Dataset Information

Low Initial Adherence with Flash Glucose Monitoring is Not a Predictor of Long-Term Glycemic Outcomes: Longitudinal Analysis of the Association Between Experience, Adherence, and Glucose Control for FreeStyle Libre Users.

ABSTRACT:

Introduction

Frequent scanning of FreeStyle Libre (FSL) flash glucose monitoring sensors is known to be important whilst wearing an active sensor, but adherence to sensor reapplication is also critical to effective glucose monitoring. We report novel measures of adherence for users of the FSL system and their association with improvements in metrics of glucose control.

Methods

Anonymous data were extracted for 1600 FSL users in the Czech Republic with ≥ 36 completed sensors from October 22, 2018 to December 31, 2021. "Experience" was defined by the number of sensors used (1-36 sensors). "Adherence" was defined by time between the end of one sensor and the start of the next (gap time). User adherence was analyzed for four experience levels after initiating FLASH; Start (sensors 1-3); Early (sensors 4-6); Middle (sensors 19-21); End (sensors 34-36). Users were split into two adherence levels based on mean gap time during Start period, "low" (> 24 h, n = 723) and "high" (≤ 8 h, n = 877).

Results

Low-adherence users reduced their sensor gap times significantly: 38.5% applied a new sensor within 24 h during sensors 4-6, rising to 65.0% by sensors 34-36 (p < 0.001). Improved adherence was associated with increased %TIR (time in range; mean + 2.4%; p < 0.001), reduced %TAR (time above range; mean - 3.1%; p < 0.001), and reduced glucose coefficient of variation (CV; mean - 1.7%; p < 0.001).

Conclusions

With experience, FSL users became more adherent in sensor reapplication, with associated increases in %TIR, and reductions in %TAR and glucose variability.

SUBMITTER: Soupal J

PROVIDER: S-EPMC10241748 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Low Initial Adherence with Flash Glucose Monitoring is Not a Predictor of Long-Term Glycemic Outcomes: Longitudinal Analysis of the Association Between Experience, Adherence, and Glucose Control for FreeStyle Libre Users.

Šoupal Jan J Kao Kalvin K Brandner Laura L Grunberger George G Prázný Martin M

Diabetes therapy : research, treatment and education of diabetes and related disorders 20230522 7

<h4>Introduction</h4>Frequent scanning of FreeStyle Libre (FSL) flash glucose monitoring sensors is known to be important whilst wearing an active sensor, but adherence to sensor reapplication is also critical to effective glucose monitoring. We report novel measures of adherence for users of the FSL system and their association with improvements in metrics of glucose control.<h4>Methods</h4>Anonymous data were extracted for 1600 FSL users in the Czech Republic with ≥ 36 completed sensors from O ...[more]

PMID: 37211580

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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

Low Initial Adherence with Flash Glucose Monitoring is Not a Predictor of Long-Term Glycemic Outcomes: Longitudinal Analysis of the Association Between Experience, Adherence, and Glucose Control for FreeStyle Libre Users.

Introduction

Methods

Results

Conclusions

Publications

Low Initial Adherence with Flash Glucose Monitoring is Not a Predictor of Long-Term Glycemic Outcomes: Longitudinal Analysis of the Association Between Experience, Adherence, and Glucose Control for FreeStyle Libre Users.

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