Omada Health Research Articles

THU296 Effect Of Tirzepatide In GADA-positive Individuals With T2D: A Post Hoc Analysis Of The SURPASS 2-5 Trials

Abstract Disclosure: A.L. Peters: Advisory Board Member; Self; Abbott Diabetes Care, Eli Lilly & Company, Medscape, Novo Nordisk, Zealand. Grant Recipient; Self; Dexcom, Insulet Corporation. Stock Owner; Self; Omada Health, Teladoc. Other; Self; Abbott Diabetes Care. R. Buzzetti: Consulting Fee; Self; Sanofi, Novo Nordisk, Eli Lilly & Company. Speaker; Self; AstraZeneca, Abbott Laboratories. C.J. Lee: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. I. Pavo: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. M. Liu: Other; Self; Eli Lilly & Company. J.S. Paik: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. Tirzepatide, a novel once weekly GIP and GLP-1 receptor agonist, is approved for treatment of type 2 diabetes (T2D). People with T2D and positive glutamic acid decarboxylase autoantibodies (GADA), which is also referred to as latent autoimmune diabetes in adults (LADA), may often remain undetected and may be associated with more rapid progression to insulin therapy. The diagnosis is primarily made by the presence of GADA in patients previously diagnosed with T2D. The aim of this post hoc analysis was to evaluate the effect of tirzepatide on hemoglobin A1c (HbA1c) levels in people with T2D who were GADA-positive versus GADA-negative from the Phase 3 SURPASS clinical trial program. Tirzepatide-treated patients from SURPASS 2-5 studies were included in this analysis. Patients who had GADA concentrations ≥5 IU/mL were categorized as GADA-positive (ELISA, RSR Ltd., Cardiff, UK). Change from baseline in HbA1c at 40/42 weeks was assessed in GADA-positive vs GADA-negative patients using mixed model repeated measures from the efficacy analysis set, adjusting for baseline covariates including study, sex, HbA1c, and body mass index (BMI). All randomized patients who took at least one dose of study drug, excluding patients who discontinued study drug due to inadvertent enrollment and excluding data after initiation of rescue medication or premature discontinuation of study drug, were included in this analysis. Of the 3827 tirzepatide-treated patients who were tested for GADA, 3671 (95.9%) were GADA-negative, 120 (3.2%) were GADA-positive, and 36 (0.9%) were “no GADA status”. Baseline parameters were similar between the groups, except for baseline BMI and serum triglyceride concentration which were slightly lower in GADA-positive patients compared to GADA-negative patients (mean baseline BMI [SD] 32.2 [6.1] vs 33.6 [6.3] kg/m2, mean triglycerides 169.2 [101.3] vs 188.1 [131.4] mg/dL). At 40/42 weeks, both groups achieved significant reductions in HbA1c (-2.11% vs -2.32%; p<0.001 for both groups) and body weight (-9.2 kg vs -9.6 kg; p<0.001 for both groups), for GADA-positive vs. GADA-negative patients, respectively. Reductions in HbA1c were slightly greater in GADA-negative patients (estimated treatment differences [95% confidence interval]: 0.21% [0.03, 0.39]; p=0.024), whereas reductions in body weight did not significantly differ between groups (0.38 kg [-0.99, 1.75]; p=0.588). These data demonstrate that tirzepatide was effective in reducing HbA1c and body weight, irrespective of GADA status in adults with T2D, thus suggesting that tirzepatide may be effective to improve glycemic control in GADA-positive individuals. Future studies could help elucidate the long-term impact of GADA positivity on the progression of diabetes. Presentation: Thursday, June 15, 2023

836-P: Glucose-Dependent Insulin Production and Insulin-Independence in Type 1 Diabetes from Stem Cell–Derived, Fully Differentiated Islet Cells—Updated Data from the VX-880 Clinical Trial

VX-880 is an investigational allogeneic stem cell-derived, fully differentiated, pancreatic islet cell replacement therapy being evaluated in a phase 1/2 clinical trial in patients with T1D and impaired hypoglycemic awareness and severe hypoglycemia. The phase 1/2 trial has three parts: Part A in which 2 patients are enrolled sequentially and receive half the target dose (presented at ADA 2022), Part B in which 5 patients are enrolled sequentially and receive the target (full) dose, and Part C where 10 patients are enrolled concurrently and receive the target (full) dose. The first two patients infused with VX-880 at half the target dose (in Part A) had restored insulin production and glucose control. One of these patients achieved and has maintained insulin independence, defined as at least one week off exogenous insulin, HbA1C ≤7%, post-prandial serum glucose at 90 minutes ≤180 mg/dL, fasting serum glucose ≤126 mg/dL, and fasting or stimulated C-peptide ≥166 pmol/L (latter 3 measured during mixed-meal tolerance test). The safety profile was consistent with the immunosuppressive regimen used in the study and the perioperative period. Part B is now fully enrolled and multiple patients have been dosed with the full (target) dose. Longer-term data on both patients in Part A and new data on patients who received the full (target) dose in Part B will be provided in the presentation. These results are the first from a clinical trial of allogeneic, fully differentiated, insulin producing, stem cell-derived islets which has demonstrated the potential to restore insulin production and glycemic control and provide insulin independence in patients with T1D. Disclosure T.W.Reichman: Consultant; Sernova, Corp., Research Support; Vertex Pharmaceuticals Incorporated. J.L.Shih: Employee; Vertex Pharmaceuticals Incorporated. C.Wang: Employee; Vertex Pharmaceuticals Incorporated. D.Melton: None. F.Pagliuca: Employee; Vertex Pharmaceuticals Incorporated, Stock/Shareholder; Vertex Pharmaceuticals Incorporated. B.Sanna: Employee; Vertex Pharmaceuticals Incorporated. L.S.Kean: Advisory Panel; HiFiBio, Mammoth Biosciences, Consultant; Vertex Pharmaceuticals Incorporated, Other Relationship; Bristol-Myers Squibb Company, Research Support; Bristol-Myers Squibb Company, Adaptive Biotechnologies, Merck & Co., Inc., Tessera, Novartis. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. P.Witkowski: Advisory Panel; Vertex Pharmaceuticals Incorporated, Novartis. M.R.Rickels: Consultant; Sernova, Corp., Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Dompé. C.Ricordi: Advisory Panel; Vertex Pharmaceuticals Incorporated. A.Naji: None. J.F.Markmann: None. B.A.Perkins: Advisory Panel; Dexcom, Inc., Insulet Corporation, Novo Nordisk, Sanofi, Vertex Pharmaceuticals Incorporated, Other Relationship; Abbott, Medtronic, Sanofi, Research Support; Novo Nordisk, Bank of Montreal (BMO). M.Wijkstrom: None. S.Paraskevas: None. B.Bruinsma: Employee; Vertex Pharmaceuticals Incorporated. G.Marigowda: Employee; Vertex Pharmaceuticals Incorporated.

161-OR: Validation of the Short Type 1 Diabetes Stigma Assessment Scale (DSAS-1) and Its Association with Affective States, Diabetes Distress, Diabetes Self-Management, and Glycemic Control

Introduction: We validated an 8-item version of the DSAS-1 and examined its relationship with momentary ratings of affective states, diabetes distress, diabetes self-care, and glycemic control over time. Methods: We recruited 184 adults with T1D from Los Angeles, California, and the Bronx, New York. Participants completed a short version of the DSAS-1, other validated questionnaires, and 10-14 days of intensive longitudinal data collection using blinded continuous glucose monitoring and Ecological Momentary Assessment (EMA) via smartphone. Psychometric validation included exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and internal consistency reliability assessment. We used Spearman's rho correlations to explore the convergent validity using EMA data. Results: EFA indicated an acceptable fit of a 3-factor model (Bartlett's = 0.000; KMO = 0.774). This was corroborated with CFA, which demonstrated a reasonable three-factor fit (chi-squared = 36.44; RMSEA = 0.079; SRMR = 0.036; TLI = 0.985; CFI = 0.991); less so for a single-factor model. Satisfactory convergent and discriminant validity was demonstrated. The DSAS-1 was significantly correlated with momentary ratings of negative emotions (0.30, p = <0.001), diabetes distress (0.32, p = <0.001), insulin regimen adherence (-0.20, p = 0.007), diabetes self-care (-0.24, p = 0.002), mean blood glucose (0.20, p = 0.008) and time in range (-0.21, p = 0.006), but was not significantly associated with positive emotions. Conclusions: The 8-item DSAS-1 is a valid and reliable measure of T1D stigma. Convergent validity confirms the importance of diabetes-related stigma in relation to psychosocial and blood glucose outcomes, and underscores the need for further examination of stigma in diabetes, which may be facilitated by this shorter scale. Disclosure G.Crespo-ramos: None. H.Jin: None. E.Pyatak: Research Support; Abbott Diabetes. D.Spruijt-metz: None. J.S.Gonzalez: Consultant; Virta Health Corp. C.J.Hoogendoorn: None. S.Schneider: None. R.Hernandez: None. L.T.Pham: None. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. V.F.Ruelas: None. J.P.Crandall: Research Support; Abbott. P.Lee: None. Funding National Institutes of Health (R01DK121298)

897-P: Real-World Glycemic Outcomes of >400 Adults with Type 2 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management

The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system approved for use in people with type 1 diabetes ages 2 and up and was recently evaluated in adults with type 2 diabetes (T2D) during an 8-week outpatient feasibility study. The System allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments and enables automatic upload of data for all users, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with T2D aged ≥18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 417 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged 18 to 49y (n=108), 50 to 64y (n=156), and ≥65y (n=153), were available at the time of analysis. Users were aged mean±SD 57.9±12.8y with median 131 days of system use. Outcomes are shown in the Table. Median time in target range (70-180mg/dL) was 68.7%, 71.7%, and 74.0% for each age group, respectively. Time spent in hypoglycemia (<70mg/dL) was low (median 0.3%) in each age group. These data are the first to provide valuable insights to the highly favorable impact of AID on real-world glycemic outcomes among adults with T2D using the Omnipod 5 System. Disclosure A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. F.J.Pasquel: Consultant; Dexcom, Inc., Medscape, Research Support; Dexcom, Inc., Ideal Medical Technologies. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation. Funding Insulet Corporation

641-P: Diabetes Distress and Blood Glucose in the Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) Study—Which Comes First, the Chicken or the Egg?

Introduction: Diabetes Distress (DD) has been consistently linked with suboptimal blood glucose in T1D. However, prior studies have rarely used methods that can adequately evaluate the directionality of this relationship. This study paired ecological momentary assessment (EMA) and continuous glucose monitoring (CGM) to examine the relative strength of lagged effects of blood glucose (BG) on DD and vice versa. Methods: FEEL-T1D participants (N=182, 40±14 yrs, 54% women, 41% Latino, 29% White, 15% Black) wore blinded CGM for 10-14 days and completed 5-6 smartphone EMA surveys per day. Using multilevel cross-lagged panel modeling, we evaluated within-person lagged effects from momentary ratings of DD (scale: 0-100) to various BG metrics (BG average, Time in Range [TIR, 70-180 mg/dL], % time 181-250 mg/dL, % time > 250 mg/dL, % time 54-69 mg/dL, % time <54 mg/dL, and coefficient of variation [CV]) over the subsequent 3 hours and between 3 hours of BG metrics and subsequent DD ratings. Results: Unstandardized within-person parameter estimates and 95% confidence intervals for lagged effects of BG on subsequent DD ratings were significant for average BG (0.01; 0.01, 0.02), TIR (−0.01; −0.02, −0.004), % time 181-250 mg/dL (0.01; 0.001, 0.02), and % time > 250 mg/dL (0.02; 0.01, 0.04), but not for CV or % time in low BG; as expected, higher BG predicted subsequently higher DD. Lagged effects of DD ratings on subsequent 3-hour BG metrics were only significant for % time 54-69 mg/dL (−0.02; −0.04, −0.002); unexpectedly, DD was predictive of less % time with low BG. Conclusion: These novel findings reveal that the experience of DD is significantly influenced by preceding suboptimal BG levels, particularly high BG, even when individuals are blinded to their BG values. Results suggest that interventions that improve BG levels may reduce DD but do not support the hypothesis that reductions in DD will conversely lead to improvements in BG. Disclosure J.S.Gonzalez: Consultant; Virta Health Corp. P.Lee: None. S.Schneider: None. E.Pyatak: Research Support; Abbott Diabetes. R.Hernandez: None. D.Spruijt-metz: None. C.J.Hoogendoorn: None. G.Crespo-ramos: None. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. J.P.Crandall: Research Support; Abbott Diabetes. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. L.T.Pham: None. Funding National Institutes of Health (R01DK121298, P30DK111022)

663-P: Dynamic Real-Time Relationships among Glucose and Cognitive Performance in Diverse Adults with T1D

Introduction: Blood glucose (BG) regulation is linked to cognitive performance among people with diabetes. Most studies are cross-sectional and limited to adults with T2D. Pairing continuous glucose monitoring (CGM) with ambulatory cognitive tests, we examined real-time bidirectional associations between BG and cognition in everyday life among adults with T1D. Methods: Participants wore a blinded CGM for 10-14 days and completed ambulatory cognitive tests 5-6 times daily. Using dynamic structural equation modeling, we evaluated within-person bidirectional relationships between BG and cognition over sequential 3-hr periods. BG metrics included mean BG, time in range (TIR; 70-180 mg/dL), % time in low (50-69 mg/dL), high (181-250 mg/dL) and very high BG (>250 mg/dL), and coefficient of variation (CV). Cognitive variables included processing speed and sustained attention. Results: Among 182 adults with T1D (40±14 yrs, 46% male, 41% Latino, 29% White, 15% Black), greater mean BG (beta=0.03), lower TIR (beta=-0.03), and more time in high (beta=0.03) and very high BG (beta=0.03) predicted slower processing speed 3 hrs later (ps<.05); no BG metric predicted sustained attention ability. Surprisingly, slower processing speed predicted lower mean BG (beta=-0.05), more TIR (beta=0.04) and less time in high (beta=-0.01) and very high BG (beta=-0.04) over the next 3 hrs. Reduced sustained attention predicted more time in very high BG (beta=-0.01) and lower CV (beta=0.03) (ps<0.05). Conclusion: Our findings suggest that poorer BG regulation negatively influences processing speed over short time frames. Slower processing speed predicted subsequent improvements in CGM metrics, suggesting that individuals may take steps to correct BG when experiencing cognitive effects of poor BG regulation. These short-term relationships illuminate opportunities for in-the-moment interventions. Disclosure C.J.Hoogendoorn: None. D.Spruijt-metz: None. E.Pyatak: Research Support; Abbott Diabetes. J.S.Gonzalez: Consultant; Virta Health Corp. R.Hernandez: None. S.Schneider: None. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. J.P.Crandall: Research Support; Abbott. G.Crespo-ramos: None. H.Jin: None. L.T.Pham: None. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. Funding National Institutes of Health (R01DK121298, P30DK020541, P30DK111022)

684-P: Momentary, Daily, and Long-Term Impacts of Diabetes on Daily Activities—The Function and Emotion in Everyday Life with Type 1 Diabetes (FEEL-T1D) Study

Introduction: While it is widely recognized that T1D can interfere with daily activities, the extent and impact of these disruptions are poorly understood. Using FEEL-T1D study data, we examined how T1D interfered with daily activities, and the association between activity disruptions, illness intrusiveness, and diabetes-related quality of life (DQoL). Methods: FEEL-T1D prompted 14 days of surveys via smartphone at 3-hr intervals 5-6x/day. At each survey, participants indicated what activity they were doing, their activity performance and satisfaction, and whether/how T1D interfered with the activity. At end-of-day, they noted activities they could not do due to T1D. At study end, participants completed the T1D and Life (T1DAL) measure of DQoL and Adapted Illness Intrusiveness Rating Scale (AIIRS). Descriptive statistics and multilevel regressions were used to identify daily activity disruptions and their associations with DQoL and illness intrusiveness. Results: Overall, 190 participants (40±14 yrs old, 54% female, 29% White, 40% Hispanic/Latinx, 31% other) completed 14,387 momentary surveys, of which 12.1% indicated activity disruptions, most often personal care (16.1% disrupted), sleep (14.6%), and housework/errands (13.4%). Participants were unable to do desired activities due to T1D on 8.2% of days, most often housework/errands (3.8% of days), work/school, personal care, and leisure (2.6% for each). Performance and satisfaction were poorer for disrupted vs. non-disrupted activities (p<.0001). Those with more activity disruptions had greater illness intrusiveness (p<.0001) and lower DQoL (p<.0001). Discussion: T1D-related activity disruptions are common and associated with poorer activity performance/satisfaction, more illness intrusiveness, and lower DQoL. Validating the impact of T1D on daily activities, and seeking strategies to minimize this impact, may improve QoL for adults with T1D. Disclosure E.Pyatak: Research Support; Abbott Diabetes. G.Crespo-ramos: None. R.Hernandez: None. L.T.Pham: None. J.S.Gonzalez: Consultant; Virta Health Corp. D.Spruijt-metz: None. P.Lee: None. S.Schneider: None. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. J.P.Crandall: Research Support; Abbott Diabetes. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. H.Jin: None. C.J.Hoogendoorn: None. Funding National Institutes of Health (1R01DK121298)

578-P: Telemedicine Intervention Is Effective in Changing Psychological and Behavioral Correlates of Weight Loss in the REAL HEALTH-Diabetes Trial

Prior studies have shown that telemedicine (telemed) weight loss interventions are non-inferior to in-person in achieving weight loss. The REAL-HEALTH Diabetes RCT studied the effectiveness of a group lifestyle intervention (LI) for weight loss in adults with T2D and overweight/obesity. Intervention was delivered either in-person (LI-IP) or via telephone (LI-Tele) . We found clinically significant weight loss with no difference between arms. We sought to determine whether there was a difference between the LI-IP and LI-Tele arms in change of psychological and behavioral correlates of weight loss from baseline to 6 months. We compared the change scores for psychological (diabetes-related distress, depression, diet self-efficacy and autonomous motivation for regulation of diet) and behavioral (dietary restraint, fat related diet behavior) measures between the LI-IP (n=69) and LI-Tele (n=72) groups. There was no significant difference between the groups in mean age (62 years) , percent male (44.7%) , race (79.4% white) , baseline HbA1c (7.7%) and baseline BMI (34.7 kg/m2) . At 6 months, scores for all the measures improved from baseline in both arms with no significant difference between LI-IP and LI-Tele (Table 1) , demonstrating that telemed LI was as effective as the in-person intervention at improving psychological and behavioral correlates of weight loss. Disclosure J. Vakharia: None. L.M. Delahanty: Advisory Panel; Lilly Diabetes, Omada Health, Inc., WW International, Inc., ZOE Limited. Stock/Shareholder; Jana Care Inc., Omada Health, Inc., ZOE Limited. T. Thaweethai: None. D.J. Wexler: Other Relationship; Elsevier, Novo Nordisk, UpToDate. Funding T32 DK007028

579-P: Diabetes-Related Distress Is Inversely Associated with Weight Loss with Lifestyle Intervention in T2D

Measures of depression (e.g., PHQ-8) and diabetes-related distress (e.g., Problem Areas In Diabetes, or PAID) are associated with diabetes self-care and adherence to lifestyle regimens in patients with T2D. The REAL HEALTH-Diabetes trial evaluated a Look-AHEAD adapted group lifestyle intervention (LI) . We sought to determine baseline characteristics that were associated with achieving ≥5% weight loss during the first year of the intervention. Participants were randomly assigned to receive LI either in-person (IP, n = 69) or by telephone (Tele, n =72) . At baseline, 12.9% had a PHQ-8 score of ≥ 10, indicating current depression, and 50.4% had a baseline PAID score of ≥ 40, indicating severe emotional distress. At 6 months and 12 months, 46.8% and 45.7% achieved ≥ 5% weight loss (Table 1) . Participants who achieved ≥ 5% weight loss at 6 and 12 months had lower mean baseline PAID scores than non-achievers (35 vs. 44, P=0.021 at 6 months; 35 vs. 43, P=0.036 at 12 months) . Achievers also had lower mean baseline PHQ-8 scores compared to non-achievers, but this difference was not statistically significant (4.0 vs. 5.1, P=0.596 at 6 months; 3.8 vs. 5.1, P=0.842 at 12 months) . We found that diabetes distress was more common than depression, and that baseline levels of diabetes-related distress were inversely associated with achievement of ≥ 5% weight loss at 6 and 12 months of LI. Disclosure J.Vakharia: None. D.J.Wexler: Other Relationship; Elsevier, Novo Nordisk, UpToDate. T.Thaweethai: None. C.Yu: None. L.M.Delahanty: Advisory Panel; Lilly Diabetes, Omada Health, Inc., WW International, Inc., ZOE Limited, Stock/Shareholder; Jana Care Inc., Omada Health, Inc., ZOE Limited. Funding T32 DK007028

1123-P: Racial Differences in Glycemia and A1C in the Vitamin D and Diabetes (D2d) Study

Understanding the association between glycemia and A1c by race can improve screening for prediabetes and type 2 diabetes (T2D) . This association was examined cross-sectionally in 1016 Black and 2658 White persons screened for D2d (mean age 60; fasting glucose [FG] 1mg/dL; A1c 5.9%) . Of these, 22with at least 2-of-3 ADA glycemic criteria for prediabetes (mean age 60, FG 1mg/dL, A1c 5.9%, 28% Black) were followed longitudinally for median 2.5 years with annual OGTT and semi-annual FG and A1c. Numerical integration methods were used for the estimation of area under the OGTT-derived glucose curve (AUC) . Mean A1c was estimated for a given AUC quintile using linear regression for Whites, Blacks, and Asians. Adjusting for covariates, the A1c was higher by 0.2-0.25% among Black vs. White participants with similar glycemia in all AUC quintiles. During follow-up, Black participants were more likely to be diagnosed with T2D based on A1c; White participants were more likely to be diagnosed by FG. The absolute increase in A1c over time according to baseline AUC-glucose quintiles differed by race. Compared to White participants, Black participants in lower baseline AUC quintiles had greater increases in A1c over time, while A1c increased similarly in White and Black persons in the two highest baseline AUC quintiles. In summary, Black participants had higher A1c than White participants for similar degree of glycemia defined by AUC; the glycemic criteria contributing to the diagnosis of T2D differed by race; and there were AUC by racial interactions in A1c increase over time. Disclosure E.S.Leblanc: n/a. S.Dagogo-jack: Consultant; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Sanofi. J.P.Nelson: None. D.S.Hsia: None. D2d research group: n/a. A.G.Pittas: None. R.Chatterjee montgomery: Research Support; Bristol-Myers Squibb Company, Epigenomics AG. N.Rasouli: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Allergan, Eli Lilly and Company, Novo Nordisk. M.K.Rhee: Research Support; Kowa Company, Ltd. R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck & Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. C.Desouza: Advisory Panel; AstraZeneca, Bayer AG, Novo Nordisk A/S, Consultant; Asahi Kasei Corporation. L.M.Neff: Employee; Eli Lilly and Company, Research Support; Amryt Pharma Plc, Novo Nordisk, Stock/Shareholder; Eli Lilly and Company. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. Funding American Diabetes Association (1-14-D2d-01) ; National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases and Office of Dietary Supplements (U01DK098245)

259-OR: Stem Cell–Derived, Fully Differentiated Islet Cells for Type 1 Diabetes

Cadaveric islet transplantation can achieve glycemic control in T1D, but cadaveric islet quantity and quality are limiting. We report the first patient-administered VX-880, an investigational allogeneic stem cell–derived, fully differentiated, pancreatic islet cell replacement therapy. A 64-year-old male with a 40-year history of T1D complicated by impaired awareness of hypoglycemia with 5 severe hypoglycemic events (SHEs) the year before VX-880 was receiving 34U insulin/day at baseline (HbA1c 8.6%; undetectable fasting and stimulated C-peptide) . After a single VX-880 infusion at half target dose, fasting C-peptide was detected by Day 29 and increased rapidly; HbA1c and daily insulin decreased in parallel. At Day 90, robust increases in fasting and stimulated C-peptide, improved glycemic control, and a substantial reduction in exogenous insulin administration were observed and continued to improve through last time point assessed (Table) . VX-880 was generally safe and well tolerated; most AEs were mild or moderate and consistent with immunosuppression. The most common AEs were SHEs (not serious or related to VX-880) , which occurred in the perioperative period. There was 1 serious AE of rash (mild, unrelated to VX-880) , which resolved. These unprecedented results are the first evidence that stem cell–derived islets can restore insulin production and glucose control in T1D. The study continues to enroll and dose patients. Disclosure J.F.Markmann: Consultant; Vertex Pharmaceuticals Incorporated. L.S.Kean: Advisory Panel; HiFiBio, Mammoth Biosciences, Other Relationship; Bristol-Myers Squibb Company, Research Support; Bluebird Bio, Gilead Sciences, Inc., Magenta Therapeutics, Merck & Co., Inc., Novartis AG, Regeneron Therapeutics. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. P.Witkowski: Advisory Panel; Sernova, Corp., Vertex Pharmaceuticals Incorporated. C.Ricordi: Advisory Panel; Vertex Pharmaceuticals Incorporated. A.Naji: None. M.R.Rickels: Advisory Panel; Sernova, Corp., Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Consultant; L-Nutra Inc. M.Alba: None. G.Marigowda: None. L.Ross: Employee; Vertex Pharmaceuticals Incorporated. C.Wang: Employee; Vertex Pharmaceuticals Incorporated. F.Pagliuca: Employee; Vertex Pharmaceuticals Incorporated, Other Relationship; Vertex Pharmaceuticals Incorporated, Stock/Shareholder; Vertex Pharmaceuticals Incorporated. B.Sanna: Employee; Vertex Pharmaceuticals Incorporated.

769-P: Glycemic Outcomes in Adults with Type 2 Diabetes over 21 Weeks with the Omnipod 5 Automated Insulin Delivery System

As there is a pressing need for better treatment options for type 2 diabetes (T2D) , it is crucial to explore new technologies such as automated insulin delivery (AID) in this population. Little is known about how successful these systems will be in T2D, especially over a longer duration of use. The safety and practicability of the Omnipod 5 AID System in adults with T2D was previously demonstrated during an 8-week outpatient feasibility trial. Those completing this initial study were invited to continue system use for an additional 26 weeks to assess longer-term efficacy. We present results from the first 13-week follow-up assessment of the extension study. In the initial study, adults with T2D (A1C >8%) previously on either basal-only (n=12) or basal-bolus insulin injections (n=12) , with or without CGM, used AID for 8 weeks following 14 days of their standard therapy. Those participating in the extension study continued AID use, and A1C was measured again after 13 weeks (21 weeks of total AID use) . Efficacy was assessed by change in A1C from baseline. Most participants (N=22, 92%) continued into the extension phase. Two of these participants had completed the initial study before the extension study was available but were allowed to re-join, resulting in a 2-4-month return to their standard therapy before resuming AID. Participants were aged (mean±SD) 61±8y with BMI 33.9±4.4kg/m2, diabetes duration 19±9y, and baseline A1C 9.4±0.9% (range: 8.1-11.7%) . Mean A1C decreased to 8.0±0.7% after 8 weeks of AID (p<0.05) . After an additional 13 weeks of use, mean A1C was 7.7±0.7%, corresponding to an overall decrease of 1.6±1.0% from baseline to 21 weeks of total use (p<0.05) . There were no episodes of severe hypoglycemia during the study. The continued improvement in A1C with longer duration of AID use with the Omnipod 5 System demonstrates a durable and clinically meaningful benefit for participants with previously sub-optimal glycemic control outcomes on injection insulin therapy. Disclosure G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. B.W.Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker's Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. A.L.Carlson: Advisory Panel; MannKind Corporation, Employee; Bright Health Group, Other Relationship; Medtronic, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, UnitedHealth Group. B.Dumais: Employee; Insulet Corporation. T.Vienneau: Employee; Insulet Corporation, Stock/Shareholder; Dexcom, Inc., GlaxoSmithKline plc., Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. T.T.Ly: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. Funding This study was funded by Insulet Corporation.

665-P: Awareness of Time in Range Varies by Type of Health Care Provider

Background and Aims: Previous studies have shown an association between Time in Range (TIR) and risk of microvascular complications, but TIR is not used widely in diabetes care. This study aimed to assess differences in awareness and use of TIR among healthcare providers (HCPs) . Methods: In an online survey in September 2021, 303 HCPs, each working with a minimum of 30 patients with diabetes each month, were asked a series of questions related to challenges, evaluation, and goal-setting when discussing diabetes management with patients. Respondents were classified as either Endocrinologists (Endo) , Diabetes Educators (DE) , or primary care providers (PCP) . Statistical significance was tested at the 95% confidence level (p<0.05) . Results: DEs were more likely to be aware of (96%, n=106) and use (94%, n=106) TIR in clinical practice than Endos (92%, 88%, n=98) and PCPs (56%, 46%, n=99) . Among respondents who were aware of TIR (n=247) , Endos were more likely to use TIR when making treatment decisions (87%, n=90) than PCPs (69%, n=55) . Among those who reported using TIR in clinical practice (n=234) , PCPs were least familiar (67%, n=46) with CGM metrics compared to Endos (91%, n=88) and DEs (79%, n=100) . Conclusions: This data highlights differences in TIR use between Endos, DEs, and PCPs, and the lower levels of TIR awareness among PCPs. This study emphasizes opportunities for increased awareness of TIR through education and training of PCPs on CGM and TIR. Disclosure J.Kenney: None. A.Briskin: None. J.Tait: Employee; dQ&A. E.Shoger: Other Relationship; Diabetes industry. R.Wood: Other Relationship; Multiple companies and patient organizations (>10) . A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health.

278-OR: ADA Presidents' Select Abstract: Impact of Overnight Blood Glucose on Next-Day Functioning in T1D

Introduction: While people with T1D report that blood glucose (BG) fluctuations affect their day-to-day functioning, these relationships are poorly understood. Using continuous glucose monitoring (CGM) , accelerometry, and momentary surveys and cognitive tasks, we sought to understand how various BG metrics during sleeping hours impact functioning the following day. Methods: Participants wore a blinded CGM and accelerometer for 10-14 days, during which they completed surveys and cognitive tasks 5-6 times per day. Using dynamic structural equation modeling, we evaluated the within-person impact of overnight BG on the following day’s functioning, while controlling for the prior day’s functioning. BG variables included % time <70 mg/dL, % time >250 mg/dL, and coefficient of variation (CV) . Functioning variables included cognitive measures of sustained attention and perceptual speed; daily step count; and self-reported fatigue, task performance, and net activity demand. Results: Among 127 adults with T1D (41±15 yrs, 46% male, 39% Latinx, 35% White, 10% Black, 4% Asian, 12% multiethnic/other) , all three BG variables predicted changes in next day functioning. More time <70 predicted poorer sustained attention (standardized b= -0.06) , while more time >250 predicted more fatigue (0.09) and lower step count (-0.12) (all p<0.05) . Higher CV had the broadest impact, predicting poorer sustained attention (-0.06) , more fatigue (0.05) , and less engagement in demanding activities (-0.05) (all p<0.05) . Conclusion: Our findings indicate that overnight BG impacts cognition, physical activity, fatigue, and activity engagement the following day. While effect sizes are small, the cumulative impact of these decrements in function should be considered in the context of a life-long disorder. The consistent findings among diverse outcomes, including both objective and self-report measures, strengthen confidence in the overall conclusion that overnight BG has wide-ranging implications for functioning in adults with T1D. Disclosure E. Pyatak: Research Support; Abbott Diabetes. D. Spruijt-Metz: None. S. Schneider: None. J.P. Crandall: Research Support; Abbott Diabetes. A.L. Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust. Stock/Shareholder; Teladoc Health. Other Relationship; Omada Health, Inc. H. Jin: None. S. Agarwal: Advisory Panel; Medtronic. Consultant; Beta Bionics, Inc. L.T. Pham: None. A. Ali: None. C.J. Hoogendoorn: None. G. Crespo-Ramos: None. R. Basile: None. J.S. Gonzalez: Consultant; Virta Health Corp. Funding National Institutes of Health (1R01DK121298-01)

666-P: CGM Access Is the Main Barrier to TIR Use among Providers

Background and Aims: Previous studies have shown a correlation between Time in Range (TIR) and risk for microvascular complications, but the metric is not used widely in diabetes care. This study aimed to assess the barriers to TIR use among healthcare providers. Methods: In an online survey in September 2021, 303 HCPs, each working with a minimum of 30 patients with diabetes each month, were asked a series of questions related to challenges, evaluation, and goal-setting when discussing diabetes management with their patients. Respondents were classified as either Endocrinologists (Endo) , Diabetes Educators (DE) , or primary care providers (PCP) . Statistical significance was tested at the 95% confidence level (p<0.05) . Results: 80% of HCPs who use TIR (n=234) identify access to CGM as a main drawback of TIR and 72% (n=289) identified cost as a downside of CGM use. When TIR non-users (n=64) were asked what would convince them to use TIR with patients, 41% cited increased access to CGM and 30% cited training and resources about how to use TIR data. 83% of non-users (n=64) believe TIR would be useful in their diabetes care. When asked what would improve their diabetes care, 39% of HCPs said having more patients on CGM and 28% said the ability to use TIR data with more patients (n=246) . Conclusions: This data highlights the barriers to TIR adoption and use among HCPs. Increased access to CGM and education on TIR use in clinical practice can help advance TIR in diabetes care. Disclosure J.Kenney: None. J.Tait: Employee; dQ&A. A.Briskin: None. E.Shoger: Other Relationship; Diabetes industry. R.Wood: Other Relationship; Multiple companies and patient organizations (>10) . A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health.

279-OR: Self-Efficacy, Diabetes Distress, Self-Care, and Blood Glucose: Within-Person Pathways in Adults with T1D

Introduction: Research links self-efficacy and diabetes distress to suboptimal diabetes self-care and blood glucose (BG) regulation. However, most studies rely on between-person comparisons that cannot rule out confounding by unmeasured variables or capture the dynamic interplay among these variables in real time. Pairing continuous glucose monitoring (CGM) with ecological momentary assessment, we sought to illuminate pathways of influence among these variables in a diverse sample of adults with T1D. Methods: Participants (N=127, 41±15 yrs, 53% women, 39% Latino, 35% White, 10% Black) wore blinded CGM for 10-14 days and completed smartphone surveys 5-6 times per day. Using dynamic structural equation modeling, we evaluated within-person pathways shown in Figure 1. Results: Hypothesized pathways were significant, as were indirect effects of:1) morning self-efficacy on that day’s mean BG via diabetes distress and self-care and2) diabetes distress on mean BG via self-care. Similar results were observed for time in range and SD of BG. Conclusion: Our findings provide novel evidence for a sequential pathway of influence of psychological, emotional, and behavioral variables on BG regulation, observed over time and within individuals. These results provide a roadmap for interventions that target self-efficacy, diabetes distress, and self-care to improve BG regulation among adults with T1D. Disclosure J.S.Gonzalez: Consultant; Virta Health Corp. H.Jin: None. L.T.Pham: None. A.Ali: None. P.Lee: None. V.F.Ruelas: n/a. R.Basile: None. E.Pyatak: Research Support; Abbott Diabetes. D.Spruijt-metz: None. S.Schneider: None. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. J.P.Crandall: Research Support; Abbott Diabetes. G.Crespo-ramos: None. H.Mendez-rodriguez: None. C.J.Hoogendoorn: None. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc. Funding National Institutes of Health (1R01DK121298-01; P30 DK111022)

Prompt Access, Outreach and Engagement: Key Drivers of Clinically Meaningful Outcomes and Satisfaction with Digital Physical Therapy

<h3>Research Objectives</h3> To examine effects of access, outreach and engagement on digital physical therapy (DPT) clinical outcomes and satisfaction. <h3>Design</h3> Observational retrospective study examining data from episodes of DPT. <h3>Setting</h3> App-based DPT offered as a healthcare benefit to privately-insured employees. <h3>Participants</h3> Sample included 652 participants, 18 years and older, enrolled February 2019 through December 2020. <h3>Interventions</h3> DPT included a PT-guided course of treatment. <h3>Main Outcome Measures</h3> Binary variables defined patients with minimal clinically important differences (MCID) in pain (14% decrease on the Visual Analog Scale) and function (2.3 point increase on the Patient Specific Functional Scale). "Satisfied" participants had Net Promoter Scores of 9-10 on the question capturing likelihood to recommend the program. Prompt access was defined as completing first virtual visits within 24-hours. Outreach included the number of PT-initiated chat messages and virtual visits. Engagement included workouts per week, and a binary "engaged" variable identifying participants who completed at least 3 clinical activities a week for at least 4 weeks. <h3>Results</h3> Prompt access increased the odds of being "engaged" by 82% (p < 0.005) and the number of weekly workouts by 23% (p < 0.001). Each additional weekly PT-initiated message increased the odds of being engaged by 37% (p < 0.01) and increased weekly workouts by 15% (p < 0.001). The odds of having MCIDs in pain or function increased by 1.18 (p < 0.01) and 1.13 (p < 0.05), respectively, for each additional weekly workout completed. Participants with more virtual visits were approximately 3 times (p < 0.001) more satisfied. <h3>Conclusions</h3> Prompt access and provider outreach were related to better engagement, which was associated with better clinical outcomes and satisfaction. <h3>Author(s) Disclosures</h3> I am a shareholder of Omada Health.

Clinically Meaningful Improvement in Pain and Function from Digital Physical Therapy

Research Objectives To examine the impact of digital physical therapy (DPT) on reducing pain and improving physical function for people with a variety of musculoskeletal conditions. Design An observational, longitudinal, retrospective study examined data collected at entry to DPT and at the end of treatment. Setting DPT was delivered via a smartphone app. The program was offered nationwide to privately insured employees as a healthcare benefit from their employer. Participants The study sample included 652 participants, ages 18 years and older, enrolled from February 2019 through December 2020. Interventions DPT consisted of a remote consultation with a physical therapist followed by a course of PT-guided physical therapy delivered through a smartphone app. Main Outcome Measures Primary outcome was pain measured by the Visual Analogue Scale (VAS) from 0 “no pain” to 10 “worst pain imaginable”. Physical function was measured by the Patient Specific Functional Scale (PSFS) on a scale from 0 “completely unable to perform” to 10 “able to perform normally.” Results Average age of the sample was 40.9 years, 48% were female, 21% sought care for the back, 14% for knees, 14% for shoulder and 13% for neck; 53% obtained their initial visit within 24 hours. After controlling for demographics, comorbid conditions and symptoms, the results from multi-level random intercept models showed decreased pain (- 2.51 points, p < 0.001) and increased physical function (+ 2.4 points, p < 0.001) by end of treatment. Conclusions DPT was associated with clinically meaningful benefit for pain and function among a diverse set of program users. This early data is an encouraging indicator of the benefit of DPT. Author(s) Disclosures I am a shareholder of Omada Health. To examine the impact of digital physical therapy (DPT) on reducing pain and improving physical function for people with a variety of musculoskeletal conditions. An observational, longitudinal, retrospective study examined data collected at entry to DPT and at the end of treatment. DPT was delivered via a smartphone app. The program was offered nationwide to privately insured employees as a healthcare benefit from their employer. The study sample included 652 participants, ages 18 years and older, enrolled from February 2019 through December 2020. DPT consisted of a remote consultation with a physical therapist followed by a course of PT-guided physical therapy delivered through a smartphone app. Primary outcome was pain measured by the Visual Analogue Scale (VAS) from 0 “no pain” to 10 “worst pain imaginable”. Physical function was measured by the Patient Specific Functional Scale (PSFS) on a scale from 0 “completely unable to perform” to 10 “able to perform normally.” Average age of the sample was 40.9 years, 48% were female, 21% sought care for the back, 14% for knees, 14% for shoulder and 13% for neck; 53% obtained their initial visit within 24 hours. After controlling for demographics, comorbid conditions and symptoms, the results from multi-level random intercept models showed decreased pain (- 2.51 points, p < 0.001) and increased physical function (+ 2.4 points, p < 0.001) by end of treatment. DPT was associated with clinically meaningful benefit for pain and function among a diverse set of program users. This early data is an encouraging indicator of the benefit of DPT.

Abstract 13006: Digital Diabetes Prevention Program Reduces Medical Costs in the First 2 Years of Implementation in a Workplace Setting

Introduction: The Diabetes Prevention Program (DPP) was shown to reduce body weight and lower incidence of diabetes in a cost-effective manner. Digital versions of the DPP (dDPP) have recently been implemented and shown to reduce body weight and other risk factors for chronic disease. We asked whether implementation of a dDPP in a workplace setting would reduce medical costs. Methods: Employees and spouses of a nation-wide medical diagnostic provider were eligible to participate in dDPP (Omada Health) if they had prediabetes (fasting glucose 100 to 125 mg/dL or HbA 1C 5.7% to 6.4%) and BMI ≥25 kg/m 2 at baseline (September to December 2017), and were continuously enrolled in a health plan from September 2016 to December 2019. Of those eligible (n=3,098), 432 participated and completed ≥1 lesson (dDPP group). A control group (n=856) was matched to the dDPP group by baseline age, sex, race, geography, comorbidities, health plan type, and medical and prescription costs. Generalized estimating equations adjusted for age, race and BMI were used to obtain all estimates. Allowed costs from administrative claims data were evaluated per member per month (PMPM); dDPP costs were not included. Results: In the control group, costs were higher in the post-dDPP period (2017-2019) compared to the pre-dDPP period (2016-2017) for inpatient ($124 vs $64, P= 0.01), prescription ($183 vs $155, P =0.02), and total ($696 vs $558, P &lt;0.001; Figure). In the dDPP group, no changes were observed. Changes in total costs (post-dDPP minus pre-dDPP) were lower in the dDPP group than the control group, with a saving of $141 PMPM ( P =0.02; Figure). Conclusion: In the first two years of dDPP implementation, medical costs were unchanged in dDPP participants but higher in matched controls.

2227-PUB: The Experience of Spanish Speakers in the Real Health Study

The REAL HEALTH Diabetes study was a pragmatic trial of an intensive lifestyle intervention (ILI) for patients with type 2 diabetes (T2DM) adapted from Look AHEAD for delivery in routine primary care settings in English and Spanish. Given the high prevalence of T2DM in the Latino population, underrepresentation of this population in research, and disparities in outcomes, we evaluated the experience of Spanish speakers, as compared to English speakers, screened for and enrolled in REAL HEALTH. The trial screened 715 patients who spoke Spanish as a primary language, of whom 17 subjects (8.1% of enrollees, 2.4% of screened Spanish speakers) enrolled in the study. Compared to English speakers, Spanish speakers were less likely to decline participation due to lack of interest (OR 0.43, p&amp;lt;0.01) and equally likely to attend a screening visit (p=0.54) but more likely to be lost to recruitment due to inability to contact the patient for a phone screen (OR 2.0, p&amp;lt;0.01). Engagement of Spanish speakers was lower than among English speakers, with lower rates of completion of the ILI (OR 0.22, p=0.04) and a trend for lower attendance for medical nutrition therapy. Despite this, Spanish-speakers had higher increases in (p=0.01) and final levels of (p=0.03) self-reported physical activity. Weight loss at 12 months in the ILI did not significantly differ between groups (2.8kg among Spanish-speakers vs. 4.8kg among English speakers, p=0.11). It is important to recognize barriers to clinical trial and ILI engagement, as well as the nuances of experiences and outcomes within clinical trials. Enrollment of Spanish speakers was limited by difficulty contacting potential subjects, despite extensive recruitment efforts by study staff. Enrolled participants engaged differently but had similar weight loss compared to English speakers in the ILI. Spanish-speakers represent a unique group who may benefit from tailored interventions. Disclosure S. Cromer: Employee; Spouse/Partner; Johnson &amp; Johnson. A.R. Rodriguez: None. L. Bissett: None. A. Dushkin: None. V.M. Goldman: None. J. McCarthy: None. L.M. Delahanty: Advisory Panel; Self; Jana Care Inc., Omada Health, Weight Watchers International, Inc. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S. Funding National Institutes of Health (T32DK007028)