Insulet Corporation Research Articles

130-LB: GWave—A Novel Noninvasive Glucose Blood Monitoring Radio Wave–Based Technology

Attempts to achieve an accurate noninvasive glucose monitor to date have been unsuccessful. The GWave device (Hagar, Israel) filters out the “white noise” and uses radiofrequency that detects capillary blood glucose across the physiological range. Measuring blood as opposed to interstitial fluid glucose, allows elimination of the “lag time” and poor accuracy seen in the first day of the current invasive continuous glucose monitors. Calibration of the GWave device is not required. Original data with the first prototype device revealed a 96% and 97% zone A (N = 53) in the Clarke Error Grid (CEG) comparing to venous and capillary blood, respectively. Initial results with second generation devices in non-diabetic subjects compared to capillary blood noted 99% in CEG Zone A and a MARD of 7.1% (N = 120 measurements) (Figure). These data were reproducible with two GWave devices (MARD 5.1%). Combining first and second-generation devices (N = 43 measurements) with a range of glucose of 69 to 400 mg/dL), CEG in Zone A was 98%. Subjects with both type 1 and type 2 diabetes are now being studied to examine accuracy at a wider physiological range of glycemia. Early results from the GWave glucose monitor shows promise as the first noninvasive technology. The current on-going studies will provide more insight for its use in diabetes care. Disclosure I. B. Hirsch: Consultant; Abbott Diabetes, Lifecare, Inc., Hagar, Research Support; Beta Bionics, Inc., Insulet Corporation, Dexcom, Inc. A. Navon: Consultant; GWave. Funding Hagar Technologies

963-P: Near-Infrared Device for Diabetes Screening—ANODE01 Study

Background: Diabetes mellitus (DM) screening is currently complex, inefficient and requires resource-intensive, invasive sampling. Development of affordable, rapid, and precise mass-screening tools is valuable in identifying the millions with undiagnosed DM, especially in lower income countries. Materials and Methods: Accuracy and safety of a novel miniaturized full-spectrum near-infrared (NIR) spectroscopy device intended for DM screening was assessed in a multi-ethnic population with (n=50) or without (n=50) DM. Thirty NIR spectra scans per each middle fingernail and hand were tested for detection of dichotomised DM status based on cut-off values (< HbA1c 6.5% or 6.0 ≥) and specificity (%) of chemometrics outcomes, in assessment of glycated nail keratin versus an HbA1c point-of-care assay as control. Results: The cohort had mean age of 43.6 vs 64.4 years, 42 vs 76% females and 54 vs 68% Caucasians for non-DM and DM participants. Median (IQR) HbA1c % was 5.45 (5.2 - 5.6) and 6.8 (6.3-7.6), respectively. Clinical feasibility for NIR use was confirmed with no adverse device -related events reports for the over 6000 spectral measurements. The NIR-device demonstrated a specificity of 95.2% and 94.1% at HbA1c 6.5 and 6.0% cut-off levels, respectively (Table). Conclusions: Our preliminary results indicate high specificity and potential for clinical implementation of non-invasive NIR technology in detection of those without immediate DM risk. Disclosure P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. D.Lazaro-pacheco: Consultant; Glyconics Ltd. J.E.Salter: None. P.M.Paldanius: Consultant; Glyconics Ltd, Speaker's Bureau; Novartis. Funding Glyconics

109-LB: Quality of Life Benefits for Insulin-Using Adults with Type 2 Diabetes after Six Months of Pump Therapy—A Quasi-experimental Approach

While an increasing number of adults with type 2 diabetes (T2D) on multiple daily insulin injections (MDI) are initiating insulin pump therapy, little is known about how, or if, pump therapy may contribute to quality of life (QoL) gains. Adults with T2D on MDI who contacted Insulet about starting a tubeless insulin pump (Omnipod DASH® Insulin Management System) completed two self-report surveys: one before pump start (baseline) and one 6 months later. The surveys assessed self-reported HbA1c, and a series of QoL measures, including overall well-being (WHO-5), diabetes distress (T2-DDAS Core), diabetes impact (DIDP), and perceived restrictions due to T2D. We compared 6-month outcomes in participants who started and remained on Omnipod DASH vs. those who never started on pump therapy and remained on MDI. Of N=435 who completed the baseline survey, 220 (51%) completed the 6-month survey. Of these, the majority (80%) were current pump users, and 20% remained on MDI. There were no significant differences between pump users and continuing MDI (c-MDI) users in any baseline demographics, HbA1C or QoL measures. At 6 months, pump users evidenced a significantly greater rise than c-MDI users in overall well-being (+8.3 vs. -3.1) and greater drops in diabetes distress (-0.97 vs. -0.30), diabetes impact (-0.29 vs. +0.20), and perceived restrictions, including feeling less limited regarding food and exercise and feeling freer to live life as they might want (in all cases, p < 0.005). Also, both pump and c-MDI groups reported a significant HbA1C improvement from baseline, though the difference between groups was not significant (-1.1% vs -0.9%; p=0.10). In this sample of T2D adults, the introduction of pump therapy was associated with broad improvement in QoL after 6 months, compared to those who were interested in, but never started pump therapy. These results provide initial evidence of significant psychosocial benefits of pump therapy for adults with T2D. Disclosure W. H. Polonsky: Consultant; Abbott Diabetes, Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Insulet Corporation, Intuity Medical, Inc., MannKind Corporation, Provention Bio, Inc., Sanofi-Aventis U. S., Vertex Pharmaceuticals Incorporated. E. C. Soriano: None. Funding Insulet Corporation

1442-P: Composite Scores Using Fasting and Stimulated C-Peptide Are Equivalent and Can Track Beta-Cell Function in New-Onset Type 1 Diabetes

Composite scores using fasting samples have been developed to routinely monitor beta cell mass after islet transplantation in type 1 diabetes (T1D). They may also have utility in new onset or T1D prevention trials as an alternative to mixed meal tolerance tests measuring AUC C-peptide. We examined if a composite score using stimulated C-peptide was equivalent to fasting C-peptide in estimating beta cell mass in new onset T1D and reflected changes in AUC C-peptide over time. BETA-2 (fasting C-peptide, glucose, insulin dose, HbA1c) and BETA-2stim (using C-peptide AUC) were calculated in 1312 individuals from the TOMI dataset (median (IQR) age 16y (12, 24); 42% F). The dataset comprises 3200 participants within 100 days of diagnosis across 22 studies. Studies meeting their primary end point were deemed positive. BETA-2 and BETA-2stim were strongly correlated (R2=0.96, p<0.0001) and showed good agreement using Bland-Altman plots. Both BETA-2 and BETA-2stim showed changes over time which mirrored those for AUC C-peptide, but both composite scores showed differences between active and control participants in positive studies by 3 months while differences in AUC C-peptide were not seen until 6 months (Fig1). Composite scores using fasting C-peptide may provide a simple, sensitive and practical tool to monitor beta cell mass without complex stimulation tests in new onset diabetes. Disclosure A.Carr: None. K.S.Collins: None. S.Karpen: None. E.Atabakhsh: None. A.Lam: None. P.Taylor: None. C.Dayan: Advisory Panel; AstraZeneca, Consultant; Provention Bio, Sanofi, Avotres Inc., Other Relationship; Dompé, Merck & Co., Inc. P.A.Senior: Advisory Panel; Novo Nordisk Canada Inc., Consultant; Novo Nordisk Canada Inc., Bayer Inc., Viatris Inc., Vertex Pharmaceuticals Incorporated, ViaCyte, Inc., Insulet Corporation.

1129-P: Continuous Glucose Monitoring (CGM) Initiation Shortly after Diagnosis Does Not Worsen Psychosocial States

Psychosocial impacts of early CGM initiation in youth soon after T1D diagnosis are underexplored. We report parent/guardian (PG) and youth trends in Patient Reported Outcomes (PROs) for families in the 4T Study 1. Of the 133 participants in the 4T Study 1, 125 PG and 60 youth (≥11 years) were eligible for PROs. PROs included Diabetes Distress Scale - Parent (mean DDS-P) for PG and for youth, Diabetes Distress Scale (DDS sum), PROMIS Pediatric Global Health (PGH sum), Diabetes Technology Attitudes (DTA sum), and CGM Benefits/Burden (BenCGM and BurCGM sum). Kruskal Wallis rank sum test evaluated temporal trends and sociodemographics were evaluated (Numerical: Wilcoxon rank; Categorical: Fisher's if n<5, Chi-squared if n≥5). PROs completion rates were higher for PG than youth at baseline (74% v 59%), 3 months (70% v 53%), and 6 months (66% v 50%). PG DDS-P remained low throughout the study (Table). Youth had favorable psychosocial trends (low DDS and high PGH), and perceived technology positively (high DTA and BenCGM with low BurCGM). Age, DKA at diagnosis, gender, ethnicity, insurance status, and language spoken were not associated with PROs scores in PG or youth. CGM initiation shortly after T1D diagnosis is not associated with poor or worsening PROs for PG and youth. These data suggest that early CGM initiation does not adversely impact psychosocial states for families and youth with T1D. Disclosure A.Addala: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. V.Ritter: None. B.Shaw: None. E.Pang: None. A.L.Cortes-navarro: None. I.Balistreri: None. A.Loyola: None. S.A.Alamarie: None. A.Schneider-utaka: None. Funding National Institutes of Health (K23DK13134201, R18DK122422)

670-P: Improving Diabetes Distress in Emerging Adults with Type 1 Diabetes—The AHEAD Program

Background: The Achieving Health in Emerging Adults with Diabetes (AHEAD) Program is designed to meet the health care transition and psychosocial needs of emerging adults (EA) with type 1 diabetes (T1D). Objective: To evaluate the impact of the AHEAD Program on diabetes distress (DD) in EA with T1D. Methods: DD was evaluated using the Problem Areas in Diabetes-Teen survey (PAID-T). Mixed-effects linear regression with a random effect for individual to account for repeated measures was used to evaluate change in DD over time. Models were adjusted for age, race, ethnicity, technology use, and insurance. We assessed whether improvement varied by age, technology use, insurance, or baseline (BL) elevated DD (PAID-T≥44). Results: Sample included 489 EA with T1D (BL visit: mean age 20.3 years, 52% male, 75% Non-Hispanic White, 26% public insurance, 59% continuous glucose monitor use, 58% insulin pump use, 19% elevated DD). Overall mean PAID-T scores decreased from 31.4 at BL (95% CI: 30.1, 32.8) by 4.6 points (95% CI: -7.4, -1.7; p=0.001) at 2 years (Figure). By 2 years, mean PAID-T scores for patients with elevated DD at BL decreased by 16.2 points (95% CI: -22.9, -9.5; p<0.001) compared to a 3.3 point (95% CI: -6.2, -0.5; p=0.02) decrease in those without elevated DD at BL. PAID-T improvement did not vary by age, technology use, or insurance (all p>0.05). Conclusion: The AHEAD Program offers a promising approach to reduce DD in EA with T1D. Disclosure F.Malik: None. N.M.Ehrhardt: Advisory Panel; Novo Nordisk, Dexcom, Inc., Consultant; Nestlé Health Science. K.Hoch: None. K.Weaver: None. I.B.Hirsch: Consultant; Abbott Diabetes, Lifecare, Inc., Hagar, Research Support; Beta Bionics, Inc., Insulet Corporation, Dexcom, Inc. C.Pihoker: None. A.J.Roberts: None. C.Taplin: Stock/Shareholder; Quest Diagnostics. S.J.Lowry: None. J.P.Yi-frazier: None. A.Moss: Other Relationship; American Diabetes Association. A.Huang: None. Funding Forest Foundation; Sequoia Foundation

771-P: Tirzepatide Reduces HbA1c and Body Weight Significantly More than Placebo or Semaglutide Irrespective of Baseline Beta-Cell Function—Post Hoc Analysis from SURPASS-1 and SURPASS-2

Tirzepatide (TZP), a once-weekly GIP/GLP-1 receptor agonist, achieved significantly greater HbA1c and body weight (BW) reductions with all doses (5, 10, 15 mg) vs placebo (SURPASS-1 [S-1]) and semaglutide (SEMA) 1 mg (SURPASS-2 [S-2]) in randomized Phase 3 trials in people with type 2 diabetes controlled by diet and exercise (S-1) or metformin (S-2). Exploratory post hoc analyses examined changes from baseline in HbA1c and BW in these studies at 40 weeks across HOMA2-B (C-peptide) and HOMA2-IR (insulin) quartiles (Q) from low (lower beta-cell function/insulin resistance) (Q1) to high (Q4) as assessed by mixed model repeated measures (MMRM). HbA1c reductions were greater with all TZP doses than placebo or SEMA within each HOMA2-B and HOMA2-IR baseline Q. HbA1c reductions were largest in people within HOMA-2B Q1, yet similar across all HOMA2-IR Qs (Fig). BW reductions were greater across Qs with all TZP doses (ranging from 6%-14%) than placebo (up to 2%) or SEMA (up to 7%). TZP was more efficacious than placebo or SEMA in reducing HbA1c and BW across a spectrum of pancreatic beta-cell function, notably achieving greater glycemic improvement in people with markers of diminished pancreatic beta cell function at baseline. Disclosure J.M.Maldonado: Employee; Eli Lilly and Company. C.De block: Advisory Panel; Abbott Diagnostics, Indigo Diabetes, Insulet Corporation, Eli Lilly and Company, Novo Nordisk, Research Support; Boehringer-Ingelheim, AstraZeneca, Indigo Diabetes, Eli Lilly and Company, Speaker's Bureau; Novo Nordisk. J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. C.Lee: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. K.Brown: Employee; Eli Lilly and Company. H.Wang: None. M.K.Thomas: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

278-OR: Impact of a Parameter Change in DBLG1 System

In DBLG1 System, multiple parameters can be customized. This study aims at analyzing the impact of a change of the normoglycemia aggressiveness (NA), the hyperglycemia aggressiveness (HA) and the glucose target (GT) on the glycemic control of T1D patients. Data is collected from 5977 adult patients who gave their consent (3/2021 to 11/2022). Periods of 14 days before and after a single parameter change are collected. Conditions of 70% of data availability and of 75% of time spent in closed loop are requested for each period. The time in range 70-180 mg/dL (TIR), the time below range 70 mg/dL (TBR), the mean sensor glucose (MG), the coefficient of variation (CV) and the mean daily insulin dose (MDI) of the two periods are compared for each parameter using a Wilcoxon Signed-Rank test. Control for the multiple tests is done using the Benjamini-Hochberg procedure. The size effect is inferred using Cohen’s d. The results are summarized in the table below. On average, an increase of HA or NA improves the TIR and reduces the MG. The TBR appears to increase when the HA is increased and to decrease when HA or NA are reduced. A decrease of the GT increases TIR, TBR and CV, and decreases MG, conversely an increase of the GT decreases TIR, TBR and CV, and increases MG. The size effect is small. The impact on MDI is small or not significant. The most impactful parameter seems to be the GT which affects the MG proportionally. HA and NA had a lower than expected impact. Disclosure A.Adenis: Employee; Diabeloop SA. A.Vesin: Employee; Diabeloop SA. H.M.Romero-ugalde: Employee; Diabeloop SA. M.Louis: Employee; Diabeloop SA. C.V.Huber: Employee; Diabeloop SA. L.Pou: None. Y.Tourki: Employee; Diabeloop SA. E.Huneker: Employee; Diabeloop SA. P.Y.Benhamou: Advisory Panel; Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Consultant; Dexcom, Inc., Employee; Diabeloop SA.

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

714-P: Health-Related Quality of Life (HRQOL) in Young Adults with T1D

Challenges of young adulthood with T1D include transitioning to adult care, increased self-management responsibility, and developmental changes. Recognizing patterns of HRQOL across demographically and clinically diverse young adults with T1D may help identify who needs additional support as they transfer to adult healthcare. We hypothesized that young adults from racially, ethnically, and socioeconomically marginalized groups and those with higher A1c would report lower HRQOL. At baseline of a behavioral RCT (≤2 months after last pediatric T1D clinic visit), 82 young adults (Mage=19.9±1.3, MA1c=8.9±2.0%) self-reported demographics and HRQOL; A1c was analyzed via point of care or dried blood spot. ANOVAs, t-tests, and a regression model compare HRQOL by demographic (gender, race/ethnicity, insurance, school enrollment) and clinical variables (device use, A1c). As detailed in the table, HRQOL was significantly higher for participants in school and men (p<.01). Pump-users reported higher HRQOL on the “Handling Diabetes Well” and “Peer Relationships” subscales (p<.05). Regression analyses yielded gender and school enrollment as significant predictors of HRQOL (p<.01). Variability across groups of young adults with T1D suggests monitoring HRQOL may be helpful to identify T1D-specific psychosocial needs during this transition. Patterns suggest women and those not in school may benefit from additional support. Disclosure M.Baudino: None. M.E.Hilliard: None. S.A.Carreon: None. R.Streisand: None. T.S.Tang: Research Support; Juvenile Diabetes Research Foundation (JDRF), Speaker's Bureau; Abbott Diabetes, Insulet Corporation. S.Lyons: None. S.Mckay: None. B.J.Anderson-thomas: None. C.G.Minard: None. A.Butler: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK119246 to M.E.H.)

1127-P: 4T Study—Early CGM Initiation and Tighter Glucose Targets Improves A1C in Youth with T1D

Methods to optimize care after T1D diagnosis are needed. We hypothesized lowering A1c targets to <7% would further lower A1c in the 4T Study in which CGM with asynchronous remote patient monitoring (RPM) is initiated after T1D diagnosis. All youth with newly diagnosed T1D (June 2020-March 2022) were offered CGM and RPM after diagnosis (Study 1, n=133). We compared A1c at 1-year in Study 1 with the 4T Pilot (2018-20) and Historical cohorts (2014-16). We visualized population-based A1c trajectories using locally estimated scatter plot smoothing (Fig) and % meeting A1c targets. Mean A1c at diagnosis was similar in Pilot (12.2%±2.1%) and Study 1 (12.2±2.4%) and higher than the Historical cohort (10.7±2.5%). In Study 1, the median age of diagnosis was 10.8 years, 55% male, 40% non-Hispanic White, and 38% with public insurance. CGM initiation occurred within 30 days of diagnosis in 98.5%. At 3, 6, 9, and 12 months post-diagnosis, the Study 1 cohort had LOESS-based mean A1c differences of 0.16%, 0.24%, 0.31%, and 0.58% lower than the Pilot and 0.04%, 0.60%, 0.83%, and 1.06% lower than the Historical cohort. A1c target <7% was met by 61% of youth in Study 1, 51% in the Pilot and 28% in the Historical cohort. Time <70mg/dl was ≤2.3%. The 4T program which emphasizes early CGM initiation, RPM, tighter glucose targets, and consistent team messaging was associated with lower A1c. These data support implementation of the 4T program in youth with T1D. Disclosure P.Prahalad: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. 4t study group: n/a. V.Ding: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. A.Addala: None. F.K.Bishop: None. D.Scheinker: None. R.Johari: None. M.Desai: None. K.K.Hood: Consultant; Cecelia Health. Funding National Institutes of Health (P30DK116074), (R18DK122422 to D.M.M.); Dexcom, Inc.; Lucile Packard Children’s Hospital Auxiliaries Endowment; Stanford Maternal and Child Health Research Institute

392-P: Optimizing Duration and Threshold of Sensor Glucose for Identifying Symptomatic Hypoglycemia in Insulin-Treated Diabetes—Hypo-METRICS Study

Many episodes of hypoglycemia defined by the ATTD consensus are asymptomatic. We investigated if optimizing the glucose threshold and duration for sensor detected hypoglycemia (SDH) improves precision and sensitivity for identifying symptomatic hypoglycaemia from continuous glucose monitoring (CGM) data. We analysed 10 weeks of blinded CGM (Libre 2) and FitBit data from 435 participants [217 type 1, 218 type 2] with intact hypoglycemic awareness (Gold score <4). They self-reported symptomatic hypoglycemia on the Hypo-METRICS smartphone app. We used particle Markov chain Monte Carlo optimisation to generate the threshold and duration of SDH that maximizes detection of symptomatic hypoglycemia across our population and assessed impact of sleep status and diabetes type. The optimized threshold and duration were 70mg/dl for 27 min, with 2% gain of precision but 8% loss of sensitivity vs level 1 SDH (70mg/dl >15 min). Both level 1 SDH and our optimized definition had 3-fold increased sensitivity vs level 2 SDH (54mg/dl >15 min), with minimal loss of precision (Table). Our data validate ATTD level 1 hypoglycemia. Overall precision for detection of symptomatic hypoglycemia remains low despite optimization. Disclosure P.Divilly: None. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. Z.Mahmoudi: Employee; Novo Nordisk. G.Martine-edith: Other Relationship; Novo Nordisk A/S. D.Boiroux: Employee; Novo Nordisk A/S. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. M.Gomes: Employee; Novo Nordisk A/S. A.A.Vaag: None. B.E.De galan: Research Support; Novo Nordisk. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)

775-P: Predictors of Glycemic Control in Older People with Type 2 Diabetes Treated with iGlarLixi—A Pooled Analysis

For older adults (>65 years) with type 2 diabetes (T2D), iGlarLixi can be a simple and effective therapeutic option. We aimed to identify factors associated with achieving target HbA1c <7% and derived Time in Range (dTIR) ≥70% in this population in response to once daily iGlarLixi. This post-hoc, pooled analysis of 4 randomized trials included 465 people advancing from oral (LixiLan-O), GLP-1 RA (LixiLan-G), or insulin (LixiLan-L; SoliMix) therapies to iGlarLixi for 26 or 30 weeks. HbA1c and dTIR responses were assessed at baseline (BL) and end of treatment (EOT) for each participant and classified as attained (<7.0% or dTIR ≥70%) or unattained (≥7.0% or <70%). dTIR was calculated from 7-point self-monitored plasma glucose profiles from the three LixiLan studies (LixiLan-O. G, and L). Potential predictive factors were analyzed by univariable and multivariable stepwise logistic regression. Overall, 60% of participants achieved HbA1c <7.0% and 87.5% achieved dTIR ≥70%. Predictors of attained HbA1c response (p<0.05) included lower BL HbA1c and lower BL insulin dose. Predictor of attained dTIR response (p<0.05) was higher BL fasting plasma glucose (FPG; Table), while sex, T2D duration, and obesity had no predictive value. To conclude, in older people with T2D treated with iGlarLixi, consideration of BL HbA1c and FPG, as well as BL insulin dose may improve achieving individualized glycemic targets. Disclosure M.Munshi: Consultant; Sanofi. R.Ritzel: Consultant; Novo Nordisk, Sanofi, Speaker's Bureau; Novo Nordisk, Sanofi, Pfizer Inc., Merck Sharp & Dohme Corp., Lilly. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. I.Hramiak: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi, Speaker's Bureau; Canadian Medical & Surgical Knowledge Translation Research Group (CMS), Insulet Corporation, Medtronic, Merck & Co., Inc., Bayer Inc. F.Lauand: Employee; Sanofi. L.Melas-melt: None. E.Souhami: Employee; Sanofi, Stock/Shareholder; 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

929-P: Adaptive Therapy Settings—Qualitative Insights from People with Type 1 Diabetes Using Multiple Daily Injections Transitioning to an Automated System

Thirty adults with T1D using multiple daily injections (MDI) participated in a prospective single center 13-week study using an advanced hybrid closed-loop (HCL) system (Control-IQ Technology, Tandem Diabetes Care). In addition to advanced HCL, the system included a novel algorithm to accurately initialize insulin delivery settings and adapt them over time. Adaptation recommendations were generated by analyzing uploaded pump data and sent to study providers for safety review. Study results showed reduced hypoglycemia and immediate and sustained improvement in time in range. Here we report on six semi-structured 1-on-1 interviews with participants completed at end of study. Each interview lasted ~30 minutes using a script of open-ended questions to gather feedback and reactions to the use of advanced HCL as well as trust and confidence in the automated therapy settings recommendations. All participants reported a positive experience, particularly due to improved glucose control, relief from the burden of managing glucose, improved sleep, and overall better quality of life. Participants were generally confident with the settings that were recommended to them, and while 2 of the 6 participants questioned some therapy suggestions, they were comfortable enough with the recommended changes and felt in the end they had well-tuned therapy settings. One participant expressed hesitation about automating the settings, but this was ameliorated by education about how the algorithm worked and knowing how to stop the automated updates if needed. Two participants mentioned struggling with hypoglycemia due to exercise. All 6 participants wanted to transition from MDI to pump therapy after completing the trial. These qualitative insights reaffirm that algorithm driven workflows must result in outcomes that instill user trust in the system. Disclosure S.Habif: Employee; Tandem Diabetes Care, Inc. J.E.Pinsker: Employee; Tandem Diabetes Care, Inc. L.H.Messer: Advisory Panel; Lilly, Consultant; Dexcom, Inc., Capillary Biomedical, Inc., Employee; Tandem Diabetes Care, Inc., Research Support; Beta Bionics, Inc., Medtronic, Insulet Corporation. E.Schertz: Employee; Tandem Diabetes Care, Inc. A.Trahan: Employee; Tandem Diabetes Care, Inc. A.Constantin: Employee; Tandem Diabetes Care, Inc. A.Wheatcroft: Employee; Tandem Diabetes Care, Inc. K.N.White: Employee; Tandem Diabetes Care, Inc. N.J.Piquette: Employee; Tandem Diabetes Care, Inc. K.Carmelo: Employee; Tandem Diabetes Care, Inc. R.Katchalski: Employee; Tandem Diabetes Care, Inc. Funding Tandem Diabetes Care, Inc.

650-P: Qualitative Findings from D-COPES Emerging Adult Peer Connectors Pilot Study

Background: Emerging adults with Type 1 Diabetes (T1D) undergo transitions that necessitate a strong social support system. The Diabetes Connecting Online Peers To Enhance Support (D-COPES) pilot intervention was designed by a multidisciplinary group of researchers and people with T1D to engage emerging adults in small-group discourse with “peer connectors” through virtual biweekly sessions and in-between text communication. The purpose of this study was to determine the peer connector's acceptability of the D-COPES intervention. Methods: Five peer connectors with T1D (age 18-30) were trained to deliver D-COPES via 6 biweekly 1-hour group sessions, with text messaging between. Peer connector guides (n=24) included topic-specific discussion questions and resources. Topics addressed included disclosing T1D to others, diabetes burnout, and relationships with food. Semi-structured interviews with peer connectors were conducted at the end of the 12-week pilot study to learn about the acceptability of training, group dynamics, resources, and any areas for improvement. Data were transcribed and analyzed using a qualitative descriptive approach. Results: Key themes included 1) benefits of training, suggestion to include 1 additional training meeting; 2) variety of peer connector guides, suggestion for additional topics (e.g., menstruation, intimate relationships); 3) positive group dynamics resulting from group matching and desire to stay connected after the intervention, though group size could be increased; and 4) peer connector benefits of increased knowledge, social support and opportunity to pay it forward. Conclusion: D-COPES pilot was acceptable and will be revised (e.g., increased training and materials, larger groups) to be evaluated in a fully powered trial. Disclosure N.A.Allen: Consultant; Diathrive Health, Dexcom, Inc. J.E.Blanchette: Advisory Panel; LifeScan Diabetes Institute, Cardinal Health/Edgepark, Provention Bio, Inc., Board Member; JDRF, Consultant; WellDoc, Other Relationship; Tandem Diabetes Care, Inc., Research Support; Association of Diabetes Care & Education Specialists, Speaker's Bureau; Insulet Corporation. N.Shah: None. B.Gonzales: None. A.Moraitis: None. M.E.Hilliard: None. M.L.Litchman: None. Funding Franklin S. Ivory and Rachael C. Ivory Foundation

787-P: Glucose and Weight Outcomes Associated with Oral Semaglutide in the Real-World—Initial Results from the Association of British Clinical Diabetologists’ (ABCD) Audit

Semaglutide is the first glucagon like peptide-1 receptor agonist (GLP1-RA) available in an oral preparation. Weight and HbA1c outcomes with injectable semaglutide in the real-world are well established. The aim of this analysis is to assess weight and HbA1c response to oral semaglutide. Methods: Data were extracted from the secure online ABCD audit tool. Individuals were included if baseline and follow-up weight and/or HbA1c data were available. Change in HbA1c, body mass index (BMI) and weight from baseline was assessed using a multivariate linear regression model and change in the numbers achieving an endpoint HbA1c≤7.5% [58mmol/mol] were assessed using Chi2 tests in Stata 16. Results: Data were available for 350 individuals with baseline mean±SD HbA1c 9.2%±1.7 [76.6mmol/mol±18.3], weight 101.8kg±21.9, BMI 34.3kg/m2±6.9, median diabetes duration 11years (IQR 6-16) and age 59 years (IQR 51-68); 63.0% were male and 79.7% were white. Median follow-up was 0.5years (IQR 0.3-0.8). Significant reductions in HbA1c of 0.7% (95%CI 0.4, 0.9; P<0.001) [7.4mmol/mol; 95%CI 4.7, 10.0; P<0.001] were observed. Weight decreased by 3.3kg (95%CI 2.3, 4.3; P<0.001) and BMI fell by 1.1kg/m2 (95%CI 0.6, 1.6; P<0.001). Twice as many people achieved a HbA1c≤7.5% at follow-up compared to baseline (28.6% [52/182] vs 14.3% [26/182]) - this change was statistically significant (P<0.001). Conclusion: In the real-world, oral semaglutide is associated with statistically significant and clinically meaningful reductions in HbA1c, weight and BMI. The numbers achieving a HbA1c≤7.5% also increased. In the light of this, further data collection and analysis should be undertaken, including comparisons between oral and injectable GLP1-RAs and analysis of switches between them Disclosure T.S.J.Crabtree: Speaker's Bureau; Abbott Diabetes, Novo Nordisk, Lilly, Sanofi, Insulet Corporation. K.Adamson: None. S.Krishnasamy: Other Relationship; Novo Nordisk, Sanofi, Eli Lilly and Company, AstraZeneca. M.Khine: None. P.De: Speaker's Bureau; Novo Nordisk, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Takeda Canada, Daiichi Sankyo, Napp Pharmaceuticals Limited, Lilly Diabetes. R.Peter: None. R.E.Ryder: Other Relationship; Novo Nordisk, Speaker's Bureau; GI Dynamics, BioQuest. Funding Novo Nordisk

277-LB: Weight Cycling Is Associated with ICU Admission and Mechanical Ventilation in Adults with Diabetes Hospitalized with COVID-19

Weight variability in diabetes is an emerging risk factor for macrovascular complications and mortality, potentially via increased inflammation. We examined the impact of pre-admission weight cycling (WC) on COVID-19-related outcomes, including in-hospital mortality, ICU admission, and mechanical ventilation (MV), using a large multicenter cohort. This study included 277 adults with diabetes hospitalized with COVID-19 (March 2020-February 2021) at 5 university hospitals in the eastern US (COVIDEastDM Consortium) with body weight measurements at 0, 6, and 12 months before admission. Weight change was considered significant if it exceeded 5% in each 6-month interval. The cohort was grouped into four weight categories: unchanged (n=57; reference group), weight loss (WL; n=88), weight gain (WG; n=50) and WC (n=32), and was 54.6% male, 58.6% White, 24.2% Black, 18.5% Hispanic, with mean (SD) age 65.1 (12.6) years and HbA1c 7.7 (2.0)%. During hospitalization, 41.9% subjects were admitted to the ICU, 25.1% received MV, and 15.0% died. Age was the strongest risk factor for mortality (OR = 1.08 [95% CI: 1.03-1.13), and the presence of pre-existing comorbidity for both ICU admission (OR = 2.58 [1.13-5.90]) and MV (OR = 3.89 [1.30-11.64]). In an adjusted model, WC, but not WL or WG, was associated with ICU admission (OR = 3.09 [1.11-8.59]) and MV ((OR = 4.59 [1.48-14.19]), but not with mortality (OR = 3.19 [0.76-13.32]). The glycemic gap, shown previously to be associated with increased MV and mortality, did not change the relationship between WC and outcomes. The WC group trended toward higher peak ESR (94.3±23.1 ml/h vs. 62.2±33.5 ml/h, P=0.044) and hsCRP levels (150.0±133.9 mg/L vs. 104.1±105.3 mg/L, P=0.142). Conclusion: Weight cycling is associated with ICU admission and mechanical ventilation in adults with diabetes and COVID-19. Our findings identify a unique vulnerability of individuals with diabetes and recent weight cycling. Disclosure Y. Kang: None. 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. M. E. Mcdonnell: None. D. C. Simonson: Stock/Shareholder; Phase V Technologies, Inc., GI Windows. A. S. Chaugule: None. R. K. Garg: None. G. Gopalakrishnan: Research Support; Spruce Biosciences, Sparrow Pharmaceuticals Inc, Medtronic. K. Howard: None. J. Lebastchi: None. J. Mitri: Other Relationship; Novo Nordisk, Research Support; Kowa Company, Ltd. N. E. Palermo: Research Support; Dexcom, Inc.

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

390-P: Improving Quality of Life and Self-Efficacy through a Hypoglycemia Management Program—The HARPdoc Randomised Controlled Trial

Background: A significant minority (15-18%) of adults with type 1 diabetes (T1D) continue to experience problematic hypoglycemia despite access to structured education in flexible insulin therapy and advanced technologies. Many have impaired awareness of hypoglycemia, now recognised to be associated with significant mental health burden. The HARPdoc trial (Hypoglycemia Awareness Restoration Program for people with problematic hypoglycemia Despite Optimised Care) showed that a group programme focused on cognitions and motivation improved scores for diabetes distress, anxiety and depression compared to BGAT (blood glucose awareness training, which addresses education and behaviours), with similarly reduced rates of severe hypoglycaemia. Methods: This exploratory study addresses the further impact of these programmes on quality of life and mental health. Quality of life was measured at baseline with EQ-5D-5L and it and service use (Adult Service Utilisation Schedule) were measured at 12 and 24 months after randomised participation to either HARPdoc or BGAT. Results: Mean EQ-5D scores rose by 14%, +0.1 HRQoL utility score (HUS), over 24 months in HARPdoc and fell by 1%, -0.007 HUS in BGAT. Use of mental health services after HARPdoc or BGAT was 26 vs 56 contacts with a psychiatrist, psychologist or counsellor in months 0-12 and 1 vs 17 contacts in months 13 - 24 respectively. Conclusions: We conclude that HARPdoc reduces previously treatment-resistant severe hypoglycaemia in adults with type 1 diabetes but also enhances quality of life, whilst reducing use of mental health services. We hypothesise that the psychosocial aspects of HARPdoc increase self-efficacy and coping skills, thereby reducing disease burden and the need to access general and mental healthcare provision. Disclosure S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. E.Toschi: Advisory Panel; Eli Lilly and Company. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.A.Stadler: None. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. N.De zoysa: None. Funding JDRF (4-SRA-2017-266-M-N); National Institute of Health Research UK