IntroductionFear of hypoglycemia (FoH) affects quality of life, emotional well-being, and diabetes management among people with type 1 diabetes (PwT1D). American Diabetes Association’s (ADA) guidelines recommend assessing FoH in clinical practice. However, existing FoH measures are commonly used in research and not in clinical practice. In this study, prevalence of FoH was assessed in PwT1D using a newly developed FoH screener for clinical practice; its association with established measures and outcomes was also determined. In addition, healthcare providers’ (HCPs) perspectives on implementing FoH screener into real-world practice were explored.Research design and methodsThis multiphase observational study used mixed methods in two phases. First, we collected a cross-sectional survey (including the screener) from PwT1D (≥18 years) from T1D Exchange Quality Improvement Collaborative adult clinics. Pearson correlations and regression analyses were performed on diabetes outcome measures using screener scores. Second, we conducted focus groups among HCPs who treat PwT1D and descriptive analysis to summarize results.ResultsWe included 553 PwT1D. Participants had a mean±SD age of 38.9±14.2 years and 30% reported a high FoH total score. Regression analyses showed that higher A1c and higher number of comorbidities were significantly associated with high FoH (p<0.001). High FoH worry and behavior scores were significantly associated with 8-Item Patient Health Questionnaire and 7-Item Generalized Anxiety Disorder Scale scores. Participants with ≥1 severe hypoglycemia event(s) and impaired awareness of hypoglycemia had higher odds of high FoH. Eleven HCPs participated in focus group interviews; they expressed that the FoH screener is clinically necessary and relevant but poses implementation challenges that must be addressed.ConclusionsOur results demonstrate FoH is common in PwT1D and affects their psychosocial well-being and diabetes management. In alignment with ADA position statement, HCP focus group results emphasize importance of screening for FoH. Implementing this newly developed FoH screener may help HCPs identify FoH in PwT1D.

Background: Severe hypoglycemia (SH) is feared by people with diabetes (PwD) and those who care for them due to its impact on everyday life. Studies have shown that ready-to-use nasal glucagon (NG) is preferred over reconstitutable injectable glucagon; however, real-life experiences that PwD and health care providers (HCPs) have with NG are unknown. Objective and Methods: A cross-sectional, web-based study was conducted in the US and Germany among: i) insulin-treated adults who owned NG for at least 2 months to assess impact of NG on everyday life, and ii) HCPs who prescribed NG within 6 months of study initiation to assess HCPs’ experiences with NG in meeting their patients’ needs. Data were analysed descriptively, and US results are presented. Results: Of 292 PwD (mean age 42, 47% T1D, 86% high fear of hypoglycemia total screener score, 37% impaired hypoglycemia awareness), 68% had been treated with NG. Over 90% agreed that NG had positively impacted quality of life (QoL) items (Figure). Of 71 HCPs (endocrinologists 87%), 90% were satisfied with NG meeting patients’ needs. Over 80% of HCPs were satisfied with training time on NG and confident with patient and caregiver’s ability to apply the training for a SH event. Conclusion: The positive impact of NG on QoL, less fear of hypoglycemia, and high confidence in caregiver’s ability to use NG may help improve PwD’s everyday life related to hypoglycemia management. Disclosure B.Mitchell: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Ponce-ibarra: Employee; Lilly Deutschland GmbH, Stock/Shareholder; Eli Lilly and Company. E.Moennig: Employee; Lilly Deutschland GmbH, Stock/Shareholder; Eli Lilly and Company. S.Odak: Other Relationship; Eli Lilly and Company. D.J.Mcsorley: Other Relationship; Eli Lilly and Company, Sage Pharmaceuticals, Novavax, Bristol-Myers Squibb Company, Seattle Genetics, Inc., Boston Scientific Corporation, Blood Centers of America, Inc. E.Spaepen: Consultant; Eli Lilly and Company. L.Jackson: Other Relationship; Eli Lilly and Company. L.Zografos: Other Relationship; Eli Lilly and Company. Y.Yan: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Experiences of a severe hypoglycemic event (SHE) , although infrequent occurrences, may interfere with engaging in social activities and increase distress. Previous work in parents suggests having nasal glucagon (NG) - a ready-to-use rescue agent for SHE - alleviates some of these psychosocial concerns. To examine whether young adults also perceived psychosocial benefits from NG, we recruited individuals aged 18-26 with T1D for an online survey. Participants rated the perceived impact of possible SHEs on fully engaging in social activities and distress (‘strongly disagree’ to ‘strongly agree’) and perceived changes since starting NG (‘worsened a great deal’ to ‘improved a great deal’) . Participants then answered questions about preparedness and protection using a validated measure to compare perceptions of NG to a glucagon kit requiring reconstitution. The final sample included 364 young adults (Meanage = 21.6 years; 73.6% female; MeanHbA1c = 7.1%) . Roughly one third of participants (35.4%) agreed/strongly agreed that possible SHEs limited their engagement in social activities. Most participants (63.7%) agreed/strongly agreed that treating a SHE was distressing. Since having NG, 30.9% of participants reported their freedom to engage in social activities improved/greatly improved and 67.4% reported no change. Of those who reported some amount of distress about SHEs (n = 326) , 49.7% reported their distress improved/greatly improved (i.e., reduced) and 48.8% of participants reported no change. Participants reported greater positive perceptions of Preparedness/Protection with NG (Median = 5.9, IQR = 5.1-6.3) compared to the glucagon kit requiring reconstitution (Median = 4, IQR = 3-4.9) as analyzed with a Wilcoxon signed rank test (p &lt; .001) . Our results suggest that NG may provide meaningful psychosocial benefits for young adults, which could be especially important as they navigate this transitional age for diabetes management. Disclosure C. S. Kelly: None. H. Nguyen: None. W. Luo: Other Relationship; Lilly, Sanofi. K. S. M. Chapman: None. J. Poon: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. L. A. Baker: None. W. Wolf: None. M. Perez-Nieves: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. B. Mitchell: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Hypoglycemia risk and its impact on daily life is always present for people with diabetes and their caregivers (CG) . With the goal of positively impacting the lives of those who use insulin, advances in glucagon and its delivery, have made it ready-to-use, expanding the community of people who could act in an emergency. This qualitative study elicited experiences from people who own one option, nasal glucagon (NG) . Semi-structured 1:1 interviews were conducted in the US with AwD and CGs of children or AwD following a pre-defined concept elicitation guide and analyzed thematically. The sample included 22 AwD (20 T1DM; 2 T2DM) and 7 CGs of people with T1DM (1 Adult, 6 Children) ; female (72%) ; mean age 38.7 years; college degree 59%; insulin pump 62%. Actual use of NG was reported by 46% of AwD and 43% of CGs. A total of 45 concepts were identified, the majority (81%) identified by the first 5 interviews; saturation (the point at which no new concepts emerge) reached at 25 interviews. The most frequently stated concepts were: feeling safe having NG on hand (93%) ; ease of use for others (90%) ; comfort in having NG as a rescue treatment option (90%) ; confidence in others’ ability to use NG (86%) ; ease of instruction to others (86%) (Figure) . These firsthand experiences give useful clinical insights regarding NG, deepening our understanding for practice considerations. Disclosure B.Mitchell: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. F.G.Sowell: None. P.Williams: None. J.Poon: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

The ADA recommends that all people with diabetes at risk of level 2 or 3 hypoglycemia be prescribed glucagon. Studies of conventional reconstituted injectable glucagon showed low rates of successful delivery of a full dose and low prescription filling rates. Since July 2019, ready-to-use glucagon options have become commercially available. IBM® MarketScan® Research Database was used to study prescription patterns among people with T1D or T2D on insulin who had filled a glucagon prescription 2 years prior to July 2019 (pre-period) and/or 2 years after through July 2021 (post-period) . Logistic regression models (for feature selection of independent variables followed by two-way interaction identification from Multivariate Adaptive Regression Splines) were utilized to determine glucagon fills post-period based on variables pre-period (demographics, diabetes type, insurance, comorbidities, history of hypoglycemia, diabetes medications) . Classification trees were used to illustrate the effects of significant variables (variables added &gt;1% accuracy from cross validation) . Of all insulin-treated people (n=138,826) over the 4-year period, 13.5% (T1D 48.4%, T2D 3.5%) had glucagon prescriptions filled. Of those who filled glucagon post-period (n=14,234) , 54.3% filled a ready-to-use glucagon. The primary drivers and % of glucagon fills post-period: overall included age &lt;22 (63.3%) , T1D (37.4%) , and glucagon filled pre-period (62.2%) (each p&lt;.001) ; among people with T1D, age &lt;17 (81.6%) and glucagon filled pre-period (66.7%) (each p&lt;.001) ; among people with T2D, glucagon filled pre-period (34.0%) , basal-bolus insulin filled in the 4-year period (4.4%) , and age &lt;16 (58.6%) (each p&lt;.001) . The results suggest that, despite guideline recommendations, glucagon prescription fills are low, and mostly by young people. Though at increased risk of hypoglycemia, fill was low in the elderly and people with T2D on basal-bolus insulin. After becoming available, ready-to-use glucagon represented over 50% of glucagon fills. Disclosure B. Mitchell: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. D. R. Nelson: Employee; Eli Lilly and Company. A. Meeks: Employee; Eli Lilly and Company. Y. Yan: Employee; Eli Lilly and Company. Funding Eli Lilly and Company