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In DUAL IX, a 26-week, phase 3b, treat-to-target, open-label trial, patients with uncontrolled T2D on SGLT2i ± OADs (N=420) were randomized 1:1 to once-daily IDegLira or IGlar U100 (100 units [U]/mL) add-on therapy. IDegLira was superior to IGlar U100 for A1C (1.9 vs. 1.7% reduction), body weight (0.0 vs. 2.0 kg gain) and hypoglycemia rate (58% lower with IDegLira). PROs were measured at baseline and week 26 with the 5-domain Treatment Related Impact Measure-Diabetes (TRIM-D) questionnaire, with higher scores indicating better outcomes. After 26 weeks, improvements were significantly greater with IDegLira vs. IGlar U100 in total TRIM-D, Treatment Burden domain and especially Diabetes Management domain (Table), including 4 of the 5 individual items (estimated treatment ratio [95% confidence interval]): help you control your diabetes: 2.17 [1.47; 3.21], p In conclusion, vs. IGlar U100, IDegLira treatment resulted in better clinical and treatment management outcomes. Disclosure M. Brod: Consultant; Self; Novo Nordisk A/S. L.K. Billings: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S, Dexcom, Inc. R.S. Busch: Speaker's Bureau; Self; AbbVie Inc., AstraZeneca. Research Support; Self; Bayer AG, Intarcia Therapeutics, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Sanofi US. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Amarin Corporation. S. Harris: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Amgen Inc., Lilly/Boehringer Ingelheim, Abbott, Janssen. Consultant; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Lilly/Boehringer Ingelheim, Abbott, Janssen. Research Support; Self; Novo Nordisk A/S, Sanofi, Merck, Abbott, AstraZeneca, Janssen. Other Relationship; Self; CIHR, CDA, The Lawson Foundation. C. Morales Portillo: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. Research Support; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Theracos, Inc., Lexicon Pharmaceuticals, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Sanofi, Eli Lilly and Company, Novo Nordisk A/S. Advisory Panel; Spouse/Partner; Intas Pharmaceuticals Ltd., Pfizer Inc.. Speaker's Bureau; Self; Sanofi, Eli Lilly and Company, Boehringer Ingelheim, Dr. Reddys Laboratories, USV Private Limited, Glenmark. Speaker's Bureau; Spouse/Partner; Boehringer Ingelheim. A. Busk: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. S. Eggert: Employee; Self; Novo Nordisk A/S. N. Halladin: Employee; Self; Novo Nordisk A/S. A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca.

Purpose Responsiveness is defined as the ability of an instrument to accurately detect change when it has occurred and is an essential psychometric property of a patient-reported outcomes (PRO) measure to understand and interpret study findings. This study examined the responsiveness of 2 Treatment Related Impact Measures (TRIMs): The TRIM-Diabetes (TRIM-D) and TRIM-Diabetes Device (TRIM-DD) as well as confirmed their measurement models in a randomized controlled trial (RCT) design. Methods The data were collected in a multi-center, randomized, open-label (2 × 12 week), cross-over study of two prefilled pens in subjects with type 1 or type 2 diabetes, age 18 or older. Internal and external responsiveness were examined. To confirm the measurement model identified in the previous study, the Bentler comparative fit index (CFI) and internal consistency for the RCT sample scores were examined and compared. Results Based on a priori criteria, tests of responsiveness were confirmed with patients having significant improvements over time ranging from 2.7 (Psychological Health) to 11.1 (Treatment Burden) (P