensor data from two European studies (NCT02232698 and NCT02082184) of the FreeStyle Libre Glucose Monitoring System™ in insulin-treated Type 1 and Type 2 diabetes, 241 and 224 participants respectively, were used to determine the frequency of a low interstitial sensor glucose result (< 3.9 mmol/l) up to 4 h subsequent to a daytime (07:00-21:00 h) capillary blood glucose result ? 5 mmol/l. RESULTS:Within 4 h of a capillary blood glucose result ? 5 mmol/l a sensor glucose result of < 3.9 mmol/l occurred on 22.0% of occasions (2573 of 11 706 blood glucose readings) for those with Type 1 diabetes, and 8.4% of occasions (699/8352) for those with Type 2 diabetes; 13.8% (1610/11 628) and 4.4% (365/8203) within 2 h, and 10.0% (1160/11 601) and 3.1% (254/8152) within 1.5 h. Analysis of sensor glucose results 5-7 mmol/l demonstrated the glucose trend arrow descending on 14.7% (1163/7894, Type 1 diabetes) and 9.4% (305/3233, Type 2 diabetes) of occasions. CONCLUSIONS:Sensor-based glucose information with directional arrows has the potential to support assessment of safe glucose levels associated with driving and offers distinct advantages over blood glucose testing for individuals with Type 1 and Type 2 diabetes to concord with driving safety standards.

SUBMITTER: Rayman G

PROVIDER: S-EPMC5887912 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Could FreeStyle Libre<sup>™</sup> sensor glucose data support decisions for safe driving?

Rayman G G Kröger J J Bolinder J J

Diabetic medicine : a journal of the British Diabetic Association 20171014 4

<h4>Aim</h4>Many countries require individuals with diabetes to adhere to standards regarding blood glucose testing in order to be granted or retain a driving licence. Currently, interstitial glucose results may not be used. The aim of this study was to determine whether interstitial glucose measurements using flash glucose-sensing technology can provide additional information to augment safe driving.<h4>Methods</h4>Sensor data from two European studies (NCT02232698 and NCT02082184) of the FreeS ...[more]

PMID: 28945936

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Project description:BACKGROUND:The diagnosis of hyperglycaemia in sub-Saharan Africa (SSA) is challenging. Blood glucose levels obtained during oral glucose tolerance test (OGTT) may not reflect home glycaemic profiles. We compare OGTT results with home glycaemic profiles obtained using the FreeStyle Libre continuous glucose monitoring device (FSL-CGM). METHODS:Twenty-eight women (20 with gestational diabetes [GDM], 8 controls) were recruited following OGTT between 24 and 28?weeks of gestation. All women wore the FSL-CGM device for 48-96?h at home in early third trimester, and recorded a meal diary. OGTT was repeated on the final day of FSL-CGM recording. OGTT results were compared with ambulatory glycaemic variables, and repeat OGTT was undertaken whilst wearing FSL-CGM to determine accuracy of the device. RESULTS:FSL-CGM results were available for 27/28 women with mean data capture 92.8%. There were significant differences in the ambulatory fasting, post-prandial peaks, and mean glucose between controls in whom both primary and secondary OGTT was normal (n?=?6) and those with two abnormal OGTTs or "true" GDM (n?=?7). There was no difference in ambulatory mean glucose between these controls and the 13 women who had an abnormal primary OGTT and normal repeat OGTT. These participants had significantly lower body mass index (BMI) than the true GDM group (29.0 Vs 36.3?kg/m2, p-value 0.014). Paired OGTT/FSL-CGM readings revealed a Mean Absolute difference (MAD) -0.58?mmol/L and Mean Absolute Relative Difference (MARD) -11.9%. Bland-Altman plot suggests FSL-CGM underestimated blood glucose by approximately 0.78?mmol/L. CONCLUSION:Diagnosis of GDM on a single OGTT identifies a proportion of women who do not have a significantly higher home glucose levels than controls. This raises questions about factors which may affect the reproducibility of OGTT in this population, including food insecurity and atypical phenotypes of diabetes. More investigation is needed to understand the suitability of the OGTT as a diagnostic test in sub-Saharan Africa.

Project description:IntroductionOptimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG.MethodsThis open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%-11%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected.AnalysisEfficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed.EthicsThe study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants.Trial registration numberNCT03815006.Protocol version4.0 dated 29 June 2020.

Project description:IntroductionFrequent glucose monitoring is essential to obtain glucose control. This is done by periodic self-monitoring of blood glucose (SMBG) using finger-prick testing, or by using continuous glucose monitoring devices, wherein a sensor records interstitial glucose data automatically. This study assessed the cost-effectiveness of using the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) compared to SMBG in individuals with type 2 diabetes (T2D) treated with insulin from a Swedish societal perspective.MethodsCost-effectiveness analysis was conducted using the IQVIA Core Diabetes model v9.5, with demographic and clinical inputs from a real-world study using Swedish National Diabetes Register data. Two cohorts of individuals with T2D were considered based on baseline HbA1C (HbA1c: 8-9% [64-75 mmol/mol]; HbA1c: 9-12% [75-108 mmol/mol]). HbA1c reductions with FSL were - 0.41% (- 4 mmol/mol; SD: 0.94%-10 mmol/mol) and - 1.30% (- 14 mmol/mol; SD: 1.40%-15 mmol/mol) for the two cohorts, respectively. Utilities, treatment costs and diabetes-related complication costs were obtained from published sources. Analyses were conducted over a lifetime horizon, applying annual discounting of 3% on costs and effects. Scenario analyses and probabilistic sensitivity analyses were performed.ResultsIndividuals with T2D who had a baseline HbA1c of 8-9% (64-75 mmol/mol) and 9-12% (75-108 mmol/mol) and used FSL gained 0.50 and 0.57 quality-adjusted life-years (QALYs), respectively, at an incremental cost of SEK109,957 and SEK82,170 compared to SMBG, generating an incremental cost-utility ratio of SEK219,127 and SEK144,412 per QALY gained. Assuming a willingness-to-pay threshold of SEK300,000 per QALY gained, FSL use was considered cost-effective compared to SMBG for the majority of the individuals in both the lower and higher HbA1c cohorts. The key driver identified was the additional quality-of-life benefit that applied to FSL use.ConclusionThe FreeStyle Libre Flash Continuous Glucose Monitoring System is a cost-effective glucose monitoring alternative to SMBG for individuals with T2D in Sweden who are treated with insulin but are not reaching their glycaemic goals.

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Could FreeStyle Libre™ sensor glucose data support decisions for safe driving?

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Could FreeStyle Libre<sup>™</sup> sensor glucose data support decisions for safe driving?

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