Dataset Information

Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population.

ABSTRACT:

Introduction

The aim of this study was to investigate the relationship between actual measured glycated hemoglobin (HbA1c) and estimated glycated hemoglobin (EA1c) in the flash glucose monitoring (FGM) system in Chinese patients with type 2 diabetes.

Methods

This study was conducted in Nanjing First Hospital. Each patient used FGM twice in a 3-month period (during the first 14 days immediately after baseline and during a second 14-day period from days 76 to 90 after baseline). HbA1c measurements were made using a high-performance liquid chromatography assay before the start of the first FGM period (baseline) and at the end of the second FGM period.

Results

A total of 74 patients (35 men; mean age ± standard deviation [SD] 67.6?±?5.2 years) were enrolled in the study. The mean (± SD) duration of diabetes was 11.9?±?7.8 months. The first and second HbA1c measurements were both higher than the EA1c (both p??9.7 mmol/L, and EA1c %?=?(MG mmol/L?+?2.590)/1.590 when MG???9.7 mmol/L. The correlation coefficient for EA1c and HbA1c in this model (model 7) is higher than that reported the original model in the FGM system 1 (0.955 vs. 0.822, respectively; p?ConclusionsThe EA1c used by FreeStyle Libre™ is lower than the actual measured HbA1c. Improvement in the glucose levels during FGM in these patients may contribute to the lowering of EA1c.

Trial registration

The study is registered with ClinicalTrials.gov, number NCT03785301.

SUBMITTER: Hu Y

PROVIDER: S-EPMC7434821 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population.

Hu Yun Y Shen Yun Y Yan Rengna R Li Fengfei F Ding Bo B Wang Huiying H Su Xiaofei X Ma Jianhua J

Diabetes therapy : research, treatment and education of diabetes and related disorders 20200721 9

<h4>Introduction</h4>The aim of this study was to investigate the relationship between actual measured glycated hemoglobin (HbA1c) and estimated glycated hemoglobin (EA1c) in the flash glucose monitoring (FGM) system in Chinese patients with type 2 diabetes.<h4>Methods</h4>This study was conducted in Nanjing First Hospital. Each patient used FGM twice in a 3-month period (during the first 14 days immediately after baseline and during a second 14-day period from days 76 to 90 after baseline). HbA ...[more]

PMID: 32696267

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Project description:ObjectiveSince there is a paucity of reference data in the literature to indicate the relationship between HbA1c, and 24 h mean blood glucose (MBG) from continuous glucose monitoring (CGM) in Chinese populations, we described the above relationship in adult Chinese subjects with different glucose tolerance status.MethodsSeven-hundred-and-forty-two individuals without history of diabetes were included to the study at 11 hospitals in urban areas across China from 2007-2009 and data of 673 subjects were included into the final analysis. Oral glucose tolerance test (OGTT) classified the participants as nondiabetic subjects, including those with normal glucose regulation (NGR; n?=?121) and impaired glucose regulation (IGR; n?=?209), or newly diagnosed type 2 diabetes (n?=?343). All participants completed testing for HbA1c levels and wore a CGM system for three consecutive days. The 24 h MBG levels were calculated. Spearman correlations and linear regression analyses were applied to quantify the relationship between glucose markers.ResultsThe levels of HbA1c and 24 h MBG significantly increased with presence of glucose intolerance (NGR<IGR<type 2 diabetes; both, P<0.001). Analysis of the total population indicated that HbA1c was strongly correlated with 24 h MBG (r?=?0.735). The correlation was also found to be significant for the subgroup of participants with newly diagnosed type 2 diabetes (r?=?0.694, P<0.001). Linear regression analysis of the total study population yielded the following equation: 24 h MBG(mmol/L?)=?1.198×HbA1c-0.582 (24 h MBG(mg/dL?)=?21.564×HbA1c-10.476) (R(2)=?0.670, P<0.001). The model fit was not improved by application of exponential or quadratic modeling. When HbA1c was 6.5%, the calculated 24 h MBG was 7.2 (6.4-8.1) mmol/L (130 (115-146) mg/dL); and when HbA1c was 7.0%, the 24 h MBG was 7.8 (6.9-8.7) mmol/L (140 (124-157) mg/dL).ConclusionsOur study provided the reference data of the relationship between HbA1c and CGM in Chinese subjects.

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.

Dataset Information

Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population.

Introduction

Methods

Results

Trial registration

Publications

Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population.

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