Johnson Diabetes Institute Research Articles

856-P: Can Monetary-Based Reinforcement for Self-Monitoring Blood Glucose (SMBG) Impact Psychosocial Outcomes? A Randomized Controlled Trial

Background: Members of our group previously reported that monetary reinforcement of SMBG related behaviors shows robust increases in frequency of SMBG and modest decreases in A1c among youth with type 1 diabetes (T1D). In these secondary data analyses, we explored effects on psychosocial functioning. Methods: Sixty youth ages 12-21 (Mage=15.58, SD=2.31) with T1D, A1c 7.5-13%, and <4 BG checks per day were randomized to either a 24-week reinforce intervention or enhanced usual care (EUC). The intervention consisted of monetary incentives for completing blood glucose checks, texts with provider, glucose data uploads, and glucose pattern recognition forms. Validated psychosocial questionnaires were administered at baseline, 6, 12, 24, and 36 weeks. Measures included youth reported diabetes distress, family conflict, and negative affective responses to out-of-range glucose results. Results: Generalized linear models showed no significant time x condition effects. In t-tests at discrete follow-ups, compared to the control group, the reinforce group had significantly lower youth-reported diabetes related family conflict at 12 weeks (22.39 vs. 25.11, p=.043) and significantly higher negative affective responses to out-of-range glucose results at 24 weeks (13.62 vs. 11.71, p=.047). Conclusion: Monetary reinforcers targeting SMBG behaviors may produce transitory decreases in youth perceptions of family conflict and transitory iatrogenic increases in youth’s negative affective responses to out-of-range glucose results. The timing of changes in family conflict, negative affect, and previously reported changes in A1c suggest that psychosocial changes may reflect youth responses to A1c as well as to reinforcers per se. For broader effects, the intervention could include psychosocial components that seek to directly maintain decreased family conflict and mitigate negative affect related to increased awareness of glucose control. Disclosure J.J. Wong: None. A. Addala: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. J. Wagner: None. E. Cengiz: Advisory Panel; Self; Abvance, ADOCIA, MannKind Corporation, Novo Nordisk Inc. Speaker's Bureau; Self; Novo Nordisk Inc. E.M. Tichy: None. K. Weyman: None. D. Naranjo: Advisory Panel; Spouse/Partner; Eli Lilly and Company. Speaker's Bureau; Spouse/Partner; Johnson & Johnson Diabetes Institute. Other Relationship; Self; Abbott. Funding National Institutes of Health

255-OR: Temporal Trend in the Prevalence and Incidence of Depression and Antidepressant Usages in Incident Type 2 Diabetes from U.S. and UK

Aim: Temporal trend in the prevalence and incidence of depression (DP), any mental illness (AMI) and use of anti-depressants (ADM) in incident T2DM pts is not well known. We evaluate these trends and the risk of developing DP in young pts in real world settings from U.S. and UK. Method: Adults with diagnosis (Dx) of T2DM from 2000 from Centricity Electronic Medical Records of U.S. and The Health Improvement Network (THIN) database of UK were examined. Results: In U.S. (n= 1,395,572)/UK (n= 343,714) cohorts, the age at T2DM Dx was 59/58 years, 2/8% had Dx of DP but were not on ADM, 16/10% were on ADM without DP or AMI Dx, 9/15% were using ADM with Dx of DP. The prevalence of DP, AMI and ADM use increased exponentially in UK since 2000 (Figure B), while an increasing prevalence in AMI and ADM use was seen in U.S. (Figure A). Between 2000-2016, the use of ADM without Dx of DP or AMI increased from 16-26%/5-41% in U.S./UK cohort. Incidence rates of DP and ADM use were significantly higher in the U.S. cohort compared to UK (Figures C and D). Among pts without a co-morbid condition at T2DM Dx, younger U.S./UK pts (≤ 50 years) had 28%/18% significantly higher risks of developing DP compared to older pts (≥ 60 years); among pts with existing co-morbidity, the risks were higher by 46%/33%. Conclusion: In incident T2DM pts in UK and U.S., a striking rise in the prevalence of DP and the ADP use without Dx of AMI is seen, with younger pts having higher risk of developing DP. Disclosure J. Dibato: None. D. Koye: None. W. Polonsky: Consultant; Self; Abbott, Bigfoot Biomedical, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Johnson & Johnson Diabetes Institute, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. O. Montvida: None. S.K. Paul: Consultant; Self; AstraZeneca, Roche Pharma. Research Support; Self; Roche Pharma.

1132-P: Real-World Clinical Use of iGlarLixi in a Large U.S. Electronic Medical Records Database

iGlarLixi, a fixed-ratio combination of insulin glargine U100 (iGlar-100) and the GLP-1 RA lixisenatide, has been available in the U.S. for clinical use in patients (pts) with T2D since 01/2017. This analysis provides baseline characteristics of iGlarLixi pts and prescribers in a real-world setting from a U.S. electronic medical records database. Pts initiating iGlarLixi from 01/2017 were reviewed using the U.S. Optum Humedica database, which includes data from approximately 85 million pt lives (insured and uninsured). Pts with at least 6 months’ data prior to iGlarLixi initiation (07/2016) were included. Baseline characteristics and clinical variables using ICD-9-CM/ICD-10-CM and prescription codes were extracted. Among 1075 total pts initiating iGlarLixi, mean age was 56.5 years (SD 10.6, range 22-89); highest number of pts (41%) were 55-64 years; 53% were female. If noted, race was 76% Caucasian, 16% African American, 1% Asian, and 8% Other/Unknown; 6% were of Hispanic ethnicity. Mean HbA1c was 9.1% (SD 2.0, median 8.8); distribution: ≥7% (80%), ≥8% (60%), and ≥9% (41%). Mean BMI (kg/m2) was 36.1 (SD 6.9, median 35.4); BMI was ≥30 for 50% and 30-<40 for 35%. Mean eGFR (mL/min/1.73 m2) was 86 (SD 26.8); of pts with known eGFR, 84% had >60. Mean Diabetes Complications Severity Index (DCSI) score was 2.4 (SD 1.7); 35% had DCSI ≥3. Previous basal insulin (BI) therapy (± OADs) was used by 41%; 14% were on GLP-1 RAs (± OADs); 15% were on BI + GLP-1 RA free combination (± OADs); 15% were on at least one OAD, without BI or GLP-1 RA. OADs (≥1) were used by 72% of pts; 38% were on ≥2 OADs. The highest number of pts were from the Midwest (61%), followed by the South (27%). Over 60% of prescribers were mid-level/family practice/internal medicine; 15% were endocrinologists. In conclusion, iGlarLixi is used for pts with a wide range of baseline demographic and clinical characteristics in widespread U.S. geographic regions. The largest use was noted in pts with high HbA1c and obesity, and most pts had previous therapies of BI or GLP-1 RAs and OADs. Disclosure J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker's Bureau; Self; Merck & Co., Inc., Sanofi. A.H. Boss: Employee; Self; Sanofi. Stock/Shareholder; Self; Novo Nordisk A/S, Sanofi. R. Lubwama: Employee; Self; Merck & Co., Inc., Sanofi. A. Shaunik: Employee; Self; Sanofi. Funding Sanofi

128-LB: Insulin Glargine 300 U/mL (Gla-300) vs. First-Generation Basal Insulins (BI) in Insulin-Naïve Type 2 Diabetes (T2D) Patients (Pts) With and Without Cardiovascular Disease (CVD): Outcomes of the Randomized Pragmatic Real-Life Clinical Trial ACHIEVE Control

ACHIEVE Control demonstrated superiority of Gla-300 vs. standard of care (SOC) BIs (glargine 100 U/mL and detemir), with a significantly greater proportion of insulin-naive T2D pts treated with Gla-300 achieving the composite primary endpoint of individualized HEDIS A1C targets at 6 months without severe and/or symptomatic documented hypoglycemia (blood glucose [BG] ≤70 mg/dL). Here we report outcomes in pts with and without CVD at baseline (BL). Characteristics at BL were generally well balanced between treatments, with a potential difference in GLP-1 receptor agonist use in CVD pts. In pts without CVD, outcomes consistently favored Gla-300 (Table). In CVD pts, composite endpoint attainment at 12 months was similar with Gla-300 and SOC-BI, while avoidance of hypoglycemia, especially serious hypoglycemia (BG <54 mg/dL), showed a trend favoring Gla-300 (Table); changes in A1C from BL to 12 months with Gla-300 and SOC-BI were similar (LS mean difference [95% CI] 0.12% [-0.12 to 0.35]; p=0.34). The results of this analysis are promising and warrant further exploration of the possibility that the more stable action profile of Gla-300 translates to T2D patients with CVD experiencing serious hypoglycemia less often with Gla-300 than first-generation BIs. Disclosure J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker’s Bureau; Self; Merck & Co., Inc., Sanofi. P. Evenou: Employee; Self; Sanofi US. D. Dalton: Employee; Self; Sanofi US. K.M. Dungan: Advisory Panel; Self; Eli Lilly and Company, Elsevier, Sanofi-Aventis. Research Support; Self; Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk Inc., Sanofi-Aventis, Viacyte. Other Relationship; Self; DKBmed, UpToDate. Funding Sanofi US

2372-PUB: An EHR-Based Tool to Aid Treatment Decisions and Combat Therapeutic Inertia in Patients with Uncontrolled Type 2 Diabetes—A Pilot Study

An electronic health record (EHR)-based tool was developed for EPIC My Practice at Cleveland Clinic to aid treatment decisions and combat therapeutic inertia in patients with type 2 diabetes (T2D) and suboptimal glycemic control (A1C ≥8%). The tool consists of three separate components activated during an office visit: a best practice alert (BPA) if a patient had an A1C ≥ 8% within the past 6 months, a Smartform (patient summary and order entry form), and a Smartset for T2D medications to achieve patient-centered treatment goals, supplies, laboratory, and consult orders. The provider may acknowledge the BPA and pursue therapy intensification or defer. The tool was piloted for 3 months (primary care providers (PCP) n=12, endocrinology providers n=5). BPA acknowledgement and utilization practices were recorded by specialty. The CollaboRATE survey (3 items, scale 0-9) was used to assess patient perceptions of shared decision-making afforded by the tool. The BPA appeared for 420/1,766 T2D patients at an office-based encounter with a PCP or endocrinology provider. While the BPA was acknowledged at most endocrinology visits (95%) and approximately 50% of primary care visits, use of all three components of the tool only occurred in ∼10% of eligible encounters. The CollaboRATE survey was administered to a subset of 83 patients exposed to the tool. Most chose the highest rating for questions assessing if efforts were made to: 1. help them better understand their health issue (87%), 2. listen to what matters most to them about their health issue (93%) and 3. integrate what matters to them into next steps (92%). Use of an EHR-based tool to aid treatment decisions is variable by specialty, though appears to lead to a high perception of shared decision-making for T2D patients. Additional provider education and improved incorporation of the tool into PCP work-flow may help to address therapeutic inertia in routine clinical practice. Disclosure K.M. Pantalone: Consultant; Self; Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Research Support; Self; Merck & Co., Inc., Novo Nordisk Inc. Speaker's Bureau; Self; AstraZeneca, Merck & Co., Inc., Novo Nordisk Inc. A.D. Misra-Hebert: Research Support; Self; Agency for Healthcare Research and Quality, Merck & Co., Inc., Novo Nordisk Inc. S. Rajpathak: None. T. Weiss: Employee; Self; Merck & Co., Inc. M. Hamaty: Consultant; Self; Applied Clinical Intelligence, LLC. R.S. Zimmerman: Consultant; Self; Novo Nordisk Inc. Research Support; Self; Merck & Co., Inc., Novo Nordisk Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute, Merck & Co., Inc.

1271-P: Impact of Physician-Pharmacist Collaboration on A1C in an Interprofessional Endocrinology Clinic

Background: Comprehensive medication management (CMM) ensures an individualized plan for medication appropriateness, effectiveness, safety, and adherence. It is most often performed by pharmacists within a pharmacist-physician collaborative agreement. Published studies on CMM are few and mostly conducted in primary care settings. The aim of our study was to determine the impact of CMM on the proportion of patients that achieve ≥ 1% A1c reduction in an interprofessional specialty clinic. Methods: This is a retrospective study comparing 2 groups: group 1-without pharmacist collaboration, group 2-with pharmacist collaboration. Subjects were adults with diabetes and most recent A1c ≥ 8.5% with at least one visit in the interprofessional endocrinology clinic between 1/2016-12/2017. Exclusion criteria were pregnancy, no A1c within 6 weeks of initial visit, and no follow-up A1c. The 2 groups were matched for initial A1c, type of diabetes, age, and BMI. Results: A total of 162 participants were included. Baseline characteristics were similar between groups: Group 1: (mean age: 57.6 ± 15.8 years, BMI: 34.3 ± 8.1 kg/m2, A1c: 10.2 ± 1.2%, T1DM: 26%), Group 2 (mean age: 56.0 ±16.4 years, BMI: 32.6 ± 8.1 kg/m2, A1c: 10.1± 1.3%, T1DM: 26%). The percentage of subjects achieving ≥1% A1c reduction at 6 months was 58.0% in Group 2 compared to 40.7% in Group 1, p=0.041. More subjects achieved A1c < 8% in group 2 (32.1%) vs. Group 1 (18.5%), p=0.047. The frequency of endocrinologist visits was more in group 1 (2.37/patient) vs. group 2 (1.89/patient), p=0.01. Group 2 averaged 3.0 pharmacist visits per patient. Discussion: Physician-pharmacist collaboration led to greater A1c reduction compared to usual endocrinologist care in patients with uncontrolled A1c. However, frequency of total provider visits may account for some differences. Overall, utilizing pharmacists within diabetes health care models may reduce frequency of endocrinologist visits while improving glycemic control. Disclosure D. Isaacs: Advisory Panel; Self; BD, Sanofi-Aventis. R.S. Zimmerman: Consultant; Self; Novo Nordisk Inc. Research Support; Self; Merck & Co., Inc., Novo Nordisk Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute, Merck & Co., Inc. M. Lansang: None.

808-P: A New Measure of Diabetes-Specific Self-Compassion for Parents of Youth with Type 1 Diabetes (T1D)

Managing T1D is highly demanding while offering little in terms of rewards or positive reinforcement. Parents often experience high levels of emotional distress and burden, with implications for parent and child wellbeing and parent self-efficacy for managing diabetes. Parents may also experience self-criticism regarding their management of T1D. Diabetes-specific self-compassion (SC), or being kind to oneself in the face of challenges that arise in managing diabetes, has the potential to buffer against the negative impact of diabetes distress. The purpose of this study was to create a new tool, the Diabetes-Specific Self-Compassion Scale (SCS-Dp), to assess diabetes-specific SC in parents of youth with T1D. We adapted a previously validated measure for adults with T1D; surveyed parents (N=198; parent: 88% female; 95% non-Hispanic white; M age=44±8.9; child: 46% female; M age=13±3.4, range 2-18 years; 83% insulin pump users; 40% CGM users; A1c from clinic data available for 76 participants: M A1c=8.1±1.3%) and conducted confirmatory factor analysis (CFA), reliability and construct validity analyses. The 19-item SCS-Dp had excellent internal consistency (ɑ=.94; range of item-total correlations: .52-.81). The CFA model showed evidence of good fit: SRMR=0.04; RMSEA=0.05; CFI=0.95; χ2(171)=1637.02, p<0.0001. Validity measures included diabetes distress, diabetes empowerment, diabetes numeracy, and A1c. As predicted, greater SC was associated with lower distress (r=-.68, p<.001) and greater empowerment (r=.43, p<.001) and was not associated with diabetes numeracy (p=.61). SCS-Dp was not associated with A1c (p=.28). Results suggest that the SCS-Dp is a reliable, valid measure of diabetes-specific SC in parents and may help determine points of intervention for this population. Interventions to increase diabetes-specific SC in parents may aid in ameliorating diabetes distress through increasing self-kindness in the context of diabetes-related challenges. Disclosure M.L. Tanenbaum: None. J.J. Wong: None. S. Hanes: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute.

145-OR: Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control vs. Humalog (Lispro) in Patients with Type 2 Diabetes (T2D): PRONTO-T2D

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. This phase 3, multicenter, treat-to-target, 26-week trial evaluated the efficacy and safety of URLi vs. lispro in patients with T2D. Primary endpoint was A1C change from baseline to week 26, with multiplicity adjusted objectives for PPG excursions (PPGE) with meal test. After 8-week lead-in to optimize basal insulin glargine or degludec and transfer to prandial lispro treatment, patients were randomized to double-blind URLi (n=336) or lispro (n=337) injected 0 to 2 minutes prior to meals. Patients could continue metformin and/or SGLT2 inhibitor. Non-inferiority for primary endpoint was confirmed for URLi: estimated treatment difference (ETD) 0.06 [95% CI -0.05; 0.16], with mean change in A1C of -0.38% URLi and -0.43% lispro (Figure). Mean A1C at week 26 was 6.92% URLi and 6.86% lispro. URLi was superior to lispro in controlling 1- and 2-h PPGE with standardized meal test at week 26, with lower PPGE from 0.5-4 h with URLi (Figure). There were no significant treatment differences in rates of severe or overall hypoglycemia. Incidence of overall treatment-emergent adverse events was similar between treatments. URLi in a basal-bolus regimen led to superior PPG control vs. lispro in patients with T2D. Disclosure T. Blevins: Research Support; Self; Amgen Inc., Gan and Lee Pharma, Lilly Diabetes, Mylan, Novo Nordisk Inc. Speaker's Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Lilly Diabetes, Sanofi US. Other Relationship; Self; Medtronic MiniMed, Inc. Q. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker's Bureau; Self; Merck & Co., Inc., Sanofi. H. Jinnouchi: None. A.M. Chang: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company

1369-P: Continuous Glucose Monitoring Interventions in Toddlers with Type 1 Diabetes (T1D)

Introduction: Achieving optimal glycemic control is difficult in children with T1D even with insulin pumps and continuous glucose monitoring (CGM). Additional support focused on improving technology use may improve diabetes management. Methods: Children aged 2-6 years were enrolled in a 6-month adaptive study design (SMART) utilizing Dexcom G5 CGM. Monthly data were collected to assess time in range (70-180mg/dL) and adherence. If time in range was <60% or adherence was <6 of 7 days worn, participants’ families randomized to one of four interventions focusing on diabetes distress, developmental demands, fear of hypoglycemia, or remote monitoring. Parents completed surveys on diabetes distress, glucose monitoring satisfaction, hypoglycemia fear and confidence at enrollment and study end. HbA1c was collected at study initiation and study end. Results: Of 77 participants, 52.6% were male, mean age 4.94 ± 1.42y (2.03-7.00), diabetes duration 2.12 ± 1.13y (0.58-4.26). Each participant received an average of 3 intervention sessions. HbA1c decreased and psychological outcomes improved at statistically and clinically significant levels (Table). Conclusion: Providing interventions that address common diabetes management problem areas may help parents of young children with T1D improve glucose control and quality of life. More work is needed to identify which interventions were associated with the greatest benefit. Disclosure M.S. Lanning: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. S. Lange: Other Relationship; Self; Medtronic MiniMed, Inc. K.A. Driscoll: None. T.S. Hannon: Advisory Panel; Self; Eli Lilly and Company. A.M. Lagges: None. S. Woerner: None. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. Funding National Institutes of Health

2302-PUB: Exenatide Once-Weekly in Diabetes Patients with Stage 2/3 Chronic Kidney Disease—A Pooled 6-Month Analysis

Introduction: Exenatide is primarily eliminated through the kidneys. Safety/efficacy of exenatide once weekly (EQW) were characterized in patients (pts) with CKD stage 2 and 3 (mild and moderate renal impairment). Methods: Pts treated with EQW or placebo/non-GLP-1RA comparator drug (sitagliptin, metformin, pioglitazone, dapagliflozin, insulin) from 8 phase 3 double-blind or open-label 26/28-week studies were pooled and stratified by CKD stage. Studies were performed on a broad range of background drugs. Results: Pts with baseline CKD2 (N=772) or CKD3 (N=182) on EQW differed in some baseline characteristics: age <65 y (79% vs. 56%), mean BMI (31.6 vs. 28.3 kg/m2), and T2D duration (7.6 vs. 9.7 y), while BP (131/79 vs. 133/77) and HbA1c (8.5% vs. 8.3%) were similar. CKD3 EQW pts were mostly Asian (61% vs. 20% CKD2) as 59% of these were from a Japanese study. Efficacy was similar in CKD2 vs. CKD3 pts (Figure). Rates of any AE were slightly higher in CKD3 vs. CKD2 pts (EQW: 81% vs. 72%; comparators: 74% vs. 68%) and for AEs leading to study or treatment discontinuation (EQW: 8% vs. 5%; comparators: 4% vs. 2%) but similar for SAEs (EQW: 3% vs. 3%; comparators: 6% vs. 5%). One pt in each arm had a SAE of acute kidney injury: EQW in CKD3 and comparator in CKD2 group. Conclusion: Pooled results of 8 studies show EQW is well tolerated and efficacious in pts with CKD2 and 3. Changes in HbA1c, body weight, and SBP were similar between the 2 CKD groups. Disclosure C. Guja: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker's Bureau; Self; Merck & Co., Inc., Sanofi. L.J. Suchower: Stock/Shareholder; Self; AstraZeneca, Express Scripts, Merck & Co., Inc. Other Relationship; Self; AstraZeneca. E. Hardy: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. J. Holden: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. C. Sjöström: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. S. Jabbour: Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc. Funding AstraZeneca

993-P: A 12-Week, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Three Dose-Escalation Algorithms of Tirzepatide, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients with Type 2 Diabetes

Initiating incretin hormone receptor agonist therapy at a low dose with gradual dose escalation may improve gastrointestinal (GI) tolerability. This randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of tirzepatide, using 3 different dose escalation algorithms in patients with type 2 diabetes compared with placebo after 12 weeks. The dose-escalations included 1 algorithm to achieve 12 mg top dose by the scheme of 4 mg and 8 mg, each for 4 weeks. The scheme for the first 15 mg top dose group (15 mg-1) was 2.5 mg for 2 weeks, followed by 5 mg for 2 weeks, and then 10 mg for 4 weeks. The scheme for the second 15 mg top dose group (15 mg-2) was 2.5 mg followed by 7.5 mg, each for 4 weeks. A total of 111 subjects were randomized. Mean age was 57.4 years, HbA1c was 8.4%, and BMI was 31.9 kg/m2. At Week 12, LS mean HbA1c% (SE) was 8.6 (0.21), 6.7 (0.19), 6.3 (0.20), 6.6 (0.19) in the placebo, 12 mg, 15 mg-1 and 15 mg-2 groups, respectively. Change from baseline (SE) in HbA1c was greater in tirzepatide groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]). Weight loss was greater in tirzepatide groups compared with placebo (placebo, -0.5 kg [0.86]; 12 mg, -5.3 kg [0.78]; 15 mg-1, -5.5 kg [0.80] and 15 mg-2, -5.7 kg [0.79]). The total incidence of nausea, vomiting and/or diarrhea was 11.5% with placebo, and 48.3%, 57.1% and 46.4% with tirzepatide 12 mg, 15 mg-1, and 15 mg-2 groups, respectively. GI AEs were mild to moderate in intensity. Tirzepatide resulted in clinically meaningful improvements in glycemic control and weight loss. A lower starting dose and a longer dose-escalation period resulted in lower incidence of GI AEs than in a previously published Phase 2 study. Disclosure J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker's Bureau; Self; Merck & Co., Inc., Sanofi. M.A. Nauck: Advisory Panel; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sun Pharma. J. Van: Research Support; Self; Eli Lilly and Company, Genentech, Inc., Melior, Merck & Co., Inc., Mylan, Oramed Pharmaceuticals, Sanofi. C. Benson: Employee; Self; Eli Lilly and Company. R. Bray: Employee; Self; Eli Lilly and Company. Z. Milicevic: Employee; Self; Eli Lilly and Company. A. Haupt: Employee; Self; Lilly Diabetes. Stock/Shareholder; Self; Lilly Diabetes. D.A. Robins: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company

807-P: The Diabetes-Related Emotional and Attitude Distress (DREAD) Scale

Diabetes-related distress (DD) is defined as the emotional and regimen-specific burdens of managing diabetes and affects 38%-45% of patients. It is associated with poorer medical outcomes. Health care providers (HCPs) are on the frontline of diabetes care, but no known research has assessed DD in HCPs. This study developed a measure of DD from the perspective of HCPs. Items (N=69) were based on interviews and focus groups with HCPs who treat people with diabetes and rated on a 5-point Likert scale. The DREAD scale was completed by 135 HCPs. Mean age was 48.9 years, 90.8% female, 79.6% white, and 67.6% married. 49.3% were nurses/nurse practitioners, 16.9% endocrinologists and 16.2% dieticians. 56.3% identified as Certified Diabetes Educators. Evaluation of item distribution characteristics, Cronbach’s α, factor analysis and scree plot analysis indicated a 1-factor solution with 43 items. Cronbach’s α item to total was 0.92. A principal axis factor analysis was conducted; the Kaiser-Meyer-Olkin test supported sampling adequacy (KMO = .80, p < .001). The eigenvalue for the single factor was 9.11. Factor loadings ranged from 0.63 to 0.31. To test convergent validity, the DREAD total score was correlated with the Maslach Burnout Inventory Human Services Survey for Medical Personnel (r = 0.56, p< .001 for emotional exhaustion; r = 0.39, p < .001 for depersonalization; and r = 0.40, p < .001 for personal accomplishment) and the Marlow-Crowne Social Desirability Scale (r = 0.32, p < .001). Test-retest reliability (n = 93) was conducted >2-4 weeks after the first survey: coefficient r = 0.78 (p < .001). Diabetes-related distress is part of the caregiving experience among HCPs who treat diabetes. The DREAD scale demonstrated acceptable levels of validity and reliability in a diverse sample of HCPs. These results suggest that the DREAD scale measures a related, yet distinct, construct from general physician burnout. This measure may be used to evaluate the psychological impact of treating diabetes among HCPs in future samples. Disclosure M. de Groot: Consultant; Self; Eli Lilly and Company, Johnson & Johnson Diabetes Institute. M. Craven: None. E.A. Vrany: None. Z. Simons: None.

1358-P: Early CGM Initiation in New-Onset Type 1 Diabetes Patients

A minority of children and adolescents with T1D meet HbA1c targets as recommended in the ADA guidelines. We have previously shown that in our clinic there is a sharp inflection point in HbA1c trajectory starting between 5 and 6 months of diagnosis with a rise in HbA1c from 7.0 ± 1.5% at 5 months post-diagnosis to 8.0 ± 1.7% at 12 months post-diagnosis. Given the benefits of CGM and improved CGM technology, we started a clinical program to initiate CGM therapy within the first month of diabetes diagnosis aimed at decreasing the rise in HbA1c that occurs over the first year of diagnosis. Since initiating this program in August 2018, 20 youth with T1D were started on the Dexcom G6 CGM system within the first month of diagnosis (average time to start is 8.5 ± 1.3 days post-diagnosis, 3 declined CGM initiation). The average age at T1D onset was 10.1 ± 0.8 years and 50% presented in DKA. Mean HbA1c at diagnosis was 12.0 ± 4.0%. In this cohort, 45% were male, 50% non-Hispanic white, 85% had private insurance, and 85% spoke English as the primary language. A majority of clinic patients used the mobile phone as their CGM receiver (73%) and all of these individuals used the Share feature. A majority of clinic patients (75%) have had at least 2 follow-up visits. By the second follow-up visit (46.1 ± 3.9 days since CGM start), patients were wearing the CGM on average of 94.5 ± 5.9% of the days over the last 2 weeks. Of the 20 individuals initially started on CGM, 3 were no longer using it at the time of their most recent visit. Two of the individuals had issues with insurance coverage and the third had issues with the transmitter. The incidence of hypoglycemia was low (2.2 ± 0.7%) and the patients had a time in range (TIR, glucose 70 - 180 mg/dL) of 71.1 ± 4.6%. In our cohort, patients continued to use CGM with a high percent of wear time. Although we do not have a control or comparison group, our population had a low incidence of hypoglycemia and high percentage of TIR. These data suggest that CGM can be successfully started within 2 weeks of T1D diagnosis with potential benefits on glucose control. Disclosure P. Prahalad: None. D. Scheinker: Advisory Panel; Self; Carta Healthcare. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. D.M. Wilson: Advisory Panel; Self; Tolerion, Inc. Research Support; Self; Beta Bionics, Dexcom, Inc., Medtronic. A. Chmielewski: None. B.P. Conrad: None. E. Geels: None. J. Leverenz: None. K. Peterson: None. D.M. Maahs: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; Abbott, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care.

80-OR: 670G Clinical Experience

Objective: In September 2016, the FDA approved the Medtronic 670G “hybrid” closed-loop system. In “Auto Mode,” this system automatically controls basal insulin delivery based on CGM data, but requires users to enter carbohydrate intake and blood sugar for boluses. Studies show improved time in range associated with the use of Auto Mode. In an effort to track our real-world experience with this first commercial closed-loop device, we followed pediatric and adult patients placed on the 670G. Methods: This was a 1-year prospective observational study, recruiting 5/2017-9/2018, of patients with type 1 diabetes, ≥7 years, starting the 670G system. Results: 84 patients started on the 670G (range 9-61 years), 26 (31%) were <18 years. Figure 1 shows a violin plot of percentage time in Auto Mode at each visit. Upon starting Auto Mode, 96% of participants continued for the first week. For those with available data by 3 months 22% stopped using Auto Mode, at 6 months 30%, at 9 months 43% and by 12 months 50% (70% <18, 40% ≥18). Reasons for discontinuation included CGM issues, too many alarms and lack of control. At 6 months there was a significant correlation between improved A1c and time in Auto Mode (r = 0.4, p = 0.01). Conclusions: While use of closed-loop technology correlates with improved glycemic control, a focus on usability and human factors is necessary to ensure patients stay on treatment. Alarms and sensor calibration are a major patient concern, which next generation technology should alleviate. Disclosure R. Lal: Consultant; Self; Abbott. M. Basina: None. D.M. Maahs: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; Abbott, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. B.P. Conrad: None. J. Leverenz: None. A. Chmielewski: None. K. Peterson: None. D. Wilson: Advisory Panel; Self; Tolerion, Inc. Research Support; Self; Beta Bionics, Dexcom, Inc., Medtronic. Funding National Institute of Diabetes and Digestive and Kidney Diseases (T32DK007217); Seiler Fund

338-OR: Leveraging the Project ECHO Model for Type 1 Diabetes (T1D) in California and Florida: Democratizing Knowledge in Underserved T1D Communities

T1D care for many patients in both the pediatric and adult populations in the U.S. falls on primary care providers (PCPs). Persistently suboptimal outcomes for people with T1D and a lack of access to subspecialty care mandates the development of innovative healthcare delivery models. Using the Project ECHO (Extension for Community Healthcare Outcomes) model, Stanford University and the University of Florida partnered to develop and pilot a “ECHO T1D” teleECHOTM clinic. The goal of the pilot was to demonstrate the feasibility of an ECHO model for T1D and improve the ability of PCPs to manage patients with T1D. Utilizing a “Hub-and-Spoke” model, we recruited and partnered with PCPs at non-specialty diabetes practices across Florida and California and held weekly hour teleECHO sessions consisting of didactic presentations and case reviews. Precision recruitment methods to target clinics in remote and medically underserved regions included: (1) geocoding to identify high-need areas, (2) claims data to identify PCPs treating T1D, (3) survey data from PCPs. The 18-month pilot program is ongoing and enrollment demonstrated extremely high interest amongst PCPs as the pilot program filled beyond capacity. In California, 11 Spoke sites enrolled with 37 clinics serving roughly 900 adult and pediatric patients with T1D who do not receive specialty T1D care. In Florida, 12 Spoke sites enrolled with 67 clinics who serve roughly 1,300 patients with T1D. PCPs and their clinic staff have become local experts in T1D, providing a more informed level of care for the many patients who lack access to endocrinologists. Project ECHO T1D is an innovative healthcare delivery model which appears capable of building capacity for diabetes management education in the medically underserved. Having demonstrated proof-of-concept for ECHO T1D, future efforts will focus on replicating the model and on designing studies to demonstrate improvements in patient level outcomes. Disclosure N. Cuttriss: None. C. Anez-Zabala: None. L.G. Baer: None. A. Bernier: None. M. Basina: None. S.L. Filipp: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute. M.J. Gurka: None. R. Lal: Consultant; Self; Abbott. M.J. Haller: Advisory Panel; Self; Pancreum, SAB Biotherapeutics. D.M. Maahs: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; Abbott, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. H. Hu: None. M. Town: None. E. Sheehan: None. C. Wang: None. K. Yabut: None. A.F. Walker: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust

831-P: Comparing Experience and Satisfaction of Adults with Type 1 Diabetes Participating in Interventions to Reduce Diabetes Distress

Diabetes distress (DD) refers to the emotional burdens that arise from living with a demanding chronic disease like diabetes. T1REDEEM was a randomized-controlled trial comparing two group interventions to reduce DD among adults with type 1 diabetes (T1D): KnowIt (KI), a comprehensive education program, and OnTrack (OT), a program focused on identifying and addressing diabetes-related emotions. Both programs included a group workshop and 4 online group meetings over 3 months. Both programs were equally effective in reducing high DD. The aim of this report is to compare participant satisfaction between programs, and to identify key themes related to participation. 267 of 293 (91.1%) participants completed surveys following the 3-month intervention program to rate satisfaction and experience. T-tests compared group mean scores. A thematic analysis of open-ended survey questions identified overarching experiential themes. Participants in OT were significantly more satisfied than those in KI on multiple measures: they rated OT as more helpful (3.62 (1.1) vs. 3.13 (1.1)), had a more positive group workshop experience (4.22 (.9) vs. 3.68 (1.1)), and reported profiting more from group discussion (3.98 (1.0) vs. 3.58 (1.1)) and group support (3.72 (1.2) vs. 3.19 (1.3), all p<.05). Main themes related to satisfaction and experience differed by group. KI participants reported higher levels of disappointment, especially concerning lack of novelty of program content. OT participants reported greater exploration of new health behaviors, gaining a new perspective on their diabetes, and finding the experience of meeting other adults with T1D to be more assuring. Feeling support from and connection with other group participants was a more common theme in OT than KI. Findings suggest that high DD T1D adults participating in an emotion-focused intervention were more satisfied than those attending an education-focused program to address high DD. Disclosure V. Bowyer: None. L. Fisher: Consultant; Self; Abbott, Eli Lilly and Company. D.M. Hessler: Consultant; Self; Eli Lilly and Company. W. Polonsky: Consultant; Self; Abbott, Bigfoot Biomedical, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Johnson & Johnson Diabetes Institute, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. U. Masharani: Research Support; Self; Clementia Pharmaceuticals. J. Parra: Employee; Self; Behavioral Diabetes Institute. M. Dedhia: None. Funding National Institutes of Health

83-LB: Missed Insulin Bolus Doses Are Associated with Hypoglycemic Fear

When people with diabetes (PwD) are introduced to real-time continuous glucose monitoring (rtCGM), they may still struggle to meet glycemic targets, as highlighted by the T1D Exchange. We assessed missed bolus doses (MBD) in relation to psychosocial factors and rtCGM use in PwD using insulin. This 12-week, single-arm, observational study enrolled PwD who reported A1C ≥8% and taking ≥3 insulin boluses/day. We administered the Adult Low Blood Sugar Survey short form (ALBSS), which evaluates hypoglycemic fear at baseline. Data from a connected insulin pen and CGM (1st 6 weeks blinded, 2nd 6 weeks rtCGM) were used to calculate MBD as defined by an 80 mg/dL glucose increase over ≤2 hours not preceded within 1 hour by an insulin dose. A mixed-effect model for repeated measures tested the association of MBD with ALBSS. Logistic regression assessed the relationship of MBD change (blinded to rtCGM) with ALBSS. Covariates in both models were baseline A1C (≤ or >9%), diabetes type and duration, sex, ethnicity, age, and BMI. Participants (N=68), mean age 48 (range 22-65 years), were 44% female, 18% Hispanic, 59% T1D. The mean ALBSS score was 13.7 (range 0-34). In the blinded period, a mean of 0.94±0.39 MBD/day were calculated, which reduced in rtCGM (0.85±0.37 MBD/day, p=0.05). For blinded and rtCGM, more frequent MBD were independently associated with greater hypoglycemic fear (ALBSS, p=0.04) and higher baseline A1C (p=0.001). Participants with greater hypoglycemic fear were more likely to miss more bolus doses even after switching to rtCGM (odds ratio 1.1, p=0.045). MBD were relatively common in PwD using multiple daily injections who had not achieved adequate glycemic control. Hypoglycemic fear was associated with more MBD, even following the introduction of rtCGM. Therefore, when managing PwD using bolus insulin, clinicians should address fear of hypoglycemia as a potential barrier to appropriate dosing. As shown in this exploratory study, without attention to psychosocial factors, technology may not contribute to improved self-care. Disclosure S.S. Edwards: Employee; Self; Eli Lilly and Company. J. Johnson: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. H. Wolpert: Employee; Self; Eli Lilly and Company. X. He: Employee; Self; Eli Lilly and Company. C.Y. Kao: None. E. Meadows: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J. Poon: Employee; Self; Eli Lilly and Company. D.A. Price: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Johnson & Johnson. W. Polonsky: Consultant; Self; Abbott, Bigfoot Biomedical, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Johnson & Johnson Diabetes Institute, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier.

649-P: Making Glucose the Next Vital Sign: An Educational Intervention to Teach Clinicians How to Improve Inpatient Glycemic Control

Background: Although the American Diabetes Association recommends avoiding hypoglycemia and hyperglycemia in the inpatient setting, there is a lack of comprehensive education offered to clinicians to learn steps to achieve these goals. Objectives: 1) Decrease rates of malglycemia while increasing percent of patients in target BG ranges by 3% on medicine units. 2) Increase prescriber test scores post educational intervention. Methods: We developed interactive role specific educational interventions for physicians, nurse practitioners, physician assistants and registered nurses focusing on strategies to improve glycemic control while preventing adverse events. Education was tailored to each profession with case based face-to-face and on-line educational modules. Glycemic Management pocket cards and dosing guidelines for steroids, enteral feedings and preparation for surgery were distributed as well as "Glucose: The Next Vital Sign" Buttons to create a culture of safety and shared vision. Conclusion: Results to date indicate an improvement in target BG readings. At the end of February 2019, we will calculate overall rates of hypoglycemia and hyperglycemia as well as in target BGs for the 6 month period and compare to the same months one year earlier. We will analyze prescriber and RN test scores, revise educational intervention and offer the program to other service lines. Disclosure J. Seley: Advisory Panel; Self; AstraZeneca, Sanofi US. Consultant; Self; Ascensia Diabetes Care, Johnson & Johnson Diabetes Institute. F.A. Mendelsohn Curanaj: None. T. Yeh: None. M. Yeung: None. J. Falcone: None. Funding Weill Cornell Medicine

998-P: Efficacy and Safety of Semaglutide by Baseline BMI in SUSTAIN 1-5 and 7

Semaglutide, a once-weekly glucagon-like peptide-1 analog for type 2 diabetes, showed significant, clinically meaningful reductions in HbA1c and body weight in the SUSTAIN clinical trial program. Higher body mass index (BMI) at baseline (BL) was associated with greater weight loss during semaglutide therapy. This post hoc analysis evaluated change in HbA1c by BL BMI (<25, 25-<30, 30-<35 and ≥35 kg/m2) for semaglutide vs. comparators by trial for SUSTAIN 1-5 and 7. Safety data were pooled and analyzed stratified by trial. Reductions in mean HbA1c (%) from BL were greater in all BMI subgroups with semaglutide vs. comparators (Figure). There were no significant interactions between treatment and BMI, indicating a consistent effect of semaglutide vs. comparator on change in HbA1c across BMI subgroups. In all treatment arms, adverse events (AEs) occurred in a similar proportion of subjects across BMI subgroups. Gastrointestinal AEs were higher with semaglutide, but decreased with increasing BL BMI, vs. comparators (semaglutide: <25 kg/m2=48.8%, 25-<30 kg/m2=43.0%, 30-<35 kg/m2=39.4% and ≥35 kg/m2 =39.3% vs. comparators range: 21.2-28.9%). Premature treatment discontinuation due to AEs was higher in all BMI subgroups with semaglutide vs. comparators (5.6-15.3% vs. 2.3-8.3%). In conclusion, the efficacy of semaglutide in lowering HbA1c does not appear to be influenced by BL BMI. Semaglutide had an acceptable safety profile in all BMI subgroups. Disclosure A. Viljoen: Advisory Panel; Self; NAPP Pharmaceuticals Limited. Research Support; Self; Eli Lilly and Company, Sanofi-Aventis. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk A/S. J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker's Bureau; Self; Merck & Co., Inc., Sanofi. T. Gondolf: Employee; Spouse/Partner; Chr. Hansen Holding A/S. Employee; Self; Novo Nordisk A/S. O. Hansen: Employee; Self; Novo Nordisk A/S. N. Wijayasinghe: None. J. Unger: Advisory Panel; Self; Abbott Laboratories, Novo Nordisk Inc. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc. Funding Novo Nordisk A/S

204-OR: Advancing Our Understanding of the Relationships between Diabetes Distress and Depressive Symptoms with Biobehavioral Variables in Adolescents with Diabetes

In adolescents with diabetes, associations of depressive symptoms and diabetes distress (DD) with self-care behaviors and glycemic control vary considerably across studies, yet in adults, DD is a stronger predictor than depressive symptoms. This secondary data analysis compared the strength of the association of DD and depressive symptoms on bio-behavioral (HbA1c and average daily blood glucose monitoring checks [BGM]) and perceived global health among adolescents with diabetes. Results: Data from 119 adolescents (75% T1D; diabetes duration of 4.8±4.5 years; HbA1c 8.7 ±2.3%; 62% female; mean age of 15.8±2.1 years; 36% Hispanic, 31% white) screened in clinic were analyzed. Teens completed the 2-item DD Scale (DDS2), the PHQ-9, and PROMIS Pediatric Global Health (PGH). Demographics, HbA1c, and BGM were obtained from medical chart review. Of the 119, 6% had severe depression (PHQ >10) and 22% had moderate to severe DD. DD was significantly correlated with HbA1c and BGM (r=.27, -.32;p=.004, .002; respectively); and both DD and PHQ were significantly correlated with the PGH (r=.43, -.57;ps<.001; respectively). In the regression models that included both DD and PHQ along with demographic and clinical covariates, DD was a significant predictor of HbA1c (ß= .31, partial r=.27, p=.004) and BGM (ß= -.24, partial r=-.23, p=.03). PHQ was not a significant predictor of either, but was a significant predictor of PGH (ß=-.6, partial r=-.47, p<.001). Type of diabetes was not a significant covariate. Conclusion: DD had stronger associations with diabetes biobehavioral variables than depressive symptoms. Considering the outcomes are diabetes-specific, this is not surprising. However, it shows that simply screening for depression may miss an important aspect of the psychosocial health of adolescents with diabetes. Appropriate intervention should follow positive screens of DD to improve adolescents’ diabetes-related variables. Disclosure H. Abujaradeh: None. J.J. Wong: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute.