Roche Diabetes Care Research Articles

173-OR: CGM-Measured Differences in Pregnancies With vs. Without Gestational Diabetes (GDM) and Adverse Perinatal Outcomes (APO)

An objective of the study was to characterize if continuous glucose monitor (CGM) glycemic patterns throughout pregnancy are indicative of gestational diabetes (GDM) and adverse pregnancy outcomes (APOs). A prospective observational cohort of 760 pregnant patients enrolled <17 weeks with A1c <6.5% wore a blinded CGM sequentially during pregnancy. Patients with ≥14 days of CGM data overall with ≥10 days in the 2nd trimester, oral glucose tolerance test (OGTT), and an APO assessment were included. The primary outcome was GDM diagnosis by abnormal OGTT. Large gestational age (LGA) birthweight >90% and hypertensive disorder of pregnancy (HDP) were analyzed. Glycemic metrics using CGM between those with and without GDM and each APO were compared. Participants had a mean±SD of 112±42 days of CGM data. Prevalence of GDM, LGA, and HDP were 7%, 16%, and 27%. Mean glucose, glucose standard deviation, time > 120 mg/dL and > 140 mg/dL were significantly higher during the entire gestational period prior to OGTT (mean 27 ± 2 weeks) in those who developed GDM. TIR 63-120 mg/dL and 63-140 mg/dL were significantly lower in those who developed GDM (Table 1). Similar findings were noted for the diagnosis of LGA and HDP. CGM use during pregnancy revealed glycemic differences between those with vs without GDM, LGA, and HDP throughout gestation. Higher glucose levels during pregnancy are associated with these APOs. Disclosure C.Durnwald: None. P.Calhoun: None. A.L.Carlson: Advisory Panel; MannKind Corporation, Novo Nordisk, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk, Insulet Corporation, UnitedHealth Group, Sanofi. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. Z.Li: None. E.Norton: None. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. M.Banfield: None. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. S.Dunnigan: None. J.Sibayan: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust; United Health Group

899-P: Patient Reported Outcomes (PROs) for Young Children Using the Control IQ Hybrid Closed-Loop System (CIQ)

The objective was to examine PROs after use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children. Children with T1D ages 2-<6 years (n=102) were randomized 2:1 to either CIQ or standard care (SC) with pump or MDI plus CGM for 13 wks. Both groups could use CIQ for an additional 13 wks. Parents completed PROs at baseline, 13-, and 26-wks examining hypoglycemia concerns, quality of life, parenting stress, and sleep (see table). At 26 wks, 28 families participated in focus groups about their experiences with CIQ. Repeated measures analysis with False Discovery Rate correction and accounting for baseline showed that all 5 PROs surveys moved in the positive direction. Four showed that CIQ was superior to SC at 26 wks (p values < 0.05). Focus group findings showed optimized glycemic control overall and nighttime control specifically (28 of 28 families endorsed). All but 2 families noted substantial reduction in management burden resulting in less mental burden and all but 4 stated that they wanted their kids to continue using CIQ. Families utilizing CIQ experienced glycemic benefit coupled with substantial benefit in PROs, documented on surveys and focus groups. Families utilizing CIQ had reduced hypoglycemia concerns and parenting stress, and improved quality of life and sleep. These findings demonstrate benefit of CIQ in young children with T1D that goes beyond documented glycemic benefit. Disclosure A.Schneider-utaka: None. C.Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. M.D.Breton: Consultant; Dexcom, Inc., Tandem Diabetes Care, Inc., Roche Diabetes Care, Sanofi, Arecor, Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Novo Nordisk. K.K.Hood: Consultant; Cecelia Health. Pedap trial study group: n/a. Z.Reed: None. B.A.Buckingham: Advisory Panel; Medtronic, Novo Nordisk, Consultant; Lilly, Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc. E.C.Cobry: None. M.D.Deboer: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. L.Ekhlaspour: Consultant; Ypsomed AG, Tandem Diabetes Care, Inc., Other Relationship; NIH - National Institutes of Health, Research Support; MannKind Corporation, Tandem Diabetes Care, Inc., JDRF, Speaker's Bureau; Insulet Corporation. M.Schoelwer: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation. R.Wadwa: Consultant; Eli Lilly and Company, Other Relationship; Dexcom, Inc., Eli Lilly and Company, Research Support; Dexcom, Inc., Eli Lilly and Company, Beta Bionics, Inc., Tandem Diabetes Care, Inc. J.W.Lum: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK127551); Tandem Diabetes Care, Inc.; Dexcom, Inc.

777-P: Early Weight Loss and Late Metabolic Outcomes in Tirzepatide-Treated Participants with Type 2 Diabetes

Tirzepatide (TZP), a novel, once-weekly GIP/GLP-1 receptor agonist, significantly improved glycemic control with robust weight loss vs comparators in the SURPASS 1-5 trials. The aim of this analysis was to assess whether the magnitude of early weight loss with TZP (<5% or ≥5% at Week 8) would be associated with different clinical response in terms of HbA1c and weight at Week 40/42 across the SURPASS 1-5 trials. These phase 3 trials included participants with type 2 diabetes receiving TZP as monotherapy or add-on to background antihyperglycemic medications. This post-hoc analysis used pooled data from all TZP arms (5, 10, and 15 mg) across trials. Participants achieving ≥5% early weight loss at Week 8 had lower HbA1c and weight at baseline, and experienced greater reductions in HbA1c and weight at Week 40/42 vs those achieving <5% early weight loss (Table). Among participants achieving ≥5% early weight loss, greater proportions met HbA1c <7% and ≤6.5%, ≥10% weight loss, and the composite endpoint of HbA1c <7% and ≥10% weight loss. Early weight loss with TZP predicts greater reductions of HbA1c and weight at Week 40/42. However, even the one third of participants achieving <5% weight loss early in the course of therapy are likely to meet the ADA/EASD dual treatment goals of HbA1c <7% and ≥10% weight loss. Disclosure I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. F.Giorgino: Advisory Panel; Boehringer-Ingelheim, Amarin Corporation, Medtronic, Roche Diabetes Care, Sanofi, Bayer Inc., Novo Nordisk, Consultant; Novo Nordisk, Lilly, Research Support; Lilly, Roche Diabetes Care, AlfaSigma, Speaker's Bureau; Abbott, Boehringer-Ingelheim, Lilly, Sanofi, Medscape. L.Van gaal: Advisory Panel; Merck Sharp & Dohme Corp., Speaker's Bureau; Boehringer Ingelheim Pharma GmbH&Co.KG, Eli Lilly and Company, Novo Nordisk. M.Liu: Consultant; Eli Lilly and Company. Á.Rodríguez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Torcello-gomez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. J.I.Kiljanski: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

580-P: Influence of Daily Step Counts on Glucose Outcomes in Adults with Type 1 Diabetes (T1D)

Achieving 7-10K steps per day is recommended to maintain health; however, the influence of step count on time in range (70-180mg/dL: TIR), time above range (>180mg/dL: TAR), and time below range (<70mg/dL: TBR) in adults with T1D on different insulin delivery modalities (multiple daily injections [MDI], standard pump [SP], closed loop system [CLS]) is unclear. Using data from the Type 1 Diabetes Exercise Initiative, we examined the impact of failing to meet (<7k), meeting (7k-10k) and exceeding (>10k) step count goal on glycemic outcomes by insulin modality. Adults with T1D (37±14 yrs, 73% F, A1C 6.6±0.7%) wore a Verily Study Watch and CGM (Dexcom G6) for 4 weeks. Participants had at least two days where they failed to meet, met, and exceeded step count goal. For all users, mean TIR was 2% lower and TAR was 2% higher on days when participants failed to meet step count goal compared to meeting or exceeding step goal. TBR was 0.3% higher on days exceeding step count goal compared to failing to meet or meeting goal. Trends were similar across insulin delivery modalities, but variation differed, which affected significance levels. Meeting or exceeding 7-10K steps per day is associated with marginal improvements in TIR in adults with T1D. Disclosure L.Turner: None. F.J.Doyle: Other Relationship; Insulet Corporation, Roche Diabetes Care, Dexcom, Inc., Stock/Shareholder; Mode AGC. J.R.Castle: Advisory Panel; Novo Nordisk, Zealand Pharma A/S, Research Support; Dexcom, Inc., Stock/Shareholder; Pacific Diabetes Technologies. M.B.Gillingham: None. M.R.Rickels: Consultant; Sernova, Corp., Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Dompé. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. P.G.Jacobs: Board Member; Pacific Diabetes Technologies, Other Relationship; Pacific Diabetes Technologies, Research Support; Dexcom, Inc. M.Riddell: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Indigo Diabetes, Consultant; Lilly Diabetes, Eli Lilly and Company, Jaeb Center for Health Research, Speaker's Bureau; Dexcom, Inc., Novo Nordisk, Sanofi, Stock/Shareholder; Supersapiens, Zucara Therapeutics. T1dexi study group: n/a. C.Marak: None. P.Calhoun: None. R.L.Gal: None. Z.Li: None. G.Young: None. S.R.Patton: None. M.A.Clements: Consultant; Glooko, Inc., Research Support; Dexcom, Inc., Abbott Diabetes. C.K.Martin: Board Member; EHE Health, Wondr Health, Other Relationship; ABGIL, Research Support; Pack Health, Evidation Health, Lilly, WW International, Inc. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Verily Life Sciences; Dexcom, Inc.

773-P: Consistent Glycemic Efficacy and Safety of Concomitant Use of iGlarLixi and Sodium–Glucose Cotransporter-2 Inhibitor Therapy for Type 2 Diabetes—A Patient-Level Pooled Analysis

SGLT2i therapy is recommended for people with T2D, especially those at high cardiovascular risk or with chronic kidney disease or heart failure, due to its protective effects. This analysis evaluated glycemic and safety outcomes for iGlarLixi with or without existing SGLT2i therapy. This exploratory analysis examined outcomes in people with T2D who were receiving an SGLT2i when initiating iGlarLixi (SGLT2i users) and those who were not (SGLT2i non-users) in a pooled dataset of LixiLan-G (people advancing therapy from a GLP-1 RA), and SoliMix and LixiLanOne CAN (people advancing from basal insulin). Baseline characteristics were generally similar between SGLT2i users and non-users (Table). Least squares mean change (LSMC) (95% CI) from baseline to Week 26 in HbA1c was −1.2% (−1.4%, −1.1%) for users and −1.2% (−1.2%, −1.1%) for non-users. LSMCs in fasting/post-prandial glucose and body weight were similar in both groups. There was no increased risk of hypoglycemia in SGLT2i users. Gastrointestinal adverse events were comparable between groups. Concomitant SGLT2i and iGlarLixi therapy provides improvements in glycemic control with low hypoglycemia and gastrointestinal adverse event rates, as demonstrated in trials with different populations and study designs in people with T2D. Disclosure F.Giorgino: Advisory Panel; Boehringer-Ingelheim, Amarin Corporation, Medtronic, Roche Diabetes Care, Sanofi, Bayer Inc., Novo Nordisk, Consultant; Novo Nordisk, Lilly, Research Support; Lilly, Roche Diabetes Care, AlfaSigma, Speaker's Bureau; Abbott, Boehringer-Ingelheim, Lilly, Sanofi, Medscape. C.Guja: Advisory Panel; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi, Speaker's Bureau; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Servier Laboratories, Viatris Inc. M.J.Davies: Advisory Panel; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Lexicon Pharmaceuticals, Inc., Pfizer Inc., Medtronic, ShouTi Pharma Inc., Consultant; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Research Support; AstraZeneca, Novo Nordisk, Sanofi-Aventis U.S., Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., Speaker's Bureau; Lilly, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Napp Pharmaceuticals Limited, Novartis, Sanofi. H.Aydin: Advisory Panel; Sanofi, Novo Nordisk, Boehringer Ingelheim Inc., Speaker's Bureau; Novo Nordisk. F.Lauand: Employee; Sanofi. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. L.Melas-melt: None. V.R.Aroda: Consultant; Applied Therapeutics Inc., Fractyl Health, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Other Relationship; Janssen Pharmaceuticals, Inc., Research Support; Applied Therapeutics Inc., Eli Lilly and Company, Fractyl Health, Inc., Novo Nordisk, Sanofi. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. Funding Sanofi

172-OR: Normative CGM Glucose Levels throughout Gestation in Patients with Uncomplicated Pregnancies

Glycemic patterns throughout pregnancy are not well described, particularly early pregnancy. CGM used throughout the gestational period in uncomplicated pregnancies may help describe glycemic patterns in more detail. Blinded CGM data were collected throughout pregnancy from 760 pregnant patients ≥18 years old, with HbA1c <6.5%, no known diabetes, and gestational age <17 weeks. CGM data from uncomplicated pregnancies (pregnancy without gestational diabetes, large for gestational age birth, or hypertensive disorder of pregnancy) established the normative data set. Uncomplicated pregnancies (n=427, mean±SD age 32±4 years, 73% White non-Hispanic, mean HbA1c 5.1±0.3%) showed mean glucose during the entire gestational period was 99±7 mg/dL. Trimester specific mean glucose was: 103±7, 98±7 and 98±8 mg/dL for 1st, 2nd, 3rd trimesters. Figure 1 shows mean glucose by hour/trimester. Median (quartiles) percent time in range (TIR) 63-120 mg/dL was 86% (82-89%) for gestational period, and 84% (79-89%), 87% (82-90%), and 85% (80-90%) for 1st, 2nd, 3rd trimesters. Figure 2 shows TIR 63-120 mg/dL by 4-week periods. In uncomplicated pregnancies, mean glucose and TIR 63-120 mg/dL remained consistent throughout the gestational period. These normative CGM data will help set pregnancy-specific glycemic targets and will be important to compare to those 333 women in this study with complicated pregnancies. Disclosure A.L.Carlson: Advisory Panel; MannKind Corporation, Novo Nordisk, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk, Insulet Corporation, UnitedHealth Group, Sanofi. J.Sibayan: None. P.Calhoun: None. C.Durnwald: None. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. Z.Li: None. E.Norton: None. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. S.Dunnigan: None. M.Banfield: None. K.J.Krumwiede: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust; United Health Group

984-P: Importance and Use of Smart Insulin Pens with Connectivity for Diabetes Management

Smart insulin pens have the potential to fulfill some of the unmet needs of people with diabetes through the accurate administration of bolus doses, the simplification of documentation relating to diabetes therapy, the improvement of communication and the quality of advice given to patients. 305 (2021) and 336 diabetologists in Germany (2022; 38% female, average age 55.2 years) were asked via an online survey about the importance and use of smart insulin pens. In 2022, only 4.8% of all people with type 1 diabetes and 1.5% of all people with type 2 diabetes used a smart pen. The total estimated utilization in 5 years is 18.3% (2021: 23.9%). The importance of smart pens is currently estimated by diabetologists at 8.0%, which is not very high and lower than in 2021 (15.5%). This also applies to the estimated relevance in 5 years (2022: 24.7 %; 2021: 37.9 %). However, 29.7% of all people with type 1 diabetes are considered to have an indication for a smart pen, 30.8% of people with type 2 diabetes and basal insulin therapy, and 37.6% with multiple injection therapy. The main barriers to smart pens identified were patient preference for prefabricated pens (54.6% agreement), low added benefit (49.4%), lack of interoperability with glucose analysis software (44.3%), lack of interoperability with apps (35.6%), too little choice (need to change insulin), and too high cost (33.9%). Despite a very positive attitude towards digitization of diabetes therapy among physicians (2021: 81.9%; 2022: 86.3%), smart pens are currently used only very rarely and their importance for diabetes therapy is considered rather low. Better, simpler, and patient-friendly solutions are needed so that all types of smart insulin devices can be read easily by glucose management software and users experience perceivable benefits. Disclosure L.Heinemann: Consultant; 9am.health. D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. T.Roos: None. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care.

263-OR: Older Adults Benefit from Virtual Support for CGM Use but Require Longer Visits

The Virtual Diabetes Specialty Clinic (VDiSC) provided type 1 (T1D) and type 2 diabetes (T2D) adults taking insulin virtual care with remote CGM training and support. HbA1c improved from baseline to 6 months in T1D (7.8% to 7.0%) and T2D (8.2% to 7.0%) with increased time in range (70-180 mg/dL; TIR). Here we compare glycemic outcomes (Table 1) and duration of remote CGM training visits (Table 2) in adults ages <40 yr, 40-59 yr and ≥ 60 yr. HbA1c and %TIR improved in each group. Limitations include a small sample size that was mostly White. Results suggest that both T1D and T2D adults ≥60 years of age experience glycemic benefit after remote training and support in the use of CGM from CDCESs, but when compared to young adults, older adults require more time for training. Support for approaches that address the individual needs of older adults with diabetes is required. Disclosure R.S.Weinstock: Consultant; Jaeb Center for Health Research, Other Relationship; Wolters Kluwer Health, Research Support; Insulet Corporation, Medtronic, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim Inc., Hemsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Inc., Kowa Pharmaceuticals America, Inc. T.S.Mcarthur: None. B.A.Olson: Stock/Shareholder; Abbott. S.Oser: Advisory Panel; Cecelia Health, Dexcom, Inc., Consultant; Medscape, Research Support; Abbott Diabetes. T.Oser: Advisory Panel; Cecelia Health, Consultant; Dexcom, Inc., Medscape, Research Support; Abbott. D.Raghinaru: None. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. Z.Thompson: None. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. T.L.Cushman: None. R.L.Gal: None. C.Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. D.F.Kruger: Advisory Panel; Abbott Diabetes, Lilly, Medtronic, Novo Nordisk, Research Support; Dexcom, Inc., Beta Bionics, Inc., Speaker's Bureau; Dexcom, Inc., Lilly, Xeris Pharmaceuticals, Inc., Novo Nordisk. K.K.Hood: Consultant; Cecelia Health. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.

59-OR: Glycemic Control with Extended Use of Automated Insulin Delivery (AID) in Children Age 2–6 Years with Type 1 Diabetes (T1D)

T1D management in children < age 6 yrs is challenging due to unpredictable food intake and activity. Efficacy of AID with the Tandem t:slim X2 insulin pump with Control-IQ technology (CIQ) in this age group has not been well studied. Data included 95 children with T1D age 2 to < 6 yrs (age 3.9±1.2 yrs, 46% male, 75 % non-Hispanic white, 34% on multiple daily injections) enrolled in a 13-week extended use phase of a randomized trial of closed loop control (CLC) with CIQ. In this phase, the group assigned to CLC for the initial 13 weeks continued on CLC (CLC-CLC) and those initially using standard care (SC) were placed on CLC (SC-CLC). CGM time in range 70-180 mg/dL (TIR) was the primary outcome. The SC-CLC group (n=33) increased TIR using CLC in the extension compared to the SC period (68±9% vs. 56±13%, p<0.001) with no significant change in hypoglycemia (%CGM < 54 mg/dL 0.4±0.3% vs. 0.5±0.6%, p=0.03). TIR increased within the first week of CLC use similar to the first 13 weeks of AID use for the CLC-CLC group (Figure). CLC training was completed virtually for 82% of the SC-CLC group. The CLC-CLC group (n=62) maintained TIR (71±11% vs. 70±10%, p=0.80) with slightly lower rates of hypoglycemia (%CGM < 54 mg/dL 0.5±0.4% vs. 0.6±0.5%, p=0.08). In conclusion, these data show that in young children age 2 to < 6, CLC with Control-IQ technology leads to increased TIR without an increase in time in hypoglycemia. Disclosure R.Wadwa: Consultant; Eli Lilly and Company, Other Relationship; Dexcom, Inc., Eli Lilly and Company, Research Support; Dexcom, Inc., Eli Lilly and Company, Beta Bionics, Inc., Tandem Diabetes Care, Inc. C.Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. M.D.Breton: Consultant; Dexcom, Inc., Tandem Diabetes Care, Inc., Roche Diabetes Care, Sanofi, Arecor, Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Novo Nordisk. Pedap trial study group: n/a. Z.Reed: None. B.A.Buckingham: Advisory Panel; Medtronic, Novo Nordisk, Consultant; Lilly, Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc. M.D.Deboer: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. L.Ekhlaspour: Consultant; Ypsomed AG, Tandem Diabetes Care, Inc., Other Relationship; NIH - National Institutes of Health, Research Support; MannKind Corporation, Tandem Diabetes Care, Inc., JDRF, Speaker's Bureau; Insulet Corporation. E.C.Cobry: None. M.Schoelwer: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation. C.Berget: Consultant; Insulet Corporation, Dexcom, Inc., Other Relationship; Tandem Diabetes Care, Inc. J.W.Lum: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK127551); Tandem Diabetes Care, Inc.; Dexcom, Inc.

149-LB: Telemedicine Intervention Impact on Diabetes Self-Management—Twelve-Month Virtual Diabetes Specialty Clinic (VDISC) Study Outcomes

The impact of a telemedicine model for a virtual diabetes clinic was assessed 6 months following completion of a 6-month intervention of education and support for diabetes self-management, including initiation and use of CGM. One hundred and sixty-one participants ≥18 years old with T1D (N=109) or T2D (N=52) using MDI/pump participated in the 12-month study. At the end of the 6-month intervention period, mean HbA1c decreased from 7.6% at baseline to 7.0% in T1D and from 8.1% to 7.0% in T2D (P<0.001). At 12 months (6 months after discontinuation of the intervention), mean HbA1c was 7.0% for T1D and 7.2% for T2D (P<0.001 compared with baseline). Mean time in range 70-180 mg/dL was 51% at baseline, increasing to 62% at 6 months (P<0.001) and 64% at 12 months in T1D (P<0.001) and from 49% to 66% (P<0.001) and 68% (P<0.001), respectively, in T2D. Similar improvements were observed for mean glucose and hyperglycemia metrics. A sustained reduction in hypoglycemia also was observed. The virtual diabetes clinic intervention was successful in promoting improved glycemic outcomes, which were sustained 6 months after the intervention was completed. These findings demonstrate the impact that virtual care and education can have on self-management over time and provide opportunity to expand care models that could minimize barriers to specialty care access. Disclosure R. L. Gal: None. S. Oser: Advisory Panel; Cecelia Health, Dexcom, Inc., Consultant; Medscape, Research Support; Abbott Diabetes. T. Oser: Advisory Panel; Cecelia Health, Consultant; Dexcom, Inc., Medscape, Research Support; Abbott. K. K. Hood: Consultant; Cecelia Health. T. L. Cushman: None. M. L. Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. C. Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. R. Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. D. Raghinaru: None. G. Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. B. A. Olson: Stock/Shareholder; Abbott. D. F. Kruger: Advisory Panel; Abbott Diabetes, Lilly, Medtronic, Novo Nordisk, Research Support; Dexcom, Inc., Beta Bionics, Inc., Speaker's Bureau; Dexcom, Inc., Lilly, Xeris Pharmaceuticals, Inc., Novo Nordisk. R. M. Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. R. S. Weinstock: Consultant; Jaeb Center for Health Research, Other Relationship; Wolters Kluwer Health, Research Support; Insulet Corporation, Medtronic, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim Inc., Hemsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Inc., Kowa Pharmaceuticals America, Inc. A. Bradshaw: None. T. S. Mcarthur: None.

1450-P: Profiles of Glycemic Control in People with Type 1 Diabetes Using CGM—A Clustering Approach in the SFDT1 Study

CGM-derived data are usually analyzed in silos, metric by metric, for diabetes care or therapeutic strategy. Simultaneous analysis of the various dimensions of glycemic control would allow a more comprehensive overview. We analyzed data of people with type 1 diabetes (PWT1D) in the SFDT1 cohort study. A K-means clustering model was developed with HbA1c, coefficient of variation (CV), time in range (TIR), time below 70 mg/dl (TBR), Gold score and Glycemic Risk Index (GRI). We included 618 participants (53% men, age 41±14 years) from 20 centres in France. The optimal model had 3 clusters. The “Euglycemia” cluster (n=280, 45%) was characterized by a high TIR (mean 69.3%); low TBR ​​(4.2%), TAR (time above 180 mg/dl: 26.5%), CV (35.7%), HbA1c (7.0%) and GRI (36.4) values. The “Hyperglycaemia" cluster (n=197, 32%) was characterized by high TAR (56.5%), GRI (71.8) and HbA1c (8.5%) and low TIR (40.3%), TBR (3.2%) and Gold score (2.3). The “Hypoglycemia” cluster (n=141, 23%) was characterized by high TBR (15.8%), CV (46.1%), GRI (69.2) and Gold score (3.0). Participants in the “Hyperglycemia” cluster were younger, socially vulnerable, and had more frequent hypertension than those in the “Euglycemia” cluster. To conclude, we identified three distinct, clinically relevant glycemic control profiles, enabling better characterization of PWT1D and, thus, more personalised management. Disclosure E.Cosson: Board Member; Abbott, Medtronic. G.A.Aguayo: None. L.Sablone: None. M.Huet: None. J.Riveline: Board Member; Abbott Diabetes, Medtronic, Dexcom, Inc., Novo Nordisk, Eli Lilly and Company, Sanofi. G.Fagherazzi: Advisory Panel; Roche Diabetes Care, Consultant; AbbVie Inc., Lilly. Sfdt1 study team: n/a.

198-LB: Dynamic Behavior of Healthy People with Different Numbers of Autoantibodies

Background and aims: The risk of type 1 diabetes (T1D) can be assessed by the number of islet autoantibodies (Ab), genetic, and metabolic markers to predict the progression to diabetes. Prior OGTT-based work had suggested that β cell dysfunction exists prior to T1D diagnosis. Here, we test whether the frequently sampled glucose, insulin, and C-peptide responses to a mixed meal depend on the number of Ab. Methods: Sixty healthy relatives to T1D with mean±SD age of 23.7±10.7 years, HbA1c of 5.3±0.3%, and BMI of 23.8±5.6 kg/m2 with zero (N=21), one (N=18), and ≥2 (N=21) Ab, were enrolled in an ancillary study from the NIH-funded TrialNet Pathway to Prevention study. At 08:00, the participants consumed a 6ml/kg standardized liquid mixed meal (SLMM). To estimate the SLMM glycemic and hormonal behavior, 14 blood samples were collected from -30 (relative to the SLMM ingestion) to 120 minutes for insulin, C-peptide, and glucose. Glucose-Insulin-C-peptide features were extracted from the post-SLMM period to compare the different Ab groups. Results: Among all glycemia metrics, only two were different across the Ab groups: glucose incremental AUC for the “tail” (60 min- 120 min; during the decline, after glucose reaches its peak) and glucose at 90 min with p-value 0.036, and 0.025 respectively. Regarding the insulin features after the post-SLMM; the insulin AUC for the tail, insulin at 30 min, insulin at 120 min, and the baseline insulin were different across the Ab groups (p=0.043, 0.033, 0.029, and 0.019 respectively), with higher insulin values for those with 1 Ab. As well, the C-peptide features: C-peptide at SLMM time, max C-peptide, and C-peptide at 120 min were different across the different Ab groups (p=0.019, 0.038, and 0.041 respectively), with higher C-peptide values for those with 1 Ab. Conclusion: The study suggests that the progression to T1D may be marked by detectable simultaneous changes in glycemia, insulin, and C-peptide in the very early stages of the disease even before transitioning to the first stage of T1D. Disclosure E. Montaser: None. M. D. Breton: Consultant; Dexcom, Inc., Tandem Diabetes Care, Inc., Roche Diabetes Care, Sanofi, Arecor, Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc., Novo Nordisk. S. A. Brown: Research Support; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc. M. D. Deboer: Research Support; Dexcom, Inc., Tandem Diabetes Care, Inc. A. L. Mccall: None. B. Kovatchev: Other Relationship; Dexcom, Inc., Johnson & Johnson Medical Devices Companies, Novo Nordisk, Sanofi, Research Support; Dexcom, Inc., Novo Nordisk, Tandem Diabetes Care, Inc., Speaker's Bureau; Tandem Diabetes Care, Inc. L. Farhy: Research Support; Dexcom, Inc., Novo Nordisk. Funding National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK106907); Commonwealth Research Commercialization Fund (MF20-007-LS); The Leona M. and Harry B. Helmsley Charitable Trust (2204-05134); JDRF (2-SRA-2022-1260-S-B)

804-P: Similar Hypoglycemia Duration with Once-Weekly Icodec vs. Degludec or Glargine U100 in Insulin-Treated T2D—A Post Hoc CGM Analysis from ONWARDS 2 and 4

Once weekly (OW) icodec is a basal insulin in development. Hypoglycemia duration during the switch (weeks 0-4) and steady state (weeks 22-26) periods from two phase 3, randomized, treat-to-target trials in T2D was investigated, using double-blinded Dexcom G6 CGM. Insulin-treated individuals were randomized to OW icodec or once-daily (OD) degludec (ONWARDS 2), or OW icodec or OD glargine U100 with mealtime insulin aspart (ONWARDS 4). When switching, a one-time only additional 50% icodec dose was administered. Basal insulins were titrated weekly. Median hypoglycemia <70 mg/dL duration for episodes lasting ≥ 15 minutes and the proportion of such episodes spent <54 mg/dL were assessed. Median duration of hypoglycemia <70 mg/dL was similar between icodec and comparators during switch and at steady state (Figure), with no apparent clustering in either time-period. At steady state (icodec/degludec and icodec/glargine U100), of the episodes <70 mg/dL, 66.6/63.9% and 60.4/60.0% spent no time <54 mg/dL; 23.2/26.6% and 29.2/28.8% included episodes <54 mg/dL for ≥15 minutes; and 10.2/9.5% and 10.4/11.2% included episodes <54 mg/dL for <15 minutes, respectively. In insulin-treated T2D, the duration of hypoglycemic episodes <70 mg/dL was similar, with no apparent clustering, during switch and at steady state for OW icodec versus OD degludec or glargine U100. Disclosure H.S.Bajaj: Research Support; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Anji Pharmaceuticals, Eli Lilly and Company, Kowa Company, Ltd., Novo Nordisk, Pfizer Inc., Sanofi, Tricida, Inc. B.Ásbjörnsdóttir: Employee; Novo Nordisk. L.Carstensen: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. L.Lang lehrskov: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. C.Mathieu: Advisory Panel; Novo Nordisk A/S, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated, Roche Diabetes Care, Imcyse, Speaker's Bureau; Novo Nordisk A/S, AstraZeneca, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health. T.Battelino: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Sanofi, Medtronic, Abbott Diabetes, Consultant; Indigo Diabetes, Research Support; Novo Nordisk, Sanofi, Medtronic, Novartis, Speaker's Bureau; Eli Lilly and Company, Novo Nordisk, Sanofi, Medtronic, Abbott Diabetes, Dexcom, Inc. Funding Novo Nordisk A/S

764-P: Time in Range and Time in Tight Range in Tirzepatide-Treated Patients Achieving Normoglycemia in the SURPASS-3 CGM Substudy

Tirzepatide (TZP), a novel once-weekly GIP/GLP-1 receptor agonist, demonstrated superior glycemic control vs insulin degludec (IDeg) in SURPASS-3 CGM. This post-hoc analysis evaluated changes from baseline to Week (Wk) 52 in Time in Range (TIR) (71-180 mg/dL), Time in Tight Range (TITR) (71-140 mg/dL), and glycemic variation (within-day coefficient of variation (CV) and Mean Amplitude of Glycemic Excursions (MAGE)) in TZP-treated patients achieving or not achieving HbA1c <5.7% at Wk 52. Interstitial glucose values were collected by CGM at 5-minute intervals for 7 days at baseline, Wk 24, and Wk 52 in a subset of patients in the SURPASS-3 trial. Analyses used pooled data from all TZP arms (5, 10, 15 mg) only due to limited sample size for IDeg patients achieving HbA1c <5.7% at Wk 52. Patients achieving HbA1c <5.7% were slightly younger, had lower HbA1c and FSG, and higher TITR and TIR vs those not achieving HbA1c <5.7% at baseline (Table). Increases in daily TITR and TIR from baseline (61.02% and 41.12% respectively) were seen in patients achieving HbA1c <5.7% while those not achieving HbA1c <5.7% had increased daily TITR and TIR of 36.62% and 32.40% (Table). Within-day CV and MAGE were reduced in both patient groups but more apparent in those achieving HbA1c <5.7%. In TZP-treated patients, improvements in TIR, TITR, and glycemic variability were more pronounced in those achieving HbA1c <5.7%. Disclosure R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. Á.Rodríguez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. B.D.Benneyworth: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. C.Nicolay: Employee; Eli Lilly and Company. K.Brown: Employee; Eli Lilly and Company. Funding Eli Lilly and Company

429-P: Evaluation of Hypoglycemic Risk in Patients with Type 2 Diabetes on Hemodialysis under Tight Glycemic Control

Patients with type 2 diabetes on hemodialysis (T2HD) have unique glycemic profile resulting from hemodialysis, especially hemodialysis-related hypoglycemia, which is present in approximately 20% of them. We analyzed 48-hour sensor glucose level (SGL) on dialysis and non-dialysis days, and time in range (TIR, 70-180 mg/dL), time below range (TBR, <70 mg/dL) in 115 T2HD using continuous glucose monitoring (CGM) and evaluated the difference in clinical parameters between well-controlled group (TIR >70% and TBR <4%) and hypoglycemia group (TIR >70% and TBR ≥4%). Sixty-six patients of well-controlled group (46 males, age 62±12 years, HbA1c 6.0±0.9%, glycated albumin (GA) 18.5±4.1%) and 11 cases of hypoglycemia group (8 males, age 65±13 years, HbA1c 5.9±0.7%, GA 17.4±3.6%) were selected for retrospective analysis. There were no differences in sex, age, dry weight, body mass index, duration of diabetes, or duration of dialysis between two groups. Likewise, HbA1c and GA were not significantly different (P=0.7044, P=0.4151). Glucose levels at both the beginning and the end of dialysis were significantly lower in the hypoglycemia group (164.1±42.8 mg/dL vs. 131.0±49.2 mg/dL (P=0.0227) and 118.8±40.2 mg/dL vs. 86.8±26.1 mg/dL (P=0.0130), respectively). On the other hand, CGM data showed significantly lower mean SGL (P=0.0005) and significantly higher coefficient of variation of SGL (P=0.0014) in the hypoglycemia group. Thus, both HbA1c and GA are not sufficient to predict the presence of hypoglycemia in strict glycemic control in T2HD. Therefore, for good glycemic control without hypoglycemia in T2HD, it is important to measure glucose levels at the beginning and end of dialysis and to evaluate glucose profiles by CGM. Disclosure A.Hayashi: Research Support; Abbott Japan Co., Ltd., Roche Diabetes Care, Speaker's Bureau; Abbott Japan Co., Ltd., Medtronic, Terumo Corporation. N.Shimizu: None. A.Suzuki: None. R.Fujishima: None. K.Matoba: None. T.Masaki: None. T.Miyatsuka: Speaker's Bureau; Eli Lilly Japan K.K., Novo Nordisk, Sanofi K.K., Mitsubishi Tanabe Pharma Corporation, Sumitomo Dainippon Pharma Co., Ltd., Teijin Pharma Limited, Sanwa Kagaku Kenkyusho, Daiichi Sankyo. Funding TERUMO Life Science Foundation (21-III-5030); Japan Association for Diabetes Education and Care (2021-YNG-028); Japan Society for the Promotion of Science (22K15674)

108-LB: Randomized Trial of Automated Insulin Delivery in Pregnant Women with Type 1 Diabetes

Objective: To examine the clinical efficacy of automated insulin delivery (AID) during type 1 diabetes (T1D) pregnancy. Methods and Outcomes: We randomized pregnant women with T1D from nine UK clinical sites to hybrid closed-loop (CamAPS FX) or standard insulin therapy with continuous glucose monitoring. The primary outcome was the between-group difference in percentage time in the pregnancy-specific target glucose range (63-140mg/dl) from 16-weeks’ gestation until delivery. Analyses were performed according to intention-to-treat principles. Key secondary outcomes included overnight time-in-range (TIR), time spent hyperglycaemic (time-above-range, TAR >140mg/dl), HbA1c and safety events. Results: 124 participants (aged 31.1 ± 5.3yrs, HbA1c 7.7 ± 1.2%, T1D duration 2-31yrs, weight 49.0-138.0kg, total daily insulin doses 0.3-1.4units/kg) were randomized. The percentage of time that maternal glucose levels were within target was higher during AID than standard insulin therapy; mean between-group treatment difference 10%; 95% CI 7 to 10%; p < 0.001. Participants randomized to AID had larger reductions in hyperglycemia (AID vs control -11%; 95% CI -14 to - 7%; p<0.001), higher overnight time-in-range; (13%; 95% CI 9 to 17%; p<0.001), and lower HbA1c (-0.34%; 95%CI -0.52 to -0.15%; p<0.001), without additional insulin, weight gain or hypoglycemia. The treatment effect was apparent from early pregnancy, consistent across clinical sites, maternal HbA1c categories and previous insulin pump or injections. A significantly higher percent of AID participants reached CGM targets (TIR >70%: 46% vs 10%; p<0.001 and TAR <25%: 37% vs 11%; p=0.007 [AID vs. control]). One neonatal death that was unrelated to standard insulin therapy occurred. Conclusions: AID significantly improved maternal glycemia throughout T1D pregnancy. Our results support proposed NICE guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with T1D. Disclosure H. R. Murphy: Advisory Panel; Medtronic, Research Support; Dexcom, Inc. L. Shepstone: None. M. E. Wilinska: Consultant; CamDiab Ltd. S. Bergford: None. J. Sibayan: None. C. Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. R. Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. R. Hovorka: Advisory Panel; Ypsomed AG, Consultant; Abbott Diabetes, B. Braun, Speaker's Bureau; Eli Lilly and Company, Stock/Shareholder; CamDiab Ltd. T. T. M. Lee: None. C. Collett: None. S. Hartnell: Advisory Panel; Dexcom, Inc., Medtronic, Consultant; CamDiab Ltd., Other Relationship; AskDiabetes Ltd, Speaker's Bureau; Abbott Diabetes, Ypsomed AG. E. M. Scott: Research Support; Abbott Diabetes, Speaker's Bureau; Abbott Diabetes. R. S. Lindsay: None. K. F. Hunt: None. D. R. Mccance: None. M. Hammond: None. Funding National Institute for Health Research (16/35/01); JDRF (22-2013-266, 2-RSC-2019-828-M-N); Diabetes Research and Wellness Foundation (SECF/21 to T.T.M.L.)

701-P: Psychological Resources of Young Adults with Type 1 Diabetes Mellitus during Transition from a Pediatric to Adult Diabetes Clinic—A Multicenter Cross-Sectional Study

Introduction: The period of transition of patients with type 1 diabetes from pediatric to adult-oriented health care is very vulnerable time, as it is associated with poorer glycemic control and less frequent clinic attendance. Aim: The purpose of this study was to evaluate psychological parameters of transitioning young patients with type 1 diabetes during the 1st visit in adult outpatient clinic. Methods: We examined 50 consecutive patients (56% females) transitioning from 03.2021 - 11.2022 into adult care (3 diabetes centers from 3 regions in southern Poland (A=16; B=21; C= 13)) and their basic demographic information. All patients fulfilled the following psychological questionnaires: STAI, GSES, PSS-10, SWLS, AIS, MHLC and CECS. Furthermore, we made comparison of data obtained in the study with data for general healthy population and general population with persons with diabetes. Results: During the first adult outpatients visit patients mean age was 19.2±1.4 yrs. with 9.8±4.3 yrs. of diabetes duration and BMI 23.5±3.1 kg/m2. Considering the therapy type: 67% of patients were treated with insulin pump therapy while 33% with multiple daily injections. There was no difference regarding the level of life satisfaction, perceived level of stress and state anxiety between studied population and general/diabetes population. Studied patients had similar locus of health control and negative emotions control in comparison to general population of diabetes. Patients had higher level of suppression of negative emotions: anger, depression, and anxiety than age matched general population. In addition, our population was characterized by higher acceptance of illness and higher level of self-efficacy compared to general/diabetes population. Conclusions: This study indicated good psychological resources and coping mechanisms of young patients transitioning to adult outpatient clinic. Disclosure B.Matejko: Consultant; Medtronic, Roche Diagnostics, BIOTON S.A. K.M.Cyranka: Other Relationship; Ascensia Diabetes Care, Roche Diabetes Care, Abbott, Research Support; Medtronic. A.Juza: None. K.Nabrdalik: Research Support; BIOTON S.A., Speaker's Bureau; Novo Nordisk, Abbott, Boehringer-Ingelheim, Lilly Diabetes, AstraZeneca. H.Kwiendacz: Speaker's Bureau; Sanofi, Novo Nordisk. J.Gumprecht: Advisory Panel; Abbott, Medtronic, Speaker's Bureau; Novo Nordisk A/S, Lilly, AstraZeneca, Merck & Co., Inc., Sanofi, Bayer Inc., KRKA, Ascensia Diabetes Care. M.Malecki: Advisory Panel; Abbott Diabetes, Novo Nordisk, Lilly, Sanofi, Dexcom, Inc., Bayer Inc., Research Support; Medtronic, Speaker's Bureau; AstraZeneca, AlfaSigma, Merck & Co., Inc., BIOTON S.A., Servier Laboratories, KRKA. T.Klupa: Advisory Panel; Abbott Diabetes, Ascensia Diabetes Care, Sanofi, BIOTON S.A., Speaker's Bureau; Medtronic, Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim Inc., Servier Laboratories.

936-P: Three-Month Interim Analysis from the Prospective Bigfoot Unity Real World Study (BURST)

Background: The Bigfoot Unity® System is an FDA-cleared smart pen cap system incorporating CGM data (Abbott FreeStyle Libre 2), real-time alerts, and clinician-directed insulin dose recommendations. The objective was to analyze real world, 3-month data for System users. Methods: We conducted a per-protocol 3-month interim analysis (N=54, 15 clinics) from the prospective, BURST study (NCT05088265). Participants reported baseline demographics and completed adverse event surveys every 2 weeks. For A1C data, an at-home kit or electronic medical record was used for baseline and 3-month values; CGM metrics were collected post System initiation. Results: Most (85%) had T2D and median age was 57 years; 58% were Caucasian and 58% were female. Mean A1C decreased from 9.2±1.8% at baseline to 7.9±1.3% at 3 months (mean difference −1.2%, 95%CI −1.6 to −0.8, p<0.001). Four severe hypoglycemia events in 3 participants and 1 DKA occurred and were not related to the System. Percent time below range and other 3-month glycemic outcomes and System use data are shown (Table). Discussion: In this cohort, consisting primarily of older adults with T2D using MDI and suboptimal glycemic control, durable glycemic improvement occurred using Bigfoot Unity at 3 months. The observed reduction in A1C in this older cohort does not compromise them in meeting established hypoglycemia targets of <4 and <1% for percent time below 70 and 54 mg/dL, respectively. Disclosure J.K.Malone: Employee; Bigfoot Biomedical, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. J.Tillman: Employee; Bigfoot Biomedical, Inc. P.Calhoun: None. T.J.Mouse: None. R.Bailey: None. B.P.Olson: Employee; Bigfoot Biomedical, Inc. S.Vaughan: Employee; Bigfoot Biomedical, Inc. F.Sheikh: Employee; Bigfoot Biomedical, Inc. Funding Bigfoot Biomedical, Inc.

123-LB: Implementing a Multidisciplinary Model of CGM Care in Real-World Pharmacy Practice—A Clinical Consensus for Canadian Pharmacists

Background: Continuous glucose monitoring (CGM) devices have transformed diabetes care, but there is a lack of guidance for pharmacists to follow when onboarding patients to begin using CGM systems. Our study aimed to develop a blueprint for best practices for pharmacists to support people living with diabetes (PWD) using CGM systems. Methods: We used a modified DELPHI process to gather insights from 11 Key Opinion Leaders (KOLs) across Canada, including two endocrinologists, one family physician, and eight pharmacists. Consensus was reached for each criterion when 75% agreement was achieved. Criteria for CGM device initiation, short-term or episodic CGM use, and best practices for CGM onboarding and monitoring were developed based on the results. Results: Amongst the ideal candidates for CGM use are PWD using insulin, those with type 1 diabetes, individuals not reaching their A1C target, those experiencing frequent hypoglycemia, pregnant individuals, and others at risk of hypoglycemia. Best practices for onboarding and monitoring included shared decision-making conversations, a comprehensive overview of cost and coverage options, customized alerts and alarms, and timely follow-up sessions. Discussion: The KOL group ensured a comprehensive and diverse perspective. The developed blueprint provides a valuable resource for pharmacists to improve the use of CGM devices and enhance diabetes management for their patients. Incorporating these best practices into clinical practice has the potential to transform diabetes care and improve outcomes. Disclosure A. S. Sihota: Consultant; Novo Nordisk Canada Inc., Other Relationship; Becton, Dickinson and Company. S. Sivapalan: Advisory Panel; Novo Nordisk, Pfizer Inc., AstraZeneca, Consultant; Pear Healthcare Solutions Inc., Other Relationship; Boehringer Ingelheim (Canada) Ltd., GlaxoSmithKline plc., Novo Nordisk, Bristol-Myers Squibb Company, Pfizer Inc., AbbVie Inc., Ferring Pharmaceuticals, AstraZeneca. T. Smith: Advisory Panel; Novo Nordisk Canada Inc., Dexcom, Inc., Emergent Biosolutions. I. Halperin: Advisory Panel; Sanofi, Speaker's Bureau; 3Boehringer Ingelheim Canada Ltd. /Ltée, Abbott Diabetes, Dexcom, Inc., Novo Nordisk. A. B. Jain: Advisory Panel; Abbott, Amgen Canada, Dexcom, Inc., AstraZeneca, Novo Nordisk, Bayer Inc., Insulet Corporation, Takeda Canada, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Research Support; Abbott, Amgen Canada, Novo Nordisk, Speaker's Bureau; Abbott, Amgen Canada, Dexcom, Inc., AstraZeneca, Novo Nordisk, Bausch Health, Canada, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Pfizer Inc. A. Chin: Other Relationship; Abbott Diabetes, BMO Bank of Montreal, Diabetes Canada, Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care, Inc., Research Support; Novavax, Centricity Research. W. Chow: Advisory Panel; GlaxoSmithKline plc., Pfizer Inc., Speaker's Bureau; Abbott Diagnostics, AstraZeneca, Bayer Inc., Bausch Health, Canada, Boehringer Ingelheim (Canada) Ltd., Eisai Inc., Novo Nordisk. S. Jin: Advisory Panel; Dexcom, Inc., Eisai Inc., Novo Nordisk Canada Inc., Board Member; Wounds Canada, Consultant; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals Inc., Canadian Collaborative Research Network, Diabetes Canada, GlaxoSmithKline plc., HLS Therapeutics Inc., MDBriefcase, Novo Nordisk Canada Inc., AstraZeneca, Speaker's Bureau; Eisai Inc., Dexcom, Inc., Novo Nordisk Canada Inc. T. Molberg: None. S. Patil: None. R. Siemens: Consultant; Canadian Collaborative Research Network, Novartis Canada, AstraZeneca, Montmed, Sanofi, MDBriefcase, Other Relationship; Abbott Diabetes, Amgen Canada, Boehringer Ingelheim and Eli Lilly Alliance, GlaxoSmithKline plc., HLS Therapeutics, Novo Nordisk, Dexcom Canada, Diabetes Canada. Funding Dexcom Canada

276-OR: Postprandial Hyper- and Hypoglycemia Are Related to Injection Time—An Insulclock Connected Insulin Cap–Based Real-World Study

Background: Reaching the optimal postprandial glucose dynamics is a daily challenge for people with T1D. The study aimed to analyze postprandial hyperglycemia excursion (PHE) and late postprandial hypoglycemia (LPH) risk according to insulin injection time. Methods: Real-world, retrospective study in T1D using multiple daily injection (MDI) insulin. Five hours of paired CGM and automatically tracked insulin injections were collected with the Insulclock® connected cap. Meal events were identified using the ROC detection methodology. Postprandial glucometrics and LPH (glucose <70 mg/dL 2-5 hours after a meal) were evaluated according to insulin injection time. Results: Meal glycemic excursions (n=2784) were analyzed in 82 people. In 63% insulin was injected after the meal started. The best balance between PHE control and LPH risk is obtained by injecting -15 to 0 minutes before meals. Higher PHE (glucose peak-baseline; mg/dL) was observed in delayed injections (mean±SD): Early (-45-15 min) (n=348) 101.8 ± 34.0; Optimal (-15-0 min)(n=612) 98.3± 29.8; Delayed (0-+45 min) (n=1528) 114.8±40,2 (n=348), (p <0.001). LPH risk also increased with delayed injections, n (%): Early 31 (8.9); Optimal 47 (7.7); Delayed 171 (11.2), (p 0.038). Conclusion: The correct timing of insulin injection is crucial to reduce postprandial hyper- and hypoglycemia. Disclosure F.Gomez-peralta: Advisory Panel; Abbott Diabetes, Insulcloud S.L., Speaker's Bureau; A. Menarini Diagnostics, Boehringer Ingelheim and Eli Lilly Alliance, Lilly Diabetes, Novartis, Novo Nordisk. C.Cerqueira: Employee; Insulcloud S.L. J.Pérez: Employee; Insulcloud S.L. L.Ruiz-valdepeñas: Employee; Insulcloud S.L., Stock/Shareholder; Insulcloud S.L. X.Valledor: Employee; Insulcloud S.L. A.Lopez-picado: Employee; Insulcloud S.L.. C.Abreu: Speaker's Bureau; Lilly, Novo Nordisk. E.Fernández-rubio: Speaker's Bureau; Lilly Diabetes, Novo Nordisk, AstraZeneca. P.Pujante alarcón: None. E.García: Advisory Panel; Airliquide, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Boehringer Ingelheim and Eli Lilly Alliance, Novo Nordisk, Sanofi, Airliquide. S.Azriel: Advisory Panel; Boehringer-Ingelheim, Novo Nordisk, Medtronic, Speaker's Bureau; Dexcom, Inc., Lilly Diabetes, AstraZeneca, Sanofi. R.Corcoy: Advisory Panel; Novo Nordisk, Other Relationship; Novo Nordisk, Lilly, Sanofi, Abbott, Speaker's Bureau; Sanofi, Roche Diabetes Care.