1366-P: Significant and Sustained Improvement in Hypoglycemia-Associated Diabetes Distress in Older Adults with Type 1 Diabetes during One Year: AIDE Trial

Introduction and Objective: Older adults with T1D are prone to develop hypoglycemia resulting in emotional distress and diminished quality of life. Limited data are available regarding hypoglycemia associated diabetes distress (Hypo DD) in this population. Methods: In our multicenter, crossover AIDE trial, we randomized 82 participants to three 12-week periods using hybrid closed loop (HCL), predictive low glucose suspend (PLGS) and sensor augmented pump (SAP) followed by 12 weeks of an extension phase. We assessed DD (T1-DDS) at baseline and end of each period. T1-DDS has an overall score and 7 subscales including Hypo DD. Moderate Hypo DD was classified as score ≥ 2 and severe as ≥ 3. Minimal clinical improvement in Hypo DD (MCID) was defined as 0.2. Results: Baseline data in Figure 1A represent characteristics of mild or no DD vs. moderate or severe Hypo DD (MS-Hypo DD). At baseline, 29 participants had MS-Hypo DD; In this subset, 26 participants completed DDS in extension phase, HbA1c improved from 7.3 ± 0.8 % to 6.7 ± 0.7%, time below range (TBR= 70 mg/dl) improved from 3.2 ± 1.7 % to 1.9 ± 1.3 % and 25 participants (86%) experienced MCID (Fig.1B) as per last DDS. This improvement in Hypo DD (p=0.001, CI=0.9-1.6) and TBR was consistent during all study periods (with different technology modes) till extension phase (Figure 1C and 1D). Conclusion: In the AIDE trial, improvement in MS-Hypo DD was significant and sustained in older adults with T1D. Disclosure S.R. Rizvi: None. R. Henderson: None. A. Kahkoska: Other - Dexcom provides Devices for clinical research in kind or at reduced cost, through my institution; Current; Dexcom, Inc. C. Kurek: None. D. Desjardins: None. N. Chaytor: None. S. Bzdick: None. R. Weinstock: Research Support; Current; Amgen Inc., Eli Lilly and Company, JDRF, Diasome, DEKA Research and Development, Tandem Diabetes Care, Inc. Research Support; Ended; Kowa Research Institute, Inc. Research Support; Current; National Institutes of Health. Research Support; Ended; Insulet Corporation. Research Support; Current; T1D Exchange. R. Pratley: Consultant; Current; Lilly USA LLC. Research Support; Current; National Institutes of Health, Novo Nordisk. Speaker's Bureau; Current; Novo Nordisk. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Current; Novo Nordisk. Consultant; Current; Pfizer Inc., Recordati Rare Diseases Inc., Regeneron Pharmaceuticals Inc., Response Pharmaceuticals, Rona Therapeutics Ltd. Research Support; Current; Sanofi. Consultant; Current; Scholar Rock Inc. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Current; Sun Pharmaceutical Industries Ltd. Consultant; Current; Third Rock Ventures, Verdiva Bio Dev Limited. Research Support; Current; AstraZeneca AB, Boehringer Ingelheim International GmbH, Abbott Laboratories. Consultant; Current; Abbott Laboratories, AbbVie Inc. Other - Consulting; stock options; Current; Altanine, Inc. Consultant; Current; Amgen Inc., AstraZeneca Pharmaceuticals LP. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Current; Bayer AG, Bayer HealthCare Pharmaceuticals Inc. Research Support; Current; Biomea Fusion. Consultant; Current; Boehringer Ingelheim Pharmaceuticals Inc., Carmot Therapeutics, Inc., Corcept Therapeutics. Research Support; Current; Dompé, Eli Lilly and Company. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Current; Eli Lilly and Company. Research Support; Current; Endogenex Inc. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Current; Endogenex Inc. Consultant; Current; F. Hoffmann-La Roche Ltd. Research Support; Current; Fractyl Health, Inc. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Ended; Gasherbrum Bio Inc., Genprex. Consultant; Current; Hanmi Pharm. Co., Ltd. Other - Consulting: Thru 12/31/2023 payment directed to Dr. Pratley's employer; as of 1/1/2024 payment directed to Dr. Pratley personally.; Ended; Intas Pharmaceuticals Ltd. Research Support; Current; Lexicon Pharmaceuticals, Inc. Consultant; Current; Lexicon Pharmaceuticals, Inc. Speaker's Bureau; Current; Lilly USA LLC. M.R. Rickels: Consultant; Ended; Novo Nordisk. Consultant; Current; Vertex Pharmaceuticals Incorporated. Other - Invited speaker; Ended; Bayer AG. Consultant; Current; Sernova, Corp., Sanofi. Research Support; Current; Dompé, vTv Therapeutics, Hua Medicine. Research Support; Ended; Tandem Diabetes Care, Inc. Y. Kudva: Advisory Panel; Current; Tandem Diabetes Care, Inc., Vertex Pharmaceuticals Incorporated, Novo Nordisk. Research Support; Current; Insulet Corporation. Funding 1RO1DK122603-01