OBJECTIVE: To investigate whether the FreeStyle Libre, an intermittent scanning continuous glucose monitoring (isCGM) system, influences confidence in managing hypoglycemia in adults with type 1 diabetes.
METHODS: This longitudinal, observational study conducted at one facility included 121 adults with type 1 diabetes. Participants used the conventional finger-prick method for self-testing glucose before using isCGM. At baseline and 12 months after initiating isCGM, the Hypoglycemic Confidence Scale (HCS), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and HbA1c were performed. At 12 months, the percentage of individuals utilizing isCGM trend arrows for glucose management was observed. The primary endpoint was hypoglycemic confidence change attributed to using isCGM.
RESULTS: After using isCGM, HCS scores improved significantly from 2.89 (2.56, 3.22) to 3.00 (2.20, 3.33) (p < 0.001); median (25%, 75%). Among participants with level 3 hypoglycemia at baseline, hypoglycemic confidence during sleep (p < 0.05), in social situations (p < 0.05), and in avoiding serious hypoglycemia-related problems (p < 0.05) were improved. Despite hypoglycemia risk, participants could continue daily activities by using isCGM (p < 0.05), and sixty-nine percent utilized trend arrows effectively.
CONCLUSIONS: Using isCGM improved hypoglycemic confidence among adults with type 1 diabetes. Data analysis indicated that people with type 1 diabetes could live more freely and better manage hypoglycemia using isCGM.

The Swedish National Diabetes Register (NDR) initiated registration of the FreeStyle Libre® system and other continuous glucose monitoring (CGM) systems in June 2016. We investigated change in HbA1c for people with type 2 diabetes (T2DM) using FreeStyle Libre in Sweden.
We included adults with T2DM, registered in the NDR after January 1, 2014, and an index date for first use of FreeStyle Libre of June 2016 or later. Methodology was a before/after comparison of HbA1c within 6 months before the index date versus HbA1c around 6 and 12 months after the index date.
711 adults with T2DM using FreeStyle Libre had HbA1c measurements within the study period. Mean HbA1c was significantly reduced at 6 months (-0.50%-unit) and at 12 months (-0.52%-unit) in this group. Degree of change was negatively correlated to baseline HbA1c. Reductions in HbA1c were observed in incident users of FreeStyle Libre with T2DM who were truly naïve to CGM or had unknown prior experience of CGM, and aged 25-74 years.
This real-world study on the Swedish NDR shows that people with T2DM using FreeStyle Libre system for 6 and 12 months significantly reduced their HbA1c.

UNASSIGNED: To evaluate the alternate use of flash glucose monitoring (FGM) with self-monitoring blood glucose (SMBG), in patients with type 1 diabetes (T1D).
UNASSIGNED: Two weeks of open FGM (P2), both preceded (P1) and followed by 2 weeks (P3) of SMBG with a blinded FGM system. Mean absolute relative difference (MARD) was calculated by (|FGMi - SMBGi|) / SMBGi, where it was a paired data sample.
UNASSIGNED: In total, 34 patients were evaluated. Time in range (TIR) did not change between P1 and P2. In 12 patients (35.3%), TIR increased from 40% at P1 to 52% at P2 (p = 0.002) and in 22 (64.7%), TIR decreased or did not change. FGM use resulted in decreased % time spent in hypoglycemia (<70 mg/dL) (6.5% vs. 5.0%; p = 0.005), increased % time spent in hyperglycemia (>180 mg/dL) (44.5% to 51%; p = 0.046) with no significant change in % TIR. The proportion of patients who reached sensor-estimated glycated hemoglobin (eA1c) < 7% decreased from 23.5% at P1 to 12.9% at P2, p = 0.028. For the whole sample, the MARD between the two methods was 15.5% (95% CI 14.5-16.6%). For normal glucose range, hyperglycemic levels and hypoglycemic levels MARD were 16.0% (95% CI 15.0-17.0%), 13.3% (95% CI 11.5-15.2%) and 23.4% [95% CI 20.5-26.3%)], respectively.
UNASSIGNED: FGM after usual SMBG decreased the % time spent in hypoglycemia concomitant with an undesired increase in % time spent in hyperglycemia. Lower accuracy of FGM regarding hypoglycemia levels could result in overcorrection of hypoglycemia.

暂无摘要。

OBJECTIVE: Examine the glycemic control on Type 1 Diabetes (T1D) wearing the Flash Glucose Monitoring (FGM) system for a one-year period of time.
METHODS: This prospective study done using 187 patients with T1D (14-40yrs) who self-tested their glucose levels by FGM. Continuous glucose monitoring (CGM) metrics were gathered i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events at the 3, 6, and 12 month time periods.
RESULTS: At 6th, 9th and 12th months, for values of GV, % in target, TAR and %>250 mg/dL, no significant changes (p > 0.05) were noted compared to 3 months. However, significant changes from the baseline were evident for the values of the mean glucose level at the 3rd (p = 0.028), 9th (p = 0.048) and 12th months (p = 0.022). When the mean glucose value at 3 months was compared to the same at 6, 9, and 12 month period, no significant changes (p > 0.05) were seen. When compared with baseline values, low glucose events at 3 months (p = 0.028), 6 months (p = 0.048), 9 months (p = 0.022) and 12 months (p = 0.038) showed significant changes. However, the percentage below 70 mg/dL (barring the value at 12 months, p = 0.046), no significant changes were observed. The HbA1c revealed significant drop in 3, 6, 9 and 12 months compared to baseline values.
CONCLUSIONS: Significant improvement was noted in CGM metrics when patients switched from conventional finger pricking method over to FGM system, and the effect was observed during the entire study period.

OBJECTIVE: To examine the efficacy of FreeStyle Libre Flash Glucose Monitoring System (FGMS) on Diabetes Self-Management Practices (DSMP) and glycemic control among patients with type 2 diabetes (T2D).
METHODS: This prospective study was conducted among 105 patients with T2D (aged 30-70 years), who self-tested their glucose levels by conventional finger-prick method using blood glucose meters (BGM). At baseline visit, FGMS sensors were fixed by a diabetes educator to all patients. At the baseline and at 12 weeks of the study, an interviewer collected the responses of Diabetes Self-Management (DSM) from all the study population using a questionnaire.
RESULTS: At 12 weeks, significant improvements in the DSM subscales were observed, which includes glucose management (P = 0.042), dietary control (P = 0.048), physical activity (P = 0.043), health care use (P = 0.001) and self-care (P = 0.001), compared to the values at baseline. At baseline, when the HbA1c level was 8.2%, at 12 weeks, it dropped to 7.9%. Also, at baseline, when the hypoglycemia frequency was 3.1, it declined to 1.2 episodes/month at 12 weeks. While comparing the blood glucose monitoring through BGM at the baseline (1.92/day), a higher degree of frequency of blood glucose monitoring was evident at 12 weeks (6.84/day), after the patients employed the FreeStyle Libre.
CONCLUSIONS: After 12 weeks of using the FreeStyle Libre, the frequency of hypoglycemic episodes and the HbA1c levels were dropped, while the practice of DSM and frequency of blood glucose monitoring were improved.

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.

FreeStyle Libre has been approved for use in patients undergoing hemodialysis (HD) in Japan, unlike Europe and the United States; however, evidence regarding its accuracy in such patients is sparse. Forty-one participants with type 2 diabetes undergoing HD were recruited. The overall mean absolute relative difference and mean absolute difference were 23.4% and 33.9 mg/dL, respectively. Sensor glucose levels and capillary glucose levels were significantly correlated (r = 0.858, P < .01), although the sensor glucose levels were significantly lower than the capillary glucose levels. The accuracy of FreeStyle Libre in patients undergoing HD became deteriorated with the days of usage. The percentage of sensor results in Zones A and B in the consensus error grid analysis and in the Clarke error grid analysis were 99.7% and 99.0%, respectively. Its insufficient accuracy necessitates adjunct usage of FreeStyle Libre with self-monitoring of blood glucose in patients undergoing HD.

OBJECTIVE: Patients with type-2 diabetes mellitus (T2DM) on multiple glucose-lowering therapies who fast during Ramadan are at increased risk of hypoglycemia. We have assessed the utility of the flash glucose monitoring system after adjusting the dose of insulin and sulphonylureas to mitigate the risk of hypoglycemia in patients with T2DM who fast during Ramadan.
METHODS: Patients with T2DM on either basal insulin or a sulphonylurea and at least 2 other glucose-lowering agents received structured education and adjustment of insulin or sulphonylurea dose according to the PROFAST Ramadan protocol. Glucose variability and episodes of hypoglycemia were assessed using the flash glucose monitoring system (Free Style Libre) before and during Ramadan.
RESULTS: A total of 33 patients with T2DM (on sulphonylurea (SU+) (n = 21), on basal insulin (BI+) (n = 12) aged 50.8 ± 1.6 years with a diabetes duration of 13.1 ± 6.5 years were studied. The average sensor glucose was 154 ± 34 mg/dl (8.5 ± 1.88 mmol/l) with 65.2% in the target range before Ramadan and the average sensor glucose was 156 ± 36 mg/dl (8.6 ± 2.0 mmol/l) with 67.1% in the target range during Ramadan. The incidence of hypoglycemia in the whole group (2.9 v 2.9) and in the SU+ (3.7 vs 3.0) and BI+ (1.7 vs 2.9) groups and eHbA1c (P = 0.56, P = 0.93), average glucose (P = 0.56, P = 0.92) and time within range (P = 0.63, P = 0.73) did not change in the SU+ and BI+ groups, respectively, before and during Ramadan.
CONCLUSIONS: Structured education with adjustment of the dose of glucose lowering medication alongside use of the FGMS can effectively mitigate the increased risk of hypoglycemia in patients with T2DM on multiple glucose-lowering therapies who fast during Ramadan.

BACKGROUND: Teenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D.
METHODS: This is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13-20 years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6 months ≥75 mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6 months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6 months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability.
CONCLUSIONS: >If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group.
BACKGROUND: This trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 ( ACTRN12618000320257p ) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784).