FreeStyle Libre Research Articles

The Interplay between Dietary Habits and Glycemic Control in Type 1 Diabetes: A Comprehensive Prospective FGM Study.

Type 1 diabetes has become prevalent among the adult population, who have increasingly gained access to sensing technology. This study delved into the impact of diet, nutritional status, and the use of a continuous glucose monitoring system (CGM) on glycemic regulation among adults diagnosed with T1D. Employing a prospective design, data were gathered from 151 participants aged 18-60 across multiple cycles. Participants utilized the FreeStyle Libre (FSL) Flash Glucose Monitoring (FGM) System and provided dietary details via questionnaires and diaries. The findings unveiled correlations between dietary patterns and glycemic control, with higher protein intake associated with improved glycated hemoglobin A1C values (p = 0.019), yet elevated fat and protein consumption was linked to heightened rates of hyperglycemia. Conversely, no significant relationship was observed between dietary variables and hypoglycemia occurrence. Interestingly, subjects with more readings of glucose levels consumed fewer carbohydrates (p = 0.004) and more proteins (p = 0.000). Furthermore, physical activity and marital status correlated with glycemic stability, while higher education was associated with enhanced glycemic control (p = 0.021). This study confirmed the importance of structured education on glycemic regulation and the importance of dietary patterns in glucose management. Also, the educational role of the FGM system in changing dietary habits was confirmed, which is one of the key factors for improving glycemic regulation in continuous glucose monitoring system users.

Glycemic metrics in Japanese isCGM users - Analysis by diabetes type and therapy.

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. 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. 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%). 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.

Association of Changes in A1C Following Continuous Glucose Monitoring Acquisition in People with Sub-Optimally Treated Type 2 Diabetes Taking GLP-1 RA Therapy.

Both glucagon-like peptide-1 receptor agonists (GLP-1 RA) and continuous glucose monitoring (CGM) improve glycemia in patients with type 2 diabetes (T2D). However, it is unknown whether adding CGM to GLP-1 RA therapy further improves A1c. We evaluated changes in A1c levels 6months after initiation of FreeStyle Libre (FSL) in adults with sub-optimally controlled T2D already on GLP-1 RA therapy. This retrospective, observational study used Optum's de-identified Market Clarity Data, a linked electronic health record-claims database to assess changes in A1c after FSL acquisition. Inclusion criteria were T2D diagnosis, ≥ 18years, baseline A1c ≥ 8%, with the first FSL acquisition between 2018 and 2022. Patients were required to be on GLP-1 RA prior to FSL with at least one GLP-1 RA prescription within 90days of FSL acquisition. GLP-1 RA initiation was defined as the earliest GLP-1 RA prescription from 2017 onwards. Paired changes in A1c were assessed at 6months after initial FSL acquisition. The study cohort included 1454 adults with T2D (age 55 ± 10years, 52% male, 38% with intensive insulin therapy, median 471days from GLP-1 RA initiation to FSL, and baseline A1c 9.8 ± 1.5%). After FSL acquisition, patients experienced an A1c decrease of 1.5 ± 1.9% (p < 0.001). Patients with a baseline A1c > 10% had the largest reduction (n = 497, - 2.7 ± 2.2%, p < 0.001). Significant improvements were observed in subgroups based on insulin therapy and GLP-1 RA formulation. Those initiating GLP-1 RA therapy > 24months before FSL acquisition also showed improvements in A1c (n = 478; - 1.3 ± 1.7%, p < 0.001). In a large, real-world study of adults with T2D, those on prior GLP-1 RA therapy experienced significant A1c improvements after acquiring FSL, irrespective of GLP-1 RA duration, GLP-1 RA formulation, or insulin therapy type. These findings support the use of FSL in adults with T2D treated with GLP-1 RA.

Accuracy and Functionality of Select Continuous Glucose Monitoring Systems Are Not Impacted by Implantable Cardioverter Defibrillator Devices.

Increasing numbers of individuals with diabetes are adopting use of continuous glucose monitoring (CGM) in their daily self-management. Many of these individuals have advanced heart disease. Implantable cardioverter defibrillator (ICD) devices can effectively reduce arrhythmic death and all-cause mortality in individuals with advanced heart disease. However, the potential impact of ICD devices on CGM system accuracy and functionality has not been well studied. This evaluation assessed whether FreeStyle Libre (FL) CGM systems can coexist and function within the same patient in the presence of wireless interference devices, including current ICD devices. Interferer sources included Wi-Fi devices, Bluetooth devices, cellular mobile devices, implantable medical devices, Bluetooth Low-Energy (BLE) devices, BLE accessory devices and BLE mobile devices, and ICD-programmer interferers. Five testing methodologies were used to evaluate the accuracy and functionality of the CGM systems when exposed to ICD functions: high-energy emergency shocking, pacing modes, anti-tachycardia pacing mode (ATP), and DC Fibber mode. All acceptance criteria and testing requirements were met for the CGM and ICD system for wireless coexistence evaluation. Our findings demonstrated that coexisting ICD devices and FL CGM systems provide safe and effective wireless communications with functional and accurate transfer of data during scenarios expected in clinical use.

Continuous glucose monitoring (CGM) for 308 older-age participants in an English birth cohort: variability and correlates

Introduction &amp; BackgroundEpochs of hyperglycaemia and hypoglycaemia may each increase risk of common chronic diseases and impair both cognitive and physical function even in people without diabetes. Older people may have greater frequency of adverse glycaemic excursions, partly due to disordered autonomic function and sleep quality. Data for older, non-diabetic people are however scant. Objectives &amp; Approach1) To describe blood glucose variability (completed) and 2) its socio-demographic and lifestyle correlates in a predominantly non-diabetic cohort of older adults (planned). Participants were recruited during 2021-2023 from an English birth cohort (the 1946 National Survey for Health and Development Study). They wore a continuous glucose monitor (Freestyle libre Abbott), which measured circulating glucose four times/hour, for seven days. Summary statistics and time outside range (4.4-7.8mmol/L) were calculated. Further information on glycaemic excursions and day-to-day variability will be gleaned using the R “iglu” package. For all CGM summary and excursion measures, future analyses will investigate: associations with HbA1c, socio-demographics, body composition, physical activity, diet and alcohol use. Results will be stratified by sleep/ wake time periods estimated from simultaneous actigraphy (Philips Actiwatch Spectrum Plus). Sensitivity analyses will exclude people taking hypo/ hyperglycaemic medications and those with diabetes. Relevance to Digital FootprintsDerived summary measures can be used by future studies to give insights into glycaemic variability as a population-level risk factor. This work will bring together multiple data sources, i.e. from CGM, actigraphy and baseline cohort data. ResultsParticipants were aged 75-76 years, 45% female and 10% had diagnosed diabetes; median (IQR) BMI was 26.8 (24.6-29.2) kg/m2. CGM data from 308 participants was collected, for a median (IQR) of 6.9 (6.7-7.6) days. Average glucose over the recording period was 5.7mmol/L (5.3-6.2mmol/L), standard deviation was 1.0mmol/L (0.8-1.3mmol/L), time outside range was 12.8% (6.2-24.7%) and 16% of participants spent ≥1 hour/day above and ≥1 hour/day below range. Conclusions &amp; ImplicationsCGM was feasible for this cohort of older adults, and demonstrated high levels of time outside range for a predominantly non-diabetic group. Future analysis will determine whether enhanced characterisation of glycaemic variability is a potentially more accurate tool for predicting future disease risk than isolated glucose measurements.

Assessing satisfaction, quality of life, and HbA1c changes in type 1 diabetes patients who are using freestyle libre glucose monitoring

ABSTRACT Introduction: Type 1 diabetes mellitus (T1DM) is a chronic auto-immune disease in which loss of pancreatic islet β-cells leads to the deficiency of insulin in the body thus resulting in enhanced blood sugar levels. Effective blood glucose monitoring is crucial in T1DM management to prevent complications, particularly hypoglycemia. Method: The study adopted a cross-sectional survey to assess satisfaction and quality of life among T1DM patients using the freestyle libre continuous glucose monitoring (FSL-CGM), and a retrospective cohort study design to evaluate changes in HbA1c over a year. Result: The study involved 98 Saudi subjects, with 46.9% (n = 46) being male. The results indicated a high level of user satisfaction, with more than 85% of the participants responding positively, yielding a total satisfaction score of 30.86. User satisfaction with FSL-CGM was found to be significantly associated with the level of education. The use of FSL-CGM was also found to significantly improve the patients’ quality of life. However, the levels of HbA1c had an impact on both satisfaction and quality of life. Before using the FSL-CGM system, the mean HbA1c was 9.83%, which significantly decreased to 8.63% after using the system (P-value &lt;0.001). Conclusion: The study’s findings align with previous literature on satisfaction and quality of life, but there are conflicting results regarding the reduction of HbA1c levels using FSL-CGM. Given the limited sample size, future research could explore the topic more comprehensively, potentially utilizing a longitudinal study design to better measure changes in HbA1c level.

#2103 Accuracy of a continuous glucose monitor in people with diabetes on peritoneal dialysis

Abstract Background and Aims Globally 40% of people receiving peritoneal dialysis (PD) have a diagnosis of diabetes. Good glycaemic control can by complicated by the obligate glucose load associated with PD. Monitoring and treatment of people with diabetes (PwD) on PD has been limited by reduced reliability of traditional markers of glycaemia such as HbA1c in end-stage kidney disease. Continuous glucose monitors (CGMs) have been increasingly used in the care of PwD over the last 20 years. Monitors worn on the upper arm or abdomen measure glucose in interstitial fluid at regular intervals over the 24 hour period. CGMs are currently unlicensed in PD populations as they have not been tested in large scale studies. Concerns remain around accuracy in the presence of potentially interfering substances generated by the breakdown of osmotic agents used in PD fluid (e.g. Icodextrin). We aimed to assess the analytical and clinical accuracy of the FreeStyle Libre(FSL) CGM system in PwD on maintenance PD. Method We conducted a single centre observational study of 10 PwD who had been on PD for at least 3 months. For the 10 day study period participants wore a blinded research model FSL monitor which measured interstitial glucose levels every 15 minutes. Results from the FSL were compared with; Analytical accuracy was assessed using three methods; Clinical accuracy was assessed using the Parkes consensus error grid to assign each pair of readings to one of five risk zones and quantify the clinical implications of any difference between the two measurements. The International Organisation for Standardisation guidelines stipulates 99% of pairs should be in zones A and B, denoting little or no effect on clinical actions. Results Of 11 recruited participants, 10 completed the 10 day study period resulting in 76 paired CGM-YSI measurements and 375 paired CGM-CBG measurements. 7 participants were on APD and 3 on CAPD. All participants were prescribed a PD regime that included one daily dwell with Icodextrin. The aggregate MARD was 9.4% (95% CI 7.9, 10.4) for CGM-YSI matched pairs and 17.6% (95% CI 17, 19.3) for CGM-CBG matched pairs. Spearman's r was 0.94 (p &amp;lt; 0.0001) for CGM-YSI and 0.89 (p &amp;lt; 0.0001) for CGM-CBG. From Bland-Altman analysis, the systematic error of the CGM compared with YSI and CBG was −0.81 mmol/l (SD 0.81) and −1.6 mmol/l (SD 1.9) respectively. Parkes consensus error grid analysis showed that compared with YSI and CBG respectively, 100% and 99.9% of sensor values were in the clinically acceptable zones A and B (Fig. 1). Conclusion We have demonstrated satisfactory performance of the FSL monitoring system by both analytical and clinical metrics in this cohort of PD patients using treatment regimens including Icodextrin based fluids. CGMs provide much more information for the PwD and their clinical care team compared with random CBGs (which in themselves have been shown to exhibit significant between user variability) and time averaged markers such as HbA1c. They allow detection of asymptomatic hypoglycaemia and direct monitoring of the systemic effects of any change to the PD prescription resulting in a larger or smaller glucose load. These results should be reassuring for clinicians wishing to utilise the greater depth of information provided by CGMs to improve clinical care for their patients with diabetes on PD.

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

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. 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. 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. 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. The online version contains supplementary material available at 10.1007/s40200-024-01424-4.

Changes in glucometric parameters in people living with diabetes users of the free-style libre 2 system before and after the update possibility to real-time glucose readings in real world practice

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.

A concept for human use of real-time and remote monitoring of diabetic subjects using intermittent scanned continuous glucose measurement

BackgroundFlash glucose monitoring systems like the FreeStyle Libre (FSL) sensor have gained popularity for monitoring glucose levels in people with diabetes mellitus. This sensor can be paired with an off-label converted real-time continuous glucose monitor (c-rtCGM) plus an ad hoc computer/smartphone interface for remote real-time monitoring of diabetic subjects, allowing for trend analysis and alarm generation.ObjectivesThis work evaluates the accuracy and agreement between the FSL sensor and the developed c-rtCGM system. As real-time monitoring is the main feature, the system's connectivity was assessed at 5-min intervals during the trials.MethodsOne week of glucose data were collected from 16 type 1 diabetic rats using the FSL sensor and the c-rtCGM. Baseline blood samples were taken the first day before inducing type 1 diabetes with streptozotocin. Once confirmed diabetic rats, FSL and c-rtCGM, were implanted, and to improve data matching between the two monitoring devices, the c-rtCGM was calibrated to the FSL glucometer readings. A factorial design 2 × 3^3 and a second-order regression was used to find the base values of the linear model transformation of the raw data obtained from the sensor. Accuracy, agreement, and connectivity were assessed by median absolute relative difference (Median ARD), range averaging times, Parkes consensus error grid analysis (EGA), and Bland–Altman analysis with a non-parametric approach.ResultsCompared to the FSL sensor, the c-rtCGM had an overall Median ARD of 6.58%, with 93.06% of results in zone A when calibration was not carried out. When calibration frequency changed from every 50 h to 1 h, the overall Median ARD improved from 6.68% to 2.41%, respectively. The connectivity evaluation showed that 95% of data was successfully received every 5 min by the computer interface.Conclusions and clinical importanceThe results demonstrate the feasibility and reliability of real-time and remote subjects with diabetes monitoring using the developed c-rtCGM system. Performing calibrations relative to the FSL readings increases the accuracy of the data displayed at the interface.

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

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. 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. 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). 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.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study

ObjectivesThis study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.DesignProspective, multicentre...

HPB P01 Evaluating quality of life outcomes following Total Pancreatectomy and Islet Autotransplant for Chronic Pancreatitis

Abstract Background Chronic Pancreatitis (CP) is a debilitating condition that is associated with significant patient morbidity. The disease is characterised by chronic abdominal pain that is recurring and relapsing, which subsequently has a significant impact on the patients’ quality of life. In addition to the stigma associated with the disease, patients often undergo social isolation and are unable to maintain functional status. Total Pancreatectomy and Islet Auto transplant for Chronic Pancreatitis (TPIAT) serves as opportunity to alleviate the pain whilst preserving endocrine function. Our aim was to evaluate whether TPIAT also improved patients quality of life. Methods A retrospective review of all patients referred to the TPIAT service in Oxford between 2019 -2022 was performed. Clinical information was recorded regarding patient demographics, aetiology and previous treatment of CP, intraoperative data (islet yield secured) and post operative complication rate. Long term endocrine function, analgesic use and quality of life was formally assessed. Results Of the 39 patients referred to the service, 23 (59%) were listed for TPIAT. TPIAT was successfully performed in 21 patients. The median age of this cohort was 22. Hereditary pancreatitis was the most frequent aetiology in 48%. The median length of stay post procedure was 12.5 days. During the last follow up, freestyle libre interrogation highlighted that 79% of patients had blood sugars within the target range. A significant reduction in analgesia use was noted (p=0.001), in addition to a marked reduction in opiate based analgesics (p=0.001). Resolution of pancreatic pain was also significantly apparent in the cohort (p=0.001). Conclusions TPIAT for CP serves as an effective treatment strategy as it provides symptomatic relief for patients, reduces long term narcotic use, permits glycaemic control and improves quality of life for patients.

Intermittently scanned continuous glucose monitoring and hypoglycaemia awareness in drivers with diabetes: Insights from the Association of British Clinical Diabetologists Nationwide audit.

Frequent hypoglycaemia results in disruption to usual hypoglycaemic autonomic responses leading to impaired awareness of hypoglycaemia, which is associated with an increased risk of severe hypoglycaemia requiring third-party assistance (SH). The UK Driving and Vehicle Licensing Agency (DVLA) does not permit car driving if they have either a complete loss of hypoglycaemia awareness or more than one SH event a year. The FreeStyle Libre (FSL) Association of British Clinical Diabetologists (ABCD) Nationwide Audit consists of data collected by clinicians during routine clinical work, submitted into a secure web-based tool held within the National Health Service (NHS) N3 network. Analysis of paired baseline and follow-up data for people with type 1 diabetes who also held a driving licence was undertaken. The study consisted of 6304 people who had data recorded about driving status from 102 UK specialist diabetes centres, of which 4218 held a driving licence: 4178 a group 1, standard licence, 33 a group 2, large lorries and buses, seven a taxi licence; 1819 did not drive. Paired baseline and follow-up data were available for a sub-cohort of 1606/4218. At a mean follow-up of 6.9 months [95% CI (6.8, 7.1)], the Gold score had improved (2.3 ± 1.5 vs. 2.0 ± 1.3 p < .001), and the number of people who experienced an SH episode was also significantly lower (12.1% vs. 2.7%, p < .001). This study suggests that intermittently scanned continuous glucose monitoring may improve impaired awareness of hypoglycaemia and reduce the number of people with type 1 diabetes with a driving licence experiencing a severe hypoglycaemic episode.

1803-PUB: Effectiveness and Safety of the Insulin Degludec U100 vs. Glargine U300 in People with Type 1 diabetes—The IneoxPlus Real-World Study

Objective: The INEOX-Plus study aims to compare the efficacy and safety of Deg-U100 and Gla-U300 in people with T1d incorporated to the Flash Glucose Monitoring (FGM) technology for over 6 months. Materials and Methods: Cross-sectional study in 161 of the 260 T1D participants of the INEOX randomized study (NCT 03328845) who were initially randomized between 2017 and 2019 to receive Gla-U300 or Deg-U100 insulin and incorporated to FGM technology after. Participants were re-evaluated in the INEOX_Plus visit, at an average 2.8 years after the final INEOX visit. Sociodemographic variables, insulin dose, plasma HbA1c and episodes of severe hypoglycemia and ketosis in the previous year were collected together with data on Freestyle libre 2® system downloaded from the last 90 days: sensor use, number of daily scans, GMI, mean glucose, CV, TIR 70-180, TBR 69-54, TBR &amp;lt;54, TAR 181-250, TAR &amp;gt;250 and hypoglycemia events- number/90 days and rate/year-. Results: 90 men (56%) and 71 women (44%), mean age 44±11 years, with diabetes evolution of 23.5±10 years belonging to the INEOX study accepted to participate; 75 subjects (46%) used Gla-U300 and 86 (54%) Deg-U100. A significant reduction in HbA1c was observed between the final INEOX and INEOX-Plus visit (7.65±1.04% vs 7.43±0.84%, p= 0.002) regardless of the type and dose of second-generation long-acting insulin analogue used. There were no episodes of severe hypoglycemia or ketoacidosis reported. We did not find significant differences in insulin doses, HbA1c and FGM metrics except in the Hypoglycemia events incidence rate -213.65 vs 260.05 events/person/year; p=0.001 - for Gla-U300 vs Deg-U100 respectively. Conclusions: For people with T1D in routine clinical follow-up with FGM, Gla-U300 and Deg-U100 insulin have a similar effect on the efficacy and safety variables except for significantly lower incidence rate of yearly hypoglycemia events for Gla-U300 users. Disclosure M.S.Ruiz de adana: None. L.I.Navas vela: None. C.Maldonado-araque: None. G.Olveira: Other Relationship; Abbott Diabetes, Novo Nordisk, Speaker's Bureau; Lilly. G.Rojo martínez: None. M.E.Domínguez-lópez: None. M.Vallejo mora: None. N.Colomo: None. F.Linares: None. V.Morillas: Other Relationship; Boehringer Ingelheim and Eli Lilly Alliance. M.Vallejo herrera: None. S.Alonso gallardo: None. M.Padilla fuentes: None. Funding Instituto de Salud Carlos III (PI 17/00861)

1034-P: Access to Continuous Glucose Monitoring Systems in a Primary Care Clinic for Underserved Patients with Type 2 Diabetes—A Pilot Study

B-Disparities in diabetes care are well documented. Continuous Glucose Monitoring Systems (CGMs) have improved patient experience without the need for finger sticks and have been shown to effectively lower Hemoglobin A1c (HbA1c), decrease clinical inertia and decrease the number of hypoglycemic events. Medically underserved and historically marginalized persons are disproportionately affected by diabetes, yet limited data exist on use of CGMs in this population. M-We report a pilot initiative that brought CGM access (FreeStyle Libre 2) to a Federally Qualified Community Health Center (FQHC). Patients with type 2 diabetes and an HBA1c &amp;gt;8.0% were referred to be enrolled in CGM. Each patient had an initial nurse visit for device placement of FreeStyle Libre (FSL) and several follow up visits to review glycemic trends and make medication changes with a provider. Baseline HBA1c was collected and repeated at the end of the study. Provider and patient surveys were distributed at each visit. R-Fifty participants were enrolled in the CGM study and had FSL placed. The CGM active time was greater than 50% in 76% of participants and those who continued with CGM had an increase in active time. Initial mean A1C for the entire cohort was 9.64% and average glucose after 2 weeks was 195 mg/dl. Hypoglycemia, especially overnight, reduced overtime. The use of CGM data was associated with clinician-initiated medication changes. Provider surveys revealed an increase in likelihood of medication changes based on glycemic trends and patients reported better understanding of their disease process. C-This pilot study demonstrates the feasibility of utilizing diabetes technology (FreeStyle Libre 2) in underserved patients at a primary care clinic staffed with internal medicine residents, physicians, and nurse practitioners. CGM is beneficial in under resourced primary care outpatient settings to determine glycemic trends and make appropriate medication recommendations. Disclosure R.G.Sgroi: None. S.Gumireddy: None. W.Tan: None. R.Kaplan: None. Y.Milambwe: None. L.H.Rosoph: None. D.A.Salama: None. C.R.Feher: None. N.J.Rennert: None.

Low Initial Adherence with Flash Glucose Monitoring is Not a Predictor of Long-Term Glycemic Outcomes: Longitudinal Analysis of the Association Between Experience, Adherence, and Glucose Control for FreeStyle Libre Users.

Frequent scanning of FreeStyle Libre (FSL) flash glucose monitoring sensors is known to be important whilst wearing an active sensor, but adherence to sensor reapplication is also critical to effective glucose monitoring. We report novel measures of adherence for users of the FSL system and their association with improvements in metrics of glucose control. Anonymous data were extracted for 1600 FSL users in the Czech Republic with ≥ 36 completed sensors from October22, 2018 to December31, 2021. "Experience" was defined by the number of sensors used (1-36 sensors). "Adherence" was defined by time between the end of one sensor and the start of the next (gap time). User adherence was analyzed for four experience levels after initiating FLASH; Start (sensors 1-3); Early (sensors 4-6); Middle (sensors 19-21); End (sensors 34-36). Users were split into two adherence levels based on mean gap time during Start period, "low" (> 24h, n = 723) and "high" (≤ 8h, n = 877). Low-adherence users reduced their sensor gap times significantly: 38.5% applied a new sensor within 24h during sensors 4-6, rising to 65.0% by sensors 34-36 (p < 0.001). Improved adherence was associated with increased %TIR (time in range; mean + 2.4%; p < 0.001), reduced %TAR (time above range; mean - 3.1%; p < 0.001), and reduced glucose coefficient of variation (CV; mean - 1.7%; p < 0.001). With experience, FSL users became more adherent in sensor reapplication, with associated increases in %TIR, and reductions in %TAR and glucose variability.

Sleep quality and glycemic control in children and adolescents with type 1 diabetes mellitus.

This study aimed to investigate the frequency of sleep disorders, and the relationship between glycemic control and sleep characteristics in diabetic children and adolescents. Sixty-one patients followed for at least one year for type 1 diabetes mellitus (T1DM) aged 6-16 years old, and eighty-three group-matched healthy controls were included in the study. Time in range (TIR) and hypoglycemia episode numbers were recorded using the freestyle libre sensor data. The sleep characteristics were evaluated using the Sleep Disturbance Scale for Children (SDSC) validated survey. The diabetic patients were trichotomized according to SDSC scores, as low, medium, and high score groups. Sleep duration, SDSC total score, and subgroup scores except for sleep hyperhidrosis (3.11±1.53 vs. 2.16±0.85, p<0.001, respectively) were similar (p>0.05) between the diabetic and control group. According to the survey, 1.6% of diabetic cases and 6.1% of the control group had clinically significant sleep disturbances (p>0.05). Duration of diabetes (DD) was lower (p=0.01), and the level of HbA1C was higher (p=0.02) in the high-score group than the others. Regression analysis revealed that TIR was the only independent determinant for the SDSC score (β=-1.27, t=-1.90; p=0.012). Sleep habits and problems should be routinely evaluated in diabetic children and adolescents.

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.

The long-term impact of glucose monitoring with the FreeStyle Libre on glycaemic control and hypoglycaemia awareness in people with type1 diabetes: Insights from the Association of British Clinical Diabetologists national audit.

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. 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). 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. In people with T1D, FSL use resulted in a sustained improvement in HbA1c, hypoglycaemia awareness and diabetes-related distress for over two years.