144-OR: A Randomized Clinical Trial of Automated Insulin Delivery in Elderly with Type 1 Diabetes
Authors: KUDVA YOGISH C. , HENDERSON ROBERT , KANAPKA LAUREN , WEINSTOCK RUTH S. , RICKELS MICHAEL R. , PRATLEY RICHARD E. , CHAYTOR NAOMI , JANESS KAMILLE , DESJARDINS DONNA , PATTAN VISHWANATH , PELECKIS AMY , CASU ANNA , RAZA RIZVI SHAFAQ , BZDICK SUZAN , WHITAKER KERI J. , JO KAMIMOTO JORGE L. , MILLER KELLEE , BECK ROY 
Published: June 2024

Background: Older adults with T1D are a growing population at risk for severe hypoglycemia. Automated insulin delivery (AID) approaches that can reduce risk have not been sufficiently evaluated in this population.

Methods: We conducted a multicenter, randomized, crossover trial in adults ≥65 years with T1D experiencing hypoglycemia (&gt;1.5% time &lt; 70 mg/dL based on CGM). Participants completed 3 sequential 12-week periods of hybrid-closed (HCL) loop with Tandem Control-IQ technology, predictive low glucose suspend (PLGS) with Tandem Basal-IQ technology, and sensor augmented pump (SAP) insulin delivery. The primary outcome was % time &lt;70 mg/dL measured by Dexcom G6 CGM.

Results: 82 randomized participants were 65-86 years, 45% female, with a mean (±SD) baseline HbA1c 7.2±0.9%. AID was active a median of 97% of the time during the HCL period and 96% during the PLGS period. Mean (±SD) time &lt;70 mg/dL was 2.49±1.78% at baseline, 1.58±0.95% during HCL, 1.67±0.96% during PLGS, and 2.57±1.54% during SAP (p&lt;0.001 for HCL vs. SAP and PLGS vs. SAP; Table). CGM hypoglycemic events and time &lt;54 mg/dL were reduced during HCL and PLGS compared to SAP. HCL improved time in range 70-180 mg/dL (TIR), time &gt;180 mg/dL, time &gt;250 mg/dL, and HbA1c compared to SAP and PLGS (Table).

Conclusions: In older adults with T1D, HCL and PLGS both reduced hypoglycemia compared to SAP. HCL also improved TIR, hyperglycemia, and HbA1c compared to SAP and PLGS.

Disclosure

Y.C. Kudva: Research Support; Dexcom, Inc. Other Relationship; Tandem Diabetes Care, Inc., Medtronic. R. Henderson: None. L. Kanapka: None. R.S. Weinstock: Research Support; Eli Lilly and Company, Tandem Diabetes Care, Inc., Diasome, Amgen Inc., MannKind Corporation, Insulet Corporation, Novo Nordisk. Other Relationship; Dexcom, Inc. M.R. Rickels: Consultant; Vertex Pharmaceuticals Incorporated, Sernova, Corp. Research Support; Dompé. R.E. Pratley: Other Relationship; Bayer AG, Dompé, Endogenex, Inc., Gasherbrum Bio, Inc., Hengrui (USA) Ltd., Intas Pharmaceuticals Ltd., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk, Novo Nordisk, Pfizer Inc., Rivus Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd. Consultant; AbbVie Inc., AstraZeneca. Other Relationship; Bayer HealthCare Pharmaceuticals, Inc., Biomea Fusion, Carmot Therapeutics, Inc., Corcept Therapeutics, Fractyl Health, Inc., Genprex. Consultant; Getz Pharma. Other Relationship; Lilly USA LLC, Sanofi. Consultant; Scholar Rock, Inc. N. Chaytor: None. K. Janess: None. D. Desjardins: None. V. Pattan: Stock/Shareholder; Tandem Diabetes Care, Inc. A. Peleckis: None. A. Casu: None. S. Rizvi: None. S. Bzdick: None. K.J. Whitaker: None. J.L. Jo Kamimoto: None. K. Miller: Consultant; Dexcom, Inc. Research Support; Dexcom, Inc. R. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel.

Funding

Funding provided by NIDDK. Study materials provided by Tandem Diabetes Care and Dexcom.