Roche Diabetes Care Research Articles

Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.

A sizeable minority of commercially available blood glucose monitoring (BGM) systems fail to satisfy regulatory accuracy requirements, such as ISO 15197:2013, after approval. This study assessed whether the BGMs tested could consistently meet these ISO requirements by investigating their accuracy in a non-standardized setting. In this 18-month post-market performance study, using the ISO criteria, healthcare professionals tested the accuracy of four CE-marked BGM systems (Roche Diabetes Care, Mannheim, Germany) on European adults with diabetes mellitus. ISOcriteria included 95% of blood glucose (BG) values being within ± 15mg/dl of a reference measurement for BG < 100mg/dl or ± 15% for BG ≥ 100mg/dl and, in the Parkes Consensus Error grid for type 1 diabetes comparing capillary BGM measurements versus reference method, 99% of BG values falling within zone A (no effect on clinical action or outcome) and zone B (altered clinical action with little or no effect on clinical outcome). BGM readings were obtained from 1650 participants, and the number of readings per BGM system was between 1712 and 2376. The percentage of BGM readings that fell within ISO 15197:2013 limits ranged from 99.4 to 99.9%. For all meter types, 100% of data points fell within zone A or zone B, and most data points for each meter (≥ 99.9%) were in zone A. All four CE-marked BGM models showed results within the accuracy limits defined by ISO 15197 in a non-standardized setting and thus consistently met regulatory accuracy requirements.

355-OR: Glycemic Outcomes with CGM Use in Patients with Type 2 Diabetes—Real-World Analysis

Introduction &amp; Objectives: While the benefits of CGM use in T1D are well documented, its efficacy across the spectrum of T2D patients in real-world settings has not been evaluated. We assessed the effects of CGM use in a large T2D adult population across the treatment spectrum, considering non-insulin therapies (NIT), basal insulin (BIT), and prandial insulin (PIT) with/without non-insulin medications. Methods: This retrospective,12-month analysis used data from a large claims database that included &amp;gt;7.1 million patients with T2D in the electronic medical records. The two observation periods were: pre-index period -- 360 days prior to patients' first CGM claim; and post-index period -- 360 days after to the first CGM claim. The index date (baseline) was the date of the first CGM claim between December 27, 2019, and January 5, 2022. The primary outcome was change in HbA1c closest to 12 months after CGM acquisition. Results: The analysis included 16,410 adults with T2D (NIT, n=4,659; (BIT, n=6,182, and PIT, n=5,569) with mean baseline HbA1c 8.8% and mean age 59 years. At 12 months, the mean change in HbA1c was significant in all three subgroups compared with HbA1c levels in the pre-index period. (Figure) Conclusions: In this 12-month, real-world study, CGM use was associated with significant improvements in glucose control in both non-insulin and insulin-treated patients with T2D. Disclosure S.K. Garg: Research Support; Eli Lilly and Company. Advisory Panel; Medtronic. Research Support; Medtronic. Advisory Panel; Novo Nordisk. Research Support; DarioHealth Corp., Dexcom, Inc., Diasome. Advisory Panel; Roche Diabetes Care. I.B. Hirsch: Advisory Panel; Abbott. Research Support; Dexcom, Inc. Advisory Panel; Roche Diabetes Care. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc. Advisory Panel; embecta. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Vertex Pharmaceuticals Incorporated. E. Repetto: Employee; Roche Diabetes Care. B. Ulmer: Employee; Roche Diabetes Care. C. Perkins: Employee; Roche Diabetes Care. J.K. Snell-Bergeon: None. R.M. Bergenstal: Other Relationship; Abbott. Research Support; Arkray Marketing. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur. Other Relationship; Dexcom, Inc., Eli Lilly and Company. Consultant; embecta, Hygieia. Research Support; Insulet Corporation. Consultant; MannKind Corporation. Other Relationship; Medtronic, Novo Nordisk. Consultant; Onduo LLC, Roche Diabetes Care. Other Relationship; Sanofi. Research Support; Tandem Diabetes Care, Inc. Other Relationship; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. Funding Roche Diabetes Care

239-OR: CGM Has a Specific Effect on the Reduction of Nocturnal Hypoglycemia in People with Type 1 Diabetes on an MDI Treatment Regimen

MDI users with type 1 diabetes may be less able to respond to circadian changes in insulin demand than CSII or AID users, which may increase the risk of nocturnal hypoglycemia. Therefore, we re-analyzed data from the HYPO.DE RCT to evaluate the effect of CGM on the percentage of low glucose levels &amp;lt; 70 mg/dl (% &amp;lt; 70 mg/dl) and &amp;lt; 54 mg/dl (% &amp;lt; 54 mg/dl) during 12 two-hour periods throughout the day. We compared 4-week baseline data from 141 participants using spot glucose monitoring (SMBG) with 4-week outcome data after a 6-month follow-up period in which the control group (n=66) remained on SMBG and the intervention group (n=75) used CGM (Dexcom G5). At baseline without CGM, there were significantly higher proportions of %&amp;lt;70 mg/dl or %54 mg/dl during the night (00:00 am - 06:00 am) than during the day (8.5 ±1.0% vs. 6.5 ±0.6%, p&amp;lt;0.001 respectively 4.0 ±0.6% vs. 2.4 ±0.3%, p&amp;lt;0.001). CGM had a greater effect on nocturnal hypoglycemia than on daytime hypoglycemia (see Figure 1). The greatest reduction in favor of the CGM users was between 04:00 a.m. and 06:00 a.m., with a between-group difference of -8.5% (95% CI -10.4% to -6.7%, p&amp;lt;.001) for %&amp;lt;70 mg/dl and -5.5% (95% CI 4.4 - 6.6%, p&amp;lt;.001) for %&amp;lt;54 mg/dl. The data suggest that CGM provides benefits to MDI users with type 1 diabetes in preventing nocturnal hypoglycemia, potentially compensating for lack of responsiveness to a circadian changing insulin demand. Disclosure N. Hermanns: Speaker's Bureau; Berlin-Chemie AG, Sanofi-Aventis Deutschland GmbH. Research Support; Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Roche Diabetes Care. Research Support; Roche Diabetes Care. Speaker's Bureau; Dexcom, Inc. Advisory Panel; Abbott Diagnostics, Ypsomed AG. D. Ehrmann: Advisory Panel; Dexcom, Inc. Speaker's Bureau; Dexcom, Inc., Sanofi-Aventis Deutschland GmbH. Advisory Panel; Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care, Berlin-Chemie AG. B. Kulzer: Advisory Panel; Abbott Diagnostics, Berlin-Chemie AG, Dexcom, Inc., Sanofi, embecta, Novo Nordisk, Roche Diabetes Care. Speaker's Bureau; Bayer Inc., Insulet Corporation, Lilly Diabetes. G. Freckmann: Advisory Panel; Abbott. Research Support; Ascensia Diabetes Care. Advisory Panel; Boydsense, Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Novo Nordisk. Advisory Panel; Perfood, PharmaSens. Consultant; Roche Diabetes Care. Research Support; Roche Diabetes Care. Consultant; Sinocare. Speaker's Bureau; Terumo Corporation. Consultant; Ypsomed AG. L. Heinemann: Stock/Shareholder; Science Consulting in Diabetes GmbH, Profil Institut für Stoffwechselforschung GmbH. Advisory Panel; embecta. Board Member; Lifecare A/S. Stock/Shareholder; diateam GmbH. Funding The HYPO.DE study was funded by Dexcom, San Diego

1446-P: Gender Inequalities in Cardiovascular Risk Factors in Primary Prevention Adults Living with Type 1 Diabetes in Germany and France—Findings from DPV and SFDT1

Introduction &amp; Objectives: To evaluate whether medical care for and level of cardiovascular risk factors differ in primary prevention between adult men and women with type 1 diabetes (T1D) in two European countries in 2020-2022. Methods: We included 2657 participants from the DPV registry (Germany, mean age 40±15, diabetes duration 23±14 years; 50.9% men) and 1172 from the SFDT1 study (France, age 39±14, diabetes duration 22±13 years; 53.2% men). Results: HbA1c levels and body mass indexes were similar in women and men with similar proportions of HbA1c&amp;lt;7% (DPV: 36.6 vs. 33.0%, respectively; SFDT1: 22.8 vs. 24.9%; both n.s.). Women had less overweight in DPV (55.4 vs. 61.0%, p&amp;lt;0.05) but not in SFDT1 (48.0 vs. 44.9%, n.s.) and were less prone to smoke (DPV: 19.7 vs. 25.8%, p&amp;lt;0.05; SFDT1: 21.0 vs. 26.0%, n.s.). Systolic blood pressure was lower in women than men (DPV: 124±15 vs. 129±15; SFDT1: 121±16 vs. 126±14mmHg, both p&amp;lt;0.05) with similar rates of antihypertensive therapy in case of systolic/diastolic blood pressure ≥140/90mmHg (DPV: 70.5 vs. 63.6%; SFDT1: 73.3 vs. 68.6%, both n.s.). In case of microalbuminuria, ACEi-ARB were less prescribed in women than men in DPV (21.4 vs 37.6%, p&amp;lt;0.05) but not SFDT1 (70.6 vs 62.0%, n.s.). In women compared to men, HDL-cholesterol levels were higher; triglycerides lower and LDL-cholesterol similar in DPV and SFDT1. In those with LDL-cholesterol &amp;gt;130 mg/dL (DPV: 19.9 vs. 23.9%; SFDT1 17.0 vs. 19.2%, both n.s.), statin therapy was less prescribed in women than men in DPV (7.9 vs. 17.0%, p&amp;lt;0.05), SFDT1 (18.2 vs. 21.0%, n.s.). Conclusion: Women in primary prevention have a better cardiovascular risk profile than men in both studies. We observed a high rate of therapeutic inertia, which might be higher in women for statin and nephroprotection with ACEi-ARB especially in Germany. Disclosure E. Cosson: Advisory Panel; Abbott, AstraZeneca, Lilly Diabetes, Novo Nordisk, Sanofi, Roche Diagnostics, Novartis AG, Amgen Inc. M. Auzanneau: Other Relationship; Insulet Corporation. G.A. Aguayo: None. W. Karges: None. J. Riveline: Board Member; Abbott, Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Medtronic, Dexcom, Inc., Insulet Corporation, Air Liquide, AstraZeneca. P. Augstein: None. L. Sablone: None. P.M. Jehle: None. G. Fagherazzi: Speaker's Bureau; Sanofi. Advisory Panel; Timkl, SAB Biotherapeutics, Inc., Vitalaire, Roche Diabetes Care. R.W. Holl: None.

Design and Development of a Non-invasive Opto-Electronic Sensor for Blood Glucose Monitoring Using a Visible Light Source.

Background The management of diabetes is critically dependent on the continuous monitoring of blood glucose levels. Contemporary approaches primarily utilize invasive methods, which often prove to be uncomfortable and can deter patient adherence. There is a pressing need for the development of novel strategies that improve patient compliance and simplify the process of glucose monitoring. Aim and objectives The primary objective of this research is to develop a non-invasive blood glucose monitoring system (NIBGMS) that offers a convenient alternative to conventional invasive methods. This study aims to demonstrate the feasibility and accuracy of using visible laser light at a wavelength of 650 nm for glucose monitoring and to address physiological and technical challenges associated with in vivo measurements. Methods Our approach involved the design of a device that exploits the quantitative relationship between glucose concentration and the refraction phenomena of laser light. The system was initially calibrated and tested using glucose solutions across a range of concentrations (25-500 mg/dL). To get around the problems that come up when people's skin and bodies are different, we combined an infrared (IR) transmitter (800 nm) and receiver that checks for changes in voltage, which are indicative of glucose levels. Results The prototype device was compared with a commercially available blood glucose monitor (Accu-Chek active machine; Roche Diabetes Care, Inc., Mumbai, India). The results demonstrated an average linearity of 95.7% relative to the Accu-Chek machine, indicating a high level of accuracy in the non-invasive measurement of glucose levels. Conclusions The findings suggest that our NIBGMS holds significant promise for clinical application. It reduces the discomfort associated with blood sampling and provides reliable measurements that are comparable to those of existing invasive methods. The successful development of this device paves the way for further commercial translation and could significantly improve the quality of life for individuals with diabetes, by facilitating easier and more frequent monitoring.

Enhancing diabetes therapy adherence: a comprehensive study on glucometer usability for type 2 diabetes patients.

Self-monitoring of blood glucose (SMBG) is a vital practice for type 2 diabetes (T2DM), and glucometers have the potential to improve therapy adherence. However, characteristics of glucometers improving their usability are underexplored. A knowledge gap exists regarding patients under 65, warranting further research for diabetes care improvement. Thus, this study aims to gather insights on glucometer accessibility, by analyzing the case of the Accu-Chek® Instant glucometer by Roche Diabetes Care GmbH. Starting from a previous study having the objective of investigating devices' features able to improve SMBG in over 65 T2DM patients, using the same device, we enlarged the scale, designing a survey that collected answers from 1145 patients of the Center and South of Italy, both under and over 65. 957 answers were analyzed, according to a threshold of 50% completion of the answers. Our results show the major characteristics presented in Accu-Chek® Instant are appreciated differently between patients under 65 and over 65, and between patients with or without previous experience with a glucometer. It emerged how Accu-Chek® was perceived as more user-friendly among individuals under 65 compared to those aged 65 and over, where more people had prior experience, indicating how such a glucometer can be particularly helpful for naive patients. The study provides valuable insights to the academic discourse on glucometer features and their influence on therapy adherence.

Patent analysis of digital sensors for continuous glucose monitoring.

The high need for optimal diabetes management among an ever-increasing number of patients dictates the development and implementation of new digital sensors for continuous glucose monitoring. The purpose of this work is to systematize the global patenting trends of digital sensors for continuous glucose monitoring and analyze their effectiveness in controlling the treatment of diabetes patients of different ages and risk groups. The Lens database was used to build the patent landscape of sensors for continuous glucose monitoring. Retrospective analysis showed that the patenting of sensors for continuous glucose monitoring had positive trend over the analyzed period (2000-2022). Leading development companies are Dexcom Inc., Abbott Diabetes Care Inc., Medtronic Minimed Inc., Roche Diabetes Care Inc., Roche Diagnostics Operations Inc., Roche Diabetes Care Gmbh, and Ascensia Diabetes Care Holdings Ag, among others. Since 2006, a new approach has emerged where digital sensors are used for continuous glucose monitoring, and smartphones act as receivers for the data. Additionally, telemedicine communication is employed to facilitate this process. This opens up new opportunities for assessing the glycemic profile (glycemic curve information, quantitative assessment of the duration and amplitude of glucose fluctuations, and so on), which may contribute to improved diabetes management. A number of digital sensors for minimally invasive glucose monitoring are patented, have received FDA approval, and have been on the market for over 10 years. Their effectiveness in the clinic has been proven, and advantages and disadvantages have been clarified. Digital sensors offer a non-invasive option for monitoring blood glucose levels, providing an alternative to traditional invasive methods. This is particularly useful for patients with diabetes who require frequent monitoring, including before and after meals, during and after exercise, and in other scenarios where glucose levels can fluctuate. However, non-invasive glucose measurements can also benefit patients without diabetes, such as those following a dietary treatment plan, pregnant women, and individuals during fasting periods like Ramadan. The availability of non-invasive monitoring is especially valuable for patients in high-risk groups and across different age ranges. New world trends have been identified in the patenting of digital sensors for non-invasive glucose monitoring in interstitial skin fluid, saliva, sweat, tear fluid, and exhaled air. A number of non-invasive devices have received the CE mark approval, which confirms that the items meet European health, safety, and environmental protection standards (TensorTip Combo-Glucometer, Cnoga Medical Ltd.; SugarBEAT, Nemaura Medical; GlucoTrack, GlucoTrack Inc.), but are not FDA-approved yet. The above-mentioned sensors have characteristics that make them popular in the treatment of diabetes: they do not require implantation, do not cause an organism reaction to a foreign body, and are convenient to use. In the EU, in order to increase clinical safety and the level of transparency about medical devices, manufacturers must obtain certificates in accordance with Regulation (EU) 2017/745, taking into account the transition period. The development of systems, which include digital sensors for continuous glucose monitoring, mobile applications, and web platforms for professional analysis of glycemic control and implementation of unified glycemic assessment principles in mobile healthcare, represent promising approaches for controlling glycaemia in patients.

1794-PUB: Potential for Improving CGM Systems? Anticipated Benefits from Increasing the Glucose Prediction of Current CGM Algorithms

Current CGM algorithms allow a glucose prediction up to 30 minutes. To elaborate on the potential to improve current CGM systems, we investigated if a possible increase in this prediction window to up to 2 hours would be perceived as a significant benefit. People with type 1 and type 2 diabetes currently using a CGM system were invited to participate. Participants were presented with a scenario depicting the potential of a hypothetical CGM algorithm to predict the course of glucose for up to 2 hours. They were instructed to imagine how such a long-term prediction would affect their diabetes management. They were asked to complete the T1-Diabetes Distress Scale (T1-DDS) and the Hypoglycemia Fear Survey (HFS-II) and rate each item regarding the perceived potential change from using such a long-term prediction (scale: -2 strong deterioration, -1 deterioration, 0 no change, 1 improvement, 2 strong improvement). 206 people participated (29.1% type 2 diabetes). Participants expected moderate improvements in hypoglycemia and management distress (Box plots shown in Figure 1 for T1-DDS). Similar improvements in HFS-II scores (0.57±0,49) were seen with no differences between diabetes types. Increasing the glucose prediction to up to 2 hours would be seen as a potential improvement regarding reductions in hypoglycemia distress and fear of hypoglycemia by both people with type 1 and type 2 diabetes. Disclosure D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. T.Glatzer: Employee; Roche Diabetes Care, Berlin-Chemie AG. L.Priesterroth: Speaker's Bureau; Ypsomed AG. B.Olesen: Advisory Panel; AstraZeneca, Evivamed, Berlin-Chemie AG, Speaker's Bureau; Medtronic, Medtrixx. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. Funding Roche Diabetes Care

53-OR: Efficacy and Safety of Coadministered s.c. Semaglutide and s.c. Cagrilintide in Type 2 Diabetes

Combining sema (semaglutide 2.4 mg) and amylin analog cagri (cagrilintide 2.4 mg) has weight loss benefits, but the impact on HbA1c is unknown. This study is the first to assess the efficacy and safety of CagriSema (co-administered) vs sema or cagri alone in participants (pts) with T2D. In this phase 2 (NCT04982575), multicenter, double-blind trial, adults with T2D (HbA1c 7.5-10.0%) and BMI ≥27 kg/m2 on metformin ± SGLT2i, were randomized to once-weekly s.c. CagriSema, sema, or cagri for 32 weeks (all escalated over 16 weeks to 2.4 mg). The primary endpoint was change from baseline in HbA1c; key secondary endpoints were body weight and safety. Of the 92 pts randomized (64% male; mean age 58 years and T2D duration 8.7 years), those receiving CagriSema had significantly greater reductions in HbA1c (vs cagri) and body weight (vs sema and cagri) at week 32 (Figure). The proportion of pts achieving HbA1c &amp;lt;7.0% and ≤6.5%, were 89% and 75% for CagriSema, 69% and 48% for sema, and 33% and 17% for cagri at week 32. GI AEs were most common (58% for CagriSema, 32% for sema, and 33% for cagri), were mainly mild/moderate, occurred during dose escalation, and lead to treatment discontinuation in 0%, 3%, and 0% of pts with CagriSema, sema, and cagri, respectively; no level 2 or 3 hypoglycemia was reported. CagriSema improved glycemic control and led to significant weight loss vs both sema or cagri, and was well tolerated with no new safety signals. Disclosure J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck &amp; Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck &amp; Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. S.Deenadayalan: Employee; Novo Nordisk A/S. L.Erichsen: None. F.K.Knop: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Novo Nordisk, Zealand Pharma A/S, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Lundbeck. I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp &amp; Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. S.Macura: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. C.Mathieu: Advisory Panel; Novo Nordisk A/S, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated, Roche Diabetes Care, Imcyse, Speaker's Bureau; Novo Nordisk A/S, AstraZeneca, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated. S.D.Pedersen: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim (Canada) Ltd., AstraZeneca, HLS Therapeutics Inc., Bayer Inc., Viatris Inc., Bausch + Lomb, Research Support; Eli Lilly and Company, Novo Nordisk, AstraZeneca, Applied Therapeutics Inc., Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim (Canada) Ltd., AstraZeneca, Medtronic, Pfizer Inc., HLS Therapeutics Inc., Bayer Inc., Bausch + Lomb. M.J.Davies: Advisory Panel; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Lexicon Pharmaceuticals, Inc., Pfizer Inc., Medtronic, ShouTi Pharma Inc., Consultant; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Research Support; AstraZeneca, Novo Nordisk, Sanofi-Aventis U.S., Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., Speaker's Bureau; Lilly, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Napp Pharmaceuticals Limited, Novartis, Sanofi. Funding Novo Nordisk A/S

1841-PUB: Diabetes as a Risk Factor of Death in Hospitalized COVID-19 Patients—An Analysis of a National Hospitalization Database from Poland, 2020

Introduction: Diabetes has been linked with poor clinical prognosis of hospitalized COVID-19 patients. In this nationwide database retrospective study we evaluated diabetes as a risk factor of in-hospital death. Methods: We analysed data from discharge reports from 2020 of hospitalized COVID-19 patients sent to the Polish National Health Fund. To assess the risk of in-hospital death attributed to diabetes, several multivariate logistic regression models were used. In each model in-hospital death was estimated with explanatory variables, including diabetes. Models were built either on the whole cohorts or cohorts matched with propensity score matching (PSM). They examined either main effects or included interaction of diabetes with other variables. Results: We included 174,621 patients with COVID-19 infection hospitalized in Poland in 2020. There were 40,168 diabetic patients (DPs), proportion higher than in the general population (23.0% vs. 9.5%, p&amp;lt;0.001). Overall, 17,438 in-hospital deaths were recorded, the mortality was higher in DPs vs. nondiabetics (16.3% vs. 8.1%, p&amp;lt;0.001). Multivariate logistic regressions showed that diabetes was an independent risk factor of death, regardless of sex and age. In the main effect analysis, odds of in-hospital death were higher by 28.3% for DPs than for nondiabetic patients. Similarly, PSM analysis including 101,578 patients, of whom 19,050 had diabetes, showed that the risk of death was higher in DPs regardless of sex and age. Odds of in-hospital death were higher by 34.9% for DPs. The impact of diabetes on COVD-19 in-hospital death differed among age groups and was the highest for patients aged 60-69. Conclusions: This nationwide study confirmed that diabetes was an independent risk of in-hospital death in the course of COVID-19. However, the relative risk attributed to diabetes might be lower than reported earlier from most of other populations and differ significantly across the age groups. Disclosure M. Kania: None. B. Kon: None. K.M. Kaminski: Other Relationship; Roche Pharmaceuticals. J. Hohendorff: Speaker's Bureau; Abbott, Novo Nordisk, Ascensia Diabetes Care, Dexcom, Inc., Bayer Inc. T. Klupa: Speaker's Bureau; Medtronic. Advisory Panel; Abbott Diabetes. Speaker's Bureau; Abbott Diabetes. Advisory Panel; Ascensia Diabetes Care. Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. Advisory Panel; Sanofi, BIOTON S.A. Speaker's Bureau; Boehringer Ingelheim Inc., Servier Laboratories. P.W. Witek: Other Relationship; Abbott Diabetes, Ascensia Diabetes Care, Medtronic, Novo Nordisk, Sanofi-Aventis Deutschland GmbH, Boehringer-Ingelheim, Roche Diabetes Care, BIOTON S.A., KRKA. M. Malecki: Advisory Panel; Abbott Diabetes. Speaker's Bureau; AstraZeneca, AlfaSigma. Advisory Panel; Novo Nordisk, Lilly, Sanofi. Speaker's Bureau; Merck &amp; Co., Inc. Research Support; Medtronic. Advisory Panel; Dexcom, Inc. Speaker's Bureau; BIOTON S.A., Servier Laboratories, KRKA. Advisory Panel; Bayer Inc. Funding National Centre for Research and Development CRACoV-HHS project (SZPITALE-JEDNOIMIENNE/18/2020)

54-OR: Effect of Coadministered s.c. Semaglutide and s.c. Cagrilintide on Glycemic Levels Measured by CGM

Continuous glucose monitoring (CGM) offers insight into glycemic levels beyond the conventional measurement of HbA1c. This phase 2, multicenter, 32-week, double-blind trial (NCT04982575) compared the effects of CagriSema (co-administered semaglutide [sema] 2.4 mg and cagrilintide [cagri] 2.4 mg) vs sema (2.4 mg) or cagri (2.4 mg) alone, all as once-weekly subcutaneous injection, on CGM parameters (secondary endpoints). In total, 92 adult participants with T2D (HbA1c 7.5-10.0%), on metformin ± SGLT2i, and BMI ≥27 kg/m2 were randomized. Time in range (70-180 mg/dL) increased in all groups, reaching 88.9% with CagriSema at week 32 (Figure). Time in tight range (70-140 mg/dL; post-hoc analysis) increased from 16.0%, 8.8%, and 26.2% at baseline to 66.4%, 50.0%, and 36.7% at week 32 for CagriSema, sema, and cagri, respectively, with 0.8% or less in time below range for all groups. Mean glucose (measured by CGM) decreased from baseline to week 32 (CagriSema, -63.9; sema, -43.6; cagri, -23.4 mg/dL; estimated treatment difference [95% CI]: CagriSema vs sema, -20.2 [-39.8, -0.7; p=0.04], and CagriSema vs cagri, -40.5 [-59.4, -21.6; p&amp;lt;0.0001] mg/dL). Time in range with CagriSema reached nearly 90% at week 32, with little time below range in the first trial of CagriSema in people with T2D. Furthermore, CagriSema led to a greater reduction in mean glucose vs both sema or cagri alone. Disclosure C.Mathieu: Advisory Panel; Novo Nordisk A/S, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated, Roche Diabetes Care, Imcyse, Speaker's Bureau; Novo Nordisk A/S, AstraZeneca, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated. S.Deenadayalan: Employee; Novo Nordisk A/S. L.Erichsen: None. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck &amp; Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck &amp; Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. F.K.Knop: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Novo Nordisk, Zealand Pharma A/S, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Lundbeck. I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp &amp; Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. E.W.Lehmann: Employee; Novo Nordisk A/S. S.D.Pedersen: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim (Canada) Ltd., AstraZeneca, HLS Therapeutics Inc., Bayer Inc., Viatris Inc., Bausch + Lomb, Research Support; Eli Lilly and Company, Novo Nordisk, AstraZeneca, Applied Therapeutics Inc., Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim (Canada) Ltd., AstraZeneca, Medtronic, Pfizer Inc., HLS Therapeutics Inc., Bayer Inc., Bausch + Lomb. M.J.Davies: Advisory Panel; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Lexicon Pharmaceuticals, Inc., Pfizer Inc., Medtronic, ShouTi Pharma Inc., Consultant; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Research Support; AstraZeneca, Novo Nordisk, Sanofi-Aventis U.S., Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., Speaker's Bureau; Lilly, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Napp Pharmaceuticals Limited, Novartis, Sanofi. Funding Novo Nordisk A/S

104-LB: Interim Analysis of a Prospective Study Investigating User Satisfaction and Metabolic Outcome of People with T1D Using an Innovative Modular Micropump System

Aims: People with type 1 diabetes (T1D) can administer insulin by multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Despite proven clinical benefits, the uptake of CSII is still low. Thus, this study investigates the change in treatment satisfaction and metabolic outcome of people with T1D switching from MDI to CSII therapy using an innovative modular micropump system. Methods: A total of 50 CSII-naive adults with T1D from Argentina were enrolled in a multi-center, prospective, single-armed study for the Accu-Chek® Solo micropump system (ACS). Change in diabetes treatment satisfaction after 13 weeks (mean 108, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as primary outcome. In addition, changes in the DTQ after 1 year and the HbA1c after 13 weeks and 1 year were measured. Results: The change score of the “Impact and satisfaction” part of the DTQ was 113.37 ± 16.74 (mean ± SD, p &amp;lt; 0.0001) after 13 weeks and 111.42 ± 14.42 (p &amp;lt; 0.0001) after 1 year (with 90 as non-change score). Based on predefined sub-categories, the following mean DTQ change scores were measured after 13 weeks / 1 year: 3.81 ± 0.61 / 3.79 ± 0.52 for “diabetes distress and burden”, 3.96 ± 0.68 / 3.98 ± 0.60 for “hypoglycemia fear, worry and behavior”, 3.56 ± 0.71 / 3.53 ± 0.52 for “device acceptance and satisfaction” (1 = much worse, 5 = much better). The mean HbA1c decreased from 8.20 % ± 1.34 to 7.92 % ± 1.18 (-0.28 %pt, p = 0.0341) after 13 weeks and 7.87 % ± 1.26 (-0.37 %pt, p = 0.0467) after 1 year. Thereby, one event of severe hypoglycemia and diabetic ketoacidosis (DKA) was reported during 17520 device days. Conclusion: The switch from MDI to CSII using the ACS led to a significant improvement of subjects’ treatment satisfaction and HbA1c. Effects were already measurable after 13 weeks and continued through 1 year indicating that using the ACS reduces disease burden among people with T1D. Disclosure A. Dain: None. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: None.

698-P: Interoperability as an Important Factor for Achieving the Full Potential of a Digital Diabetes Logbook

A randomized controlled trial (RCT) has demonstrated the efficacy of a digital diabetes logbook (mySugr) in reducing diabetes distress compared to a control group without such an app. In a sub-group analysis, we analyzed whether those who have paired their glucose meter (glucose values were directly imported into the app) benefit differently than those who manually entered their glucose values. A total of 282 people were randomized to the intervention group using the app for 3 months (2:1 randomization; age: 51.2±14.6 years; 13.1% type 1, 66.7% type 2, 20.2% gestational diabetes). The per protocol population within the intervention group consisted of 232 participants who completed the 3-month follow-up and have used the app on ≥10% of the study days. Analysis of covariance was conducted with diabetes distress at the 3-month follow-up at dependent variable and connected glucose meter (yes/no) as independent variable, controlled for diabetes distress at baseline. Diabetes distress was measured with the Problem Areas in Diabetes (PAID) questionnaire. Within the per protocol population, 134 participants of the intervention group (57.8%) have used a connected glucose meter. Participants with a connected meter had significantly less diabetes distress at follow-up compared to participants who manually entered their glucose values (16.9±1.05 vs. 20.5±1.2, p = 0.027). There was no significant difference in demographic characteristics between the two groups. Participants with a connected meter had significantly more meal logs (3.3±2.2 vs. 2.0±1.2, p = 0.01) on days they have used the app. Overall, the digital diabetes logbook was able to reduce diabetes distress over a 3-month period. This reduction in diabetes distress was more pronounced in participants who used an interoperable glucose meter that automatically transferred glucose data into the app. Interestingly, there seems to be an increased interaction with the app regarding logging of meals in participants with a connected meter. Disclosure B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. I.Vesper: None. V.L.Schaefer: Employee; Roche Diabetes Care. S.Silbermann: Employee; Roche Diabetes Care. J.Kober: Employee; mySugr. K.Finke-groene: None. T.Roos: None. E.Bingol: Employee; Roche Diabetes Care. Funding Roche Diabetes Care GmbH (DC000097)

251-OR: The Impact of Identifying Sleep with a Fitbit on Calculated Rates of Nocturnal Hypoglycemia—The Hypo-Metrics Study

Consensus defines nocturnal hypoglycemia as occurring between 00:00 and 06:00 hrs. However, this may introduce bias, as for many, these hours only partially match real sleeping hours. Therefore, we compared rates of hypoglycemia while asleep (defined by Fitbit Charge 4) to rates of conventionally-defined nocturnal hypoglycemia. Hypo-METRICS study participants wore a Fitbit charge 4 and blinded FreeStyle Libre glucose monitor for up to 70 days. Every hypoglycemia episode (≤70mg/dL or ≤54mg/dL for ≥15 min) was classified as ‘asleep’ or ‘awake’ based on Fitbit sleep intervals and ‘nocturnal’ (00:00-06:00 hrs) or ‘day-time’. We compared weekly sensor-detected hypoglycemia (SDH) rates whilst asleep to nocturnal SDH rates using a paired sample Wilcoxon test. We included 542 participants (269 with type 1 diabetes, median (IQR) age 56 (44-66) years, HbA1c 7.3%(6.7-7.9), with 69 (65-70) nights with sleep data/participant). Sleep duration was 6.1 (5.2-6.8) hours. Median weekly rates of SDH while asleep were higher than rates of nocturnal SDH both ≤70mg/dL (1.3 (0.6-2.5) vs 0.9 (0.4-1.8), p&amp;lt;0.001) and ≤54mg/dL (0.4 (0.2-0.9) vs 0.3 (0.1-0.7), p&amp;lt;0.001). Stratifying by type of diabetes did not change the direction or magnitude of the differences in SDH rates. Using clock time to estimate nocturnal hypoglycemia underestimates hypoglycemia whilst asleep by up to a third. Using activity trackers such as Fitbit to identify sleep offers a novel way to estimate hypoglycemia whilst asleep to better reflect lived experience of nocturnal hypoglycemia. Disclosure G.Martine-edith: Other Relationship; Novo Nordisk A/S. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. E.Renard: Consultant; Abbott Diabetes, Dexcom, Inc., AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Roche Diabetes Care. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. P.Divilly: None. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. A.Kingsnorth: None. Z.Mahmoudi: Employee; Novo Nordisk. M.Gomes: Employee; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)

951-P: Intermittently Scanned Continuous Glucose Monitoring (isCGM) for T1DM—Subgroup Analysis from the FLASH-UK Study

The recently published1, multi-site, FLASH-UK, randomized controlled trial (n=156, males 56%, Baseline HbA1c 71±9 mmol/mol, age 44±15) showed improved HbA1c and sensor-based metrics in adults with type 1 DM and an HbA1c ≥58 mmol/mol. Here we present results from pre-specified subgroup analysis for HbA1c (Table 1) and “Time in range (TIR)” (Table 2). The effect of isCGM on both HbA1c and TIR did not differ significantly across subgroups for baseline HbA1c category, treatment modality, prior structured education, sex, deprivation status or depression category. The effect of isCGM on HbA1c was larger for younger people. Those with at least a bachelor’s degree had greater TIR improvement. Conclusion: isCGM is effective across a range of clinical and demographic factors. 1N Engl J Med. 2022 Oct 20;387(16):1477-1487 Disclosure L.Leelarathna: Advisory Panel; Abbott Diabetes, Medtronic, Insulet Corporation, Sanofi, Research Support; Abbott Diabetes, Novo Nordisk, Speaker's Bureau; Sanofi, Abbott Diabetes. V.P.Taxiarchi: None. M.Burns: None. M.E.Camm: None. H.Thabit: Advisory Panel; Dexcom, Inc., Roche Diabetes Care, Research Support; Dexcom, Inc., Speaker's Bureau; Eli Lilly and Company. E.G.Wilmot: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Roche Diabetes Care, Embecta, Consultant; Springer Healthcare, Research Support; Abbott Diabetes, Diabetes UK, Insulet Corporation, Novo Nordisk, NIH - National Institutes of Health, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Ypsomed AG, Glooko, Inc. On behalf of the flash-uk trial study group: n/a. C.J.Sutton: None. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. S.Neupane: Advisory Panel; Quin, Abbott Diabetes, Roche Diabetes Care, Insulet Corporation, Other Relationship; Abbott Diabetes. G.Rayman: Other Relationship; Diabetes UK, Novo Nordisk, Research Support; Abbott Diabetes, Speaker's Bureau; Abbott Diabetes, Lilly Diabetes, Sanofi. S.Lumley: None. I.C.Cranston: Research Support; Eli Lilly and Company, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, Viatris Inc. P.Narendran: Advisory Panel; Omnipod, Speaker's Bureau; Abbott Diabetes, Lilly Diabetes. K.Barnard: Advisory Panel; Abbott Diabetes, Roche Diabetes Care, Sanofi, Consultant; LifeScan Diabetes Institute, Tandem Diabetes Care, Inc., Research Support; Novo Nordisk. Funding Diabetes UK (18/0005836)

391-P: Individualized Optimization of Duration and Threshold of Sensor Hypoglycemia Improves Identification of Symptomatic Hypoglycemia Episodes—Hypo-METRICS Study

Current definitions of sensor detected hypoglycemia (SDH) give high levels of asymptomatic hypoglycemia on continuous glucose monitoring (CGM). We defined individually optimised thresholds and durations for sensor detected hypoglycemia (SDH) that better identify symptomatic hypoglycemia experienced by people with insulin treated diabetes. We analysed 10 weeks of blinded CGM (Libre 2) and FitBit data from 435 participants [217 type 1, 218 type 2]. They self reported symptomatic hypoglycemia on the Hypo-METRICS smartphone app. We used particle Markov chain Monte Carlo optimization to generate the threshold and duration of SDH that maximizes detection of symptomatic hypoglycemia for each individual (and by Fitbit sleep status). When using individual definitions of SDH, precision for detection of symptomatic hypoglycemia increased by 23% with 2% loss of sensitivity vs the consensus definition of Level 1 SDH (70mg/dl &amp;gt; 15 mins). Precision and sensitivity increased by 41% and 20% respectively vs level 2 SDH (54 mg/dl &amp;gt; 15 mins). Increased precision, with minimal change of sensitivity, were greatest during sleep, and irrespective of diabetes types and sleep status (Table). Optimizing SDH definitions at the individual level and by sleep status could minimize false alarms without increasing missed clinically important hypoglycemia episodes. Disclosure Z.Mahmoudi: Employee; Novo Nordisk. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. E.Renard: Consultant; Abbott Diabetes, Dexcom, Inc., AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Roche Diabetes Care. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. P.Divilly: None. G.Martine-edith: Other Relationship; Novo Nordisk A/S. D.Boiroux: Employee; Novo Nordisk A/S. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. M.Gomes: Employee; Novo Nordisk A/S. A.A.Vaag: None. J.Speight: Research Support; Sanofi, Medtronic, Abbott Diabetes, Lilly, Novo Nordisk A/S, Speaker's Bureau; Sanofi. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)

121-LB: Effect of Using the mySugr App on Glycemic Control in T1D patients—A Real-World Analysis from Mexico

Objectives: Describe Mexican patients with T1DM and find out if blood glucose (BG) testing frequency impacts glycemic targets (mean BG &amp; estimated HbA1c [eHbA1c]). Methods: Included mySugr users with a self-reported diagnosis of T1DM and had at least 2 BG logs in at least 14 days (G2D14) in the month prior to their first log entry. G2D14 is the lowest adherence needed to calculate eHbA1c. Users were stratified as low (G2D14 + G3D14) and high testing (G4D14 + G5D14). Subgroup analysis according to baseline eHbA1c was performed. Using a logistic regression model, an exploratory analysis to identify factors associated with BG decrease was also considered. Results: 118,210 users (13% T1DM) were considered. Users in the highest testing subgroup (G5D14; n=276) in the first month before mySugr usage had a significantly lower baseline eHbA1c (-0.8 %; p &amp;lt; 0.01) compared with users in the lowest category (G2D14; n=254). For all users in the group G2D14 or above, eHbA1c decreased from baseline (1 mo. prior to mySugr usage) and stayed below baseline levels for the entire period of 5 mo. (n=253; mean differences: -0.3% at the first month of mySugr usage, -0.2% at the fourth month of mySugr usage; both changes significantly different from 0 with p &amp;lt; 0.05). No statistically significant difference in eHbA1c between the logging subgroups after 4 months of mySugr use was found. Nevertheless, high logging users with baseline eHbA1c &amp;gt; 8% had a non-significant higher reduction. In the logistic regression model, the factor with the strongest association with BG decrease was the baseline mean BG (log OR: 2.4). Conclusion: in our RwD setting, the use of mySugr was associated with reduced eHbA1c. Baseline BG was statistically associated with BG reduction intensity. Although no significant difference in eHbA1c improvement between the high and low logging groups was found during mySugr usage, the baseline analysis suggests that users with increased logging had significantly better glycemic control before starting mySugr. Disclosure C. Vulcano: Employee; Roche Diabetes Care. H. Mikulski: Employee; Roche Diabetes Care. M. Mitter: Employee; Roche Diabetes Care. B. Ruch: Employee; Roche Diabetes Care.

715-P: How Frequently Do People with Diabetes Use a Digital Diabetes Logbook and How Satisfied Are They with It?

A randomized controlled trial (RCT) was conducted to evaluate the efficacy of a digital diabetes logbook (mySugr) to help with diabetes self-management. Frequency of use as well as satisfaction with the app were assessed. A total of 424 people were included in the RCT with 282 being randomized to the intervention group using the app for 3 months (2:1 randomization) (age: 51.2±14.6 years; 13.1% type 1, 66.7% type 2, 20.2% gestational diabetes). Frequency of use was assessed with user data from the pseudonymized study server. Satisfaction with mySugr was assessed with an adapted version of the Mobile App Rating Scale (MARS). Mean MARS scores were calculated (range: 1-5) with higher scores indicating higher satisfaction. User data from 249 participants of the intervention group (88.3%) were analyzable. The app was used on a median of 92.6% (IQR: 57.7 - 100%) of the study days (median study duration: 91 [IQR: 84-96] days). Over the study duration, participants logged 3.1±2.5 blood glucose values. Satisfaction was very high with a mean MARS score of 4.3±0.7. 64.7% of participants agreed that the app is appealing for people with diabetes and 82.5% agreed that the app is easy to use. Satisfaction was highest in women with gestational diabetes, followed by people with type 1 and people with type 2 diabetes (4.5±0.5 vs. 4.3±0.6 vs. 4.2±0.7; p=0.037). Higher satisfaction was associated with higher percentage of days with app use (r=0.23, p&amp;lt;0.001), higher logging frequency (r=0.20, p=0.002) and less problems with the app (r=-0.20, p=0.001). Those who contacted mySugr support when they had problems were significantly more satisfied than those who did not contact support when they had problems (4.6±0.4 vs. 3.8±0.7, p=0.023). Participants randomized to using mySugr for 3 months (no prior app use) were highly satisfied with the app. Frequency of use of the app across the study period was very high. Satisfaction was high in all diabetes types with women with gestational diabetes having the highest satisfaction. Disclosure N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. S.Silbermann: Employee; Roche Diabetes Care. J.Kober: Employee; mySugr. I.Vesper: None. K.Finke-gröne: None. T.Roos: None. E.Bingol: Employee; Roche Diabetes Care. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. Funding Roche Diabetes Care GmbH (DC000097)

250-OR: Majority of Sensor Hypoglycemia Is Not Detected by People Living with Diabetes—Hypo-METRICS Study

The multicentre prospective observational Hypo-METRICS study assessed rates of sensor detected hypoglycemia (SDH) and person reported hypoglycemia-PRH (symptoms resolved by carbohydrates or measured glucose &amp;lt;72 mg/dl), in people with type 1 (T1D) and insulin treated type 2 (T2D) diabetes. We report overall rates of hypoglycemia and the proportion and rates of undetected SDH. All 602 participants (277 T1D vs 325 T2D) had ≥1 PRH in the 3 months prior to the study. They wore a blinded continuous glucose monitor and recorded PRH on the Hypo-METRICS smartphone app for 10 weeks. SDH was defined by ATTD consensus. PRH without SDH ± 1 hour was consider undetected. The median (IQR) weekly rate of PRH was 3.4 (1.9-5.3) vs 0.8 (0.3-1.7) episodes/week in T1D vs T2D respectively (p&amp;lt;0.01), SDH &amp;lt;70mg/dl was 6.7 (3.9-10.8) vs 2.1 (0.9-4.3) episodes/week respectively (p&amp;lt;0.01) and SDH &amp;lt;54mg/dl was 1.3 (0.5-2.8) vs 0.3 (0-0.6) episodes/weeks respectively (p&amp;lt;0.01). The proportion of undetected episodes at SDH &amp;lt;70mg/dl was higher in T2D, 68 vs 78% (p&amp;lt;0.01) and at SDH &amp;lt;54mg/dl, 62 vs 82% (p&amp;lt;0.01). The weekly rates of undetected episodes were higher in T1D for SDH &amp;lt;70mg/dl (4.6 vs 1.8 episodes/week, p&amp;lt;0.01) and for SDH &amp;lt;54mg/dl (0.8 vs 0.2 episodes /week, p&amp;lt;0.01). Baseline characteristics are in table 1. Most sensor hypoglycemia goes undetected by people with diabetes. Further work will assess the impact of undetected episodes. Disclosure P.Divilly: None. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. G.Martine-edith: Other Relationship; Novo Nordisk A/S. Z.Mahmoudi: Employee; Novo Nordisk. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. E.Renard: Consultant; Abbott Diabetes, Dexcom, Inc., AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Roche Diabetes Care. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)

85-LB: CGM Outcomes and Hypoglycemia Duration with Once-Weekly Insulin Icodec vs. Once-Daily Insulin Glargine U100 in Insulin-Naïve T2D—ONWARDS 1 Exploratory Analysis

In ONWARDS 1, a phase 3a, treat-to-target trial (NCT04460885) in insulin-naïve T2D randomized 1:1 to once-weekly icodec or once-daily glargine U100, time in, above and below range (TIR, TAR, TBR) and hypoglycemia duration were assessed with double-blinded CGM at pre-specified periods throughout the trial. TIR (70-180 mg/dL), TAR (&amp;gt;180 mg/dL), TBR (&amp;lt;70 and &amp;lt;54 mg/dL), median duration of hypoglycemia &amp;lt;70 mg/dL and the proportion of an episode spent &amp;lt;54 mg/dL were assessed at weeks (wks) 0-4, 22-26, 48-52, and 74-78. At wks 22-26, 48-52, and 74-78, mean TIR with icodec met the recommended target of &amp;gt;70%, and TIR and TAR were significantly improved with icodec vs glargine, with no significant difference between arms in TBR &amp;lt;54 mg/dL (table). There was a difference in favor of glargine in TBR &amp;lt;70 mg/dL at wks 48-52 and 74-78, but mean TBR &amp;lt;70 mg/dL and TBR &amp;lt;54 mg/dL were below recommended targets (4% and 1%, respectively) at all time periods for both arms. TIR, TBR and TAR did not differ significantly between arms at wks 0-4. Median duration of hypoglycemia &amp;lt;70 mg/dL and proportion of time &amp;lt;54 mg/dL were similar between arms at all time periods. In summary, TIR and TAR at wks 22-26, 48-52, and 74-78 were significantly improved with icodec vs glargine U100, with no significant difference in TBR &amp;lt;54 mg/dL and a similar duration of hypoglycemia &amp;lt;70 mg/dL between arms. Disclosure R. M. Bergenstal: Advisory Panel; Abbott Diabetes. Research Support; Abbott Diabetes. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc. Research Support; Dexcom, Inc. Advisory Panel; Eli Lilly and Company. Research Support; Eli Lilly and Company. Consultant; Hygieia. Research Support; Insulet Corporation, Medtronic. Advisory Panel; Medtronic, Novo Nordisk. Research Support; Novo Nordisk. Consultant; Onduo LLC. Advisory Panel; Roche Diabetes Care. Research Support; Sanofi. Consultant; Sanofi. Research Support; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated. Advisory Panel; Zealand Pharma A/S. S. K. Watt: Employee; Novo Nordisk. A. S. A. Matos: Employee; Novo Nordisk A/S. I. Lingvay: Advisory Panel; Novo Nordisk A/S. Research Support; Novo Nordisk A/S. Advisory Panel; Lilly Diabetes, Boehringer-Ingelheim. Research Support; Boehringer-Ingelheim. Consultant; Carmot Therapeutics, Inc., Merck Sharp &amp; Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc. Advisory Panel; Sanofi. Consultant; Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer. J. K. Mader: Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics. Research Support; A. Menarini Diagnostics, Abbott Diabetes. Advisory Panel; Abbott Diabetes. Speaker's Bureau; Abbott Diabetes. Advisory Panel; Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care. Research Support; Roche Diabetes Care. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Advisory Panel; Medtronic. Speaker's Bureau; Boehringer Ingelheim Inc., Becton, Dickinson and Company. Advisory Panel; Becton, Dickinson and Company. Speaker's Bureau; Ypsomed AG, Viatris Inc., Servier Laboratories. Research Support; Dexcom, Inc., Profusa, Inc. Stock/Shareholder; Decide Clinical Software GmbH. Advisory Panel; Pharmasense, embecta. Speaker's Bureau; Medtrust. T. Nishida: Employee; Novo Nordisk Pharma Ltd. Stock/Shareholder; Novo Nordisk A/S. J. Rosenstock: Advisory Panel; Applied Therapeutics Inc. Research Support; Applied Therapeutics Inc. Advisory Panel; Boehringer Ingelheim Inc. Research Support; Boehringer Ingelheim Inc. Advisory Panel; Eli Lilly and Company. Research Support; Eli Lilly and Company, Merck &amp; Co., Inc., Novartis. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Oramed Pharmaceuticals. Research Support; Pfizer Inc. Advisory Panel; Sanofi. Research Support; Sanofi. Advisory Panel; Zealand Pharma A/S, Intarcia Therapeutics, Inc. Research Support; Intarcia Therapeutics, Inc. Advisory Panel; Hanmi Pharm. Co., Ltd. Funding Novo Nordisk A/S