Search

Automated insulin delivery (AID) systems, which connect an insulin pump, continuous glucose monitoring system, and software algorithm to automate insulin delivery based on real-time glycemic data, hold promise for improving outcomes and reducing therapeutic burden for people with diabetes. This article reviews the features of the Omnipod 5 Automated Insulin Delivery System and how it compares to other AID systems available on or currently under review for the U.S. market. It also provides practical guidance for clinicians on how to effectively train and onboard people with diabetes on the Omnipod 5 System, including how to personalize therapy and optimize glycemia. Many people with diabetes receive their diabetes care in primary care settings rather than in a diabetes specialty clinic. Therefore, it is important that primary care providers have access to resources to support the adoption of AID technologies such as the Omnipod 5 System.

OBJECTIVE Diabetes technology has improved the lives of people with diabetes (PWD), but there is little research on how insulin pumps and continuous glucose monitoring (CGM) affect couples’ relationships. The purpose of this study was to examine how the use of diabetes technology affects couple interactions. METHODS In a secondary data analysis, we used a multiple-method qualitative analysis, including a constant-comparison approach, to examine similarities and differences in couple interactions related to diabetes technology. PWD and their spouses were interviewed separately, using a semi-structured interview guide; the interviews primarily focused on how couples coped with type 1 diabetes. RESULTS Participants (n = 134 couples) were using an insulin pump or CGM system. Average age was 44 ± 12.05 years for PWD and 44 ± 12.62 years for spouses. Couples’ average length of relationship was 18 ± 12.50 years. Among the PWD, 54 used a pump only, 12 used CGM only, and 68 used both. Four main themes emerged: 1) diabetes technology facilitates shared diabetes management for couples, 2) diabetes technology facilitates spousal involvement in diabetes care, 3) diabetes technology is a source of relationship tension, and 4) diabetes technology causes positive/negative responses to sleep and alarms. CONCLUSION Overall, couples perceived diabetes technology as having a positive effect on their relationship by increasing collaboration, promoting communication, and reducing diabetes burden and vigilance. Technology also was perceived to increase relationship tension, lifestyle inconveniences, and positive/negative responses regarding sleep and alarms. Involvement of spouses in diabetes technology education should be considered.

As of 2017, more than 30 million Americans—nearly 10% of the population—have diabetes (1). More than 1.5 million new cases of diabetes were diagnosed in 2015 (1). The prevalence of both type 1 and type 2 diabetes is rapidly increasing, and by 2050, diabetes is expected to affect more than one in five adults in the United States (2–5). The economic burden of diabetes is enormous and growing; in 2017, it was estimated to be $327 billion, including $237 billion in direct medical costs (6), a nearly twofold increase from 2007 (3). The 1.25 million American adults living with type 1 diabetes comprise 5.6% of all U.S. adults with a diabetes diagnosis (7). Because these patients are unable to produce sufficient endogenous insulin, they are reliant on exogenous insulin injections for their entire lives. In addition to individuals with type 1 diabetes, roughly 30% of patients with type 2 diabetes also require insulin therapy, typically in the setting of A1C levels that are uncontrolled with oral hypoglycemic agents (8–11). Recently, exorbitant insulin prices have dominated news headlines across the United States. In just 5 years, from 2012 to 2017, the cost of insulin increased by 110% (6). Insulin costs totaled more than $14 billion in 2017, not including required supplies and equipment, which were responsible for an additional $5 billion in costs (6). Beyond the sizeable economic burden of insulin use, long-term insulin administration can also cause a host of problems for patients. In particular, repeated insulin injections and insulin pump use often result in complications and changes in the skin at injection or pump sites (Figure 1) (12). The two most common injection site complications are: 1. Fibrosis, the accumulation of stiff, dense scar tissue at the injection site (Figure 1 A , middle …

Advancements in diabetes technology have improved quality of life and glycemic control in children with type 1 diabetes. However, a subset of children is being left behind. Those from low-income families and non-Hispanic Black (NHB) children are not experiencing these benefits of technology (1,2) and continue to be at higher risk for complications and adverse outcomes through ongoing poor glycemic control (3). As Addala et al. have demonstrated in a study reported in this issue of Diabetes Care (4), this is a serious problem in the U.S., and there has been no sign of improvement in recent years. These data should be a trigger for all of us to reflect on the factors contributing to these disparities and consider our roles in driving meaningful change. In this study, Addala et al. have compared technology use and socioeconomic status (SES) in children aged

OBJECTIVE This study assessed the clinical impact of four treatment strategies in adults with type 1 diabetes (T1D): real-time continuous glucose monitoring (rtCGM) with multiple daily insulin injections (rtCGM+MDI), rtCGM with continuous subcutaneous insulin infusion (rtCGM+CSII), self-monitoring of blood glucose with MDI (SMBG+MDI), and SMBG with CSII (SMBG+CSII). RESEARCH DESIGN AND METHODS This 3-year, nonrandomized, prospective, real-world, clinical trial followed 94 participants with T1D (rtCGM+MDI, n = 22; rtCGM+CSII, n = 26; SMBG+MDI, n = 21; SMBG+CSII, n = 25). The main end points were changes in A1C, time in range (70–180 mg/dL [3.9–10 mmol/L]), time below range ( RESULTS At 3 years, the rtCGM groups (rtCGM+MDI and rtCGM+CSII) had significantly lower A1C (7.0% [53 mmol/mol], P = 0.0002, and 6.9% [52 mmol/mol], P < 0.0001, respectively), compared with the SMBG+CSII and SMBG+MDI groups (7.7% [61 mmol/mol], P = 0.3574, and 8.0% [64 mmol/mol], P = 1.000, respectively), with no significant difference between the rtCGM groups. Significant improvements in percentage of time in range were observed in the rtCGM subgroups (rtCGM+MDI, 48.7–69.0%, P < 0.0001; and rtCGM+CSII, 50.9–72.3%, P < 0.0001) and in the SMBG+CSII group (50.6–57.8%, P = 0.0114). Significant reductions in time below range were found only in the rtCGM subgroups (rtCGM+MDI, 9.4–5.5%, P = 0.0387; and rtCGM+CSII, 9.0–5.3%, P = 0.0235). Seven severe hypoglycemia episodes occurred: SMBG groups, n = 5; sensor-augmented insulin regimen groups, n = 2. CONCLUSIONS rtCGM was superior to SMBG in reducing A1C, hypoglycemia, and other end points in individuals with T1D regardless of their insulin delivery method. rtCGM+MDI can be considered an equivalent but lower-cost alternative to sensor-augmented insulin pump therapy and superior to treatment with SMBG+MDI or SMBG+CSII therapy.

OBJECTIVE To investigate temporal trends and contemporary use of insulin pump therapy and glucose monitoring in type 1 diabetes. RESEARCH DESIGN AND METHODS In a population-based study, we analyzed the use of insulin pump therapy, continuous glucose monitoring (CGM), and self-monitoring of blood glucose (SMBG) from 1995 to 2017 in patients with type 1 diabetes identified from the Diabetes Prospective Follow-up (DPV) database in Germany and Austria. Patients were stratified by age, sex, migration background, and country. RESULTS Among 96,547 patients with type 1 diabetes (median age 17.9 years, 53% males), the percentage using insulin pump therapy increased from 1% in 1995 to 53% in 2017, with the highest rates in the youngest patients (92% in preschoolers, 74% in children, 56% in adolescents aged CONCLUSIONS Since 1995, insulin pump use has continuously increased, and insulin pump therapy is now standard in patients aged

OBJECTIVE The American Diabetes Association recommends individuals with type 1 diabetes (T1D) adjust insulin for dietary fat; however, optimal adjustments are not known. This study aimed to determine 1) the relationship between the amount and type of dietary fat and glycemia and 2) the optimal insulin adjustments for dietary fat. RESEARCH DESIGN AND METHODS Adults with T1D using insulin pump therapy attended the research clinic on 9–12 occasions. On the first six visits, participants consumed meals containing 45 g carbohydrate with 0 g, 20 g, 40 g, or 60 g fat and either saturated, monounsaturated, or polyunsaturated fat. Insulin was dosed using individual insulin/carbohydrate ratio as a dual-wave 50/50% over 2 h. On subsequent visits, participants repeated the 20–60-g fat meals with the insulin dose estimated using a model predictive bolus, up to twice per meal, until glycemic control was achieved. RESULTS With the same insulin dose, increasing the amount of fat resulted in a significant dose-dependent reduction in incremental area under the curve for glucose (iAUCglucose) in the early postprandial period (0–2 h; P = 0.008) and increase in iAUCglucose in the late postprandial period (2–5 h; P = 0.004). The type of fat made no significant difference to the 5-h iAUCglucose. To achieve glycemic control, on average participants required dual-wave insulin bolus: for 20 g fat, +6% insulin, 74/26% over 73 min; 40 g fat, +6% insulin, 63/37% over 75 min; and 60 g fat, +21% insulin, 49/51% over 105 min. CONCLUSIONS This study provides clinical guidance for mealtime insulin dosing recommendations for dietary fat in T1D.

Individuals with type 1 diabetes represent only ∼6% of all patients with diabetes in the United States and require characteristically complex treatment modalities (1). Autoimmune pancreatic β-cell destruction ultimately results in an absolute insulin deficiency, the presence of autoimmune markers, and little to no residual C-peptide (2,3). Additionally, pancreatic α-cell dysfunction is present, resulting in excess glucagon in both the fasting and postprandial states, and the gastric emptying rate is altered in many patients. Exogenous insulin serves as the foundation of therapy for type 1 diabetes and is commonly delivered via a multiple-dose regimen or an insulin pump. The two most common adverse effects associated with insulin use are hypoglycemia and weight gain. Recent data suggest that 68% of people with type 1 diabetes are overweight or obese and that severe hypoglycemia occurs at a rate of 9–20% (4). The latter complication is considered a limiting factor to achieving glycemic targets in the type 1 diabetes population. Indeed, the average A1C for adults ≥18 years of age with type 1 diabetes in the United States was 7.9% in 2015, a value well above the target of 7% recommended by the American Diabetes Association for most adult patients. Further complicating matters, diabetic ketoacidosis (DKA) occurs at a rate of 10% per year in some age-groups (4). Overall, these data suggest a need for adjunctive therapies for type 1 diabetes that reduce the risk for hypoglycemia and weight gain. While β-cell dysfunction is clearly a therapeutic focus for all types of diabetes, multiple other pathways of hyperglycemia present opportunities for alternate treatment modalities that may assist in achieving glycemic targets (5). The ideal pharmacotherapy regimen for a patient with type 1 diabetes would not only target the β-cell dysfunction, but also decrease blood glucose through hyperglycemic pathways independent of β-cell …

According to the Centers for Disease Control and Prevention, 88 million people have prediabetes, and another 34.2 million have diabetes (1). Projections indicate that, by 2060, the number of adults with diabetes in the United States will triple (2). The literature is rife with data indicating that a large majority of people with diabetes fail to reach optimal glucose control despite advances in diabetes care and technology (3). Similarly, a large majority of individuals with prediabetes develop diabetes, despite widespread public health interventions (4,5). Technological advances in diabetes care to address these shortcomings are needed. Since the introduction of continuous glucose monitoring (CGM) more than 20 years ago, rapid advancements in its accuracy, reliability, and ease of use have occurred (6). As CGM technology continues to evolve, it has become clear that appropriate use of CGM can lead to improvements in glycemic control, although assessment of patient preference, willingness to wear a CGM device, potential for adherence, cost, need for alarm features, and ability to integrate with an insulin pump need to be considered for each patient (7). Although use of real-time CGM has improved, rates of adoption remain less than anticipated and lower than what is likely to be beneficial to patients in clinical practice (8). On the other hand, use of flash CGM (sometimes called intermittently scanned CGM) continues to increase rapidly in the United States …

Insulin pump therapy in pediatric type 1 diabetes has been associated with better glycemic control than multiple daily injections. However, insulin pump use remains limited. This article describes an initiative from the T1D Exchange Quality Improvement Collaborative aimed at increasing insulin pump use in patients aged 12–26 years with type 1 diabetes from a baseline of 45% in May 2018 to >50% by February 2020. Interventions developed by participating centers included increasing in-person and telehealth education about insulin pump technology, creating and distributing tools to assist in informed decision-making, facilitating insulin pump insurance approval and onboarding processes, and improving clinic staff knowledge about insulin pumps. These efforts yielded a 13% improvement in pump use among the five participating centers, from 45 to 58% over 22 months.

Introduction: Exogenous insulin antibodies are common in patients with type 1 diabetes mellitus (T1DM) on insulin. However, they are clinically irrelevant as a cause of hypoglycemia. We report a unique case of exogenous insulin antibody-mediated severe hypoglycemia in a patient with T1DM and Cushing syndrome. Case Report: A 55-year-old woman with T1DM on insulin pump presented with proximal muscle weakness and myalgia. She was diagnosed with Cushing syndrome due to an adrenal adenoma. Despite high serum cortisol, she had severe symptomatic episodic hypoglycemia with glucose levels Discussion: Our case highlights the complex nature of glycemic dysregulation in insulin antibody-mediated hypoglycemia. Literature review suggests that binding capacity and affinity to insulin, rather than the quantity of insulin antibodies, determines the severity of hypoglycemia. We hypothesize that high binding capacities in our patient resulted in rapid sequestration of exogenous insulin through formation of immunoglobulin-insulin complexes. The low affinity allowed for subsequent rapid release of insulin in a physiologically dyssynchronous manner resulting in hyperinsulinemic hypoglycemia. A distinctive aspect of our patient is the presence of severe hypoglycemia despite endogenous hypercortisolism, although she responded to prednisone. This finding may have implications for future research. Disclosure M. Amini: None. A. H. Khine: None. S. S. Lamba: None. S. Mishra: None. S. Naing: None. V. Babu: None.

Continuous glucose monitor (CGM) use in diabetes is associated with improved clinical outcomes. However, evidence is lacking on whether changes in outcomes differ by CGM type. We compared clinical events between FreeStyle Libre and Dexcom recipients. We conducted a retrospective study using IBM MarketScan™ Commercial Claims and Medicare Supplemental data on adults (18+ years) with a non-gestational T1D or T2D ICD-10 diagnosis, on rapid-/short-acting insulin (T2D), CGM naive, ≥ 6 months pre-CGM data, and FreeStyle Libre /FreeStyle Libre 14 Day or Dexcom G5/G6 system purchase between Q4 2017 - Q2 2019. After propensity score matching on demographics (age, gender, geography), provider visits, comorbidities, insulin pump, and baseline events, we assessed 6-month acute diabetes events (hyper-/hypoglycemia emergency visits/hospitalizations) and all-cause hospitalization (ACH). Separate analyses were conducted for T1D and T2D. In matched T1D (N=3564) and T2D (N=3930) cohorts, there were no significant differences between FreeStyle Libre and Dexcom in post-CGM diabetes events (Figure). ACH-free survival ranged from 90.4-95.4%, with no significant differences between CGMs. This real-world study of FreeStyle Libre and Dexcom recipients did not find differences in clinical outcomes between CGM types. Disclosure I. B. Hirsch: Consultant; Self; Abbott Diabetes, Bigfoot Biomedical, Inc., Research Support; Self; Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Medtronic. G. J. Roberts: Employee; Self; Abbott. J. Joseph: Employee; Self; Abbott. Y. Nabutovsky: Employee; Self; Abbott, Stock/Shareholder; Self; Abbott. N. Virdi: Employee; Self; Abbott Diabetes, Stock/Shareholder; Self; Johnson & Johnson. E. Miller: Advisory Panel; Self; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk Inc., Research Support; Self; Pendulum Therapeutics, Research Support; Spouse/Partner; Abbott Diabetes.

Youth with type 1 diabetes spend half their waking weekday hours at school, yet little is known about glycemic control in school. Continuous glucose monitor (CGM) metrics for youth age 7-12 during school hours (8AM-3PM) were compared between weekdays and weekends for 14 days pre COVID-19. Youth with >70% CGM wear (n=214) were identified from a large academic center: 96% white, 46% male, mean (SD) age 10.6 (1.5) years, duration 3.5 (2.5) years, HbA1c 7.5 (0.8) %, 63% with an insulin pump. For weekday school hours, median TIR (70-180 mg/dL) was 52.4%;only 34 (15%) of youth met a TIR goal of >70%. Using random coefficient multilevel linear mixed models, TIR in school was significantly associated with younger age (p=0.008), shorter duration (p 180 mg/dL) lower on weekends (p

Incidence of type 1 diabetes (T1D) is increasing in different ethnic groups. Given the rapid evolution of insulin delivery systems, it is important to evaluate their performance in diverse populations. The Control-IQ Observational (CLIO) Study is an IRB-approved, single-arm, longitudinal study evaluating real-world use of the Control-IQ system in people with T1D (PWT1D) who had been prescribed the Tandem t:slim X2 insulin pump with Control-IQ technology. We evaluated relationships between glycemic metrics, diabetes-specific items, and demographic variables at baseline and 3 months after study start for adult participants who had uploaded at least 21 days (21d) of Control-IQ feature usage data to Tandem’s t:connect® web application and had ≥75% CGM use during this time. Impact of baseline factors on glycemic outcomes were analyzed using generalized linear models. In all, 1094 PWT1D (963 Caucasians, 72 Hispanics, 45 African Americans, 25 Asians) were included in the analysis. African Americans had the highest HbA1c at baseline (8.1%) in contrast to the Caucasian majority (7.3%). Glucose Management Indicator (GMI) at 21d reflected significant glycemic improvement across all ethnic groups with Asians showing the lowest GMI (6.77%) followed by Caucasians (6.98%). At 21d, the sensor time in range (TIR) (median) of African Americans (62.7%, IQR=53.4-74.7) was significantly lower than for Caucasians (75.1%, IQR=70.3-81.0) while controlling for age, gender, reported exercise, annual income, and prior therapy (p=0.004). Baseline HbA1c was the key factor predicting TIR at 21d followed by exercise, annual income, and multiple daily injections (prior therapy). We identified disparities in glycemic outcomes across socioeconomic and demographic groups at baseline that remained after initiating an automated insulin delivery system. Nevertheless Control-IQ technology significantly improved glycemic outcomes for all ethnic groups. Disclosure S. Habif: Employee; Self; Tandem Diabetes Care. H. Singh: Employee; Self; Tandem Diabetes Care. L. Mueller: Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. M. L. Manning: Employee; Self; Tandem Diabetes Care. K. N. White: Employee; Self; Tandem Diabetes Care. S. A. Leas: Employee; Self; Tandem Diabetes Care. E. S. Aronoff spencer: None. B. Dokken: Employee; Self; Tandem Diabetes Care, Stock/Shareholder; Self; Tandem Diabetes Care. E. Aronoff spencer: None.

Objective: We evaluated two methods for successful transition from insulin pump to multiple daily injections (MDI) using long-acting insulin degludec (IDeg) in adults with type 1 diabetes (T1D). Methods: After 1 week of run-in-period, adults with T1D > 1 year, using insulin pump for > 6 months, and A1c between 6.5% and 8.5% were randomly transitioned from insulin pump to MDI using either standards of care (stopped insulin pump and started IDeg in 1:1 dose) or overlap (IDeg in 1:1 dose and insulin pump basal were overlapped for first 48 hours; 50% and 75% basal reduction for 24 and 24-48 hours, respectively). Participants wore blinded Dexcom G6 and IDeg dose was not changed during the trial. Percent time in range (70-180 mg/dL) and time below range ( Results: 17 adults (age 35.7±9.1 years, A1c 7.5±0.5%, diabetes duration 21.6±11.8 years, 53% females) were randomized to standard of care, and 13 adults (age 38.2±9.5, A1c 7.2±0.6%, diabetes duration 20.5±13.0, 46% females) were randomized to overlap. Compared to standard of care, patients on overlap transition spent greater time in normoglycemia without increasing hypoglycemia (Figure 1). Conclusion: Overlap of IDeg and insulin pump for first 48 hours results in better glycemic control without increasing hypoglycemia during transition to MDI using IDeg in adults with T1D. Disclosure V. Shah: Advisory Panel; Self; Medscape, Sanofi, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, vTv Therapeutics. H. K. Akturk: Consultant; Self; American Diabetes Association, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, IM Therapeutics, MannKind Corporation, REMD Biotherapeutics, Senseonics, Speaker’s Bureau; Self; American Diabetes Association. H. Joseph: None. N. Schneider: None. J. K. Snell-bergeon: Stock/Shareholder; Self; GlaxoSmithKline plc. Funding Novo Nordisk

Background: Older adults with type 1 diabetes (T1D) have unique health challenges and have not been specifically studied in previous closed-loop (CL) trials. Objective: To assess the efficacy and safety of CL compared with sensor-augmented pump (SAP) therapy in older adults with T1D. Methods: We conducted a two-stage randomized, crossover trial comparing 4 months of CL vs. SAP. Adults aged ≥60 years with T1D ≥10 years and using an insulin pump were eligible. SAP (with continuous glucose monitoring [CGM] alerts and optional insulin delivery suspension on low glucose) and multi-disciplinary education were provided during run-in, then CL and SAP stages were undertaken in random order. The primary outcome was CGM time in range (TIR) 70-180 mg/dL comparing the final 3 months of each stage. Results: Thirty adults (mean±SD age 67±5 years, T1D duration 37±15 years and HbA1c 59±9 mmol/mol [7.6±0.9%]) participated. Ten participants (33%) had impaired awareness of hypoglycemia (Gold score ≥4); all were cognitively healthy, and none met the criteria for frailty. CGM TIR was 75.1±6.3% during CL and 69.0±9.1% during SAP (mean difference 6.2% [95% CI 4.3, 8.0]; p Conclusions: In this trial involving adults with T1D aged ≥60 years, CL increased TIR and reduced time below range compared with SAP, particularly overnight. The therapeutic benefit was evident even with relatively low baseline HbA1c. Further research is needed to understand the long-term clinical benefit. Disclosure S. A. Mcauley: Speaker’s Bureau; Self; Sanofi. N. A. O’regan: None. V. Sundararajan: None. G. M. Ward: None. R. Macisaac: Advisory Panel; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk, Servier Laboratories, Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH, Novo Nordisk. S. Vogrin: None. S. Trawley: None. P. G. Colman: None. S. Fourlanos: Advisory Panel; Self; Pfizer Foundation, Speaker’s Bureau; Self; AstraZeneca, Eli Lilly and Company. C. Grills: None. M. H. Lee: None. A. Mohammad alipoor: None. D. N. O’neal: Advisory Panel; Self; Abbott Diabetes, Medtronic, Sanofi, Research Support; Self; Dexcom, Inc., GlySens Incorporated, Medtronic, Pacific Diabetes Technologies. Funding JDRF (3-SRA-2018-667-M-R); Diabetes Australia

Background: As CMS started to reimburse videovisits during public health emergency, virtual diabetes care became routine for diabetes clinics. Since better diabetes care depends on review of data, at UPMC, we created a workflow to facilitate diabetes data download before virtual visits. Best practices for virtual diabetes data download is not known. Objective: To analyze the diabetes technology data download workflow efficiency in our clinic for virtual visits. Methods: At University of Pittsburgh endocrine clinic, staff reaches out to patients with diabetes who are scheduled for videovisits one week before their appointment with instructions on how to download glucometer, insulin pump and/or CGM data. We completed a retrospective chart review to understand the effectiveness of this workflow in obtaining data before visits. Results: August 2020 to January 2020, our clinic staff reached out to 1197 patients with diabetes via secure portal before their videovisits to obtain diabetes data download. Patients used Tidepool software to download their pumps and glucometers or cloud technology for CGM data sharing. 164(14%) patients were on insulin pump(with or without CGM), 159(13%) patients had a CGM alone and 874(73%) patients had a glucometer alone. 190(15%) patients uploaded their data to Tidepool, 150 (12%) patients shared their CGM data via cloud using their cell phone apps.873(73%) patients did not download their blood sugar data before appointment, most of these patients had glucometer only. The barriers to sharing data virtually were reported by 104 patients. 25/104 (25%) of patients had no access to a computer. 6 patients (5%) reported having a glucometer that does not have compatibility with Tidepool software. 35/104 (32%) of patients reported not having cable to download their data. Conclusion: The most common barrier for patients to share their diabetes technology data was lack of cables. Diabetes clinics should analyze their remote diabetes data workflows to troubleshoot barriers. Disclosure E. Karslioglu-french: None. D. Sistla: None. A. C. Meyer: None.

Objectives: The healthcare utilization benefits associated with insulin pump therapy compared to multiple daily injections (MDI) therapy are not well known. This study sought to compare the impact of using a durable insulin pump versus MDI therapy on healthcare utilization and A1C among individuals with type 1 diabetes (T1D). Methods: This population-based, longitudinal analysis used a large repository of healthcare claims data to compare diabetes-related and all-cause inpatient admissions (IP) and emergency room (ER) visits in individuals with T1D using durable pumps (N=1,286) versus MDI (N=3,854). The study period was June 1, 2017 to July 31, 2019. The study index date was assigned to the first date of pump use in the pump cohort and a random index date was assigned to the MDI cohort. Continuous insurance enrollment 1-year before and 1-year after adoption/index date was required. Generalized linear model regression was used to test the difference-in-difference effect of therapy type on rates of utilization and A1C. The U.S. Agency for Healthcare Research and Quality (AHRQ) Prevention Quality Indicator (PQI) algorithm was used to define diabetes-related utilization. Results: Individuals on insulin pump therapy had a significant decrease in IP utilization compared to little change among individuals using MDI therapy (-41% vs. +3%, p=0.01), and similar decreases in ER utilization (-27% vs. -16%, p=0.64). Combining diabetes-related IP and ER utilization, individuals on insulin pump therapy experienced a decrease of 34% compared to decrease of 8% among those using MDI therapy (p= 0.02). Individuals on insulin pump therapy also experienced a larger decrease in A1C (-7% vs. -1%, p= Conclusions: Compared to MDI therapy, use of a durable insulin pump associated with a significantly smaller increase in diabetes-related healthcare utilization and A1C over time. Disclosure M. Shah: Employee; Self; Medtronic. C. Zhu: Employee; Self; Medtronic. K. Wherry: Employee; Self; Medtronic.

Objective: To evaluate the relationship of six diabetes self-management habits with Hemoglobin A1c (HbA1c) and by race and insurance. Methods: Using the electronic health record (EHR), we incorporated six patient-level diabetes self-management metrics into the clinical workflow for visits. Patients were classified as “performing the habit” if they checked glucose ≥4 times/day or used a continuous glucose monitor; administered ≥3 insulin boluses/day; used an insulin pump; bolused insulin before meals; reviewed data between visits; and changed insulin doses between visits. We then calculated a total habit score. Results: Of 1344 T1D patients seen in 2019, we excluded patients who were new onset (n=57), not on insulin (n=2); missing HbA1c (n=9); or missing documentation (n=64); leaving 1212. HbA1c was significantly lower for those who performed each habit compared with those who did not. For every one-unit increase in total habit score, we found a 0.7% (8 mmol/mol) reduction in HbA1c overall with similar reductions by race and insurance. Conclusions: The six habits are significantly associated with glycemia and will be adopted by T1D Exchange Quality Improvement Collaborative centers to support interventions to improve glycemic outcomes. Disclosure J. M. Lee: Advisory Panel; Self; GoodRx. A. Garrity: None. E. Hirschfeld: None. I. H. Thomas: None. N. Rioles: None. O. Ebekozien: None. S. Corathers: None. Funding T1D Exchange; Brehm Center for Diabetes Research

Objective: To compare the efficacy of low-dose s.c. dasiglucagon to oral carbohydrate consumption for prevention of insulin-induced hypoglycemia in people with type 1 diabetes. Methods: Twenty adults with type 1 diabetes using either multiple daily injection or insulin pump therapy completed a randomized, 3-arm cross-over study. On each study visit, an individualized s.c. insulin bolus was administered aiming for a plasma glucose concentration (PG) of 3.0 mmol/L. When reaching a PG of 4.5 mmol/L, either 80 µg dasiglucagon (D80), 120 µg dasiglucagon (D120) or 15 g carbohydrates from dextrose tablets (CHO) were administered. PG was measured frequently for the following 180 minutes. Results: Ten participants with CHO, 5 with D80 and 4 with D120 experienced a PG less than 3.9 mmol/L during the study (McNemar: CHO vs. D80, p=0.096; CHO vs. D120, p=0.034). The median time (95%CI) from intervention to first increase in PG of 1.1 mmol/L was 30 (25-50), 15 (15-20) and 15 (15-20) minutes for CHO, D80 and D120 (log-rank: CHO vs. D80, p=0.006; CHO vs. D120, p=0.003). No significant differences in visual analog scale-assessed expected adverse effects were observed between interventions. Conclusion: Low-dose dasiglucagon effectively prevented insulin-induced hypoglycemia with a faster glucose-elevating profile than dextrose tablets. Disclosure C. Laugesen: None. A. Ranjan: None. S. Schmidt: None. K. Norgaard: Advisory Panel; Self; Medtronic, Other Relationship; Self; Novo Nordisk Inc., Zealand Pharma A/S, Speaker’s Bureau; Self; Medtronic.

Aim: To identify IPISF occurrence and troubleshooting methods, determine habits and perceptions of diabetes technology use, and assess the history and satisfaction of education in those who utilize CSII. Methods: A 57-item online survey was constructed and included demographic questions, assessment with Likert scales, and open-ended questions regarding infusion sets. Participants were recruited via the T1D Exchange online community database. Statistical analysis was performed using R and JMP. Results: A total of 715 individuals were surveyed including 639 people with diabetes (PwD) and 76 caretakers among 49 states and territories from 09/2020 - 11/2020. Demographics: PwD age 51.6±15.1 years, caretaker age 46.1±7.6 years (dependent PwD age 15.2±11.2 year), 99.6% type 1 diabetes, 69% female, 92% white, CSII use for 14.1±8.5 years, 44% use AID, HbA1c 6.8±0.97%, TIR 72.3±16.1%, TIR3 days. 97% of participants experience IPISF with 41% reporting ≥1 IPISF/month. Following IPISF, participants administered correction boluses using their pump with (41%) and without (44%) changing their failed infusion set. 61% of subjects had not received IPISF education in over a year and 19% had never received IPISF education. For users who experience ≥1 IPISF/month, hyperglycemia and related symptoms were more likely to alert users of IPISF than pump alarms (n=259, p=0.0355). Respondents with ≥1 IPISF/month were also more likely to both feel burned out by their diabetes technology (p Conclusion: Developing technologies that reduce and mitigate IPISF should be a critical focus, especially as extended wear infusion sets become available. Disclosure J. H. Wilcox: Employee; Self; Diatech Diabetes, Inc. J. C. Gray: Employee; Self; Diatech Diabetes, Inc. N. R. Cooper: Employee; Self; Diatech Diabetes, Inc. L. E. Blanco: Employee; Self; Diatech Diabetes, Inc. R. Kelleher: Employee; Self; Diatech Diabetes, Inc. L. M. Vanengelen: Employee; Self; Diatech Diabetes, Inc. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool.

During the transition from multiple daily injections to an insulin pump, diabetic patients need to engage in an intense period of learning to operate their pumps successfully. Inpatient endocrinology consultants note that some new users of insulin pumps fail to manage hyperglycemia correctly and present to the hospital in diabetic ketoacidosis. We found these patients often did not know when to use manual injections instead of their pumps or did not have backup insulin pens or syringes at home. To better understand this issue, a baseline survey of diabetic patients on insulin pumps was conducted from February to September 2020. The survey was administered to 52 subjects identified though appointments scheduled with the diabetes clinic. The questionnaire asked: 1) How would you respond if your sugar remained elevated an hour after administering a correction bolus through the pump? 2) Do you have insulin syringes or pens at home? The first question reflects events that would occur in the setting of an insulin pump failure. Any response that did not include a manual injection was considered incorrect. Our data showed that 85% of respondents had backup insulin supplies. 33% of patients overall responded appropriately to the pump failure scenario. Of the subjects who had insulin supplies, 39% responded correctly. Further analyses revealed that there is a significant relationship between having supplies and responding appropriately to hyperglycemia in pump failure. There was no relationship between patients’ answers and gender or age. Results of this survey will be used to modify the electronic template for diabetes clinic visits in order to help ensure that patients have appropriate supplies and training in identifying pump malfunctions and handling hyperglycemia. As part of this quality improvement project, patients will be surveyed again after implementation of the new template to assess whether the rates of possessing backup insulin supplies and of appropriate responses to hyperglycemia increased. Disclosure A. Yuen: None. V. Tabatabaie: None.

Objective: Pediatric diabetes healthcare providers and parents of youth with type 1 diabetes (T1D) described specific fears regarding nighttime hypoglycemia and behaviors parents engage in at night to avoid nighttime lows (i.e., blood glucose < 70mg/dL). Methods: We completed semi-structured interviews with 10 diabetes providers (i.e., physicians, nurses, educators) and 15 parents of youth with T1D (Mean parent age= 41.92 ± 5.72 years, Mean child age= 10.96 ± 2.37 years). All children used a continuous glucose monitor and 87% used an insulin pump. Providers described the fears and behaviors parents express in clinic related to their child’s overnight glucose management. Parents described their own fears and behaviors specific to nighttime lows. We transcribed interviews verbatim, and used Framework Matrix Analysis to identify common themes among responses. Results: Provider and parent interviews converged on several main themes (provider percentages first, parent percentages second). Regarding specific fears, consensus among participants indicated that parents fear overnight lows will harm their child (i.e., death, seizures; 90%, 87%), parents worry they will not hear alarms or wake up to help their child at night (50%, 93%), and parents fear devices will malfunction at night (20%, 67%). Regarding avoidance behaviors, participants reported that parents provide snacks at bedtime to raise glucose levels (70%, 60%), parents set temporary (lower) basal levels (40%, 53%), under-correct at night 20%, 46%), set multiple alarms to wake up during the night to check on their child (80%, 87%), and do not allow their child to attend sleepovers (30%, 80%). Conclusions: We identified several common fears and avoidance behaviors that may be specific to overnight lows in parents of youth with T1D. As a next step, we will use our qualitative data to inform a new tool to specifically assess parental fear of nighttime hypoglycemia, which will fill a current gap in both research and clinical care for youth with T1D. Disclosure A. Monzon: None. R. Mcdonough: None. C. C. Cushing: None. M. A. Clements: Consultant; Self; Eli Lilly and Company, Employee; Self; Glooko, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc. S. R. Patton: None.

Hypoglycemia occurs frequently in children with type 1 diabetes (T1D). However, the relationship between fear of hypoglycemia (FOH) and use of diabetes technology with different insulin delivery systems has not been well studied. Similarly, little is known about the relationship of diabetes treatment satisfaction with advances in diabetes technology in the pediatric population. Caregivers of children 6-17 years with T1D (n=104, 84% female caregivers, median T1D duration 5.3 years, mean GMI 7.5 ± 0.7%, 93% insulin pump users, 92% CGM users) using any insulin delivery system (8% MDI, 0.05% pump alone, 31% sensor augmented pump, 23% predictive low glucose suspend, 38% hybrid closed loop) completed the Hypoglycemia Fear Survey - Parent (HFS-P) and the Diabetes Treatment Satisfaction Questionnaire - Parent (DTSQ-P). Youth 13-17 years (n=35, 56% males) also completed the HFS - Child (HFS-C) and DTSQ - Child (DTSQ-C). Linear regression was used to look for associations between HFS and DTSQ scores and clinical factors, and paired t-tests were used to compare scores between caregivers and youth. Female caregivers had higher mean HFS Worry and Behavior scores than male caregivers (Worry 1.4 ± 0.18 vs. 0.88 ± 0.16, p=0.004; Behavior 4.9 ± 0.39 vs. 3.9 ± 0.3, p=0.008). Longer duration of diabetes, duration of pump use, and duration of CGM use were all associated with higher mean HFS-C Worry scores, but not with HFS-P Worry scores. The use of different insulin delivery systems was not associated with any HFS scores. Caregivers had a higher mean HFS Behavior score (4.8 ± 0.29) than youth (2.2 ± 0.078) (p Disclosure F. Abdulhussein: None. J. C. Wong: Advisory Panel; Self; Provention Bio, Inc., Research Support; Self; Dexcom, Inc., Tandem Diabetes Care.

Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX. Disclosure J. Fuchs: None. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. N. Davis: None. L. Dimeglio: Advisory Panel; Self; MannKind Corporation. N. Mauras: Advisory Panel; Self; Novo Nordisk, Research Support; Self; LifeScan, Medtronic, Novo Nordisk. R. Besser: None. A. Ghatak: None. S. A. Weinzimer: Advisory Panel; Self; Dompe, Zealand Pharma A/S, Speaker’s Bureau; Self; Medtronic. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Fox: None. L. Kanapka: None. C. K. Boughton: None. C. Kollman: Consultant; Self; Diasome Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. J. Sibayan: None. R. Beck: Consultant; Self; Bigfoot Biomedical, Inc., Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, vTv Therapeutics, Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care. R. Hovorka: Research Support; Self; Abbott Laboratories, Dexcom, Inc., Medtronic, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Stock/Shareholder; Self; CamDiab Ltd. Dan05 consortium: n/a. J. M. Allen: None. M. E. Wilinska: Consultant; Self; CamDiab Ltd. M. Tauschmann: None. L. Denvir: None. A. Thankamony: None. F. Campbell: n/a. R. Wadwa: Consultant; Self; Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care. Funding National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108520)

Background: Insulin pump use is known to improve glycemic control in patients with type 1 diabetes (T1D), however, uptake of insulin pump varies among people in U.S. This study aims to examine the distribution of patient demographics and frequency of clinical outcomes across people using insulin pump. Methods: The analysis included 21,821 T1D patients in the T1D Exchange Quality Improvement (T1DX-QI) database for whom electronic medical record data was available in the T1DX-QI collaborative. Patients over 2 years with at least one completed clinic encounter between January 2014 - February 2020 were included for analysis. Results: In this population, 58% (N=12,729) of T1D patients were insulin pump users, whereas 42% (N=9,092) were non-users. HbA1c levels in the insulin pump group were lower compared to non- users (Mean [SD], %: 8.5 [2.6] vs. 8.9[2.1] [p Conclusions: This study highlights inequities in uptake of insulin pump therapy, while confirming previous findings demonstrating the use of insulin pump in combination with CGMs to be critical in effective management of blood glucose levels in one of the largest multi-center observational studies in the U.S. Disclosure N. Noor: Research Support; Self; Dexcom, Inc. M. A. Clements: Consultant; Self; Eli Lilly and Company, Employee; Self; Glooko, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc. G. T. Alonso: None. S. Rompicherla: None. N. Noor: Research Support; Self; Dexcom, Inc. S. Lyons: None. J. M. Lee: Advisory Panel; Self; GoodRx. M. Gallagher: None. J. A. Indyk: None. O. Ebekozien: None. M. Greenfield: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Real-world evidence describing clinical outcomes in people with T1D using various devices is important to support decision-making. This retrospective study characterized patient-reported clinical outcomes in adults in the United States with T1D before (baseline) and 90 days after (follow-up) the initiation of a tubeless insulin pump (Omnipod® or Omnipod DASH® Insulin Management System). The primary outcome was change in self-reported HbA1c level from baseline to follow-up. Secondary outcomes were change in self-reported total daily dose (TDD) of insulin and self-reported frequency of hypoglycemic events (HE) per week (#/week Disclosure G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. F. Lauand: Employee; Self; Insulet Corporation. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

Introduction: The first Portuguese COVID-19-related state of emergency (SE) extended between March and May 2020. The relevance of achieving the glycemic target for the person with type 1 Diabetes Mellitus (T1DM) is deepened in these circumstances, given the forced changes in daily routine. Objective: To determine the influence of work activity (WA) on glycemic control (GC) of adults with T1DM after the first SE. Material and methods: A retrospective cohort study was designed to enroll adults with ≥2 years from T1DM diagnosis. Cases of pregnancy/hospitalizations in 2019/2020, factors that affect interpretation of glycated hemoglobin (HbA1c) and/or SARS-CoV-2 infections were excluded. The participants were stratified into groups of WA after the SE: g1 (telework/lay-off/students), g2 (retired/unemployed) and g3 (WA without lockdown). HbA1c were obtained from 4 periods: t3 (4/1-6/1/2020); t4 (7/1-9/1/2020); t1 and t2 (homologous periods of 2019). Differences in HbA1c were calculated in both years and compared to each other in the same group and between groups in the same year. Hypoglycemia and insulin regimens (insulin pump and multiple injections daily) were analyzed in intragroup (t3 vs. t4) and intergroup (t3 and t4) comparisons. Results: Two hundred and seven participants were included [106 (51.2%) men; median age of 35 (25;47) years]: 144 (69.6%) in g1, 44 (21.3%) in g2 and 19 (9.2%) in g3. HbA1c increased significantly between t4 and t3 (vs. t2 and t1) in g1 (p=0.001), but not in g2 (p=0.077) and g3 (p=0.744). In 2020, HbA1c raised significantly in the analysis "g1 vs. g3" (p=0.004), but not in "g1 vs. g2" (p=0.213) and "g2 vs. g3" (p=0.083). No differences were reported in 2019, along with all the comparisons involving hypoglycemia and insulin regimens. Conclusions: This study found an overall worsening of GC in participants who returned to higher levels of activity after a total lockdown. This is probably explained by the time spent on T1DM self-care during the lockdown. Disclosure D. Ramalho: None. S. Correia: None. L. Almeida: None. H. Alves: None. G. Rocha: None. M. Ferreira: None. M. J. Oliveira: None.

Hybrid closed-loop (HCL) insulin pump therapy is a promising development for the management of type 1 diabetes (T1D), but little is known about the transition period to HCL in a real-world setting. Here, we present novel data evaluating the HCL transition experience and its effect on diabetes distress. We evaluated 32 out of 150 anticipated participants who were about to transition (Arm A), or had recently transitioned (Arm B), from standard pump therapy to the MiniMed™ 670G HCL pump. Patients completed a baseline and 6-month post-transition diabetes distress survey using the T1-DDS. In the follow-up survey, patients’ trust in HCL and treatment satisfaction were also assessed. Finally, post-survey interviews were conducted for patients to elaborate on the successes and struggles of their HCL transition experience. No significant differences were observed between the 2 arms, so the sample was analyzed as a whole. After 6 months on HCL, significant reductions were observed in overall diabetes distress (p Disclosure A. Dissanayake: None. E. Chow: None. A. White: Advisory Panel; Self; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Canada Inc. J. E. Kapeluto: None. J. Mackenzie-feder: None. B. Schroeder: Advisory Panel; Self; AstraZeneca, Novartis Pharmaceuticals Canada Inc. M. Pawlowska: Advisory Panel; Self; Novo Nordisk.

Over 25% of adults with diabetes have reported rationing insulin in the United States. Emerging adults, ages 18-25, may be even more vulnerable to rationing as they grapple with financial instability during this developmental period of increasing independence coupled with the rising cost of healthcare. The purpose of this study was to explore factors related to insulin and diabetes supply rationing in a sample of emerging adults with type 1 diabetes (T1D). Content analysis was used to examine a single open-ended response to the question, “Please tell me about your experiences rationing insulin or diabetes supplies,” in a parent cross-sectional study. The parent study explored financial stress factors, psychological factors, and self-management outcomes in 413 emerging adults from the T1D Exchange Clinic Registry. Chi-square tests were utilized to understand if rationing (yes or no) differed based on gender, race/ethnicity, employment status, type of health insurance, insulin pump usage, CGM usage, and A1c level (9.0%). Alpha was set at .05. A total of 268 participants responded to the open-ended question about rationing. Over one-third of respondents (N=99, 36.9%) reported rationing insulin or diabetes supplies. Lack of private health insurance X2(3, N=224)=8.38, p Disclosure J. E. Blanchette: Board Member; Self; JDRF, Consultant; Self; Insulet Corporation, Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care, Research Support; Self; Association of Diabetes Care and Education Specialists. V. B. Toly: None. J. R. Wood: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Insulet Corporation, Speaker’s Bureau; Self; Xeris Pharmaceuticals, Inc. M. L. Litchman: Research Support; Self; Abbott Diabetes. Funding Sigma Theta Tau Alpha Mu; Frances Payne Bolton School of Nursing

The Omnipod 5 System is a novel hybrid closed-loop (HCL) system with full on-body operation. A tubeless insulin pump containing a personalized MPC algorithm communicates directly with a Dexcom G6 CGM to automate insulin delivery. Following demonstration of positive safety and efficacy in older children (≥6y) and adults, we evaluated the system in very young children (2-5.9y) with T1D. Preschoolers with T1D often have erratic eating behaviors and may dislike being tethered to devices, and parental concern may lead to permissive hyperglycemia. This HCL system may be ideal for young children, given its customizable glucose targets from 110-150mg/dL, wireless system interaction through a mobile application, and bolus calculator that incorporates CGM trend information. Also, the system has no minimum weight or total daily dose (TDD) requirement. Participants with T1D and A1C180mg/dL was 39.4±16.5%, and ≥250mg/dL was 14.7±12.0%. The same efficacy analysis is planned for the 3-month HCL phase upon its completion in January 2021. This multi-center pivotal study has, to date, demonstrated safety of the Omnipod 5 System in very young children with T1D. At completion, this will be the largest study of HCL in this age group reported to date. Disclosure J. Sherr: Advisory Panel; Self; Cecelia Health, Insulet Corporation, Medtronic, Consultant; Self; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Speaker’s Bureau; Self; Lilly Diabetes. D. W. Hansen: None. T. T. Ly: Employee; Self; Insulet Corporation. Omnipod 5 in preschoolers study group: n/a. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, Medtronic, Nova Biomedical, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanofi, Senseonics, Viacyte, Inc., vTv Therapeutics, Xeris Pharmaceuticals, Inc., Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk, Sanofi, Stock/Shareholder; Self; AgaMatrix, Aseko, Inc., Glytec, LLC. G. P. Forlenza: Advisory Panel; Self; Medtronic, Consultant; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. L. M. Laffel: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompe, Insulogic LLC, Janssen Pharmaceuticals, Inc., Laxmi Therapeutic Devices, LifeScan, Lilly Diabetes, Medtronic, Provention Bio, Inc. S. A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. A. B. Criego: Consultant; Self; Bigfoot Biomedical, Inc., Other Relationship; Self; Sanofi, Research Support; Self; Abbott Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. Funding Insulet Corporation

Background: In phase 3 trials, ultra rapid lispro (URLi) showed superior postprandial glucose control and non-inferior HbA1c reduction compared to Humalog® (Lispro). However, infusion site reactions (combined; ISRs) were more frequent with URLi. Methods: We examined whether occurrence of ISRs was related to any intrinsic or extrinsic factors by analyzing data from the 16-week PRONTO-Pump-2 trial in patients with T1D (URLi, N=215; Humalog, N=217) between randomization and end of treatment period. Results: The most frequently reported adverse events (AEs) were infusion site reaction (URLi, n=41 [19.1%]; Humalog, n=15 [6.9%]) and infusion site pain (URLi, n=34 [15.8%]; Humalog, n=6 [2.8%]). ISRs were reported by 37.7% of patients on URLi and 10.1% on Humalog. Most ISRs with URLi started in the first 4 weeks after randomization, were primarily mild in severity (~76%) and lasted a median of 2-6 days, depending on the type of reaction. Individual ISRs resolved during the study, but another event could occur with a different infusion set/site. Overall, 7 (3.3%) patients discontinued URLi treatment due to ISRs, 6 within the first 4 weeks after randomization and 1 at week 6. Gender, age, BMI, ethnicity, race, infusion set model, bolus speed, total daily dose, duration of diabetes and duration of insulin pump use did not impact incidence of ISRs between treatments. However, significant treatment-by-subgroup interactions were observed for cannula length (6mm vs. >6mm; p=0.070) and region (US vs. non-US; p=0.046): incidence of ISRs with cannula length >6mm and incidence of ISRs in US was similar between treatments, but a higher incidence of ISRs was observed with URLi when cannula length was 6 mm or in non-US regions. Conclusions: Infusion site reaction and infusion site pain were the most frequently reported AEs, although most were mild and resolved in less than a week. Differential treatment effects on ISR occurrence were seen with cannula length or region. Further studies are needed to confirm these findings. Disclosure D. A. Ignaut: Employee; Self; Eli Lilly and Company. J. Cho: None. J. C. Elpers: Employee; Self; Eli Lilly and Company. F. B. Chigutsa: None. C. Piras de Oliveira: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Funding Eli Lilly and Company

The Tandem Diabetes Care® t:slim X2TM insulin pump with Control-IQTM technology is an advanced hybrid closed-loop system, cleared by the FDA in December 2019. To date various studies have demonstrated glycemic and patient-reported improvements using this system. However, there are no published qualitative studies evaluating real-world experiences of using Control-IQ technology. As part of a larger, real-world study involving people with type 1 diabetes (T1D) using Control-IQ technology, we randomly selected and invited participants (Ps) to phone interviews to discuss their experiences using this system. Semi-structured, in-depth interviews were conducted in May-June 2020. They were audio-recorded and transcribed verbatim. Interviews were conducted by two experienced health professionals and lasted an average of 23 minutes (range 9-50 minutes). Interview transcripts were imported into NVivo V.12 for data coding and analysis. Interviews were analyzed using inductive thematic analysis. In all, 27 T1D adults (14 women, 13 men) were interviewed. Four major themes (T) emerged: the initiation phase (T1), successes (T2), and challenges (T3) with Control-IQ technology, and its impact on quality of life (QoL) (T4). Ps reported taking some time to trust the new automated system and “feeling comfortable in letting it do its thing” (T1). Improved sleep quality, glycemic control (HbA1c), and sensor time in range were commonly reported by Ps (T2) along with reduced burden of diabetes management (T2). A few Ps discussed their need for the system to be more aggressive while managing hyperglycemia (T3). Overall, Ps described valuable improvements in their QoL, including reduced stress and decision-making around diabetes management, and increased freedom and spontaneity in daily life (T4). These qualitative findings highlight the significant impact of Control-IQ technology on Ps glycemic control, psychological health, and their ability to engage in daily life activities. Disclosure H. Singh: Employee; Self; Tandem Diabetes Care. M. Mcelwee-malloy: Employee; Self; Tandem Diabetes Care. H. Sanchez: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.

Background: Reliable insulin delivery is critical in the management of type 1 diabetes. Limitations of insulin pump therapy (IPT) are the maximum cannula life of three days, and a reported failure rate of 15-25% prior to this, which may impact glycemia and quality of life. Objective: We aimed to determine the feasibility of a prototype cannula for an extended wear infusion set. Materials and Methods: CapBio’s SteadiFlow technology (Capillary Biomedical, Irvine, CA, USA) consists of a cannula with a soft outer polymer reinforced by an internal metal coil to prevent kinking and three additional side ports to reduce the risk of cannula blockages. Adults with type 1 diabetes using IPT participated in a study with three study periods. For each period a new infusion set was inserted for an intended wear of 7 days. During Period 1 saline was infused via the investigational set through an additional insulin pump. During Periods 2 and 3 insulin lispro was delivered via the investigational set connected to the participant’s own insulin pump. Results are expressed as mean (SD). Results: Twenty participants (Medtronic 640G [n=11]; 670G [n=3]; Tandem t-slim X2 [n=6]) with type 1 diabetes (age 44Y [14]; HbA1c 7.3% [0.6]/56mmol/mol [6]; female 50%) were studied. The 7-day survival rates of the prototype cannula set were 19/20 (95%) for period one and 36/41(88%) for periods two and three combined. No serious adverse events were reported. Mild infusion site reactions occurred in 7 participants. Hyperglycemia was reported as an adverse event in 7 participants resulting in premature cannula removal in 4 cases (occurring, respectively, on Days 1, 2, 5, and 6 during Weeks 2 or 3). Infusion site infection caused the 5th premature removal (on Day 3). Post-removal, no kinked cannulas were observed. Conclusions: These study results confirm the feasibility of the extended-life investigational cannula. Larger, randomised studies are required to confirm these preliminary observations. Disclosure D. N. O’neal: Advisory Panel; Self; Abbott Diabetes, Medtronic, Sanofi, Research Support; Self; Dexcom, Inc., GlySens Incorporated, Medtronic, Pacific Diabetes Technologies. N. Venkatesh: None. K. Brown: None. E. I. Ekinci: None. S. Fourlanos: Advisory Panel; Self; Pfizer Foundation, Speaker’s Bureau; Self; AstraZeneca, Eli Lilly and Company. J. R. Kastner: None. R. Macisaac: Advisory Panel; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk, Servier Laboratories, Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH, Novo Nordisk. D. B. Muchmore: Consultant; Self; Capillary Biomedical, Inc., Diasome Pharmaceuticals, Inc., Zucara Therapeutics Inc., Stock/Shareholder; Self; Capillary Biomedical, Inc., Diasome Pharmaceuticals, Inc.

This study aims to assess the interoperability of Diabeloop’s DBLG1 Closed Loop System on glycemic control for T1D patients, based on data from clinical trials NCT02987556[1] (SP7) and NCT04190277 (SP8). SP7 study was conducted on 63 out of 68 patients randomly assigned to two arms equipped with DBLG1 system using Cellnovo pump for arm 1 and Kaleido pump for arm 2. All patients attended a 12-week open loop (OL) phase (receiving their usual treatment) and a 12-week closed loop (CL) phase (using DBLG1 system). In SP8 study, 178 out of 184 patients, randomly assigned to two arms, started with a 2-week baseline phase in OL. The next 12 weeks, patients in arm 2 remained in OL while patients in arm 1 switched to CL equipped with DBLG1 System using DANA Diabecare-i insulin pump. The study was shortened due to COVID-19 epidemic. To assess the improvement reached by DBLG1 System, we compared the average time in range 70-180 mg/dL (TIR) between OL and active CL phases. For SP7 study, we analysed data from both arms. For SP8 study, to assess the TIRs for the same patients, we compared baseline and CL phases for arm 1. As shown in Figure 1, for SP7 the average TIRs increased by 8.6% for arm 1 (32 patients) and by 14.0% for arm 2 (31 patients in CL, 30 in OL). For SP8 arm 1 the average TIR increased by 12.8% (142 patients). DBLG1 System improved the TIR despite the use of 3 different pumps. Therefore, improvement linked with DBLG1 System on the average TIR is independent of the pump used. Disclosure A. Adenis: Employee; Self; Diabeloop SA. L. Pou: Employee; Self; Diabeloop SA. H. M. Romero-ugalde: Employee; Self; Diabeloop SA. Y. Tourki: Employee; Self; Diabeloop SA. S. Franc: Advisory Panel; Self; Diabeloop SA, Board Member; Self; Novo Nordisk, Other Relationship; Self; Abbott Diabetes, Research Support; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Diabeloop SA. G. Charpentier: Other Relationship; Self; Diabeloop. P. Y. Benhamou: Consultant; Self; Diabeloop SA, Eli Lilly and Company, Insulet Corporation, Other Relationship; Self; Abbott Diabetes. M. Doron: Research Support; Self; Diabeloop SA. E. Huneker: Employee; Self; Diabeloop SA.

Background: Management of type 1 diabetes (T1D) involves achieving glycemic targets to avoid complications. However, despite advancements in diabetes technology and standards, achieving adequate glycemic control in children and adolescents remains a challenge. This study aims to identify factors associated with optimal glycemic targets of Methods: The analysis included 9,991 T1D patients (1-18 years) from eight sites in the T1D Exchange Quality Improvement (T1DX-QI) database for whom electronic health record data was available with at least one completed clinic encounter between July 2017-July 2020. Results: Among those with hemoglobin A1c 7% [p Conclusions: This study highlights real-world challenges and social disparities in achieving optimal glycemic control. A combination of CGM and insulin pump device use is beneficial for the effective management of blood glucose levels. T1Dx-QI sites are implementing best practices to improve optimal outcomes. Disclosure O. Ebekozien: None. E. L. Ospelt: None. M. K. Kamboj: None. T1dx-qi collaborative: n/a. N. Noor: Research Support; Self; Dexcom, Inc. B. Seyoum: None. S. Majidi: Advisory Panel; Self; Companion Medical. N. Jones: Consultant; Self; Companion Medical, Medtronic. R. Mcdonough: None. J. Sanchez: None. A. Kim: None. R. Izquierdo: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

The hybrid closed-loop (HCL) insulin delivery system is at the forefront of continuous subcutaneous insulin infusion technology. However, to our knowledge, no studies to date have compared inpatient glycemic control between the HCL and non-HCL delivery systems of the HCL insulin pumps. We aim to compare the efficacy and safety of glycemic control between these two insulin delivery systems in the hospital setting. We are performing a prospective study on patients using a HCL insulin pump who are admitted to a non-critical care floor. We included patients who were ≥18 years of age, diagnosed with type 1 or type 2 diabetes, on a HCL insulin pump for more than 4 weeks, and admitted for ≥2 days. The primary outcome is the comparison of percentage of point of care blood glucose readings between 70 and 180 mg/dL in the HCL system versus the non-HCL system. Secondary outcomes include percentage of glucose readings >180 mg/dL and Here, we report preliminary findings of 9 patients using the non-HCL system and 4 patients using the HCL system (Table 1). In the HCL group, >70% of the time was spent in the target blood glucose range of 70-180 mg/dL, 180 mg/dL, and Disclosure Y. Tsushima: None. A. Iqbal: None. J. F. Bena: None. M. Lansang: Consultant; Self; Sanofi. Research Support; Self; Dexcom, Inc.

Clinical outcomes describing real-world use of various devices by people with T1D are important to support decision-making. This retrospective study characterized patient-reported clinical outcomes in youth in the United States with T1D before (baseline) and 90 days after (follow-up) the initiation of a tubeless insulin pump (Omnipod® or Omnipod DASH® Insulin Management System). The primary outcome was change in self-reported HbA1c from baseline to follow-up. Secondary outcomes were change in self-reported total daily dose (TDD) of insulin and frequency of hypoglycemic events (HE) per week (#/week Disclosure D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. F. Lauand: Employee; Self; Insulet Corporation. L. M. Huyett: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation, Stock/Shareholder; Self; Insulet Corporation. T. T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

Background: The use of continuous subcutaneous insulin infusion (CSII), or insulin pump therapy, has been shown to improve glycemic control in patients with type 1 diabetes (T1D), however, there is limited real-world evidence on the rates of insulin pump use and impact on glycemic control across age groups in the U.S. This study aims to examine A1c trends among insulin pump users in one of the largest U.S. based population-based cohorts of people with type 1 diabetes. Methods: The analysis included 15,113 patients in the T1D Exchange Quality Improvement (T1DX-QI) database for whom electronic medical record data was available from eight endocrinology clinics participating in the T1DX-QI collaborative. Patients with at least one completed clinic encounter from 2017-2020 were included in this analysis. Results: In this population, 73% (N=11,046) of T1D patients were insulin pump users, whereas 27% (N=4,067) were non-users. Insulin pump use during the years of 2017 through 2020 remained constant in the range of 74%-76%. Mean Hba1c among insulin pump users was lower than for non-users (Mean [SD]: 8.0 [1.7] vs. 8.6 [1.8] (p Conclusions: This study highlights the benefit of uptake of insulin pump therapy to achieve better glycemic control across all groups using one the largest real-world databases for people with T1D. Disclosure N. Noor: Research Support; Self; Dexcom, Inc. O. Ebekozien: None. S. Corathers: None. R. Mcdonough: None. E. Carlson: None. A. B. Mekhoubad: None. S. Hsieh: None. C. Demeterco-berggren: None. S. Majidi: Advisory Panel; Self; Companion Medical. M. Desimone: None. K. Obrynba: None.

Insulin pumps provide an alternative way to conveniently and effectively bring blood glucose level under control. However, insulin pump users often face unexpectable failure of insulin delivery despite the lack of pump occlusions or insulin denaturing. One possible reason for this loss of insulin efficacy is due to phenolic excipients in insulin formulations that can induce cell death and inflammation. Here, we propose an electrochemical method that removes the phenol and m-cresol from insulin to preserve the longevity of the insulin and pump site. To achieve our goal, we modified carbon fiber paper electrodes with polydopamine to increase its hydrophilicity and introduce reaction site. Poly-L-lysine (PLL) was further covalently bound to polydopamine coating, reducing undesirable protein interactions. To reduce electrode passivation and fouling due to phenol deposition on the electrode, we incorporated copper ions to the PLL to form a PLL-Cu complex that mimics the catalytic center of tyrosinase, facilitating the conversion of phenolic compound to a more soluble quinone oxidation product rather than insoluble polyphenols. Figure shows the electrochemical modification scheme as well as cyclic voltammograms and chronoamperometric curves of 30 mM phenol in PBS buffer with 20 mg/mL glycerol on various electrodes at an applied potential of 0.75 or 0.6 V (stirring rate: 1100 min−1). Disclosure S. Pennathur: Employee; Self; Laxmi Therapeutic Devices. L. Zhou: None. F. Lorestani: None. A. Eden: None. D. Huber: None. Funding American Diabetes Association/Pathway to Stop Diabetes (1-17-VSN-18 to S.P.)

Young adults (YA) with type 1 diabetes (T1D) transfer from pediatric to adult diabetes care during a time when many of them experience suboptimal glycemic control. To determine the factors impacting glycemic control in YA transitioning to adult care, we conducted a retrospective study of YA (age 17-30 years) with T1D establishing care at an adult tertiary diabetes-only clinic. Demographic, clinical characteristics, A1c at first visit, use of insulin pump or continuous glucose monitor (CGM), referral center, and insurance information were collected from the electronic medical record. Among 329 YA with T1D (55% female, 75% white, 40% on CGM, 55% on insulin pump), average age of transition was 23±3 years and mean A1c at first visit was 8.5±1.6%. We divided YA by A1c at first visit as ≤7.5% (n=96) and A1c≥8.5% (n=130). Patients with better glycemic control (A1c Disclosure K. Flint: None. M. Bennetti: None. A. Atakov-castillo: None. E. Toschi: Consultant; Self; Medtronic. Funding Steven M. and Joyce E. Tadler Charitable Trust

Controlled in-patient studies indicate that high fat/protein meals require more insulin coverage than low fat meals with similar carbohydrate (CHO). However, it is unclear how dietary macronutrient content impacts on glycemic responses and insulin requirements in free-living T1D individuals. Adults with T1D (n=25) (mean±SD age 52±15 yrs, A1C 7.1±0.7%, 39% female) on insulin pump and continuous glucose monitoring (CGM) were enrolled in this 18-week duration study. Participants ate meals with specific macronutrient content (high glycemic index [GI], high fat [HGI-HF]; high GI, low fat [HGI-LF]; low GI, high fat [LGI-HF]; low GI, low fat [LGI-LF]). Meal, CGM, and insulin dosing data were reviewed by the study investigator, who provided dose optimization recommendations. Participants provided dosing and CGM data from 463 meals. Time-in-range (TIR) was similar for all meal types (table, p=0.72). LGI meals required significantly more insulin than HGI meals (p=0.01). Significantly more insulin per gram of CHO was used for LGI-HF vs. all other meal types (mean CHO-to-insulin ratio = 4.5 vs. 8.7 for HGI-HF, 7.6 for HGI-LF, and 5.5 for LGI-LF; p= 0.02). This exploratory study in free-living individuals with T1D highlights the complexity of mealtime insulin dosing, pointing to the need for bolus advisors that incorporate other dietary inputs in addition to CHO. Disclosure S. S. Edwards: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. W. Wang: Employee; Self; Eli Lilly and Company. E. Toschi: Consultant; Self; Medtronic. A. Atakov-castillo: None. R. Dewar: None. G. M. Steil: Consultant; Self; Abbott Diabetes, Eli Lilly and Company. H. Wolpert: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company

Recent understandings of the role of leptin in glucagon and glucose homeostasis, have flagged it as a target for management of type 1 diabetes (T1D). While historically thought to be involved in long-term regulation of appetite and energy expenditure, leptin is now known to regulate food absorption, mucus secretion, intestinal motility and inflammatory processes. Leptin was shown to directly inhibit glucose uptake and reduce glucagon levels and insulin requirements in NOD mice, to ameliorate hyperglycemia in a T1D mouse model, and reduce insulin requirements in patients with insulin-resistant diabetes. Leptin-based drugs are currently only available in injectable forms, and suffer from a short half-life in the circulation. ORMD-0701 is an oral leptin drug, specially formulated to protect the active ingredient from degradative forces in the gut and enhance its uptake across the intestinal mucosa. This first-in-human study assessed the short-term effects of a single ORMD-0701 dose (3 mg leptin) administered to fasting patients with T1D. Patients on an insulin pump and with glucose levels >100 mg% and Disclosure M. Kidron: Employee; Self; Oramed Pharmaceuticals, Inc., Stock/Shareholder; Self; Oramed Pharmaceuticals, Inc. S. Perles: Employee; Self; Oramed Ltd. R. Weiss: Consultant; Self; Lilly Global Health Partnership, Medtronic, Speaker’s Bureau; Self; Novo Nordisk.

OBJECTIVE To investigate the effect of metformin on testosterone levels in men with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS Seventy men with newly diagnosed drug-naive T2DM and HbA1c >9.0% (75 mmol/mol) were treated with intensive insulin pump therapy for 5 days to achieve glucose normalization. They were randomized to control (continued on intensive insulin only) and metformin (plus metformin) groups (1:1) for 1 month. Testosterone was measured at baseline, randomization, and after 1-month treatment. RESULTS Total, free, and bioavailable testosterone increased significantly within 5 days (all P < 0.001). After 1 month, compared with the control group, the metformin group had lower total (12.7 vs. 15.3 nmol/L), free (0.20 vs. 0.24 nmol/L), and bioavailable (4.56 vs. 5.31 nmol/L) testosterone (all P < 0.05). CONCLUSIONS In men with T2DM, 1-month oral metformin may decrease serum testosterone levels independent of blood glucose control. The effects of long-term metformin on testosterone in men need further study.

CamAPS FX (CamDiab, Cambridge, U.K.) is a hybrid closed-loop app hosting the Cambridge closed-loop algorithm on an Android smartphone, and it is approved in the European Union for use in children ≥1 year and adults (including during pregnancy) with type 1 diabetes (T1D). The interoperable CamAPS FX app receives glucose data from a compatible continuous glucose monitoring system (Dexcom G6; Dexcom, San Diego, CA), connects to a compatible insulin pump (Dana Diabecare RS and DANA-i; Sooil, Seoul, South Korea) to direct glucose-responsive insulin delivery every 8–12 min, includes a bolus calculator allowing discrete bolusing via the app, and streams data in real time to cloud-based diabetes data repositories (Diasend/Glooko, Gothenburg, Sweden). It is currently unknown how much time different user cohorts spend interacting with hybrid closed-loop systems. We aimed to investigate usage patterns of the CamAPS FX app across different populations by considering the amount of time a person spends using the app over a 24-h period. We noted time spent within the CamAPS FX app over an 11-week period from February to May 2020 in 134 individuals from six ongoing clinical studies. Each study involved a different demo graphic cohort: very young children (1–7 years) in which caregivers use the app (NCT03784027, ClinicalTrials.gov), children and adolescents (6–19 years) (NCT02925299), adolescents (10–17 years) using the closed-loop system from diagnosis of T1D (NCT02871089), adults (≥18 years) (NCT04055480), pregnant women (≥18 years) (ISRCTN56898625, www.isrctn.org), and older adults (≥60 years) (NCT04025762). All studies received regulatory and ethical approval; participants/guardians signed informed consent. User engagement is the duration of time that users have the application active and in the foreground, as calculated by an analytics cloud platform (Firebase; …

OBJECTIVE To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes). RESEARCH DESIGN AND METHODS Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70–180 mg/dL) during the final 3 weeks. RESULTS Participants were randomized to HCL (n = 61) or control (n = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA1c was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19]; P < 0.0001). For HCL, HbA1c was lower (median [95% CI] difference −0.4% [−0.6, −0.2]; −4 mmol/mol [−7, −2]; P < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9]; P < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively. CONCLUSIONS In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA1c, and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.

OBJECTIVE To determine the effect of the sodium–glucose cotransporter 2 inhibitor dapagliflozin on glucose flux, lipolysis, and ketone body concentrations during insulin withdrawal in people with type 1 diabetes. RESEARCH DESIGN AND METHODS A double-blind, placebo-controlled crossover study with a 4-week washout period was performed in 12 people with type 1 diabetes using insulin pump therapy. Participants received dapagliflozin or placebo in random order for 7 days. Stable isotopes were infused to measure the glucose Ra, Rd, and lipolysis. At isotopic steady state, insulin was withdrawn, and the study was terminated after 600 min or earlier if blood glucose reached 18 mmol/L, bicarbonate 5.0 mmol/L. RESULTS At baseline, glucose Ra was significantly higher for the dapagliflozin group than the placebo group. Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose Rd area under the curve (AUC)0–180 min and β-hydroxybutyrate (BOHB) AUC0–180 min were significantly higher. There was a small but significantly higher glycerol Ra (measure of lipolysis) AUC0–180 min with dapagliflozin. Nonesterified fatty acid concentrations were not different between treatments. When divided by BMI >27 and CONCLUSIONS During insulin withdrawal, the increase in BOHB with dapagliflozin may be partially due to increased lipolysis. However, reduced renal excretion, reduced BOHB uptake by peripheral tissues, or a metabolic switch to increased ketogenesis within the liver may also play a role.

The target time in range (TIR) for pregnant women with type 1 diabetes (T1D) by the International Consensus on TIR is 70% between 63-140 mg/dL. This is difficult to achieve and is rarely met in the literature. Insulin use increases during pregnancy, but prospective data and guidance on pump setting adjustments are limited. Insulin pump delivery and CGM data for 17 T1D women from 3 U.S. sites were prospectively collected every 2 weeks as part of the LOIS-P trial. Subjects enrolled before 17 weeks gestational age (GA) and wore personal pumps and study Dexcom G6 CGM. Changes in mean daily total, basal and bolus doses per kilogram, and TIR for every 2 weeks GA are reported, and linear mixed effects regression models are used for evaluation across trimesters. Enrollment HbA1C was 6.4±0.8%. Total daily dose increased from 0.68 to 0.73 to 0.98 U/kg during the first, second and third trimesters, respectively (p70% TIR during pregnancy. Time below target was 5%, 4% and 2%. Doses trended upwards around 24 weeks GA. Postpartum doses decreased significantly. While insulin doses were increased significantly across pregnancy, most subjects did not achieve > 70% TIR. Systems that are customized to this population’s targets with changing insulin sensitivity are needed. Disclosure G. O’Malley: Research Support; Self; Abbott, Dexcom, Inc. B. Ozaslan: None. C. Levister: None. M. Trinidad: None. K.N. Castorino: Research Support; Self; Abbott, Dexcom, Inc., Medtronic, Mylan, Novo Nordisk Inc. D. Desjardins: None. M. Church: None. B.H. Smith: None. S.J. Ogyaadu: None. M. Piper: None. C. Reid: None. S.K. McCrady-Spitzer: None. R. Kaur: None. W.K. Kremers: Research Support; Self; AstraZeneca. F.J. Doyle: Research Support; Self; DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Mode AGC. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. J.E. Pinsker: Advisory Panel; Self; Medtronic. Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. C.J. Levy: Consultant; Self; Dexcom, Inc. Employee; Spouse/Partner; Allergan plc. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation. B. Rosenn: None. Y.C. Kudva: Research Support; Self; Dexcom, Inc., Roche Diabetes Care. Other Relationship; Self; Abbott. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. Funding National Institutes of Health (R01DK120358); Dexcom, Inc. (AP-2018-016)

Background: Carbohydrate counting is used to determine prandial insulin doses in pediatric diabetes management. Benefits to carbohydrate counting include improved glycemic control, improved diabetes-specific quality of life, and improved coping ability in daily life. Patients self-report knowledge and comfort in carbohydrate counting, but we have no quantifiable way to determine the accuracy of this self-report. Thus, we implemented nutrition quizzes with photos of popular foods to assess fundamental knowledge of carbohydrate counting. Methods: Pictorial nutrition quizzes were developed to review basic, intermediate and advanced fundamentals of carbohydrate counting. The nutritionist administered the quizzes to children >8 years of age, as part of regular outpatient diabetes follow-up visits. Children completed the quizzes independently and were allowed to use their insulin pump and phone to calculate insulin doses. Quiz responses and scores were recorded, in addition to visit hemoglobin A1c (HbA1c). Demographic and clinical data were extracted from the electronic medical record. Results: Nutrition quizzes were completed by 103 youth (99 with T1D, 4 with T2). Mean age was 14.2 (SD 2.6), 44% female, 70% White, mean duration of diabetes 6 y (SD 4). 65% used insulin pumps, 68% used CGMs. All patients (n=103) completed 1 quiz, and 31 completed more than 1 quiz (range 2-5 quizzes). Patients with better glycemic control scored higher on nutrition quizzes. Mean A1c at initial quiz administration was 9%, and at follow-up was 8.6% (p=0.4). Conclusion: Pictorial nutrition quizzes engage children and adolescents with diabetes in reviewing the fundamentals of carbohydrate counting and provide opportunity for nutrition intervention during routine diabetes clinical care. Disclosure M.R. Thivierge: None. M. Waheed: None. M. Seel: None. R. Wolf: None.