Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial.

BACKGROUND: Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring of blood glucose (SMBG). However, this technology's use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting. METHODS: This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c ≥ 7.5% (n = 350) will be randomised (1:1) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia. DISCUSSION: The trial will assess the effect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefits in improving diabetes management and providing evidence for funding of CGM in this population. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021.

Reduced Rate of Hospitalizations for Acute Diabetes Events Before and After FreeStyle Libre® System Initiation in Some People With Type 2 Diabetes on Insulin-Secretagogue Oral Drug Therapy Without Insulin in France.

Objective: Glycemic management in people with type 2 diabetes mellitus (T2DM) on insulin-secretagogue regimens without insulin is of importance, as this group still represents a significant proportion of patients. Risks for acute diabetes events (ADEs), including diabetic ketoacidosis (DKA) or hypoglycemia, using insulin-secretagogue drugs are well established. Few studies have suggested that continuous glucose monitoring (CGM) could be useful for monitoring glucose dynamics associated with the use of such therapies. To document this point an exploratory analysis was conducted in a group of individuals with noninsulin treated T2DM in France who are managed with oral insulin-secretagogues and initiating the FreeStyle Libre® system (FSL). Methods: A retrospective study of the French national SNDS reimbursement claims database (≈66 million French people) was conducted to identify people with T2DM on oral insulin-secretagogues and receiving a first reimbursement of FSL between August 1, 2017 and December 31, 2018. The analysis included data for the 12 months before and up to 24 months after FSL initiation. Hospitalizations for diabetes-related acute events were identified using ICD-10 codes as main or related diagnosis, for: hypoglycemic events; DKA events; comas; and hyperglycemia-related admissions. Results: A total of 1272 people with T2DM on insulin-secretagogues without insulin initiated FSL during the selection period. Of these, 7.15% had at least one hospitalization for any ADE in the year before FSL initiation, compared with 2.52% at 12 months and 2.83% at 24 months following FSL initiation. Reductions in ADEs were driven by -73% fewer admissions for ADEs related to diabetic ketoacidosis (DKA) or other hyperglycemia-related events. These patterns of reduced ADEs persisted after 2 years. Conclusions: This study suggests the value of the FSL system in reducing ADEs in some people with T2DM in France being treated with insulin-secretagogues without insulin. Characteristics of these patients remain to be documented.

The use of FreeStyle libre improves glycaemic control along with reducing diabetes burden and hospital admissions in a socially deprived Northwest English population.

Aim: This retrospective study aimed to use mixed (qualitative and quantitative) methods to evaluate the role of FSL in reducing hospital admissions due to all causes, HbA1c, and reported hypoglycaemic episodes in people with diabetes living in a socially deprived region of Northwest England. Methods: Data were collected retrospectively from previous consultations, which coincided with the 6th -week, 6th -month and annual review including blood tests, hospital admissions due to any cause and reported hypoglycaemia. Also, FSL assessment and satisfaction semi-structured questionnaire was done to assess the impact of FSL on diabetes management and quality of life. Mixed-effects models were used to assess glycaemic control and reductions in hospital admissions and reported hypoglycaemic episodes. Results: Just 127 patients met the inclusion criteria. A multivariate linear mixed model method that analyses HbA1c data longitudinally revealed mean differences (mmol/mol) between baseline and post-FSL measurements, estimated by restricted maximum likelihood method (REML) of 9.64 (six weeks), 7.68 (six months) and 7.58 (annual review); all with a corresponding p-value of < 0.0001. For DKA patients, the bootstrap method revealed a significant reduction in mean HbA1c of 25.5, 95% confidence interval (CI) [8.8, 42.6] mmol/mol. It is demonstrated that FSL use for one year resulted in 59% reduction in hospital admissions and 46% reduction in reported hypoglycaemic episodes. Conclusion: The use of FSL resulted in statistically significant reductions in hospital admissions, HbA1c and reported hypoglycaemic episodes among diabetics in a socially deprived Northwest region of England. These outcomes show a direct association with a higher questionnaire score. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01424-4.

A dose titration protocol for once-daily insulin glargine 300 U/mL for the treatment of diabetes mellitus in dogs.

BACKGROUND: In purpose-bred dogs, insulin glargine 300 U/mL (IGla300) has long duration of action, peakless time-action profile, and low potency, making it suitable for use as a basal insulin. HYPOTHESIS: To evaluate IGla300 in client-owned diabetic dogs monitored using a flash glucose monitoring system (FGMS). ANIMALS: Ninety-five client-owned diabetic dogs, newly diagnosed or previously treated with other insulin formulations, with or without concurrent diseases. METHODS: Prospective multi-institutional study. Clinical signs and standardized assessment of FGMS data, using treatment and monitoring guidelines established a priori, guided dose adjustments and categorization into levels of glycemic control. RESULTS: The initial IGla300 dose was 0.5 U/Kg q24h for newly diagnosed dogs and (median dose [range]) 0.8 U/Kg (0.2-2.5) q24h for all dogs. Glycemic control was classified as good or excellent in 87/95 (92%) dogs. The IGla300 was administered q24h (1.9 U/kg [0.2-5.2]) and q12h (1.9 U/kg/day [0.6-5.0]) in 56/95 (59%) and 39/95 (41%) dogs, respectively. Meal-time bolus injections were added in 5 dogs (0.5 U/kg/injection [0.3-1.0]). Clinical hypoglycemia occurred in 6/95 (6%) dogs. Dogs without concurrent diseases were more likely to receive IGla300 q24h than dogs with concurrent diseases (72% vs 50%, respectively; P = .04). CONCLUSIONS AND CLINICAL IMPORTANCE: Insulin glargine 300 U/mL can be considered a suitable therapeutic option for once-daily administration in diabetic dogs. Clinicians should be aware of the low potency and wide dose range of IGla300. In some dogs, twice-daily administration with or without meal-time bolus injections may be necessary to achieve glycemic control. Monitoring with FGMS is essential for dose titration of IGla300.

Continuous glucose monitoring with FreeStyle Libre PRO sensor in patients with type 2 diabetes and end-stage renal failure on haemoDIALysis (FSLPRO-DIAL pilot study).

AIMS: For end-stage renal disease (ESRD) patients with diabetes on haemodialysis, diabetes control is difficult to achieve. Hypoglycaemia is a major problem in these frailty subjects. Continuous glucose monitoring (CGM) devices appear therefore to be a good tool to help patients monitor their glycaemic control and to help practitioners optimize treatment. We aimed to compare the laboratory value of Hba1c with the sensor-estimated value of Hba1c (= glucose management indicator, GMI) in ESRD patients with type 2 diabetes (T2D) (with or without insulin treatment) on haemodialysis. Secondly, we aimed to identify CGM-derived monitoring parameters [time in range, time in hypo/hyperglycaemia, glycaemic variability (coefficient of variation, CV)] to identify patients at risk of frequent hypo- or hyperglycaemia. METHODS: The FSLPRO-DIAL pilot study (NCT04641650) was a prospective monocentric cohort study including 29 subjects with T2D who achieve the protocol. Inclusion criteria were: age ≥ 18 years, haemodialysis duration for at least 3 months, type 2 diabetes with no change in treatment for at least 3 months. Demographic data and blood sample were collected at the day of inclusion. Freestyle Libre pro IQ sensor (blinded CGM) was inserted for 14 days. After this period, all CGMs data were collected and analysed. RESULTS: Data were available for 27 patients. Mean age was 73 ± 10, mean BMI 27.2 kg/m2, mean duration of diabetes 16.9 years and mean dialysis duration 2.9 years. Twenty-four subjects were treated with insulin. Mean HbA1c was 6.6% (SD 1.2), and mean GMI was 6.7% (SD 0.9) (no significant difference, p = 0.3). Twelve subjects (44.4%) had a discordance between HbA1c and GMI of < 0.5%, 11 (40.8%) had a discordance between 0.5 and 1%, and only 4 (14.8%) had a discordance of > 1%. Mean time in range (70-180 mg/dl) was 71.9%, mean time below range (< 70 mg/dl) was 5.6%, and mean time above range (> 180 mg/dl) was 22.1%. Mean CV was 31.8%. For 13 out of 27 patients, we reduced antidiabetic treatment by stopping treatments or reducing insulin doses. CONCLUSION: In this pilot study, there was no global significant difference between HbA1c and GMI in this particular cohort with very well-controlled diabetes. However, the use of the sensor enabled us to identify an excessive time in hypoglycemia in this fragile population and to adapt their treatment.

Cross-sectional association of continuous glucose monitoring-derived metrics with cerebral small vessel disease in older adults with type 2 diabetes.

AIM: To examine cross-sectional associations between continuous glucose monitoring (CGM)-derived metrics and cerebral small vessel disease (SVD) in older adults with type 2 diabetes. MATERIALS AND METHODS: In total, 80 patients with type 2 diabetes aged ≥70 years were analysed. Participants underwent CGM for 14 days. From the CGM data, we derived mean sensor glucose, percentage glucose coefficient of variation, mean amplitude of glucose excursion, time in range (TIR, 70-180 mg/dl), time above range (TAR) and time below range metrics, glycaemia risk index and high/low blood glucose index. The presence of cerebral SVD, including lacunes, microbleeds, enlarged perivascular spaces and white matter hyperintensities, was assessed, and the total number of these findings comprised the total cerebral SVD score (0-4). Ordinal logistic regression analyses were performed to examine the association of CGM-derived metrics with the total SVD score. RESULTS: The median SVD score was 1 (interquartile range 0-2). Higher hyperglycaemic metrics, including mean sensor glucose, TAR >180 mg/dl, TAR >250 mg/dl, and high blood glucose index and glycaemia risk index, were associated with a higher total SVD score. In contrast, a higher TIR (per 10% increase) was associated with a lower total SVD score (odds ratio 0.73, 95% confidence interval 0.56-0.95). Glycated haemoglobin, percentage glucose coefficient of variation, mean amplitude of glucose excursions, time below range and low blood glucose index were not associated with total cerebral SVD scores. CONCLUSIONS: The hyperglycaemia metrics and TIR, derived from CGM, were associated with cerebral SVD in older adults with type 2 diabetes.

Glycemic Control in Patients with Type 1 Diabetes: Comparison of Holidaysversus Schooldays.

BACKGROUND AND AIMS: To examine the influence of school life in children and adolescents with type 1 diabetes (T1D) by comparing the glycemic control and Ambulatory Glucose Profile (AGP) between the holidays and schooldays. METHODS: This is a retrospective study conducted on 147 patients with T1D (14-19 years) who used an intermittently scanned Continuous Glucose Monitoring (isCGM) system to self-test their glucose levels during the periods of school time and holiday time. A record was maintained of the Continuous Glucose Monitoring (CGM) metrics i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time above Range (TAR), Time below Range (TBR), and average time period of the hypoglycemic events during schooldays and the holidays. RESULTS: The study revealed differences between the recorded values during the holidays and schooldays, in % in target 70-180 mg/dL (38.2 vs. 49.5; p = 0.039), mean glucose (194 vs. 185; p = 0.048), frequency of low glucose events (9.2 vs. 5.1; p = 0.036), mean duration of low glucose levels (117 vs. 65; p = 0.021), % TBR below 70 mg/dL (2.9 vs. 1.45; p = 0.023), % TBR below 54 mg/dL (1.1 vs. 0.51; p = 0.031), TAR 181-250 mg/dL (21.1 vs. 16.5; p = 0.037) and TAR >250 mg/dL (8.9 vs. 6.5; p = 0.043). On comparing the HbA1c levels of the study population recorded during the holidays (8.34%) with those recorded during the schooldays (8.13%), the HbA1c values during the school days were observed to be lower; however, no significant changes were noted in the HbA1c level between the holidays and schooldays. Concerning the FreeStyle Libre (FSL) scanning, the frequency during the holidays (n = 6.2) was significantly lower than during the schooldays (n = 9.5) (p = 0.042). CONCLUSION: From the findings, it appears that children with T1D have good diabetes control during schooldays rather than during the holidays. To improve their glucose control during the holidays, these patients may also benefit from receiving greater attention and guidance.

Proposed treatment strategy for reactive hypoglycaemia.

Background/aim: Managing reactive hypoglycaemia (RH) poses challenges due to limited and often ineffective treatment options. We report a case series and draw on this to propose a stepwise treatment approach consisting of lifestyle modifications, metformin, GLP-1 analogues, and the use of flash glucose monitoring technology. Method: A retrospective review was conducted to analyse the management of 11 cases presenting with recurrent RH symptoms. Result: Two patients experienced successful resolution of symptoms through lifestyle modifications. Metformin alone was effective in treating seven out of nine patients who received pharmacological treatment. Two patients with previous upper gastrointestinal surgery showed a partial response to metformin and benefited further from additional long-acting GLP-1 analogue. Pharmacological intervention led to significant reductions in insulin and C-peptide levels in repeat mixed meal tolerance tests (P-values 0.043 for insulin and 0.006 for C-peptide). Finally, flash glucose monitoring technology was useful in early detection and preventing episodes of hypoglycaemia in one of these patients with persistent symptoms. Conclusion: These findings highlight the potential efficacy of escalated treatment strategies for RH, including the use of metformin, GLP-1 analogues, and flash glucose monitoring technology.

Real-world glycaemic outcomes in patients with type 1 diabetes using glucose sensors-Experience from a single centre in Dublin.

AIMS: To evaluate changes in glycated haemoglobin (HbA1 c) and sensor-based glycaemic metrics after glucose sensor commencement in adults with T1D. METHODS: We performed a retrospective observational single-centre study on HbA1 c, and sensor-based glycaemic data following the initiation of continuous glucose monitoring (CGM) in adults with T1D (n = 209). RESULTS: We observed an overall improvement in HbA1 c from 66 (59-78) mmol/mol [8.2 (7.5-9.3)%] pre-sensor to 60 (53-71) mmol/mol [7.6 (7.0-8.6)%] on-sensor (p < .001). The pre-sensor HbA1 c improved from 66 (57-74) mmol/mol [8.2 (7.4-8.9)%] to 62 (54-71) mmol/mol [7.8 (7.1-8.7)%] within the first year of usage to 60 (53-69) mmol/mol [7.6 (7.0-8.4)%] in the following year (n = 121, p < .001). RT-CGM-user had a significant improvement in HbA1 c (Dexcom G6; p < .001, r = 0.33 and Guardian 3; p < .001, r = 0.59) while a non-significant reduction was seen in FGM-user (Libre 1; p = .279). Both MDI (p < .001, r = 0.33) and CSII group (p < .001, r = 0.41) also demonstrated significant HbA1 c improvement. Patients with pre-sensor HbA1 c of ≥64 mmol/mol [8.0%] (n = 125), had attenuation of pre-sensor HbA1 c from 75 (68-83) mmol/mol [9.0 (8.4-9.7)%] to 67 (59-75) mmol/mol [8.2 (7.6-9.0)%] (p < .001, r = 0.44). Altogether, 25.8% of patients achieved the recommended HbA1 c goal of ≤53 mmol/mol and 16.7% attained the recommended ≥70% time in range (3.9-10.0 mmol/L). CONCLUSIONS: Our study demonstrated that minimally invasive glucose sensor technology in adults with T1D is associated with improvement in glycaemic outcomes. However, despite significant improvements in HbA1 c, achieving the recommended goals for all glycaemic metrics remained challenging.

Flash Glucose Monitoring in Croatia: The Optimal Number of Scans per Day to Achieve Good Glycemic Control in Type 1 Diabetes.

Background and Objectives: The purpose of this study is to determine the optimal number of scans per day required for attaining good glycemic regulation. Materials and Methods: The association of scanning frequency and glucometrics was analyzed according to bins of scanning frequency and bins of time in range (TIR) in the Croatian population of type 1 diabetes (T1DM) patients. Results: Intermittently scanned continuous glucose monitoring (isCGM) Libre users in Croatia performed on average 13 ± 7.4 scans per day. According to bins of scanning frequency, bin 5 with 11.2 ± 02 daily scans was sufficient for achieving meaningful improvements in glycemic regulation, while decreasing severe hypoglycemia required an increasing number of scans up to bin 10 (31 ± 0.9), yet with no effect on TIR improvement. When data were analyzed according to bins of TIR, an average of 16.3 ± 10.5 scans daily was associated with a TIR of 94.09 ± 3.49% and a coefficient of variation (CV) of 22.97 ± 4.94%. Improvement was shown between each successive bin of TIR but, of notice, the number of scans performed per day was 16.3 ± 10.5 according to TIR-based analysis and 31.9 ± 13.5 in bin 10 according to scan frequency analysis. Conclusions: In conclusion, an optimal average number of scans per day is 16.3 in order to achieve glucose stability and to minimize the burden associated with over-scanning.

Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial.

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).

Recovery of hypoglycemic confidence using intermittently scanned continuous glucose monitoring among adults with type 1 diabetes with level 3 hypoglycemia: A prospective, single-center, single-arm study.

AIM: 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. MATERIALS AND 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. CONCLUSION: 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.

Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes

BACKGROUND AND AIMS: This study aims to assess patient-reported satisfaction and metabolic outcomes following the initiation of the second generation of the Freestyle Libre 2 (FSL2) system in patients with type 1 diabetes (T1D). METHODS: This non-randomized single-arm observation study was conducted on 86 patients with T1D living in Saudi Arabia, who were asked to wear the FSL2 for 12 weeks. The demographic data were collected at baseline, while the 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 were collected at baseline, 6th week and 12 weeks. Further, the Continuous Glucose Monitoring Satisfaction (CGM-SAT) was collected at the end of the follow-up RESULTS: Compared to the 6th week, significant differences were observed in the low glucose events (p = 0.037), % TIR (p = 0.045), and % below 70 mg/dL (p = 0.047) at 12 weeks. Improvement was seen in the other glucometric variables, but no significant changes were evident (p > 0.05). On completion of the study period, the ambulatory glucose profile (AGP) metrics showed a 74.3 ± 5.01 (mg/dL) FSL2 hypoglycemia alarm threshold and a 213 ± 38.1 (mg/dL) hyperglycemia alarm threshold. A majority of the patients stated that CGM-SAT had benefits (mean score > 3.58), although they felt FSL2 had 'additional benefits. With regard to the problems with the use of FSL2 majority of the patients stated that FSL2 has minimal discomfort. CONCLUSION: Using second-generation FSL2 in patients with T1D is positively associated with patient-reported satisfaction and metabolic outcomes.

Assessment of the FreeStyle Libre 2 interstitial glucose monitor in hypo- and euglycemic cats.

BACKGROUND: Continuous glucose monitoring systems have been validated for eu- and hyperglycemic cats. The FreeStyle Libre 2 (FSL2) is sufficiently accurate in people during hypoglycemia to guide critical treatment decisions without confirmation of blood glucose concentration (BG). OBJECTIVES: Assess FSL2 accuracy in cats with hypoglycemia. ANIMALS: Nine healthy, purpose-bred cats. METHODS: Hyperinsulinemic-hypoglycemic clamps were performed by IV infusion of regular insulin (constant rate) and glucose (variable rate). Interstitial glucose concentration (IG), measured by FSL2, was compared to BG measured by AlphaTrak2. Data were analyzed for all paired measurements (n = 364) and separately during stable BG (≤1 mg/dL/min change over 10 minutes). Pearson's r test, Bland-Altman test, and Parkes Error Grid analysis respectively were used to determine correlation, bias, and clinical accuracy (P < .05 considered significant). RESULTS: Overall, BG and IG correlated strongly (r = 0.83, P < .0001) in stable glycemia and moderately at all rates of change (r = 0.69, P < .0001). Interstitial glucose concentration underestimated BG in euglycemia, but the BG-IG difference was progressively smaller as BG decreased (12.9 ± 12.2, 8.8 ± 11.2, -3.2 ± 7.4, and -7.8 ± 5.2 mg/dL in the ranges of 80-120 [n = 64], 60-79 [n = 29], 50-59 [n = 71], and 29-49 mg/dL [n = 53], respectively). CONCLUSIONS: Although IG underestimates BG throughout most of the hypo-euglycemic range, IG generally overestimates BG in marked hypoglycemia (<60 mg/dL). It is therefore imperative to evaluate FSL2 results in this critical range with caution.

Real-life 24-week changes in glycemic parameters among European users of flash glucose monitoring with type 1 and 2 diabetes and different levels of glycemic control.

AIM: To evaluate real-life changes of glycemic parameters among flash glucose monitoring (FLASH) users who do not meet glycemic targets. METHODS: 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%). RESULTS: 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). CONCLUSIONS: 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.

Safety and Accuracy of Professional Continuous Glucose Monitoring in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.

Hyperglycemia in the early days following allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a well-known risk factor for acute graft-versus-host disease (GVHD) and non-relapse mortality. The FreeStyle Libre Pro, a factory calibrated continuous glucose monitoring (CGM) device, has been used for the retrospective analysis of glucose testing in patients with diabetes. We assessed the safety and accuracy of the device in patients undergoing allo-HSCT. We recruited eight patients who underwent allo-HSCT between August 2017 and March 2020. They wore the FreeStyle Libre Pro on the day before or on the day of transplantation until 28 days after transplantation. Adverse events, especially bleeding and infection, were monitored to assess safety, and blood glucose levels were measured and compared with the device values. None of the eight participants experienced bleeding that was difficult to stop from the sensor site or local infection that required antimicrobial administration. The device value was well correlated with blood glucose (correlation coefficient r=0.795, P<0.01); however, the overall mean absolute relative difference was 32.1%±16.0%. Our study demonstrated the safety of FreeStyle Libre Pro in allo-HSCT patients. However, the sensor results tended to be lower than the blood glucose levels.

Flash glucose monitoring system in patients with type 1 diabetes in healthcare center in Brazil: real world data from a short-term prospective study

ABSTRACT Objectives: To evaluate the alternate use of flash glucose monitoring (FGM) with self-monitoring blood glucose (SMBG), in patients with type 1 diabetes (T1D). Materials and methods: 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. Results: 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. Conclusion: 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.

Comparing Glucose Outcomes Following Face-to-Face and Remote Initiation of Flash Glucose Monitoring in People Living With Diabetes.

BACKGROUND: When launched, FreeStyle Libre (FSL; a flash glucose monitor) onboarding was mainly conducted face-to-face. The COVID-19 pandemic accelerated a change to online starts with patients directed to online videos such as Diabetes Technology Network UK for education. We conducted an audit to evaluate glycemic outcomes in people who were onboarded face-to-face versus those who were onboarded remotely and to determine the impact of ethnicity and deprivation on those outcomes. METHODS: People living with diabetes who started using FSL between January 2019 and April 2022, had their mode of onboarding recorded and had at least 90 days of data in LibreView with >70% data completion were included in the audit. Glucose metrics (percent time in ranges) and engagement statistics (previous 90-day averages) were obtained from LibreView. Differences between glucose variables and onboarding methods were compared using linear models, adjusting for ethnicity, deprivation, sex, age, percent active (where appropriate), and duration of FSL use. RESULTS: In total, 935 participants (face-to-face 44% [n = 413]; online 56% [n = 522]) were included. There were no significant differences in glycemic or engagement indices between onboarding methods and ethnicities, but the most deprived quintile had significantly lower percent active time (b = -9.20, P = .002) than the least deprived quintile. CONCLUSIONS: Online videos as an onboarding method can be used without significant differences in glucose and engagement metrics. The most deprived group within the audit population had lower engagement metrics, but this did not translate into differences in glucose metrics.

Early Retinal Microvascular Changes Assessed with Swept-Source OCT Angiography in Type 1 Diabetes Patients without Retinopathy.

Type 1 diabetes is a chronic disease that can lead to vision loss when diabetic retinopathy develops. Retinal microvascular alterations occur before the appearance of clinical signs on a fundus examination. This study aimed to analyze retinal vascular parameters on optical coherence tomography angiography (OCT-A) in patients with type 1 diabetes without diabetic retinopathy in comparison with non-diabetic volunteers. This cross-sectional study was conducted at Dijon University Hospital from 2018 to 2020. Vascular densities were measured using macular OCT-A. In total, 98 diabetes patients and 71 non-diabetic volunteers were enrolled. A statistically significant lower vascular density of the inner circle was found in the superficial capillary plexus (SCP) in the diabetes group (p < 0.01). There was a statistically significant correlation between central vascular density in the deep capillary plexus (DCP) and total daily insulin intake (p = 0.042); furthermore, use of the FreeStyle Libre (FSL) device was associated with higher vascular densities in both the SCP (p = 0.034 for outer circle density) and DCP (p < 0.01 for inner circle density and p = 0.023 for outer circle density). Retinal microvascularization was early-altered in type 1 diabetes, and using the FSL device seemed to preserve retinal microvascularization.