Flash glucose monitoring: Impact on markers of glycaemic control and patient-reported outcomes in individuals with type 1 diabetes mellitus in the real-world setting

Nana, Melanie; Moore, Sacha; Ang, Eshen; Lee, Z.X.; Bondugulapati, L N Rao

doi:10.1016/j.diabres.2019.107893

Cited by 28 publications

(30 citation statements)

References 20 publications

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“…This possibility is supported by a study by Evans et al who found that changes in HbA1c levels are affected by the initial values [ 16 ]. Conversely, a number of other recent studies have shown that the introduction of FGM contributed to the reduction of HbA1c levels, similar to what we demonstrated in our study [ 16 , 17 ]. Furthermore, in our study, the SD of glucose levels and the percentage of time spent in target glucose range had improved without any increase in the percentage of time in hypoglycemia.…”

Section: Discussionsupporting

confidence: 93%

“…This possibility is supported by a study by Evans et al who found that changes in HbA1c levels are affected by the initial values [16]. Conversely, a number of Data are expressed as the mean ± standard deviation (SD) for glycated hemoglobin (HbA1c), average glucose, and SD of glucose, and as median with the interquartile range in parenthesis for the percentage of time spent within the range of glucose levels *Significant difference at P \ 0.05 compared with the values before the introduction of FGM other recent studies have shown that the introduction of FGM contributed to the reduction of HbA1c levels, similar to what we demonstrated in our study [16,17]. Furthermore, in our study, the SD of glucose levels and the percentage of time spent in target glucose range had improved without any increase in the percentage of time in hypoglycemia.…”

Section: Discussionsupporting

confidence: 87%

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Patient Satisfaction and Clinical Efficacy of Flash Glucose Monitoring in Patients with Type 1 Diabetes: A Prospective, Single-Center, Single-Arm Study

et al. 2020

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Introduction: Frequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D. Methods: Patient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated. Results: The DTSQ scores significantly improved 12 weeks after initiating FGM (P \ 0.001). The DTR-QOL scores related to ''burden in social activities'' and ''treatment satisfaction'' also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9-7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25-44.5%) (baseline) to 43% (IQR 39-50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 87%

Patient Satisfaction and Clinical Efficacy of Flash Glucose Monitoring in Patients with Type 1 Diabetes: A Prospective, Single-Center, Single-Arm Study

et al. 2020

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“…In the landmark RCTs of FGM efficacy a change in HbA1c has not been observed [ 1 , 2 ]. On the other hand, the majority of observational studies conducted in routine clinical practice have reported a significant reduction in HbA1c with the usage of FGM [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. Furthermore, recently published studies suggested that patients with good glycemic control have no benefits from FGM use, while those with suboptimal control tend to reach significant improvement in HbA1c levels probably due to the higher motivation and empowerment of patients in therapeutic decision making [ 8 , 10 , 11 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

“…Consequently, the number of sensor readings per day increases resulting in improved glycemic control and time in range (TIR) [ 18 ]. The mentioned advantages of FGM finally lead to positive impact on psychological wellbeing and improved quality of life [ 10 , 11 , 16 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

Assessment of FreeStyle Libre Flash Glucose Monitoring System Implementation in Real Life Clinical Setting: A Prospective Observational Study

et al. 2021

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Background: In this study, we investigated the effectiveness of FreeStyle Libre Flash Glucose Monitoring (FGM) implementation in a real life clinical setting with the emphasis on the effect of initial education on the use of the FGM system. Methods: This prospective observational study included 425 diabetes type 1 subjects followed up for 3 to 12 months (320 were followed up to 3 months, 267 up to 6 months and 147 up to period of one year). An FGM sensor was placed at study entry and all participants were educated through a period of 5 days on sensor usage and self-management of glycemia with follow up visits every 3 months. Results: HbA1c values significantly decreased from baseline (T0) to 3 months (T3) (p < 0.001), with a drop from 7.48% ± 0.1% to 7.30 ± 0.1%. There was no change in time spent in hypoglycemia from T3 to T12, although there was a decreasing trend present. The change in HbA1c values in the entire cohort was driven by change in the subgroup of patients with HbA1c ≥7% with a drop from 8.22% ± 1.14% to 7.68% ± 1.26% (p < 0.0001) in the first 3 months. Also, in individuals performing SMBG less than 5 times per day, there was a steady decrease in HbA1c levels up to 6 months (p < 0.05 and p < 0.001, respectively) as opposed to those who performed SMBG ≥5 times per day. Conclusions: The improvement in HbA1c was mainly driven by the increase in the number of scans per day. The subjects with poorer glycemic control and those who seldom performed SMBG benefited the most.

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“…Tyndall et al reported among 900 persons with type 1 DM a mean HbA1c reduction of 4 mmol/mol (0.37%) during a period of 245 days with FSL-FGM [4] . Nana et al showed that initiation of FSL-FGM in their hospital (n = 90) resulted in a mean HbA1c decrease of 7 mmol/mol (0.64%) over a mean follow-up time of 4.6 months [5] . Recently, our research group reported the one-year results of the nation-wide prospective registry of FSL-FGM use in the Netherlands (FLAsh monitor Registry in The Netherlands, FLARE-NL).…”

Section: Introductionmentioning

confidence: 99%

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

Lameijer

Fokkert

Edens

et al. 2020

Journal of Clinical & Translational Endocrinology

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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; R 2 = 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.

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Flash glucose monitoring: Impact on markers of glycaemic control and patient-reported outcomes in individuals with type 1 diabetes mellitus in the real-world setting

Cited by 28 publications

References 20 publications

Patient Satisfaction and Clinical Efficacy of Flash Glucose Monitoring in Patients with Type 1 Diabetes: A Prospective, Single-Center, Single-Arm Study

Patient Satisfaction and Clinical Efficacy of Flash Glucose Monitoring in Patients with Type 1 Diabetes: A Prospective, Single-Center, Single-Arm Study

Assessment of FreeStyle Libre Flash Glucose Monitoring System Implementation in Real Life Clinical Setting: A Prospective Observational Study

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

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