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Objective: The FreeStyle Libre (FSL) flash glucose-monitoring device was made available on the U.K. National Health Service (NHS) drug tariff in 2017. This study aims to explore the U.K. real-world experience of FSL and the impact on glycemic control, hypoglycemia, diabetes-related distress, and hospital admissions., Research Design and Methods: Clinicians from 102 NHS hospitals in the U.K. submitted FSL user data, collected during routine clinical care, to a secure web-based tool held within the NHS N3 network. The t and Mann-Whitney U tests were used to compare the baseline and follow-up HbA 1c and other baseline demographic characteristics. Linear regression analysis was used to identify predictors of change in HbA 1c following the use of FSL. Within-person variations of HbA 1c were calculated using [Formula: see text]., Results: Data were available for 10,370 FSL users (97% with type 1 diabetes), age 38.0 (±18.8) years, 51% female, diabetes duration 16.0 (±49.9) years, and BMI of 25.2 (±16.5) kg/m 2 (mean [±SD]). FSL users demonstrated a -5.2 mmol/mol change in HbA 1c , reducing from 67.5 (±20.9) mmol/mol (8.3%) at baseline to 62.3 (±18.5) mmol/mol (7.8%) after 7.5 (interquartile range 3.4-7.8) months of follow-up ( n = 3,182) ( P < 0.0001). HbA 1c reduction was greater in those with initial HbA 1c ≥69.5 mmol/mol (>8.5%), reducing from 85.5 (±16.1) mmol/mol (10%) to 73.1 (±15.8) mmol/mol (8.8%) ( P < 0.0001). The baseline Gold score (score for hypoglycemic unawareness) was 2.7 (±1.8) and reduced to 2.4 (±1.7) ( P < 0.0001) at follow-up. A total of 53% of those with a Gold score of ≥4 at baseline had a score <4 at follow-up. FSL use was also associated with a reduction in diabetes distress ( P < 0.0001). FSL use was associated with a significant reduction in paramedic callouts and hospital admissions due to hypoglycemia and hyperglycemia/diabetic ketoacidosis., Conclusions: We show that the use of FSL was associated with significantly improved glycemic control and hypoglycemia awareness and a reduction in hospital admissions., (© 2020 by the American Diabetes Association.)

Aim: To understand the effect of intermittently scanned continuous glucose monitoring (isCGM) in people with diabetes with a 'psychosocial' indication for access. Methods: The study utilized baseline and follow‐up data from the Association of British Clinical Diabetologists nationwide audit of people with diabetes in the UK. Diabetes‐related distress (DRD) was assessed using the two‐item diabetes‐related distress scale (DDS). Participants were categorized into two groups: high DRD (DDS score ≥ 3) and lower DRD (DDS score < 3). The t‐test was used to assess the difference in the pre‐ and post‐isCGM continuous variables. Results: The study consisted of 17 036 people with diabetes, with 1314 (7%) using isCGM for 'psychosocial' reasons. Follow‐up data were available for 327 participants, 322 (99%) of whom had type 1 diabetes with a median diabetes duration of 15 years; 75% (n = 241) had high levels of DRD. With the initiation of isCGM, after a mean follow‐up period of 6.9 months, there was a significant reduction in DDS score; 4 at baseline versus 2.5 at follow‐up (P <.001). The prevalence of high DRD reduced from 76% to 38% at follow‐up (50% reduction in DRD, P <.001). There was also a significant reduction in HbA1c (78.5 mmol/mol [9.3%] at baseline vs. 66.5 mmol/mol [8.2%] at follow‐up; P <.001). This group also experienced an 87% reduction in hospital admissions because of hyperglycaemia/diabetic ketoacidosis (P <.001). Conclusion: People with diabetes who had isCGM initiated for a psychosocial indication had high levels of DRD and HbA1c, which improved with the use of isCGM. [ABSTRACT FROM AUTHOR]

Aims: To investigate the change in glycated haemoglobin (HbA1c), hypoglycaemia awareness and diabetes‐related distress in people with type 1 diabetes (T1D) using FreeStyle Libre (FSL) over a 2‐year follow‐up period. Methods: FSL user data from U.K wide hospitals collected during routine clinical care were analysed. People living with T1D were categorised into four groups based on the duration of follow‐up. Group I (< 1 year, n = 6940), group II (1 to 1.5 years, n = 662), group III (1.5 to 2 years, n = 385), and group IV (> 2 years, n = 642). The t‐test was used to compare the baseline and follow‐up HbA1c, GOLD score (a measure of hypoglycaemia awareness) and diabetes‐related distress scale (DDS score) (quality of life measure). Results: The study consisted of 16,834 people, with follow‐up data available for 8,629 participants. The change in HbA1c, GOLD and DDS score from baseline within the follow‐up sub‐groups (group I vs group II vs group III vs group IV) was HbA1c (−6 vs −6 vs −4 vs −4 mmol/mol; p < 0.001) (−0.55 vs −0.55 vs −0.37 vs −0.37 %), GOLD score (−0.31 vs −0.45 vs −0.26 vs −0.42; p < 0.0001 group I, II, IV and p 0.07 group III), and DDS score(−0.59 vs −0.58 vs −0.63 vs −0.50; p < 0.001), respectively. Conclusions: In people with T1D, FSL use resulted in a sustained improvement in HbA1c, hypoglycaemia awareness and diabetes‐related distress for over two years. [ABSTRACT FROM AUTHOR]

GLO:EU1/01jan23:dom14841-fig-0001.jpg PHOTO (COLOR): 1 Bar chart showing the prevalence of impaired awareness of hypoglycaemia (IAH), severe hypoglycaemia (SH) episodes and complete loss of awareness of hypoglycaemia before and after FreeStyle Libre (FSL) use. The Gold score was used to assess awareness of hypoglycaemia.[9] A score of 4 or higher indicates IAH and 7 indicates a complete loss of awareness.[9] Diabetes-related distress was measured using the two-item diabetes distress screening tool (DDS2).[10] An average of the two questions of the DDS2 scale was calculated. In this audit, people with diabetes were using FreeStyle Libre or FreeStyle Libre 2. Keywords: glycaemic control; hypoglycaemia; observational study; type 1 diabetes EN glycaemic control hypoglycaemia observational study type 1 diabetes 302 305 4 12/13/22 20230101 NES 230101 BACKGROUND FreeStyle Libre (FSL), intermittently scanned continuous glucose monitoring (isCGM), is associated with less biochemical hypoglycaemia in people with diabetes, lower HbA1c and diabetes-related distress.[1] Impaired awareness of hypoglycaemia (IAH), which affects 18%-33% of people with type 1 diabetes,[2] is the reduced ability to detect the symptoms of hypoglycaemia and is associated with a 6-fold increased risk of severe hypoglycaemia (SH).[3] Many of the studies of CGM have shown a reduction in rates of hypoglycaemia but have not shown restoration of awareness.[4], [5], [6] There are limited nationwide data investigating the prevalence of IAH, complete loss of awareness of hypoglycaemia and SH. [Extracted from the article]

Aims: The aim of this study was to understand the relationship between time in range (TIR) achieved using the isCGM with changes in glycaemic control, diabetes‐related distress (DRD) and resource utilisation in people living with diabetes. Methods: Clinicians from 106 National Health System (NHS) UK hospitals submitted isCGM user baseline and follow‐up data in a web‐based tool held within the UK NHS network. Linear regression analysis was used to identify the relationship between follow‐up glucose TIR (3.9–10 mmol/L) categories (TIR% 50–70 and TIR% >70) with change in haemoglobin A1c (HbA1c), DRD and Gold score (measure of hypoglycaemia unawareness, where a score ≥4 suggests impaired awareness of hypoglycaemia). Results: Of 16,427 participants, 1241 had TIR follow‐up data available. In this cohort, the mean TIR was 44.8% (±22.5). With the use of isCGM, at 7.9 months mean follow‐up, improvements were observed in HbA1c (−6.9 [13.5] mmol/mol, p < 0.001), Gold score (−0.35 [1.5], p < 0.001) and Diabetes Distress Screening (−0.73 [1.23], p < 0.001). In the regression analysis restricted to people living with type 1 diabetes, TIR% 50–70 was associated with a −8.9 mmol/mol (±0.6, p < 0.001) reduction in HbA1c; TIR% >70 with a −14 mmol/mol (±0.8, p < 0.001) reduction in HbA1c. Incremental improvement in TIR% was also associated with significant improvements in Gold score and DRD. TIR% >70 was associated with no hospital admissions due to hypoglycaemia, hyperglycaemia/diabetic ketoacidosis, and a 60% reduction in the paramedic callouts and 77% reduction in the incidence of severe hypoglycaemia. Conclusion: In a large cohort of UK isCGM users, we demonstrate a significant association of higher TIR% with improvement in HbA1c, hypoglycaemia awareness, DRD and resource utilisation. [ABSTRACT FROM AUTHOR]

Aim: To identify the baseline demographic and clinical characteristics associated with diabetes‐related distress (DRD) and factors associated with improvement in DRD after initiating use of the FreeStyle Libre (FSL) in people living with type 1 diabetes (T1D). Methods: The study was performed using baseline and follow‐up data from the Association of British Clinical Diabetologists nationwide audit of people with diabetes who initiated use of the FSL in the United Kingdom. DRD was assessed using the two‐item diabetes‐related distress scale (DDS; defined as the average of the two‐item score ≥3). People living with T1D were categorized into two groups: those with high DRD, defined as an average DDS score ≥3 and those with lower DRD, defined as a DDS score <3. We used a gradient‐boosting machine‐learning (GBM) model to identify the relative influence (RI) of baseline variables on average DDS score. Results: The study population consisted of 9159 patients, 96.6% of whom had T1D. The median (interquartile range [IQR]) age was 45.1 (32‐56) years, 50.1% were women, the median (IQR) baseline body mass index was 26.1 (23.2‐29.6) kg/m2 and the median (IQR) duration of diabetes was 20 (11‐32) years. The two components of the DDS were significantly correlated (r2 = 0.73; P < 0.0001). Higher DRD was prevalent in 53% (4879/9159) of people living with T1D at baseline. In the GBM model, the top baseline variables associated with average DDS score were baseline glycated haemoglobin (HbA1c; RI = 51.1), baseline Gold score (RI = 23.3), gender (RI = 7.05) and fear of hypoglycaemia (RI = 4.96). Follow‐up data were available for 3312 participants. The top factors associated with improvement in DDS score following use of the FSL were change in Gold score (RI = 28.2) and change in baseline HbA1c (RI = 19.3). Conclusions: In this large UK cohort of people living with T1D, diabetes distress was prevalent and associated with higher HbA1c, impaired awareness of hypoglycaemia and female gender. Improvement in glycaemic control and hypoglycaemia unawareness with the use of the FSL was associated with improvement in DRD in people living with T1D. [ABSTRACT FROM AUTHOR]