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Aims/Introduction: The FreeStyle Libre (FSL) intermittently scanned continuous glucose monitoring (isCGM) system continually measures interstitial glucose levels and provides the data to users in numerical and graphical formats that guide users in their daily diabetes self‐management. Although numerous studies have demonstrated the glycemic benefits of FSL in pediatric and adult populations, few studies have characterized FSL use specifically by Japanese adults with type 1 or 2 diabetes. We utilized established CGM metrics to assess glycemic control in a large cohort of Japanese adults with type 1 and 2 diabetes. Materials and Methods: A total of 3,463 anonymized FSL users provided categorization into one of four therapy groups of interest: type 1 diabetes (n = 1,768), type 2 diabetes‐multiple daily injections (MDI) (n = 612), type 2 diabetes‐basal (BOI) (n = 343), and type 2 diabetes‐non‐insulin (NIT) (n = 740). Established CGM metrics were used to assess glycemic control. Results: All study groups showed relatively good glycemic control. Type 1 diabetes users showed the highest glucose variability (SD, 61 mg/dL; and %CV, 40%), above the established target level (%CV ≤ 36%). type 2 diabetes‐MDI and type 2 diabetes‐BOI users had similar levels of glucose variability (both within target). Type 2 diabetes‐NIT users had the highest mean % time in range (TIR) (84.3%) and largest percentage of users that met the target of %TIR > 70% (87.4%). In contrast, type 1 diabetes users had the lowest mean %TIR (62.6%) and the lowest percentage meeting the established %TIR target (30.5%). Conclusions: By utilizing CGM devices in daily diabetes care, both healthcare professionals and patients can monitor glycemic excursions and gain insights into their historical glucose control patterns. [ABSTRACT FROM AUTHOR]

Aim: To conduct a systematic review and meta‐analysis of randomized controlled trials (RCTs) comparing the effectiveness of real‐time continuous glucose monitoring (rtCGM) versus intermittently scanned continuous glucose monitoring (isCGM) on key glycaemic metrics (co‐primary outcomes HbA1c and time‐in‐range [TIR] 70–180 mg/dL, 3.9–10.0 mmol/L) among people with type 1 diabetes (T1D). Methods: Medline, PubMed, Scopus, Web of Science and Cochrane Central Register of clinical trials were searched. Inclusion criteria were RCTs; T1D populations of any age and insulin regimen; comparing any type of rtCGM with isCGM (only the first generation had been compared to date); and reporting the glycaemic outcomes. Glycaemic outcomes were extracted post‐intervention and expressed as mean differences and 95% CIs between the two comparators. Results were pooled using a random‐effect meta‐analysis. The risk of bias was assessed using the Cochrane RoB2 tool. The quality of evidence was assessed by the GRADE approach. Results: Five RCTs met the inclusion criteria (4 parallel and 1 crossover design; 4 with CGM use <8 weeks), involving 446 participants (354 adults; 92 children and adolescents). Overall, meta‐analysis showed rtCGM compared to isCGM improved absolute TIR by +7.0% (95% CI: 5.8%–8.3%, I2 = 0%, p < 0.01) accompanied by a favorable effect on time‐below‐range <70 mg/dL (3.9 mmol/L) – 1.7% (95%CI: −3.0% to −0.4%; p = 0.03). No differences were seen regarding HbA1c. Conclusions: This meta‐analysis highlights that for people with T1D, rtCGM confers benefits over isCGM primarily related to increased TIR, with improvements in hypo‐ and hyperglycaemia. [ABSTRACT FROM AUTHOR]

Objective: We previously showed that intermittently scanned continuous glucose monitoring (isCGM) reduces HbA1c at 24 weeks compared with self‐monitoring of blood glucose with finger pricking (SMBG) in adults with type 1 diabetes and high HbA1c levels (58–97 mmol/mol [7.5%–11%]). We aim to assess the economic impact of isCGM compared with SMBG. Methods: Participant‐level baseline and follow‐up health status (EQ‐5D‐5L) and within‐trial healthcare resource‐use data were collected. Quality‐adjusted life‐years (QALYs) were derived at 24 weeks, adjusting for baseline EQ‐5D‐5L. Participant‐level costs were generated. Using the IQVIA CORE Diabetes Model, economic analysis was performed from the National Health Service perspective over a lifetime horizon, discounted at 3.5%. Results: Within‐trial EQ‐5D‐5L showed non‐significant adjusted incremental QALY gain of 0.006 (95% CI: −0.007 to 0.019) for isCGM compared with SMBG and an adjusted cost increase of £548 (95% CI: 381–714) per participant. The lifetime projected incremental cost (95% CI) of isCGM was £1954 (−5108 to 8904) with an incremental QALY (95% CI) gain of 0.436 (0.195–0.652) resulting in an incremental cost‐per‐QALY of £4477. In all subgroups, isCGM had an incremental cost‐per‐QALY better than £20,000 compared with SMBG; for people with baseline HbA1c >75 mmol/mol (9.0%), it was cost‐saving. Sensitivity analysis suggested that isCGM remains cost‐effective if its effectiveness lasts for at least 7 years. Conclusion: While isCGM is associated with increased short‐term costs, compared with SMBG, its benefits in lowering HbA1c will lead to sufficient long‐term health‐gains and cost‐savings to justify costs, so long as the effect lasts into the medium term. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control. Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4–13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%–12.2% [58–110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks. Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: −0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97–6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70–180 mg/dL) was reduced with isCGM −6.4% (10.6 to −4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks. Conclusions: For children aged 4–13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090) [ABSTRACT FROM AUTHOR]

The FreeStyle Libre Flash Glucose Monitoring System allows users to obtain sensor glucose values by scanning with the reader or their mobile phone. We report a case of a 59‐year‐old man with type 1 diabetes mellitus who developed diabetic ketoacidosis due to a sensor defect. After replacing the sensor with a new one, the glucose value shown in the device was much lower than usual, which made him consider that he was hypoglycemic. Accordingly, he reduced his insulin dose and eventually developed diabetic ketoacidosis. He was unaware of the discrepancy due to the lack of self‐monitoring of his blood glucose, although he was educated to do. In sum, glucose monitoring with the FreeStyle Libre is helpful; however, it is necessary to remind the patient that a sensor defect leading to a severe complication frequently happens. [ABSTRACT FROM AUTHOR]

Objectives: Real-time and intermittently scanned continuous glucose monitoring are increasingly used for glucose monitoring in people with diabetes requiring renal replacement therapy, with limited data reporting their accuracy in this cohort. We evaluated the accuracy of Dexcom G6 and Abbott Freestyle Libre 1 glucose monitoring systems in people with diabetes undergoing hemodialysis. Methods: Participants on hemodialysis with diabetes (on insulin or sulfonylureas) were recruited. Paired sensor glucose from Dexcom G6 and Freestyle Libre 1 were recorded with plasma glucose analyzed using the Yellow Springs Instrument (YSI) method at frequent intervals during hemodialysis. Analysis of accuracy metrics included mean absolute relative difference (MARD), Clarke error grid (CEG) analysis and proportion of CGM values within 15% and 20% or 15 and 20 mg/dL of YSI reference values for blood glucose >100 or ≤100 mg/dL, respectively (% 15/15, % 20/20). Results: Forty adults (median age 64.7 [60.2–74.4] years) were recruited. Overall MARD for Dexcom G6 was 22.7% (2656 matched glucose pairs), and 11.3% for Libre 1 (n = 2785). The proportions of readings meeting %15/15 and %20/20 were 29.1% and 45.4% for Dexcom G6, respectively, and 73.5% and 85.6% for Libre 1. CEG analysis showed 98.9% of all values in zones A and B for Dexcom G6 and 99.8% for Libre 1. Conclusions: Our results indicate Freestyle Libre 1 is a reliable tool for glucose monitoring in adults on hemodialysis. Further studies are required to evaluate Dexcom G6 accuracy in people on hemodialysis. [ABSTRACT FROM AUTHOR]

For people living with type 1 diabetes (T1D), home glucose monitoring has evolved from occasional qualitative urine tests to frequently sampled continuous data providing hundreds of data points per day to inform optimal self-management. Continuous glucose monitoring technologies have a robust evidence base derived from randomized controlled trials (RCTs) over the last 20 years, and are now implemented in routine clinical practice, reflecting their clinical and cost effectiveness. However, while randomized studies are the gold standard, they can be slow to set-up, unrepresentative and do not provide data for efficacy in large, unselected populations. Real-world data can be responsive to rapid product cycles in technologies, provide a large, representative population, and have a lower regulatory burden. In this podcast we discuss the advantages and pitfalls of using real-world data to assess the efficacy of continuous glucose sensing technologies in people with T1D, with reference to examples of real-world data for real-time and intermittently scanned continuous glucose monitoring. Large datasets confirm the RCT data for real-time technologies and additionally provide data for work absenteeism and hospital admissions, as well as showing the impact of advanced technology features that can be difficult to assess in randomized studies. Real-world data for intermittently scanned monitoring also confirm the randomized controlled trial data, provide additional insights not shown in controlled study environments and highlight the importance of health equality. A mature real-world dataset for automated insulin delivery systems is now available and the future of glucose sensing is also discussed. [ABSTRACT FROM AUTHOR]

Introduction: Imeglimin is a novel antidiabetic drug that amplifies glucose-stimulated insulin secretion (GSIS) and improves insulin sensitivity. Several randomized clinical studies have shown the efficacy of imeglimin for glycemic control in patients with type 2 diabetes (T2D). We aimed to evaluate the short-term effects and safety of imeglimin in terms of glycemic control, as assessed by intermittently scanned continuous glucose monitoring (isCGM). Methods: This retrospective and observational study of 32 patients who were administered imeglimin in addition to existing treatment regimens was designed to evaluate glycemic profiles. The patients were monitored for more than 4 weeks, including the day of starting imeglimin. The changes in glycemic indices, including mean glucose level, coefficient of variation (CV), time in range (TIR) and time above range (TAR), before and after imeglimin administration were analyzed, and data on adverse effects were collected by interview. Results: Imeglimin administration significantly improved the mean values of glucose (from 159.0 ± 27.5 mg/dL to 141.7 ± 22.1 mg/dL; p < 0.001), TIR (from 67.9 ± 17.0% to 79.5 ± 13.3%; p < 0.001) and TAR (from 29.4 ± 17.5% to 17.9 ± 13.7%; p < 0.001) and tended to improve CV (from 29.0 ± 6.1 to 27.4 ± 5.58; p = 0.058). The curves of 24-h mean glucose level for all 32 subjects were shifted downward from the baseline after imeglimin administration. The high mean glucose level, high TAR, low TIR, low body mass index and low C-peptide were related to the efficacy of imeglimin for glycemic control. The main adverse effects were gastrointestinal disorders, and the incidence of hypoglycemia was increased in cases receiving a combination of imeglimin plus insulin or a glinide agent. Conclusion: Imeglimin clearly shifted the daily glucose profile into an appropriate range in Japanese T2D patients, indicating improvement of short-term glycemic control. Imeglimin is thought to be a promising therapeutic agent for T2D patients, especially those with a low insulin secretory capacity, which is a common phenotype in East-Asian subjects with glucose intolerance. [ABSTRACT FROM AUTHOR]

Aims: Data about sleep quality and quantity are not available in patients with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM). We questioned whether the isCGM with alarms could fragment sleep in patients and parents, compared to isCGM without alarms. Methods: A prospective, observational study including 47 child-adolescents with T1D who had experience with isCGM without alarms (Freestyle Libre 1–FSL1). They were asked to wear the isCGM with alarms (Freestyle Libre 2–FSL2) for 14 days. Patients enrolled and their caregiver (s), during a 14 day period with FSL1 and the following 14 days with FSL2, completed psychosocial and sleep-related questionnaires. Furthermore they wore an actigraph that was downloaded to a web platform and processed by the validated and certified algorithm "Dormi®." Results: By the switch to the alarmed FSL2 we found about a 5% increase in Time In Range (from 62.5 to 67.8%), a reduction in time spent in hypoglycemia, number of weekly hypoglycemic events, and coefficient of variation. We did not find significant differences in sleep parameters in patients and their parents; therefore, alarms did not worsen the duration and quality of sleep. A significant improvement in the Quality of Life was perceived by parents using FSL2. Conclusions: Introduction of alarms in isCGM systems gives, in the short term, an improvement in metabolic control in terms of time in range and reduction in hypoglycemia, without worsening duration and quality of sleep, measured by actigraphy, in children-adolescent and their parents. [ABSTRACT FROM AUTHOR]

• Currently, no studies analyzed the impact of systematic use of Ambulatory Glucose Profile (AGP) reports on glucose metrics, as well as predictors of sustained AGP use have not been previously explored. • This study compared 96 children and adolescents with type 1 diabetes who used AGP reports at least every 14 days, with 43 people not using it. • Systematic use of the AGP software for 1 year was associated with a higher percentage of sensor usage and Time In Range, with lower Time Above Range and HbA1c. No significant relationship between sustained AGP software usage and age at the enrollment, diabetes duration, socioeconomic status and parents'age was found. In this study, we aimed to analyze the possible change in Time In Range (TIR) in subjects with type 1 diabetes (T1D) using the Ambulatory Glucose Profile (AGP) and to identify the main socio-demographic and clinical predictors of sustained use. 143 youths wearing instant-scanning CGM received structured counseling on the AGP report interpretation, and who were able to use AGP at least every 14 days were enrolled in group A (n = 100), whereas no users were considered as group B (n = 43). Socio-demographic data at the enrollment, clinical data, and glucose metrics were collected at baseline and during quarterly consultations. Metabolic outcomes were evaluated during follow-up, and a comparison between groups A and B was performed. In group A compared to group B, at 12 months, the percentage of sensor usage and TIR were higher (p = 0.04 and p = 0.02), and Time Above Range and HbA1c were lower (p = 0.0004, p < 0.0001, respectively). Multiple logistic regression analysis did not show a significant relationship between sustained AGP software usage and the variables analyzed. Systematic use of the AGP software was feasible and showed improved metabolic control in youths with T1D. This may be related to increased sensor usage and more informed decisions. [ABSTRACT FROM AUTHOR]

In Spain, from October 10th, 2023, the FreeStyle Libre 2 system offers the possibility to automatically changed from isCGM to rtCGM with a system update. Our study aimed to evaluate the glucometric before and after that date. We didn't find significant changes in TIR, however time of use increased and TBR decreased. • The main findings were the increase in time of use and the decrease in time below range. • We didn't find significant changes in TIR. • The differences in TIR were significant in those patients with poor glycemic control. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effects of intermittently scanned continuous glucose monitoring (isCGM) on blood glucose control, clinical value of blood glucose monitoring and production of urinary ketone bodies in pregestational diabetes mellitus. Method: A total of 124 patients with pregestational diabetes mellitus at 12–14 weeks of gestation admitted to the gestational diabetes clinic of our hospital from December 2016 to December 2018 were selected and randomly divided into two groups. Sixty patients adopted self-monitoring of blood glucose (SMBG) were taken as the control group, and the other 64 patients adopted isCGM system by wearing the device for 14 days. Blood sugar control, glycosylated albumin level, ketone production in urine, the maximum and minimum of blood sugar value measured by different monitoring methods and their occurrence time were observed in the two groups. Result: (1) No statistically significant differences were found between the groups in terms of maternal age, gestational age at first visit, family history, duration of diabetes, education level, total insulin dose, chronic hypertension, abortion history, nulliparity, assisted reproductive technology, history of macrosomia childbirth, pre-pregnancy BMI, and overweight (%) at the first visit and hypoglycemia, (2) the value of Glycated Albumin was lower in the CGM group compared to the control group at 2ed weeks (14.6 ± 2.2 vs. 16.8 ± 2.7, p < 0.001). The women in the CGM group spent increased time in the recommended glucose control target range of 3.5–7.8 mmol/L (69 ± 10% vs. 62 ± 11%, p < 0.001) and reduced time above target compared with those in the control group at 2 weeks (25 ± 7% vs. 31 ± 8%, p < 0.001). In the second week of the study, the positive rate of urinary ketone body in isCGM group was lower than that in the control group (42 ± 5 vs. 54 ± 5, p < 0.001), and (3) the minimum blood glucose of 31.2% (20/64) cases in isCGM group appeared during 0:00–2:59 at night, and 26.6% (17/64) cases appeared during 3:00–5:59 at night. The minimum values of 40.0% (24/60) cases in the control group appeared within the 30 min before lunch, 23.3% (14/60) within the 30 min before breakfast, and 11.7% (7/60) within the 30 min before dinner. The cases of minimum of blood sugar before meals accounted for 75% of all the minimum values, and the cases of minimum at night only accounted for 8.3%. Conclusion: Intermittently scanned continuous glucose monitoring can reduce hyperglycemia exposure and ketone body formation in pregestational diabetes mellitus. In addition, isCGM is better than SMBG in detecting nocturnal hypoglycemia. [ABSTRACT FROM AUTHOR]

Aim: Assess the impact of switching from intermittently scanned (FreeStyle Libre [FSL]) to real-time (Dexcom G4 platinum [DG4]) continuous glucose monitoring systems on glycemia control in type 1 diabetes (T1D) patients with high risk of hypoglycemia and/or elevated glycated hemoglobin (HbA1c). Methods: We conducted an observational study in 18 T1D adults with poor glycemic control on FSL. Ambulatory glucose profile data were collected during the last 3 months of FSL use before inclusion (M0 period), during the first 3 months (M3 period) and the last 3 months (M6 period) of DG4 use. Data were then expressed as 24-h averages. Biological HbA1c was measured for all three periods. Patients were their own-controls and statistics were performed using paired t-test or Wilcoxon for matched-pairs. Results: The switch to DG4 at M3 resulted in a higher time-in-range (TIR) 70-180 mg/dL (median [Q1;Q3], 53.1 [44.5;67.3] vs. 41.5 [28.5;62.0], P = 0.0008), and a lower time-below-range <70 mg/dL (TBR mean ± standard deviation (SD), 5.4 ± 3.7 vs. 10.9 ± 7.1, P = 0.0009) and in the glucose % coefficient of variation (%CV mean ± SD, 40.1 vs. 46.9, P = 0.0001). Mean (SD) changes were +10.3 (8.0) percentage points for TIR, -5.5 (5.8) percentage points for TBR, and -6.8 (5.8) percentage points for %CV. These results were confirmed at the M6 period. Conclusions: Switching from FSL to DG4 appears to provide a beneficial therapeutic option without changing insulin delivery systems, regardless of the origin of the patient's initial glycemic issue. [ABSTRACT FROM AUTHOR]

Aims/Introduction: We investigated the effect of FreeStyle LibreTM on glycemic control in Japanese type 2 diabetes patients treated with basal–bolus insulin therapy. Materials and Methods: This prospective, 90‐day single‐arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14‐day masked baseline phase was followed by an 11‐week treatment phase during which participants used the device to monitor glucose levels. The primary end‐point was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76–90). Secondary end‐points included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire. Results: Time spent in hypoglycemia was low at baseline (0.51 ± 0.93 h/day) and did not significantly decrease at study end (0.47 ± 0.63 h/day, P = 0.6354). Time in range, time in hyperglycemia and estimated A1c all improved versus baseline (by +1.7 ± 3.0 h/day, −1.6 ±.4 h/day and −0.4 ± 0.8%, respectively, P < 0.0001 in each). Finger stick tests fell from 2.9 ± 1.3 to 1.9 ± 1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. The mean treatment satisfaction score increased by 11.8 ± 5.3 (P < 0.0001). Two severe hypoglycemia‐related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device‐related skin trauma, site discomfort or subcutaneous bleeding. Conclusions: Use of FreeStyle Libre by Japanese type 2 patients diabetes treated with basal–bolus insulin therapy showed a low baseline of hypoglycemia, and enabled improved glycemic control and treatment satisfaction. [ABSTRACT FROM AUTHOR]

Objective: We undertook a 24‐month prospective observational single‐center real‐world trial to study impact of access to intermittently scanned continuous glucose monitoring (isCGM) on quality of life (QOL) and glycemic control of youth with type 1 diabetes (T1D). Methods: Between September 2016 and November 2017, 138 children and adolescents with T1D were recruited. Demographic, metabolic, and QOL data were collected during 24 months of routine follow‐up. Primary endpoint was the evolution of QOL, with secondary outcomes change in HbA1c, occurrence of acute diabetes complications, and school absenteeism. Results: Ninety‐two percent of participants found isCGM more user‐friendly than capillary finger‐stick tests and had high treatment satisfaction, without change in diabetes‐specific QOL. HbA1c significantly increased from 7.2% (7.0‐7.3) (55 mmol/mol [53‐56]) at baseline to 7.6% (7.4‐7.8) (60 mmol/mol [57‐62]) at 12 months (P <.0001) and was unchanged up to 24 months. Overall increase was mainly driven by children with baseline HbA1c <7.0% (<53 mmol/mol). Additionally, BMI adjusted for age was higher at study end. In year before isCGM, 228 days per 100 patient‐years of school absenteeism were reported, which dramatically decreased to 13 days per 100 patient‐years (P =.016) after 24 months. Parents of children also reported less work absenteeism (P =.011). Conclusion: The use of isCGM by T1D pediatrics is associated with high treatment satisfaction and fewer days of school absence. However, increased HbA1c and weight may reflect a looser lifestyle, with less attention to diet and more avoidance of hypoglycemia. Intensive education specifically focusing on these points may mitigate these issues. [ABSTRACT FROM AUTHOR]

To date, studies of patients with islet transplantation addressing intermittently scanned continuous glucose monitoring profile and the flexibility of the graft islet function under different doses of insulin administration, both of which reflect the real daily life of patients, are quite limited. Here, we report a case of a 46‐year‐old woman who received islet transplantation after kidney transplantation. The patient was followed up over a period of 2 years after initial islet transplantation. Our results show that intermittently scanned continuous glucose monitoring can be useful for monitoring the reduction of glycemic variability, and suggest the appropriate regulation of insulin secretion from graft islets during mixed‐meal test by using different doses of exogenous insulin administration. Additionally, during the 2‐year observational period, glucagon elevation was detected only at hypoglycemia, whereas the level was within the normal range at normoglycemia or hyperglycemia. [ABSTRACT FROM AUTHOR]

Background: People with diabetes experiencing hypoglycemia are at increased risk of recurrence because of attenuated autonomic warning. We assessed the efficacy of intermittently scanned continuous glucose monitoring (isCGM; FreeStyle Libre™, Abbott) compared with usual-care self-monitoring of blood glucose (SMBG) in reducing this risk in type 1 and insulin-treated type 2 diabetes. Methods: Insulin-treated adults with diabetes and an episode of clinically significant biochemical hypoglycemia (blood glucose [BG] <3.0 mM) or symptomatic hypoglycemia and BG <4.0 mM were randomized to 6 months of isCGM (intensive group) or SMBG (control group) against a background of usual care. The primary outcome was hypoglycemia requiring second-party assistance for recovery. Prespecified secondary outcomes included other hypoglycemic episodes (self-reported, and BG <3.0, 3.0-3.9, <4.0 mM) and change in HbA1c at 24 weeks. Results: Of 59 participants (mean age 53.6 years, 44.1% males, median HbA1c 61.8 mmol/mol or 7.8%), 30 were allocated to isCGM and 29 to SMBG. The incidence of severe hypoglycemia was not significantly different between the two groups (incident rate ratio [95% confidence interval]: 1.49 [0.46-5.56], P = 0.47). The incidence of other recorded hypoglycemic episodes in the intervention group was double that in the control group (P < 0.001). There was no difference in the change in HbA1c between the two groups (P = 0.74). There were seven serious adverse events and none was considered related to the intervention. Conclusions: Although isCGM is safe, it does not appear to have a role in preventing recurrent severe hypoglycemia in at-risk individuals with diabetes. [ABSTRACT FROM AUTHOR]

Current intermittently scanned continuous glucose monitoring (isCGM) devices do not allow calibration and require confirmatory self-monitored blood glucose (SMBG) under specific defined conditions. The overall time spent in an SMBG-indicated state while using isCGM has not been reported in the existing literature. We present the time spent in an SMBG-indicated state and the daily number of transitions to an SMBG-indicated state during isCGM use in a high-risk cohort of adults with type 1 diabetes. This is a post hoc analysis of participants randomized to isCGM as part of a clinical study. The percentage of values meeting one or more of the criteria for SMBG testing (hours per day) and the number of transitions to an SMBG-indicated state per day were calculated according to the manufacturer's label in the United Kingdom. Complete data sets for 20 participants on isCGM for 8 weeks were included in the analysis. Participants spent a mean (SD) of 5.61 (1.81) h/day in an SMBG-indicated state and there were 5.43 (1.42) transitions to an SMBG-indicated state per day while using isCGM. These findings have important implications for cost-effectiveness and for decision-making around insulin dose calculations and driving. Our findings emphasize the need for continued SMBG testing among people at high risk of hypoglycemia who use isCGM. Cost-effectiveness analyses for isCGM may require revision. [ABSTRACT FROM AUTHOR]

Aims: In 2016 intermittently scanned continuous glucose monitoring (isCGM) became the first reimbursed CGM system in Belgium. Many children with type 1 diabetes (T1D) treated with multiple daily injections as well as with continuous subcutaneous insulin infusion (CSII) switched from self-monitoring of blood glucose to isCGM to monitor their treatment. In 2017 the Enlite® real-time CGM (rtCGM) system was reimbursed enabling its use with the Minimed® 640G insulin pump with integrated SmartGuard technology. In this study we compared the metabolic control during CSII with isCGM with that during rtCGM. Patient's satisfaction and side effects of the rtCGM system were also evaluated.Methods: 20 children with T1D, aged 5-16 years, were included. Metabolic control during the last month of isCGM use was compared to that during the 3rd and 6th month of rtCGM.Results: Three patients stopped early rtCGM mainly due to calibration burden. The HbA1c level and the mean glucose value in the other patients did not change after switching to the rtCGM system. Glucose variability was smaller (46.2% vs 38.4% and 36.4%, p = 0.000). Time in hypoglycemia (<70 mg/dl) was lower (7.4% vs 1.6% and 1.5%, p = 0.000). The main patient inconvenience was the sensor calibration.Conclusions: Our data show that during Enlite® rtCGM with the Minimed® 640G pump system glucose variability was smaller and the patients spent less time in hypoglycemia than during isCGM. The need for timely calibrations is considered as the main drawback of the system. [ABSTRACT FROM AUTHOR]

Background: A factory‐calibrated sensor for intermittently scanned continuous glucose monitoring (isCGM) is accurate and safe in children with type 1 diabetes (T1D). Data on isCGM effectiveness as a replacement for self‐monitoring of blood glucose (SMBG) in this population is scarce. Objective: The aim of this study was to evaluate the non‐adjunctive use of isCGM in children with T1D during 2 weeks in a challenging summer‐camp setting. Methods: In this two‐arm, parallel, randomized, outpatient clinical trial we enrolled 46 children (25 females, mean ± SD: age 11.1 ± 2.6 years, glycated hemoglobin (HbA1c) 7.4% ± 0.7%): 26 in the isCGM group were blinded for the SMBG and insulin dosing was isCGM‐based, whereas 20 in the control group were blinded for isCGM and performed SMBG‐based insulin dosing. The primary outcome of intention‐to‐treat analysis was between‐group difference in the proportion of time within range 3.9 to 10 mmol/L (TIR). Results: There was no significant difference in TIR (3.9‐10 mmol/L) between the two groups. In participants with suboptimal metabolic control (HbA1c > 7%) we observed a significant reduction in time spent above 10 mmol/L (P < 0.05) and an improvement in TIR (P = 0.05) in the isCGM group. No severe hypoglycemic events or serious adverse events occurred. Overall mean absolute relative difference (MARD) between isCGM and SMBG was 18.3%, with median absolute relative difference (ARD) of 8%. Consensus error grid analysis demonstrated 82.2% and 95.2% of results in zone A, and zone A + B, respectively. Conclusion: The non‐adjunctive use of isCGM was as safe and effective as SMBG, and reduced time spent in hyperglycemia in a sub‐population of children with T1D with suboptimal glycemic control. Trial registration: NCT03182842. [ABSTRACT FROM AUTHOR]

To conduct an Australian community-led survey of adults with type 1 diabetes (T1D), identifying priorities for, and barriers to, optimal use of advanced glucose management technologies. A 30-question online survey of current or past users of insulin pump therapy (IPT), real-time continuous glucose monitoring (RT-CGM), or intermittently scanned CGM (isCGM) explored perceptions regarding device design, access, education, outcomes, and support. Between November 2021 and January 2022, surveys were completed by 3,380 participants (age [mean ± SD] 45 ± 16 years; 62% female; 20 ± 14 years diabetes), with 55%, 82%, and 55% reporting experience with IPT, RT-CGM, and isCGM, respectively. Overall, most considered diabetes technology '(extremely) important' for maintaining target glucose levels (98%) and reducing hypoglycaemia severity and frequency (93%). For most, technology contributed positively to emotional well-being (IPT 89%; RT-CGM 91%; isCGM 87%), which was associated with device effectiveness in maintaining glucose in range, comfort, and convenience. Barriers included affordability (IPT 68%; RT-CGM 81%; isCGM 69%) and insufficient information for informed choices about device suitability (IPT 39%; RT-CGM 41%; isCGM 36%). Technology is perceived by adults with T1D as important for managing glycaemia and emotional well-being. Modifiable barriers to use include affordability, and information regarding device suitability. [ABSTRACT FROM AUTHOR]

To evaluate real-life changes of glycemic parameters among flash glucose monitoring (FLASH) users who do not meet glycemic targets. De-identified data were obtained between 2014 and 2021 from patients using FLASH uninterrupted for a 24-week period. Glycemic parameters during first and last sensor use were examined in four identifiable groups: type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) on basal-bolus insulin, T2DM on basal insulin, and T2DM without insulin treatment. Within each group, subgroup analyses were performed in persons with initial suboptimal glycemic regulation (time in range (TIR; 3.9–10 mmol/L) < 70%, time above range (TAR; >10 mmol/L) > 25%, or time below range (TBR; <3.9 mmol/L) > 4%). Data were obtained from 1,909 persons with T1DM and 1,813 persons with T2DM (1,499 basal-bolus insulin, 189 basal insulin, and 125 non-insulin users). In most of the performed analyses, both overall and in the various subgroups, significant improvements were observed in virtually all predefined primary (TIR) and secondary endpoints (eHbA1c, TAR, TBR and glucose variability). 24-weeks FLASH use in real life by persons with T1DM and T2DM with suboptimal glycemic regulation is associated with improvement of glycemic parameters, irrespective of pre-use regulation or treatment modality. [ABSTRACT FROM AUTHOR]

The switch from intermittently scanned continuous glucose monitoring (isCGM) to real-time (rt) CGM could improve glycemic management in suboptimal controlled type 1 diabetes patients, but long-term study is lacking. We evaluated retrospectively the ambulatory glucose profile (AGP) in such patients after switching from Free Style Libre 1 (FSL1) to Dexcom G4 (DG4) biosensors over 1 year. Patients (n = 21, 43 ± 15 years, BMI 25 ± 5, HbA1c 8.1 ± 1.0%) had severe hypoglycemia and/or HbA1c ≥ 8%. AGP metrics (time-in-range (TIR) 70–180 mg/dL, time-below-range (TBR) <70 mg/dL or <54 mg/dL, glucose coefficient of variation (%CV), time-above-range (TAR) >180 mg/dL or >250 mg/dL, glucose management indicator (GMI), average glucose) were collected the last 3 months of FSL1 use (M0) and of DG4 for 3, 6 (M6) and 12 (M12) months of use. Values were means ± standard deviation or medians [Q1;Q3]. At M12 versus M0, the higher TIR (50 ± 17 vs. 45 ± 16, p = 0.036), and lower TBR < 70 mg/dL (2.5 [1.6;5.5] vs. 7.0 [4.5;12.5], p = 0.0007), TBR < 54 mg/dL (0.7 [0.4;0.8] vs. 2.3 [0.8;7.0], p = 0.007) and %CV (39 ± 5 vs. 45 ± 8, p = 0.0009), evidenced a long-term effectiveness of the switch. Compared to M6, TBR < 70 mg/dL decreased, %CV remained stable, while the improvement on hyperglycemia exposure decreased (higher GMI, TAR and average glucose). This switch was a relevant therapeutic option, though a loss of benefit on hyperglycemia stressed the need for optimized management of threshold alarms. Nevertheless, few patients attained the recommended values for AGP metrics, and the reasons why some patients are "responders" vs. "non-responders" warrant to be investigated. [ABSTRACT FROM AUTHOR]