Citations 1
Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial
O’Malley, Grenye , Messer, Laurel H. , Pinsker, Jordan E. , Forlenza, Gregory P. , Isganaitis, Elvira , Kudva, Yogish C. , Ekhlaspour, Laya , Raghinaru, Dan, Lum, John W. , Brown, Sue A. , Kovatchev, Boris, Anderson, Stacey M. , Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Laffel, Lori M. , E.I., Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, J.E.P., Church, Mei Mei , André, Camille , Piper, Molly, C.J.L., Lam, David W. , G.O., Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya , Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Wadwa, R. Paul, Alonso, G. Todd, Slover, Robert H., Jost, Emily , L.H.M., Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, L.E., Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Paulson, John A., Beck, Jan-Philipp, Passman, Samantha, Campos, Tiffany, Kollman, D.R. Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas L., Green, Neal, Kovatchev, Boris, Arreza-Rubin, Guillermo, J.E.P., C.J.L., Y.C.K., Wadwa, R. Paul, Reznik, Yves , Arreza-Rubin, Guillermo, Buckingham, Bruce A. , Forlenza, Gregory P , Messer, Laurel H , Buckingham, Bruce , Levy, Carol J. , Pinsker, Jordan E. , Kovatchev, Boris , Kovatchev, Boris, Oliveri, Mary Clancy , E.I., J.E.P., C.J.L., G.O., Wadwa, R Paul , Kumari, Kanchan , Wadwa, R. Paul, L.H.M., L.E., Town, Marissa, Paulson, John A., Patibandla, Nandan, Arreza-Rubin, Guillermo, Kovatchev, Boris, Arreza-Rubin, Guillermo, J.E.P., C.J.L., Y.C.K., Wadwa, R. Paul, Renard, Eric , Cobelli, Claudio , Arreza-Rubin, Guillermo
Diabetes Technology & Therapeutics | November 6, 2020 | Volume: 23 | Issue: 4 | Pages: 245-252
Background: Data are limited on the need for and benefits of pump setting optimization with automated insulin delivery. We examined clinical management of a closed-loop control (CLC) system and its relationship to glycemic outcomes. Materials and Methods: We analyzed personal parameter adjustments in 168 participants in a 6-month multicenter trial of CLC with Control-IQ versus sensor-augmented pump (SAP) therapy. Preset parameters (BR = basal rates, CF = correction factors, CR = carbohydrate ratios) were optimized at randomization, 2 and 13 weeks, for safety issues, participant concerns, or initiation by participants' usual diabetes care team. Time in range (TIR 70–180 mg/dL) was compared in the week before and after parameter changes. Results: In 607 encounters for parameter changes, there were fewer adjustments for CLC than SAP (3.4 vs. 4.1/participant). Adjustments involved BR (CLC 69%, SAP 80%), CR (CLC 68%, SAP 50%), CF (CLC 44%, SAP 41%), and overnight parameters (CLC 62%, SAP 75%). TIR before and after adjustments was 71.2% and 71.3% for CLC and 61.0% and 62.9% for SAP. The highest baseline HbA 1c CLC subgroup had the largest TIR improvement (51.2% vs. 57.7%). When a CR was made more aggressive in the CLC group, postprandial time >180 mg/dL was 43.1% before the change and 36.0% after the change. The median postprandial time <70 mg/dL before making CR less aggressive was 1.8%, and after the change was 0.7%. Conclusions: No difference in TIR was detected with parameter changes overall, but they may have an effect in higher HbA 1c subgroups or following user-directed boluses, suggesting that changes may matter more in suboptimal control or during discrete periods of the day. Clinical Trials Registration number: NCT03563313.