Lilly Diabetes Research Articles

1-LB: Advancing Therapy in Basal Insulin Users with Type 2 Diabetes (T2D): Hypoglycemia as a Function of HbA1c in the SoliMix Trial

Introduction: Therapeutic approaches to advancing treatment from basal insulin in T2D require assessment of the benefits and risks of any chosen intervention. Methods: SoliMix was a 26-week, open-label, multicenter study in which adults (N=887) with T2D and HbA1c ≥7.5-≤10.0 % (≥58-≤86 mmol/mol) using basal insulin + metformin ± sodium-glucose co-transporter-2 inhibitors were randomized to once-daily iGlarLixi (fixed-ratio combination of basal insulin glargine 100 U/mL + lixisenatide) or twice-daily premix insulin 30/70 analog (BiAsp 30). HbA1c improved and bodyweight changes were favorable with iGlarLixi vs. BiAsp 30 (primary outcomes), while hypoglycemia event rates were also lower with iGlarLixi vs. BiAsp 30. This subanalysis assessed estimated hypoglycemia event rates over the whole treatment period as a function of HbA1c at Week 26. Results: Modelled event profiles for clinically significant hypoglycemia (ADA Level 2 [ Conclusion: Lower rates of hypoglycemia with iGlarLixi across a broad range of HbA1c suggests that iGlarLixi facilitates greater HbA1c improvement vs. premix insulin 30/70. Disclosure R. J. Mccrimmon: Advisory Panel; Self; Novo Nordisk Inc., Sanofi-Aventis, Board Member; Self; Novo Nordisk Foundation, Research Support; Self; AstraZeneca. J. Rosenstock: Board Member; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Consultant; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Research Support; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Genentech, Inc., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Oramed Pharmaceuticals, Inc., Pfizer Inc., REMD Biotherapeutics, Sanofi. P. Home: Consultant; Self; American Diabetes Association, Kriya Technologies, Sanofi, Other Relationship; Self; Association of British Clinical Diabetologists, AstraZeneca, Novartis Malaysia, Sanofi, Research Support; Self; Sanofi. A. Y. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Sanofi, Research Support; Self; Applied Therapeutics, The Medicine Company, Speaker’s Bureau; Self; Abbott, AstraZeneca, Bausch Health, Canada, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Sanofi. F. Giorgino: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Roche Diabetes Care, Sanofi, Research Support; Self; Lilly Diabetes, Roche Diabetes Care. V. Fonseca: Consultant; Self; Abbott Diabetes, Asahi Kasei Corporation, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Stock/Shareholder; Self; Amgen Inc., Bravo4health, Mellitus Health. E. Souhami: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. A. Alvarez: Employee; Self; Sanofi. A. H. Boss: Employee; Self; Sanofi, Stock/Shareholder; Self; Novo Nordisk A/S. L. Melas-melt: None. Funding Sanofi

796-P: Cardiorenal Outcomes with Ertugliflozin by Baseline Cardiorenal Medications: An Analysis from VERTIS CV

VERTIS CV was a placebo-controlled cardiovascular (CV) outcome trial evaluating the SGLT2 inhibitor ertugliflozin. The aim of current analyses was to examine pre-specified CV and kidney outcomes by Cox proportional hazard assessment according to use of renin-angiotensin-aldosterone system inhibitors (RAASi), diuretics, and mineralocorticoid receptor antagonists (MRA) at baseline. Among 8246 randomized patients, at baseline 6686 (81%) were treated with RAASi, 3542 (43%) with diuretics, including 1252 (15%) with loop diuretics, and 674 (8%) with MRA. No significant interactions were observed for cardiorenal outcomes by baseline use of RAASi or MRA (Pinteraction > 0.05 for all; FIGURE). Nominally significant interactions for first event of hospitalization for heart failure (HHF) and HHF/CV death were observed with baseline use of diuretics, including loop diuretics, with an increased benefit of ertugliflozin vs. placebo. In VERTIS CV, baseline use of diuretics, including loop diuretics, appeared to be associated with greater benefit of ertugliflozin on first HHF and HHF/CV death, with no modification of effect based on baseline use of RAASi or MRA.View largeDownload slideView largeDownload slide DisclosureD. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. I. Gantz: Employee; Self; Merck & Co., Inc. R. Frederich: Employee; Self; Pfizer Inc., Other Relationship; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Bristol-Myers Squibb Company, Pfizer Inc. J. P. Mancuso: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Pfizer Inc., Stock/Shareholder; Self; Pfizer Inc., Stock/Shareholder; Spouse/Partner; Pfizer Inc. U. Masiukiewicz: Employee; Self; Pfizer Inc. C. P. Cannon: Advisory Panel; Self; Aegerion Pharmaceuticals Inc., Amarin Corporation plc, Corvidia Therapeutics, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Sanofi, Consultant; Self; Alnylam Pharmaceuticals, Inc., Amgen Inc., Applied Therapeutics, Ascendis Pharma A/S, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, HLS Therapeutics Inc., Kowa Company, Ltd., Research Support; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Sankyo, Janssen Research & Development, LLC, Kowa Company, Ltd., Merck & Co., Inc., Novo Nordisk Pharma Ltd., Pfizer Inc. F. Cosentino: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Pfizer Inc., Speaker’s Bureau; Self; Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Mundipharma International, Novo Nordisk. D. K. Mcguire: Consultant; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., CSL Behring, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi. B. Charbonnel: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi, Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. S. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. R. E. Pratley: Other Relationship; Self; Hanmi Pharmaceutical, Merck Sharp & Dohme Corp., Metavention, Monster Energy Company, Inc., Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. W. J. Shih: None. M. Maldonado: Employee; Self; Merck Sharp & Dohme Corp. A. Pong: None.

717-P: Real-World, Patient-Reported Data on Training and Use of 670G Hybrid Closed-Loop (HCL) among Children and Adults with Type 1 Diabetes (T1D)

This report describes patient-reported data from persons with T1D initiating use of the Medtronic MiniMed 670G HCL insulin delivery system (670G) for clinical care. Questionnaires were completed in clinic before starting the system, and then follow up surveys were emailed at 6 weeks, 6 months and 12 months from the time of enrollment. Participants who completed the 6 week survey (n=97) had a mean HbA1c of 8.2%, T1D duration of 19 yrs, median age of 37 yrs, with 57% being female, 88% non-Hispanic white. Most were on pump therapy at baseline with 87% using a sensor. Nearly all who completed the training questionnaire agreed/strongly agreed that he/she received adequate training on the majority of the 670G components. Alarms were described as somewhat to very bothersome during the day by nearly half of participants/parents and more than half had issues with sleep interruption at night (Table). Close to half (~40%) noted frequent exits from Auto Mode were somewhat to very bothersome. In this real-world assessment of 670G use, while many were satisfied by device training, issues with the system were prevalent amongst those who persisted with device use. With this first in-class device, this study highlights that methods to minimize burdens of HCL use, such as the number of alarms and frequent exits from automation, will be essential for alternate and next generation systems.View largeDownload slideView largeDownload slide DisclosureC. Bauza: None. S. Dubose: None. A. Verdejo: 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. M. Bergenstal: Advisory Panel; Self; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Onduo LLC., Roche , Sanofi, United Healthcare , Consultant; Self; Abbott Diabetes, Ascensia , Dexcom, Inc., Eli Lilly and Company, Hygieia, Johnson & Johnson, Medtronic, Novo Nordisk, Onduo LLC., Roche, Sanofi, United Healthcare, Other Relationship; Self; HealthPartners Institute, Research Support; Self; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Helmsley Charitable Trust, Hygieia, Johnson & Johnson, Medtronic, NIDDK, Novo Nordisk, Onduo LLC., Roche, Sanofi, United Healthcare. 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.FundingThe Leona M. and Harry B. Helmsley Charitable Trust

951-P: Diabetes Management Delivery and Pregnancy Outcomes in Women with Gestational Diabetes Mellitus during the First Wave of the 2020 COVID-19 Pandemic: A Single Reference Centre Report

The COVID-19 pandemic has forced a rapid adaptation of healthcare services to secure medical care for many patients’ groups. This includes women with Gestational diabetes mellitus (GDM). We evaluated the impacts of the first COVID-19 wave on parameters such as the GDM treatment, glycemic control and pregnancy outcomes. In this retrospective study from a reference diabetes centre (Krakow, Poland), we compared patient data from two different time periods: the first wave of COVID-19 pandemic (March 2020 - June 2020) and the preceding five months (October 2019 - February 2020). Data was collected from the medical records and telephone surveys. No patient was diagnosed with concomitant COVID-19. We included 155 women - Group 1 N=73 and Group 2 N= 82 from the COVID-19 pandemic period and non-COVID-19 period, respectively. During the COVID-19 pandemic, almost half of all GDM women (N1=36, 49.3%) used telemedicine as a method of contacting their diabetic specialist while this tool was not utilized in the earlier period. Moreover, these patients reported difficulties in performing blood glucose self-control more often (N1=20, 27.4% vs. N2=7, 8.5% p=0.002) and spent less time on diabetes education and training than the control group on average (N1=39, 53.4% vs. N2=9, 9.8% below 2 hours of training; p≤0.001). Glycemic control parameters were very similar and most analysed pregnancy outcomes occurred with comparable frequencies. Differences were found with respect to the incidence of prolonged labour which was more frequent in the COVID-19 period Group 1 (N1=12, 16.4% vs. N2=3, 3.7% p=0.007) whereas no episodes of pre-eclampsia were observed in this group (N1=0 vs. N2=7, 8.5% p=0.01) during this same time period. We report that the first wave of the COVID-19 pandemic did not seem to have a negative impact on glycemic control and pregnancy outcomes in GDM women, in spite of difficulties in diabetes management delivery. Disclosure M. Wilk: None. P. Surowiec: None. B. Matejko: Other Relationship; Self; Ascensia Diabetes Care, Roche Diabetes Care. K. Cyganek: Advisory Panel; Self; Medtronic, Speaker’s Bureau; Self; Lilly Diabetes, Novo Nordisk. H. Huras: None. M. Malecki: Advisory Panel; Self; Abbott Diabetes, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi-Aventis, Servier Laboratories.

783-P: Cardiorenal Outcomes with Ertugliflozin by Baseline (BL) Glucose-Lowering Agent (GLA): An Analysis from VERTIS CV

VERTIS CV was the cardiovascular (CV) outcome trial for the SGLT2 inhibitor ertugliflozin, conducted in patients with type 2 diabetes (T2D) and atherosclerotic CV disease. In the overall population, ertugliflozin was noninferior to placebo for major adverse CV events (MACE). Although superiority for the composite endpoint of CV death or hospitalization for heart failure (HHF) and the renal composite (that included doubling of serum creatinine from BL) were not met, the prespecified secondary objective of HHF showed a 30% risk reduction and a prespecified exploratory renal composite (sustained ≥40% decrease in eGFR from BL, dialysis/transplantation, or renal death) showed improved kidney outcomes. This analysis assessed cardiorenal endpoints of VERTIS CV by BL GLA.Among 8246 patients in VERTIS CV, at BL 6292 (76%) used metformin, 3900 (47%) insulin, 3390 (41%) sulfonylureas (SU), and 911 (11%) dipeptidyl peptidase-4 inhibitors (DPP4i), alone or in combination therapy (67% used >1 GLA at BL). For each of the GLAs, metformin, insulin, SU, and DPP4i, no significant differences were observed for cardiorenal outcomes by BL use (yes, no) of the GLA (FIGURE; all interaction P values >0.05). Cardiorenal outcomes were generally similar across the BL GLA subgroups.In VERTIS CV, the effects of ertugliflozin on cardiorenal outcomes in patients with T2D were generally consistent regardless of BL GLA.View largeDownload slideView largeDownload slide DisclosureB. Charbonnel: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi, Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. I. Gantz: Employee; Self; Merck & Co., Inc. R. Frederich: Employee; Self; Pfizer Inc., Other Relationship; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Bristol-Myers Squibb Company, Pfizer Inc. J. P. Mancuso: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Pfizer Inc., Stock/Shareholder; Self; Pfizer Inc., Stock/Shareholder; Spouse/Partner; Pfizer Inc. R. E. Pratley: Other Relationship; Self; Hanmi Pharmaceutical, Merck Sharp & Dohme Corp., Metavention, Monster Energy Company, Inc., Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. S. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. C. P. Cannon: Advisory Panel; Self; Aegerion Pharmaceuticals Inc., Amarin Corporation plc, Corvidia Therapeutics, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Sanofi, Consultant; Self; Alnylam Pharmaceuticals, Inc., Amgen Inc., Applied Therapeutics, Ascendis Pharma A/S, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, HLS Therapeutics Inc., Kowa Company, Ltd., Research Support; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Sankyo, Janssen Research & Development, LLC, Kowa Company, Ltd., Merck & Co., Inc., Novo Nordisk Pharma Ltd., Pfizer Inc. D. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. F. Cosentino: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Pfizer Inc., Speaker’s Bureau; Self; Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Mundipharma International, Novo Nordisk. D. K. Mcguire: Consultant; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., CSL Behring, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi. W. J. Shih: None. J. Liu: Employee; Self; Merck Sharp & Dohme Corp. A. Pong: None.FundingMerck Sharp & Dohme Corp

1275-PUB: Call to Action: COVID-19 Pandemic Prompts Subcutaneous Treatment Option for Diabetes Ketoacidosis (DKA) in Hospital

COVID-19 challenges organizations to modify approaches to optimize diabetes management while reducing Personal Protective Equipment (PPE) use and nurse time, and maintaining patient safety. In April 2020, Scripps Health, a five-hospital health system in southern California created a subcutaneous Diabetes Ketoacidosis (DKA) treatment option for use with adults, admitted with mild to moderate DKA. Primary aims were to achieve DKA resolution and glycemic targets similar to the intravenous (IV) insulin treatment option, and no hypoglycemia <70 mg/dL. The new order set utilized weight-based dosing, with similar orders for labs, electrolyte and IV fluid replacement, and resolution criteria. Differences included automatic insulin dosing and basal/bolus insulin. Key changes were a reduced frequency of point of care testing (POCT) and ≤140 mg/dL hypoglycemia prevention orders. Post-implementation audits between April - July 2020 showed no hypoglycemia and resolution time similar to IV insulin. However, only 6% (N=17) of DKA cases were managed with subcutaneous, as compared to IV insulin. To help understand why there was such a limited uptake, a detailed retrospective chart review was undertaken on a subset of twenty-two DKA cases managed with IV insulin. Findings showed that 17 (77%) had type 2 diabetes, 5 (23%) had type 1 diabetes. 47% of cases had opportunities for subcutaneous management based on DKA classification and no contraindications for subcutaneous therapy. Findings indicate organizations should consider a DKA subcutaneous option. Lack of knowledge of DKA severity may be a factor in low utilization, therefore an EHR DKA Classification tool was implemented to support providers. Research is needed to determine if this increases utilization of the subcutaneous treatment option and what other barriers exist. Disclosure D. Meehan: None. L. Talavera: None. A. Philis-tsimikas: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Consultant; Self; Sanofi-Aventis, Employee; Spouse/Partner; Ionis, Other Relationship; Self; Merck & Co., Inc., Research Support; Self; Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi-Aventis. A. L. Fortmann: None.

791-P: Ertugliflozin in Older Patients with Type 2 Diabetes (T2D): An Analysis from VERTIS CV

VERTIS CV was a cardiovascular (CV) outcome trial of ertugliflozin vs. placebo in patients (pts) with T2D and atherosclerotic CV disease. Here we analyzed the cardiorenal outcomes and safety of ertugliflozin in older pts.Among 8238 pts randomized and treated with ertugliflozin 5 mg, 15 mg, or placebo, 4093 (49.7%) were <65 yrs, 4145 (50.3%) were ≥65 yrs, with 903 (11.0%) ≥75 yrs. Baseline characteristics were similar across treatment groups within each age group; mean eGFR was lower in older pts (82.2, 69.9, and 63.6 mL/min/1.73m2 for pts <65, ≥65, and ≥75 yrs, respectively). Cardiorenal outcomes for ertugliflozin vs. placebo did not differ between pts ≥65 and <65 yrs, with interaction P values >0.05 for all outcomes assessed (FIGURE). The incidences of adverse events (AEs), serious AEs (including deaths), and discontinuations due to an AE were higher in older vs. younger pts, but generally similar across treatment groups in pts ≥65 and ≥75 yrs. The incidence of renal-related AEs was similar across treatment groups in younger and older pts. The incidences of genital mycotic infection and urinary tract infection were higher with ertugliflozin vs. placebo in older pts. The incidences of hypovolemia AEs with ertugliflozin vs. placebo in pts ≥65 was 5.3% vs. 4.5% and in pts ≥75 yrs was 6.9% vs. 5.8%.Cardiorenal outcomes were similar in pts ≥65 and <65 yrs. Ertugliflozin was generally well tolerated in pts ≥65 and ≥75 yrs.View largeDownload slideView largeDownload slide DisclosureR. E. Pratley: Other Relationship; Self; Hanmi Pharmaceutical, Merck Sharp & Dohme Corp., Metavention, Monster Energy Company, Inc., Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. I. A. Adamsons: Employee; Self; Merck Sharp & Dohme Corp. D. Lawrence: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Becton, Dickinson and Company. W. J. Shih: None. C. P. Cannon: Advisory Panel; Self; Aegerion Pharmaceuticals Inc., Amarin Corporation plc, Corvidia Therapeutics, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Sanofi, Consultant; Self; Alnylam Pharmaceuticals, Inc., Amgen Inc., Applied Therapeutics, Ascendis Pharma A/S, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, HLS Therapeutics Inc., Kowa Company, Ltd., Research Support; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Sankyo, Janssen Research & Development, LLC, Kowa Company, Ltd., Merck & Co., Inc., Novo Nordisk Pharma Ltd., Pfizer Inc. S. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. B. Charbonnel: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi, Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. D. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. F. Cosentino: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Pfizer Inc., Speaker’s Bureau; Self; Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Mundipharma International, Novo Nordisk. D. K. Mcguire: Consultant; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., CSL Behring, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi. M. N. Essex: Employee; Self; Pfizer Inc., Stock/Shareholder; Self; Pfizer Inc. P. L. S. Jones: Employee; Self; Pfizer Inc. J. Liu: Employee; Self; Merck Sharp & Dohme Corp.FundingMerck Sharp & Dohme Corp

13-LB: Measured vs. Estimated GFR in Young Adults with Uncomplicated T1D

Background: eGFR equations are used to monitor progression of kidney disease, but their performance is incompletely understood in young adults with T1D and preserved GFR. To address this deficit, we compared two eGFR equations (creatinine-based CKD-EPI and modified Schwartz) to mGFR in this population. Methods: GFR based on plasma iohexol clearance was measured in 53 patients (24 males) with T1D, as part of the CAN-SOLVE CKD study Results: Mean age was 20.6±2.1 yrs with mean diabetes duration of 13.1±3.3 yrs. Mean HbA1c and ACR were 8.1±1.3 and 1.6±1.9 mg/mmol, respectively. Mean mGFR was 107.6±15.9 ml/min/1.73 m2. The Schwartz eGFR had a smaller mean bias (5.6 vs. 27.4 ml/min/1.73m2), better accuracy, and overall correlation compared to the CKD-EPI eGFR, while the latter had slightly superior precision. However, both equations were in poor agreement with mGFR. Examination of the Bland Altman plots reveals that, in the lower normal range, the CKD-EPI equation overestimated mGFR. The modified Schwartz equation showed no discernible tendencies. Conclusion: In young adults with T1D and preserved GFR, the modified Schwartz eGFR performed slightly better than CKD-EPI eGFR. Overall, however, both were in poor agreement with mGFR suggesting caution about the use of eGFR as a surrogate outcome in longitudinal studies and emphasizing the need to develop novel equations for this population. Disclosure K. Gaebe: None. C. A. White: None. F. H. Mahmud: Advisory Panel; Self; Insulet Corporation, Lilly Diabetes. J. W. Scholey: None. L. Motran: None. M. Palaganas: None. Y. T. Elia: None. D. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. E. B. Sochett: None. Funding Canadian Institutes of Health Research (20R26070); JDRF

561-P: Hispanic/Latino Adults with or at Risk of Type 2 Diabetes: Adequate Activity but Not Enough Sleep?

Sufficient sleep and physical activity (PA) are key for optimal health; low PA and sleep are established risk factors for type 2 diabetes (T2D). The American Academy of Sleep Medicine and Sleep Research Society recommend 7 hours/ night for adults; less than 7 hours on a regular basis is associated with adverse health outcomes. Similarly, 8,000 steps/day is associated with 51% lower risk than 4,000 steps/day for premature death. This study assessed PA and sleep in Hispanic/Latino adults with or at risk of T2D. Sleep and PA were measured by Fitbit InspireHR worn on the non-dominant wrist 24 hours/day for 7 consecutive days by 105 Hispanic/Latino adults (mean±SD 57.4±10.3 years, 67 women, 92 with T2D, HbA1c 7.9±2.0). BMI and waist circumference (WC) differed by gender (BMI women (W) 32.3±5.9 vs. men (M) 29.2±4.8, p≤0.01; WC W 102.4±13.6 vs. M 97.1±10.2cm, p≤0.05). Sleep duration was below recommended levels in W and M. Average weekday steps differed significantly from weekend steps. In W, average steps/weekday was negatively correlated with WC -0.26, BMI -0.26, and age -0.27, all p≤0.05. In M, average steps/weekday was negatively correlated with HbA1c -0.44 and total sleep time -0.37, p≤0.05. In these Hispanic/Latino adults with or at risk of T2D, PA was within recommended levels, but sleep was low in both W and M at ~6 hours/night. More weekday steps was associated with lower WC and BMI in W and with lower HbA1c and sleep duration in M. Disclosure W. C. Bevier: Research Support; Self; Abbott Diabetes, Eli Lilly and Company. A. J. Larez: Research Support; Self; Abbott, Eli Lilly and Company. C. Conneely: Research Support; Self; Abbott, Eli Lilly and Company. N. M. Glantz: Research Support; Self; Abbott, Eli Lilly and Company. K. N. Castorino: Consultant; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Abbott Laboratories, Dexcom, Inc., Drawbridge Health, Inc., Lilly Diabetes, Medtronic, Novo Nordisk Inc. D. Kerr: Advisory Panel; Self; Novo Nordisk, Sanofi-Aventis, Research Support; Self; Abbott Diabetes, Elsevier, Lilly Diabetes, Stock/Shareholder; Self; Glooko, Inc. Funding Eli Lilly and Company

50-OR: Validation of Fear of Hypoglycemia Screener: Results from the T1D Exchange Registry

Objective: To examine reliability and validity of a newly developed fear of hypoglycemia (FoH) screener as a practical and actionable tool for in-clinic use in adults with type 1 diabetes (T1D), in accordance with ADA’s position on psychosocial care. Methods: In this validation study, adults with T1D were recruited from the T1D Exchange Registry to complete a draft screener online; potential items were previously identified from literature review, and interviews with health care professionals (HCPs) and people with T1D. Standard psychometric analyses assessed reliability and validity of the screener. The final FoH screener comprised 9 items assessing 2 domains - “worry” (6 items) and “behavior” (3 items). Results: The final sample comprised 592 adults with T1D (age 43.1 ± 15.3 years; duration of T1D 24.1 ± 15 years, 66.7% females, 91.6% White, 5.2% Hispanic, self-reported HbA1c 7.1% ± 1.2%). Approximately 30% of participants reported severe hypoglycemia in the past 12 months; 33.4% reported impaired awareness of hypoglycemia. The FoH screener showed internal consistency (Cronbach’s α=0.88) and was highly correlated (r=0.71-0.75) with the Hypoglycemia Fear Survey (“worry” and “behavior” subscales and total scores), confirming reliability. Construct validity of the FoH screener was demonstrated with significant correlations with depression (r=0.44), anxiety (r=0.47), Diabetes Distress Subscales (powerlessness, management distress, hypoglycemia distress) (r=0.49-0.66); These correlations are considered moderate. Additionally, multivariable regression analysis showed that higher FoH screener scores were significantly associated with higher HbA1c (regression coefficient, β=0.04) and multi-morbidities (β=0.03). Conclusions: This 9-item FoH screener demonstrated good reliability and validity. Further research is planned to assess clinical usability to help appropriately identify patients and assist effective HCP-patient conversations around FoH. Disclosure J. Liu: None. J. Poon: Employee; Self; Eli Lilly and Company. J. Bispham: None. M. Perez-nieves: Employee; Self; Eli Lilly and Company. A. Hughes: None. K. S. M. Chapman: None. B. Mitchell: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. F. J. Snoek: Advisory Panel; Self; Abbott Diabetes, Lilly Diabetes, Novo Nordisk, Roche Diabetes Care, Sanofi, Research Support; Self; Novo Nordisk, Sanofi. L. Fisher: Consultant; Self; Ascensia Diabetes Care, Lilly Diabetes, Speaker’s Bureau; Self; Dexcom, Inc. Funding Eli Lilly and Company

712-P: International Consensus on the Ethics of Open-Source Automated Insulin Delivery

Background: Despite observational evidence for the efficacy and safety of open-source automated insulin delivery (OS-AID) there is a lack of guidance for healthcare providers. The ethics of providing care for those using unregulated technology is a concern. Methods: Consensus guidelines are in development, through the OPEN project, by an experienced multi-disciplinary group of endocrinologists, diabetes care and education specialists, exercise physiologists and psychologists. Results: The principles of biomedical ethics - autonomy, justice, beneficence and non-maleficence - provide a framework for analysis. Autonomy requires that the user understands system risks and benefits. OS-AID provides complete transparency and customization, facilitating understanding and control. Algorithms used in commercial systems are proprietary, impeding the ability to discuss and personalize operation. Justice requires burdens and benefits be distributed fairly. Commercial systems are not uniformly accessible. OS-AID provides freely available software and allows the mixing and matching of compatible CGMs and pumps, supporting equity. Beneficence means doing good for the individual. In real-world observational trials both open-source (OpenAPS: n=34, mean TIR 71-&amp;gt;80% at max 2.5 years; Loop: n=558, mean TIR 67-&amp;gt;73% at 6 months) and commercial AID systems (670G: n=3141, mean TIR 66-&amp;gt;73% at 3 months; Control-IQ: n=1659, median TIR: 68-&amp;gt;78% at 1 month) provide a statistically significant and clinically meaningful increase in TIR at the population level. Non-maleficence requires treatment does not harm the individual. AID systems can reduce burden, hypoglycemia and hyperglycemia. Conclusions: The international consensus group concludes OS-AID is ethical, but unregulated. We recommend legal interpretations and frameworks be clarified and updated so that individuals are not deprived of beneficial therapy. Commercial AID systems may benefit from transparency and equity offered by OS-AID systems. Disclosure K. Braune: None. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. T. C. Skinner: Advisory Panel; Self; Liva Health Care, Novo Nordisk. K. Raile: Advisory Panel; Self; Abbott Diabetes, Lilly Diabetes, Research Support; Self; Dexcom, Inc. C. Johnston: None. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. S. Hussain: Speaker’s Bureau; Self; Novo Nordisk. M. Quigley: None. L. Petruzelkova: None. G. Scheiner: Advisory Panel; Self; Capillary Biomedical, Inc., Companion Medical, Eli Lilly and Company, Consultant; Self; ADOCIA, Ascensia Diabetes Care, mySugr, Triple Jump, Ypsomed, Speaker’s Bureau; Self; Dexcom, Inc., Xeris Pharmaceuticals, Inc. P. Winterdijk: None. S. Schmidt: None. L. H. Raimond: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. Funding National Institute of Diabetes and Digestive and Kidney Diseases (T32DK007217, 1K12DK122550, 1K23DK122017, P30DK116074); European Commission’s Horizon 2020 Research and Innovation Programme/Marie Sklodowska-Curie Action Research and Innovation Staff Exchange (RISE) grant agreement number 823902

206-LB: Indian Americans as Compared with Indians Exhibit Increased Beta-Cell Responsivity and Insulin Clearance in Absence of Changes in Insulin Sensitivity

Studies suggest that Indian Americans (IA) living in US have higher basal insulin resistance than other ethnic groups thereby increasing risk for T2DM. To characterize glucose metabolism between IA to Indians (I) living in India, we studied thirty-one Indians recruited at the Chellaram Hospital in Pune, India and twenty Indian Americans at Mayo Clinic, MN. All underwent a 3-hour 9-point OGTT with analyses of glucose, insulin and C-peptide. The oral minimal model was used to estimate β-cell function (φtotal) and insulin sensitivity (SI), with assessment of β-cell responsivity (Disposition Index: DI). Insulin clearance was calculated as AUC of insulin secretion rate over insulin concentrations. Both I and IA were similar with respect to age (33±7 vs. 39±13y), BMI (25.0±1.8 vs. 24.7± 3.2kg/m2) and sex (13F and 9F) respectively. Results are in fig 1. Fasting and iAUC glucose did not differ between groups (p=0.478), while integrated C-peptide and Insulin concentrations were higher in I than IA (p Disclosure V. Purandare: None. A. Galderisi: None. M. Maertino: None. A. Basu: None. C. Cobelli: None. A. Unnikrishnan: Advisory Panel; Self; Sanofi-Aventis, Other Relationship; Self; Novo Nordisk A/S, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes. R. Basu: None. Funding National Institutes of Health (R01DK029953 to R.B.), (R01DK085516 to A.B.)

107-OR: Six-Day Subcutaneous GIP Infusion Increases Circulating Free Fatty Acids without Altering the Adipose Tissue Transcriptome, Adipocyte GIP Receptor Levels, or Circulating Inflammation Markers in Patients with Type 1 Diabetes

Glucose-dependent insulinotropic polypeptide (GIP) has been proposed to increase adipose tissue lipolysis (at low insulin levels), adipokine secretion and circulating levels of inflammation markers via the GIP receptor (GIPR) in adipose tissue. We investigated the effect of a 6-day subcutaneous (sc) GIP infusion on circulating lipids and inflammation markers, the adipose tissue transcriptome and the presence of GIPR mRNA (ISH) in adipose tissue in patients with type 1 diabetes (T1D). In a randomized, placebo-controlled, double-blind, crossover study, 20 men with T1D (age [mean± SD] 26±8 years, BMI 23.8±1.8 kg/m2, HbA1c 51±10 mmol/mol (6.8±3.1%) underwent 2 × 6 days of continuous sc GIP (6 pmol/kg/min) infusion and placebo (saline) infusion, with an interposed 7-day washout period. Fasting blood samples were drawn frequently within the initial 3 hours and after 1 and 6 days of infusion. Adipose tissue biopsies were collected before and after 6 days of infusion. During the initial 3 hours of infusion, but not at day 1 and 6, GIP increased baseline-subtracted area under the curve of plasma free fatty acids (FFA) compared to placebo (16.8±10.4 vs. 4.4±9.2 min × mmol/L, P &amp;lt;0.001) without affecting plasma glycerol and triglycerides. A panel of 23 circulating inflammation markers were unaffected by the GIP infusion. Adipose tissue transcriptomics did not show differentially expressed genes after 6 days of GIP infusion compared to placebo. In situ hybridization (ISH) localized the GIPR mRNA in the adipocyte and not in connective tissue. ISH verified GIPR mRNA levels were not altered by 6 days of GIP infusion. In patients with T1D, a 6-day sc GIP infusion temporarily increases circulating levels of FFA without altering the adipose tissue transcriptome, GIPR mRNA levels in adipocytes or circulating inflammation markers. Disclosure S. M. Nguyen heimbürger: Speaker’s Bureau; Self; AstraZeneca. T. F. Dejgaard: Advisory Panel; Self; Novo Nordisk, Consultant; Self; Boehringer Ingelheim International GmbH, Research Support; Self; AstraZeneca, Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. C. Pyke: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. M. B. Christensen: None. F. K. Knop: Advisory Panel; Self; MSD Corporation, Novo Nordisk A/S, Sanofi, Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Pharmacosmos, Zealand Pharma A/S, Research Support; Self; Novo Nordisk A/S, Zealand Pharma A/S, Speaker’s Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S. B. Hoe: None. C. N. Nielsen: None. B. Hartmann: None. J. J. Holst: Consultant; Self; Novo Nordisk, Other Relationship; Self; Antag Therapeutics, Bainan Biotech, MSD Corporation, Novo Nordisk, Other Relationship; Spouse/Partner; Antag Therapeutics, Bainan Biotech, Synklino ApS. F. Dela: None. A. Overgaard: Stock/Shareholder; Self; Novo Nordisk A/S. J. Størling: None. T. Vilsbøll: Consultant; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Mundipharma International, Novo Nordisk, Sanofi, Sun Pharmaceutical Industries Ltd. Funding The Leona M. and Harry B. Helmsley Charitable Trust (2018PG-T1D037)

339-P: Glycemic Variability Assessed by CGM Relates to Hypoglycemia across the Lifespan in Type 1 Diabetes (T1D)

Aim: CGM can predict and reduce hypoglycemia in persons with T1D by providing real-time (RT) glucose levels and trend arrows. Using CGM data, one can assess glycemic variability with coefficient of variation for glucose (CV, glucose SD/mean x 100%). Current guidelines target a CV ≤36, given its association with reduced occurrence of hypoglycemia. Methods: As glycemic levels fluctuate across the lifespan, we aimed to evaluate associations between CV and hypoglycemia (time below range [TBR] Results: Across all studies, higher CV was associated with more TBR (all p 36 vs. CV≤36, TBR was higher in all 3 cohorts (p Summary: CGM use helped to reduce CV and TBR over time. These 3 studies affirm that glycemic variability (CV) relates to hypoglycemia across the lifespan in T1D. Disclosure B. A. Cooper: Speaker’s Bureau; Self; Regeneron Pharmaceuticals Inc. K. Miller: Other Relationship; Self; Dexcom, Inc., Tandem Diabetes Care, Research Support; Self; JDRF, Leona M. and Harry B. Helmsley Charitable Trust. 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. Funding National Institute of Diabetes and Digestive and Kidney Diseases (P30DK036836); The Leona M. and Harry B. Helmsley Charitable Trust

90-OR: Vision-Threatening Diabetic Retinopathy (DR) Is Associated with Modifiable Risk Factors in Children with Type 1 Diabetes (T1D)

Vision-threatening DR (vtDR) is commonly defined as moderate nonproliferative or more severe DR, or the presence of diabetic macular edema (DME). Modifiable risk factors of DR and vtDR are well-established in adults. This study identified risk factors associated with DR and vtDR in a large pediatric cohort with T1D. Medical chart review was performed of baseline visits of pediatric (≤21 yrs old) patients at an academic eye center from 2005-2020 to collect demographic characteristics, medical history and DR severity. Analyses were adjusted for correlation between eyes of the same person. In total, 1735 subjects (3454 eyes) were included with mean±SD age 15.4±4.6 years, T1D duration 7.1±5.3 years, T1D onset 8.3±5.4 years, and A1c 8.4±1.3; 50.7% were female, 30.7% were overweight/obese and 4.1% had elevated/high BP. Any DR was present in 8.5% and vtDR in 2.4% of eyes. Unadjusted analyses found DR presence associated with higher A1c (p&amp;lt;.0001), longer T1D duration (p&amp;lt;.0001), younger age of T1D onset (p=0.0002), older age (p&amp;lt;.0001), female sex (p=0.001), higher BMI (p&amp;lt;.0001) and elevated/high BP (p&amp;lt;.0001). After backwards elimination modeling, older age (p&amp;lt;.0001), longer T1D duration (p=0.002) and higher A1c (p=0.01) were significantly associated with DR. In unadjusted analyses, vtDR was associated with higher A1c (p&amp;lt;.0001), longer T1D duration (p&amp;lt;.0001), younger age of T1D onset (p=0.001), older age (p&amp;lt;.0001), female sex (p=0.009), higher BMI (p=0.009) and elevated/high BP (p&amp;lt;.0001). Using backwards elimination modeling, older age (p&amp;lt;.0001), younger age of T1D onset (p&amp;lt;.0001) and elevated/high BP (p=0.0007) were significantly related to vtDR. In this pediatric cohort, DR or vtDR were present in 8.5% of eyes and were associated with modifiable risk factors of hyperglycemia and elevated BP. Future longitudinal studies can assess if early intervention to improve glycemic control and BP can reduce vtDR in youth with T1D. Disclosure C. Jacoba: None. K. Sampani: None. C. Gilbert: None. P. S. Silva: Research Support; Self; Hillrom, Optomed, Optos plc. J. Keady: 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. L. P. Aiello: Consultant; Self; KalVista Pharmaceuticals, Novo Nordisk, Regeneron Pharmaceuticals Inc., Stock/Shareholder; Self; KalVista Pharmaceuticals. J. Sun: Other Relationship; Self; Novo Nordisk, Roche Pharma, Research Support; Self; Adaptive Sensory Technology, Boehringer Ingelheim Pharmaceuticals, Inc., KalVista Pharmaceuticals, Optovue, Roche Pharma.

807-P: Adding CGM to Diabetes Care of Young Children with T1D Increases Caregiver Time

Caregivers, mostly parents, of youth with T1D are integral to management; yet little is known about their care time burden. We assessed time spent providing care to youth with T1D (aged 2- Disclosure A. Glynn: None. L. Kanapka: None. K. Miller: Other Relationship; Self; Dexcom, Inc., Tandem Diabetes Care, Research Support; Self; JDRF, Leona M. and Harry B. Helmsley Charitable Trust. 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. L. Dimeglio: Advisory Panel; Self; MannKind Corporation. T. Songer: Employee; Spouse/Partner; Boehringer Ingelheim Pharmaceuticals, Inc. Funding The Leona M. and Harry B. Helmsley Charitable Trust

227-OR: Physical Activity and Glucose Control among Youth with T1D

Background: Challenges with exercise related glucose control in type 1 diabetes (T1D) may impact adherence to guidelines which recommend 60 minutes daily of moderate to vigorous intensity aerobic activity for youth ages 6-17 years. We examined the association between physical activity and glucose control in youth with T1D. Methods: Interstitial glucose data from flash continuous glucose monitors (CGM, Abbott Diabetes Care’s Freestyle Libre Pro Flash Glucose Monitor) and physical activity data (Metria IH1 activity patch) were objectively measured. Data from 52 youth 9-17 years old with a median diabetes duration of 6 years (IQR: 3 to 8) and mean (±SD) HbA1c of 9.1 ± 1.5% were analyzed. Partial Pearson’s correlation coefficients adjusting for age, gender, and baseline HbA1c were used to assess the association between daily physical activity and glucose control; the primary analysis used a linear regression model adjusted for age, gender, and baseline HbA1c. Results: Participants with higher average energy expenditure, as measured by metabolic equivalent minutes (MET-min), on their active days had higher average % time in range (TIR: 70-180 mg/dL) in the 24 hours after exercise than participants with lower average MET-min on active days (p&amp;lt;0.001). For individuals with &amp;lt;200 average daily MET-min, TIR was 26% ± 21%, while TIR was 34% ± 14% for those with 200 to &amp;lt;600 average MET-min, and 49% ± 14% for those with ≥600 average MET-min. Percent time &amp;gt;180 mg/dL decreased with increased activity (p=0.002). Activity was significantly associated with lower mean glucose (p=0.02) without an increase in % time &amp;lt;70 mg/dL or % time &amp;lt;54 mg/dL. Conclusions: Among youth with T1D, objectively measured physical activity levels are associated with improved glucose control and decreased hyperglycemia. Use of biometric technology, such as activity trackers, may motivate youth to be more physically active, but integration with other diabetes-specific technologies, such as CGM and insulin pumps, may offer solutions for improved blood sugar management. Disclosure J. Gal: None. Z. Li: None. S. M. Willi: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Medtronic, Other Relationship; Self; National Institute of Diabetes and Digestive and Kidney Diseases. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. Funding The Leona M. and Harry B. Helmsley Charitable Trust

648-P: Glucose-Dependent Insulinotropic Polypeptide (GIP) Induces Lipolysis during Stable Basal Insulin Substitution and Hyperglycemia in Men with Type 1 Diabetes

Glucose-dependent insulinotropic polypeptide (GIP) contributes importantly to postprandial insulin secretion, and - perhaps primarily due to this insulinotropic effect - affects glucose and lipid metabolism. We investigated the effects of exogenous GIP on lipid metabolism during hyperglycemia and stable insulin levels. Ten male patients with type 1 diabetes without endogenous insulin secretion (C-peptide negative), aged [mean±SD: 26±4 years; BMI: 24±2 kg/m2; HbA1c 7.3±0.8%) were studied in a randomized, double-blind, crossover study with continuous intravenous infusions of GIP (4 pmol/kg/min) or placebo (saline), during two separate 90-minute hyperglycemic (12 mmol/L) clamps with basal insulin substitution (0.1-0.2 mU/kg/min). Plasma glycerol concentrations increased from baseline during GIP infusions and decreased during placebo infusions (baseline-subtracted area under the curve (bsAUC): 703±407 vs. -262±240 µmol/L × min, respectively, P&amp;lt;0.001). Free fatty acids increased only during GIP infusions (bsAUC: 5,431±6,393 during GIP vs. -74±2,363 µmol/l × min during placebo infusion, P&amp;lt;0.05). Plasma concentrations of glucose, insulin, and glucagon were similar during GIP and placebo infusions (P=NS). Compared to placebo, GIP increased plasma glycerol and free fatty acids in patients with type 1 diabetes during hyperglycemia and stable basal insulin levels. With this experimental design it was possible to clearly identify an important effect of GIP on lipolysis in humans. Disclosure C. N. Nielsen: None. S. M. Nguyen heimbürger: Speaker’s Bureau; Self; AstraZeneca. S. Calanna: Employee; Self; Novo Nordisk A/S. J. J. Holst: Consultant; Self; Novo Nordisk, Other Relationship; Self; Antag Therapeutics, Bainan Biotech, MSD Corporation, Novo Nordisk, Other Relationship; Spouse/Partner; Antag Therapeutics, Bainan Biotech, Synklino ApS. T. Vilsbøll: Consultant; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Mundipharma International, Novo Nordisk, Sanofi, Sun Pharmaceutical Industries Ltd. F. K. Knop: Advisory Panel; Self; MSD Corporation, Novo Nordisk A/S, Sanofi, Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Pharmacosmos, Zealand Pharma A/S, Research Support; Self; Novo Nordisk A/S, Zealand Pharma A/S, Speaker’s Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S. M. B. Christensen: None.

31-LB: Limited Physical Activity among Overweight and Obese Young Adults with Type 1 Diabetes: Results from Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON)

This pilot and feasibility study aimed to identify dietary strategies to optimize glycemic control and weight management in overweight or obese young adults with T1D. In a sequential multiple assignment randomized trial, participants were randomized to a hypocaloric low-carbohydrate (CHO; 20-25% CHO), hypocaloric moderately low fat (30% energy fat), or Mediterranean (not calorie restricted) diet, with advice to maintain usual physical activity (PA). PA data were collected in a convenience sample of participants from 06/20 to 02/21. Young adults with T1D (n=27, age 25±3 years, 78% female, A1c 7.3±1.2%, BMI 30.7±3.4) wore PA trackers for 2-week periods during diet assignments. Median (IQR) daily steps were 4,931 (3,443-7,363), 5,562 (4,191-9,931), 6,457 (4,394-9,655) for Low CHO, Look AHEAD, and Mediterranean diets, respectively and daily moderate-to-vigorous PA (MVPA) mins were 16 (4-31), 18 (5-31), and 22 (6-32), respectively. Daily steps, active time, or MVPA did not differ by diet (p>0.05). We demonstrate that in a pilot study emphasizing diet and weight loss in young adults with T1D, PA was often below the recommended target of 30 mins MVPA/day (or 150 mins/week). Thus, a larger, adaptive weight management intervention will need to incorporate diet as well as safe and effective PA strategies for overweight and obese young adults with T1D. Disclosure D. P. Zaharieva: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. For the act1on study: n/a. F. R. Muntis: None. N. Arrizon- ruiz: None. J. Thomas: None. E. J. Mayer-davis: None. A. Addala: None. M. A. Clements: Consultant; Self; Eli Lilly and Company, Employee; Self; Glooko, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc. A. Kollu: None. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1DP3DK113358)

177-LB: The Association between the Baseline Glycemic Control and Antihyperglycemic Therapy with the Severity of SAR-CoV2 Infection in Ethnic Minority Patients with Diabetes

Objective: To analyze the relationship between the baseline glycemic control and antihyperglycemic therapy with the severity of the SARS-COV-2 infection (COVID-19) in ethnic minority patients with diabetes. Methods: We conducted a retrospective chart review of 179 consecutive patients at an academic hospital in Chicago, Illinois. A sample of patients who tested positive for COVID-19 between March 21st, 2020 and January 12th, 2021were divided in 3 groups according to the clinical severity of COVID: 1) Mild (outpatient treatment only); 2) Moderate (hospital admission); 3) Severe (ventilatory support and/or death). Results: Mean hemoglobin A1c (HbA1c) before COVID-19 was 8.43 (±2.0) %. Mean age was 59.6 (±11.9) years, 57.54% were male, 51.9% Hispanic and 41.9% African Americans. Sixty-four patients (35.8%) had mild disease (outpatient treatment, group 1), 93 (52%) moderate (hospital admission without the need for ventilatory support, group 2), and 22 (12.3%) severe disease (intubation and/or death, group 3). Baseline glycemic control was not associated with the clinical outcomes of COVID. Among various therapeutic agents, only metformin use was significantly associated with mild disease versus moderate and severe forms of COVID, controlling for GFR. Fifty-four patients (84.4%) in group 1 were taking metformin, compared with 63 (35%) and 11 (50%) in the moderate and severe groups, respectively. Conclusion: Here we report that use of metformin was associated with a lower chance of developing moderate (hospitalization) or severe forms (ventilatory support and/or death) of COVID-19 in ethnic minority patients with diabetes. Prospective investigation is required to make precise estimates of the impact of metformin in COVID-19 outcomes. Disclosure J. Berardo: None. D. Mihailescu: None. B. Tahsin: None. L. Fogelfeld: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Sanofi.