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Background: Safety and effectiveness outcomes of individuals using the MiniMed™ 780G system with the no-calibration Guardian™ 4 sensor during the first three months of use were analyzed. Methods: Participants (N=176, aged 7-75 years) with T1D used the Conformitè Europëenne-marked MiniMed™ 780G system. Safety and effectiveness endpoints (mean A1C, sensor glucose [SG], percentage of time spent at SG ranges and glucose variability) were collected over three months and summarized. Endpoints were also assessed when recommended settings (target of 100mg/dL and active insulin time of 2-3 hours) were used. Results: There was no DKA or severe hypoglycemia. At 3 months, A1C was 7.1% (N=164) , 7.2% (N=101) and 6.8% (N=63) for overall, pediatric and adult participants, respectively. Additional glycemic metrics are shown (Table) . With recommended settings, time spent in target range (TIR, 70-180 mg/dL) was 74.7% (N=119) , 72.7% (N=65) and 77.0% (N=54) , respectively, and time spent below range (TBR Conclusion: This analysis demonstrates that individuals safely exceeded international consensus-recommended TIR and TBR goals when using the MiniMed™ 780G system with the Guardian™ 4 sensor. These results mirror those of the pivotal trial during use of the calibration-requiring Guardian™ sensor 3. Disclosure R. A. Vigersky: Employee; Medtronic. C. Pihoker: None. R. Pop-busui: Advisory Panel; Averitas Pharma, Inc., Boehringer Ingelheim International GmbH, Nevro Corp., Novo Nordisk, Reata Pharmaceuticals, Inc., Regenacy Pharmaceuticals, Inc. J. Reed: None. J. Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Cecelia Health, Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Consultant; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Jaeb Center for Health Research, JDRF, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Speaker’s Bureau; Lilly Diabetes. D. I. Shulman: Advisory Panel; Medtronic. R. H. Slover: None. J. Thrasher: Advisory Panel; Eli Lilly and Company, Medtronic, Board Member; Medtronic, Consultant; Eli Lilly and Company, Medtronic, Research Support; Eli Lilly and Company, Medtronic, Novo Nordisk, Speaker’s Bureau; Bayer AG, Eli Lilly and Company, Medtronic, Sanofi. X. Chen: Employee; Medtronic, Medtronic. M. Liu: None. T. L. Cordero: Employee; Medtronic, Medtronic. B. W. Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker’s Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. M. Vella: Employee; Medtronic. A. S. Rhinehart: Employee; Medtronic, Stock/Shareholder; Medtronic. J. Shin: Employee; Medtronic. R. L. Brazg: Research Support; Abbott Diabetes, Lilly Diabetes, Medtronic, Novo Nordisk, Roche Diagnostics, Senseonics. B. A. Buckingham: Advisory Panel; Arecor, Lilly Diabetes, Medtronic, Other Relationship; Insulet Corporation, Research Support; Insulet Corporation, Lilly Diabetes, Medtronic. A. L. Carlson: Advisory Panel; MannKind Corporation, Employee; Bright Health Group, Other Relationship; Medtronic, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, UnitedHealth Group. K. B. Kaiserman: Advisory Panel; Medtronic, Consultant; Medtronic, Employee; MannKind Corporation, Research Support; Medtronic, Speaker’s Bureau; Medtronic, Stock/Shareholder; MannKind Corporation. M. Kipnes: None. D. R. Liljenquist: None. A. Philis-tsimikas: Advisory Panel; Bayer AG, Novo Nordisk, Research Support; Lilly Diabetes, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Viking Therapeutics.

As there is a pressing need for better treatment options for type 2 diabetes (T2D) , it is crucial to explore new technologies such as automated insulin delivery (AID) in this population. Little is known about how successful these systems will be in T2D, especially over a longer duration of use. The safety and practicability of the Omnipod 5 AID System in adults with T2D was previously demonstrated during an 8-week outpatient feasibility trial. Those completing this initial study were invited to continue system use for an additional 26 weeks to assess longer-term efficacy. We present results from the first 13-week follow-up assessment of the extension study. In the initial study, adults with T2D (A1C >8%) previously on either basal-only (n=12) or basal-bolus insulin injections (n=12) , with or without CGM, used AID for 8 weeks following 14 days of their standard therapy. Those participating in the extension study continued AID use, and A1C was measured again after 13 weeks (21 weeks of total AID use) . Efficacy was assessed by change in A1C from baseline. Most participants (N=22, 92%) continued into the extension phase. Two of these participants had completed the initial study before the extension study was available but were allowed to re-join, resulting in a 2-4-month return to their standard therapy before resuming AID. Participants were aged (mean±SD) 61±8y with BMI 33.9±4.4kg/m2, diabetes duration 19±9y, and baseline A1C 9.4±0.9% (range: 8.1-11.7%) . Mean A1C decreased to 8.0±0.7% after 8 weeks of AID (p Disclosure G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. B.W.Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker's Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. A.L.Carlson: Advisory Panel; MannKind Corporation, Employee; Bright Health Group, Other Relationship; Medtronic, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, UnitedHealth Group. B.Dumais: Employee; Insulet Corporation. T.Vienneau: Employee; Insulet Corporation, Stock/Shareholder; Dexcom, Inc., GlaxoSmithKline plc., Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. T.T.Ly: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. Funding This study was funded by Insulet Corporation.

Two retrospective chart review studies evaluated the effectiveness of the FreeStyle Libre® Flash Glucose Monitoring System on HbA1c when used by adults with type 2 diabetes (T2D) in a real-world setting. Each study aimed to determine the effect of FreeStyle Libre when used for between 3 months to 6 months on HbA1c. Each study population included adults on a basal insulin regimen for at least 1 year who had been using FreeStyle Libre regularly for at least 3 months and with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol). Pregnant patients were excluded, as were patients on dialysis. This meta-analysis comprised of a total of 191 records from basal insulin using patients with T2D from 14 medical centers across Canada and the US. On average, HbA1c was 9.2±1.0% (76.8±10.7 mmol/mol) prior to FreeStyle Libre use, age was 60.0±11.3 years and average duration of insulin use 4.3±3.3 years (mean±SD), 95.8% of patients were on oral antidiabetic medications and 60.2% were male. Renal and CVD complications were reported by 31.4% and 28.3% of patients, respectively. HbA1c results were recorded between 90 and 194 days from the start of use of FreeStyle Libre, between December 2017 and March 2020. Overall mean change in HbA1c, after at least 3 months of using FreeStyle Libre, was significantly reduced by 1.1±0.14% (mean±SE); p This meta-analysis of two real-world, chart review studies concludes that people with T2D on basal insulin therapy, using FreeStyle Libre for between 3 to 6 months significantly reduced HbA1c. Disclosure A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. T. D. Daniel: Advisory Panel; Self; Abbott Diabetes, Bayer Healthcare Pharmaceuticals Inc. A. Desantis: None. S. Jabbour: None. E. Karslioglu-french: None. D. F. Kruger: Advisory Panel; Self; Abbott Diabetes, Novo Nordisk, Sanofi US, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Novo Nordisk, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Stock/Shareholder; Self; Pendulum Therapeutics. 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. K. Ozer: Research Support; Self; Abbott Diabetes, AbbVie Inc., Eli Lilly and Company, Novo Nordisk, Senseonics, Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk. T. Elliott: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk, Other Relationship; Self; Abbott Diabetes. Funding Abbott Diabetes Care

This retrospective, real-world, chart review study determined the effectiveness of the FreeStyle Libre® Flash Glucose Monitoring System on HbA1c when used by adults with type 2 diabetes (T2D) in a real-world setting between 3 months to 6 months after starting FreeStyle Libre. The study population included adults on a basal insulin regimen for at least 1 year, with HbA1c between 8.0 and 12.0% (64 to 108 mmol/mol), using FreeStyle Libre regularly for at least 3 months. Pregnant patients were excluded, as were patients on dialysis. A total of 100 records from basal insulin using patients with T2D from 8 clinical sites in the US were included in this chart review. Mean HbA1c was 9.4±1.0% (79.2±11.1 mmol/mol), prior to FreeStyle Libre use, age was 56.0±10.3 years, BMI was 36.1±7.8 kg/m2 and average duration of insulin use 4.5±3.5 years (mean±SD); 96.0% of patients were on oral anti-diabetic medications in addition to basal insulin and 52.0% were male. HbA1c results were recorded between 90 to 194 days from the start of use of FreeStyle Libre, between December 2017 and March 2020. To minimise selection bias records were selected on a systematic basis. After at least 3 months of using FreeStyle Libre in addition to their usual clinical care, HbA1c (primary outcome) was significantly reduced by 1.4±1.3% (mean±SD); p This real-world, chart review study concluded that people with T2D on basal insulin therapy, using FreeStyle Libre for between 3 to 6 months significantly reduced HbA1c. Disclosure A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. T. D. Daniel: Advisory Panel; Self; Abbott Diabetes, Bayer Healthcare Pharmaceuticals Inc. A. Desantis: None. S. Jabbour: None. E. Karslioglu-french: None. D. F. Kruger: Advisory Panel; Self; Abbott Diabetes, Novo Nordisk, Sanofi US, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Novo Nordisk, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Stock/Shareholder; Self; Pendulum Therapeutics. 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. K. Ozer: Research Support; Self; Abbott Diabetes, AbbVie Inc., Eli Lilly and Company, Novo Nordisk, Senseonics, Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk. Funding Abbott Diabetes Care

Safe and effective use of the Omnipod 5 System was demonstrated in adults and children with type 1 diabetes (T1D) during a 3-month pivotal study. Longer studies are needed to evaluate durability of glycemic benefit. Those completing the pivotal study were invited to continue system use for an additional 12 months, with 95% enrolling in the extension. We present results from the first 3-month follow-up. Participants aged 6-70y with T1D≥6 months and A1C Disclosure A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. 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. S. N. Mehta: None. 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. V. Shah: Advisory Panel; Self; Medscape, Sanofi, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, vTv Therapeutics. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Boston Therapeutics, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Kowa Pharmaceuticals America, Inc., Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Poxel SA, Quintiles, Sanofi, Senseonics, Tolerion, Inc., Viking Therapeutics. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. T. C. Jones: None. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. A. B. Criego: Consultant; Self; Bigfoot Biomedical, Inc., Other Relationship; Self; Sanofi, Research Support; Self; Abbott Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. T. Ly: Employee; Self; Insulet Corporation. Omnipod 5 research group: n/a. 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. 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, Medtro Funding Insulet Corporation

Many of those with T1D in the US use MDI as their insulin delivery method. Hybrid closed-loop (HCL) systems such as the Omnipod 5 System may improve glycemic outcomes and reduce treatment burden, however, these systems must be accessible to current MDI users. We performed a subgroup analysis of participants transitioning directly from MDI in the pivotal study of the Omnipod 5 System. Children (6-13.9 y) and adults (14-70 y) with T1D≥6 months and A1C Disclosure V. Shah: Advisory Panel; Self; Medscape, Sanofi, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, vTv Therapeutics. 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. G. Aleppo: Consultant; Self; Dexcom, Inc., Insulet Corporation, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker’s Bureau; Self; Dexcom, Inc. I. B. Hirsch: Consultant; Self; Abbott Diabetes, Bigfoot Biomedical, Inc., Research Support; Self; Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Medtronic. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. J. E. Pinsker: Advisory Panel; Self; Medtronic, Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. T. Ly: Employee; Self; Insulet Corporation. A. B. Criego: Consultant; Self; Bigfoot Biomedical, Inc., Other Relationship; Self; Sanofi, Research Support; Self; Abbott Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic. A. L. Carlson: Board Member; Self; JDRF, Other Relationship; Self; Medtronic, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Omnipod, Sanofi, UnitedHealth Group. A. Bhargava: Research Support; Self; Abbott, AbbVie Inc., Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Covance Inc., Dexcom, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Gan & Lee Pharmaceuticals, Insulet Corporation, Janssen Research & Development, LLC, Madrigal Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Mylan N. V., Novo Nordisk, Quintiles, Sanofi, Senseonics, Senseonics, Tolerion, Inc., viking. 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. S. A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc. Funding Insulet Corporation

Background: Automated insulin delivery systems improve glycemic control including time spent in, below and above range (TIR, TBR and TAR, respectively) in people with T1D. A next generation system, the MiniMedTM AHCL system, that offers a target set point (SP) of 100 or 120mg/dL, autocorrects to 120mg/dL every 5 mins and has fewer Auto Mode exits, was evaluated. Methods: A 16-site, single-arm, in-home trial of the AHCL system in 39 adolescents (14-21yrs) and 118 adults (≥22yrs) with T1D was conducted. After a baseline period of sensor-integrated pump, HCL feature, or predictive low glucose feature use (~14 days), the AHCL feature was enabled with a 100 or 120mg/dL SP for ~45 days and then the other SP for ~45 days. Study endpoints included safety events, change in A1C, sensor glucose (SG), %TIR, %TBR and %TAR. Results: There were no DKA or severe hypoglycemia episodes during the study period. Auto Mode was used ≥95% of the time; autocorrection was 22% of daily bolus. The table shows outcomes (mean±SD) for the overall group and each age group at baseline and study period (100 and 120mg/dL SP), and at the 100mg/dL SP. Best glycemic results (SG of 141±8.8mg/dL, TIR of 78.8±5.5% and TBR of 2.6±2.0%; N=29) were seen with a 100mg/dL SP and active insulin time of 120 minutes. Conclusion: These pivotal trial data demonstrate that AHCL is safe and significantly improved A1C and SG in subjects aged ≥14 years with T1D. Disclosure A.L. Carlson: Consultant; Self; Medtronic. Research Support; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, Sanofi, UnitedHealth Group. B.W. Bode: Advisory Panel; Self; Medtronic, Novo Nordisk A/S. Consultant; Self; Eli Lilly and Company, Medtronic, Novo Nordisk A/S. Research Support; Self; Abbott, Advance, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, National Institutes of Health, Nova Biomedical, Novo Nordisk A/S, Provention Bio, Inc., Sanofi, Senseonics. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Senseonics. Stock/Shareholder; Self; Aseko. R.L. Brazg: None. M.P. Christiansen: Research Support; Self; Abbott, Ascensia Diabetes Care, Biolinq, Dexcom, Inc., Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi-Aventis, Senseonics, ViroMed Laboratories, Xeris Pharmaceuticals, Inc. S.K. Garg: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diagnostics France. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. K. Kaiserman: Advisory Panel; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Medtronic. Speaker’s Bureau; Self; Medtronic. M. Kipnes: None. D.R. Liljenquist: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. R. Pop-Busui: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Consultant; Self; Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk Inc. Research Support; Self; AstraZeneca. Other Relationship; Self; American Diabetes Association. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Cecelia Health. Consultant; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi, T1D Exchange. D.I. Shulman: Advisory Panel; Self; Medtronic. K.K. Singh: None. R.H. Slover: None. J. Thrasher: Advisory Panel; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Board Member; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. X. Chen: Employee; Self; Medtronic. B. Grosman: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. L.J. Lintereur: Employee; Self; Medtronic. M. Liu: Employee; Self; Medtronic. N. Parikh: None. A.S. Rhinehart: Employee; Self; Glytec, Medtronic. Stock/Shareholder; Self; Dexcom, Inc., Glytec, Lexicon Pharmaceuticals, Inc., MannKind Corporation, Tandem Diabetes Care. F. Peng: None. A. Roy: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. D. Wu: None. R. Vigersky: Employee; Self; Medtronic.

URLi is a novel ultra rapid formulation of insulin lispro that shows improved postprandial glucose control and similar compatibility with continuous subcutaneous insulin infusion (CSII) vs. Humalog. In this study URLi was evaluated for the first time in a hybrid closed-loop system using the Medtronic MiniMed 670G. Primary objective was to compare URLi to Humalog with respect to the percentage of time with glucose values within target range 70-180 mg/dL (%TIR). This double-blind, crossover study included two 4-week treatment periods with URLi or Humalog. After a 2-week lead-in on Humalog, 42 adults with type 1 diabetes using personal MiniMed 670G pumps were randomized to 1 of the 2 treatment sequences with boluses initiated 0-2 minutes before meals. Both treatments achieved good glycemic control with mean TIR >75% (Fig 1). Mean time above and below range met consensus recommendations for both treatments. The percentage of time in Auto Mode was similar between treatments: URLi 92.0%; Humalog 91.4%. Insulin doses and pump settings were generally similar between treatments. There were no serious adverse events or early discontinuations. Overall incidence of treatment-emergent adverse events was similar between treatments. URLi demonstrated comparable glycemic control and a similar safety profile to Humalog with the MiniMed 670G system in patients with type 1 diabetes. Disclosure B.W. Bode: Advisory Panel; Self; InPen, Medtronic. Consultant; Self; ADOCIA, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Pfizer Inc. Research Support; Self; Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Medtronic, Novo Nordisk A/S, Provention Bio, Inc., Senseonics, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., InPen, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Sanofi, Senseonics, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Glytec. A.L. Carlson: Consultant; Self; Medtronic. Research Support; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, Sanofi, UnitedHealth Group. R. Liu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. T. Hardy: Other Relationship; Self; Eli Lilly and Company. J. Boyd: None. R.M. Bergenstal: Consultant; Self; Ascensia Diabetes Care, Johnson & Johnson. Other Relationship; Self; Abbott, Dexcom, Inc., Hygieia, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Onduo, Roche Diabetes Care, Sanofi, UnitedHealth Group. S. Morrett: Other Relationship; Self; Eli Lilly and Company. D.A. Ignaut: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Funding Eli Lilly and Company

Patient-reported outcomes are a useful tool to understand the impact of treatments in clinical application on a large scale. This retrospective study characterized patient-reported outcomes of a large cohort of adults in the United States with type 2 diabetes using a tubeless insulin pump (Omnipod® or Omnipod DASH™ Insulin Management System, Acton, MA). From Jan. 2015-Jan. 2020, patient-reported outcomes were recorded before and ≥90 days after initiating system use. Primary outcomes were change in self-reported A1C and total daily dose of insulin. Patients (N=2,335) were aged (mean±SD) 58±11y and 53% female. The percentage of users with a self-reported A1C ≤8% increased from 33% pre-tubeless pump to 64% post-tubeless pump, and the percentage with a self-reported A1C >9% decreased from 44% to 15% (p These patient-reported outcomes provide positive evidence that use of a tubeless insulin pump was associated with glycemic outcomes that exceed U.S. National Healthcare Effectiveness Data and Information Set (HEDIS) standards for adequate diabetes management. Disclosure A.L. Carlson: Consultant; Self; Medtronic. Research Support; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, Sanofi, UnitedHealth Group. L.M. Huyett: Employee; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. A. Chang: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. T. Vienneau: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

We evaluated the impact of baseline A1c on the performance of day-and-night hybrid closed-loop (CL) applying Cambridge control algorithm over 4 weeks in adults with type 1 diabetes. We combined data from 3 multi-national randomized studies [N=85; three groups defined: A1c 180 mg/dl without an increase in the time Disclosure L. Leelarathna: Advisory Panel; Self; Abbott, Dexcom, Inc., Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis. Research Support; Self; Dexcom, Inc., Novo Nordisk Inc. Speaker's Bureau; Self; Insulet Corporation, Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi. H. Thabit: Research Support; Self; Dexcom, Inc. M.E. Wilinska: None. L. Bally: None. J.K. Mader: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Prediktor Medical, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; Abbott, AstraZeneca, Dexcom, Inc., Novo Nordisk Inc. Stock/Shareholder; Self; decide Clinical Software GmbH. S. Arnolds: None. T.R. Pieber: Advisory Panel; Self; ADOCIA, Arecor Limited, AstraZeneca, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Novo Nordisk A/S. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. A. Carlson: Consultant; Self; Sanofi US. Research Support; Self; Abbott, Dexcom, Inc., JDRF, Medtronic, National Institutes of Health, Novo Nordisk A/S. R.M. Bergenstal: Research Support; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Glooko, Inc., Hygieia, JDRF, Johnson & Johnson Medical Devices Companies, Lilly Diabetes, Medtronic MiniMed, Inc., Merck & Co., Inc., National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk Inc., Roche Diabetes Care, Sanofi. Other Relationship; Self; Abbott, Helmsley Charitable Trust, Hygieia, Lilly Diabetes, Novo Nordisk Inc., Onduo LLC, Sanofi, UnitedHealth Group Inc. M. Evans: Advisory Panel; Self; Dexcom, Inc., Medtronic, Roche Diabetes Care, Zucara Therapeutics Inc. Research Support; Self; MedImmune, Sanofi. Speaker's Bureau; Self; AstraZeneca. Other Relationship; Self; Abbott, Eli Lilly and Company, Novo Nordisk Inc. R. Hovorka: Advisory Panel; Self; Novo Nordisk A/S. Research Support; Self; Abbott, Dexcom, Inc., Medtronic. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. Other Relationship; Self; B. Braun Medical Inc., Medtronic. Funding JDRF; European Union; National Institute for Health Research Cambridge Biomedical Research Centre; Medtronic; Abbott Diabetes care

The time needed to reliably assess closed-loop performance in adults with sub-optimal glucose control (A1c 59 to 86 mmol/mol) including changes in behavioral adaptation is currently unknown. We combined data from 2 multi-national randomized closed-loop studies of 12-week duration (N=56; mean±SD, A1c 68±7mmol/mol, age 39±10 year, diabetes duration 21±9 year). For each participant, glucose sensor metrics were computed for the full 12-week period and restricting data to 60 time periods representing 1 to 60 days. For each metric, the association between the value from each sampling period and the value using all 12 weeks of data, determined using Pearson or Spearman correlation coefficient (r). The number of days needed to reach an ‘r’ value of 0.95 (equaling 90% of total variance) for different metrics, mean glucose, % time >180 mg/dl, 70-180mg/dL, >250mg/dL, In conclusion, closed-loop studies of 4-week duration are likely to provide representative data for mean glucose, normoglycemia and hyperglycemia while 6 weeks may be required for a reliable estimate of hypoglycemia and glucose variability. Figure: Correlation coefficients of data collected over the full 12-week period and taken over the first 60 days. Disclosure L. Leelarathna: Advisory Panel; Self; Abbott, Dexcom, Inc., Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis. Research Support; Self; Dexcom, Inc., Novo Nordisk Inc. Speaker’s Bureau; Self; Insulet Corporation, Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi. H. Thabit: Research Support; Self; Dexcom, Inc. M.E. Wilinska: None. L. Bally: None. J.K. Mader: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Prediktor Medical, Roche Diabetes Care, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Dexcom, Inc., Novo Nordisk Inc. Stock/Shareholder; Self; decide Clinical Software GmbH. S. Arnolds: None. C. Benesch: None. T.R. Pieber: Advisory Panel; Self; ADOCIA, Arecor Limited, AstraZeneca, Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Novo Nordisk A/S. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. A.L. Carlson: Consultant; Self; Sanofi US. Research Support; Self; Abbott, Dexcom, Inc., JDRF, Medtronic, National Institutes of Health, Novo Nordisk A/S. R.M. Bergenstal: Research Support; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Glooko, Inc., Hygieia, JDRF, Johnson & Johnson Medical Devices Companies, Lilly Diabetes, Medtronic MiniMed, Inc., Merck & Co., Inc., National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk Inc., Roche Diabetes Care, Sanofi. Other Relationship; Self; Abbott, Helmsley Charitable Trust, Hygieia, Lilly Diabetes, Novo Nordisk Inc., Onduo LLC, Sanofi, UnitedHealth Group Inc. M. Evans: Advisory Panel; Self; Dexcom, Inc., Medtronic, Roche Diabetes Care, Zucara Therapeutics Inc. Research Support; Self; MedImmune, Sanofi. Speaker’s Bureau; Self; AstraZeneca. Other Relationship; Self; Abbott, Eli Lilly and Company, Novo Nordisk Inc. R. Hovorka: Advisory Panel; Self; Novo Nordisk A/S. Research Support; Self; Abbott, Dexcom, Inc., Medtronic. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. Other Relationship; Self; B. Braun Medical Inc., Medtronic.

Hypoglycemia is a ubiquitous challenge with insulin treatment in type 1 diabetes (T1D), with nocturnal episodes of particular concern. Severe (as defined by the ADA) or blood glucose-confirmed ( In summary, analysis across two large trials supports the safety of mealtime FA, with lower rates of nocturnal hypoglycemia with FA vs. IAsp. ClinicalTrials.gov: NCT01831765; NCT02500706. Disclosure C. De Block: None. A. Carlson: Advisory Panel; Self; Sanofi, Insulet Corporation. Consultant; Self; Merck & Co., Inc.. Research Support; Self; Medtronic, Novo Nordisk A/S. L. Rose: Advisory Panel; Self; Novo Nordisk A/S. Consultant; Self; Member of Association of Statutory Health Insurance Physicians. T. Gondolf: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Chr. Hansen A/S. A. Gorst-Rasmussen: Employee; Self; Novo Nordisk A/S. W. Lane: Advisory Panel; Self; Novo Nordisk A/S, Insulet Corporation, Intarcia Therapeutics, Inc., Sanofi. Research Support; Self; Novo Nordisk A/S, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Sanofi, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Insulet Corporation.