Dataset Information

Determinants of HbA1c reduction with FreeStyle Libre flash glucose monitoring (FLARE-NL 5).

ABSTRACT: Aims:To identify factors predicting HbA1c reduction in patients with diabetes mellitus (DM) using FreeStyle Libre Flash Glucose Monitoring (FSL-FGM). Methods:Data from a 12-month prospective nation-wide FSL registry were used and analysed with multivariable regression. For the present study we included patients with hypoglycaemia unawareness or unexpected hypoglycaemias (n = 566) and persons who did not reach acceptable glycaemic control (HbA1c > 70 mmol/mol (8.5%)) (n = 294). People with other indications for use, such as sensation loss of the fingers or individuals already using FSL-FGM or rtCGM, were excluded (37%). Results:Eight hundred and sixty persons (55% male with a mean age of 46.7 (±16.4) years) were included. Baseline HbA1c was 65.1 (±14.5) mmol/mol (8.1 ± 1.3%), 75% of the patients had type 1 DM and 37% had microvascular complications. Data concerning HbA1c was present for 482 (56.0%) at 6 months and 423 (49.2%) persons at 12 months. A significant reduction in HbA1c (?5 mmol/mol (0.5%)) was present in 187 (22%) persons. For these persons, median HbA1c reduction was -9.0 [-13.0, -4.0] mmol/mol (-0.82 [-1.19, -0.37]%) at 6 months and -9.0 [-15.0, -7.0] mmol/mol (-0.82 [-1.37, -0.64]%) at 12 months. In multivariable regression analysis with age, gender and SF-12 physical and mental component scores as covariates, only baseline HbA1c was significant: -0.319 (SE 0.025; p < 0.001; R2 = 0.240 for the model). In exploratory analysis among subgroups with different indications for FSL-FGM use (hypoglycaemia unawareness or persistently high HbA1c) and persons with a significant HbA1c decrease over the study period, baseline HbA1c remained the only significant predictor. Conclusions:Among the variables we analysed in the present study, only high HbA1c at baseline predicts significant HbA1c reduction during FSL-CGM use.

SUBMITTER: Lameijer A

PROVIDER: S-EPMC7578738 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Determinants of HbA1c reduction with FreeStyle Libre flash glucose monitoring (FLARE-NL 5).

Lameijer A A Fokkert M J MJ Edens M A MA Slingerland R J RJ Bilo H J G HJG van Dijk P R PR

Journal of clinical & translational endocrinology 20201012

<h4>Aims</h4>To identify factors predicting HbA1c reduction in patients with diabetes mellitus (DM) using FreeStyle Libre Flash Glucose Monitoring (FSL-FGM).<h4>Methods</h4>Data from a 12-month prospective nation-wide FSL registry were used and analysed with multivariable regression. For the present study we included patients with hypoglycaemia unawareness or unexpected hypoglycaemias (n = 566) and persons who did not reach acceptable glycaemic control (HbA1c > 70 mmol/mol (8.5%)) (n = 294). Peo ...[more]

PMID: 33102135

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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: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.

Dataset Information

Determinants of HbA1c reduction with FreeStyle Libre flash glucose monitoring (FLARE-NL 5).

Publications

Determinants of HbA1c reduction with FreeStyle Libre flash glucose monitoring (FLARE-NL 5).

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