Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial
Grenye O'Malley, Laurel H Messer, Carol J Levy, Jordan E Pinsker, Gregory P Forlenza, Elvira Isganaitis, Yogish C Kudva, Laya Ekhlaspour, Dan Raghinaru, John Lum, Sue A Brown, iDCL Trial Research Group, Boris Kovatchev, Stacey Anderson, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Linda Gondor-Fredrick, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc Breton, Lori Laffel, Louise Ambler-Osborn, Emily Flint, Kenny Kim, Lindsay Roethke, Mei Mei Church, Camille Andre, Molly Piper, David Lam, Camilla Levister, Selassie Ogyaadu, Jessica Lovett, Vinaya Simha, Vikash Dadlani, Shelly McCrady-Spitzer, Corey Reid, Kanchan Kumari, R Paul Wadwa, Gregory P Forlenza, G Todd Alonso, Robert Slover, Emily Jost, Cari Berget, Lindsey Towers, Alex Rossick-Solis, Bruce Buckingham, Tali Jacobson, Marissa Town, Ideen Tabatabai, Jordan Keller, Evalina Salas, John A Paulson, J L Roy Beck, Samantha Passman, Tiffany Campos, D R Craig Kollman, Carlos Murphy, Nandan Patibandla, Sarah Borgman, Guillermo Arreza-Rubin, Thomas Eggerman, Neal Green, Boris Kovatchev, Stacey Anderson, Marc Breton, Lori Laffel, R Paul Wadwa, Bruce Buckingham, Eric Renard, Claudio Cobelli, Yves Reznik, Guillermo Arreza-Rubin, J L Roy Beck, Grenye O'Malley, Laurel H Messer, Carol J Levy, Jordan E Pinsker, Gregory P Forlenza, Elvira Isganaitis, Yogish C Kudva, Laya Ekhlaspour, Dan Raghinaru, John Lum, Sue A Brown, iDCL Trial Research Group, Boris Kovatchev, Stacey Anderson, Emma Emory, Mary Voelmle, Katie Conshafter, Kim Morris, Mary Oliveri, Linda Gondor-Fredrick, Harry Mitchell, Kayla Calvo, Christian Wakeman, Marc Breton, Lori Laffel, Louise Ambler-Osborn, Emily Flint, Kenny Kim, Lindsay Roethke, Mei Mei Church, Camille Andre, Molly Piper, David Lam, Camilla Levister, Selassie Ogyaadu, Jessica Lovett, Vinaya Simha, Vikash Dadlani, Shelly McCrady-Spitzer, Corey Reid, Kanchan Kumari, R Paul Wadwa, Gregory P Forlenza, G Todd Alonso, Robert Slover, Emily Jost, Cari Berget, Lindsey Towers, Alex Rossick-Solis, Bruce Buckingham, Tali Jacobson, Marissa Town, Ideen Tabatabai, Jordan Keller, Evalina Salas, John A Paulson, J L Roy Beck, Samantha Passman, Tiffany Campos, D R Craig Kollman, Carlos Murphy, Nandan Patibandla, Sarah Borgman, Guillermo Arreza-Rubin, Thomas Eggerman, Neal Green, Boris Kovatchev, Stacey Anderson, Marc Breton, Lori Laffel, R Paul Wadwa, Bruce Buckingham, Eric Renard, Claudio Cobelli, Yves Reznik, Guillermo Arreza-Rubin, J L Roy Beck
Abstract
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 HbA1c 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 HbA1c 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.
Keywords: Automated insulin delivery; Closed-loop control; Continuous glucose monitor; Pump parameters; Type 1 diabetes.
Conflict of interest statement
G.O. receives research support from Tandem Diabetes, DexCom, and Abbot. L.H.M. has received speaking/consulting honoraria from Tandem Diabetes and DexCom, Inc., and Capillary Biomedical; her institution receives research grants from Medtronic, Tandem Diabetes, DexCom, Beta Bionics, Abbott, and Insulet Corp. C.J.L. has received research support from Insulet, Abbott Diabetes, Tandem Diabetes, and Dexcom and has received consulting fees from Dexcom. J.E.P. reports receiving grant support, provided to his institution, and consulting fees and speaker fees from Tandem Diabetes Care; grant support, provided to his institution, and advisory board fees from Medtronic; grant support, provided to his institution, and consulting fees from Eli Lilly; grant support and supplies, provided to his institution, from Insulet; and supplies, provided to his institution, from Dexcom. G.P.F. conducts research sponsored by Medtronic, Dexcom, Abbott, Insulet, Tandem, Lilly, and Beta Bionics; he has been a consultant/speaker for Medtronic, Dexcom, Abbott, Insulet, Tandem, Lilly, and Beta Bionics. E.I. reports no disclosures. Y.C.K. receives research support from Tandem Diabetes, Dexcom, and Roche Diabetes. L.E. reports receiving consultancy fees from Tandem Diabetes Care and Ypsomed. D.R. and J.L. report no disclosures. S.A.B. reports nonfinancial support from Tandem Diabetes Care, nonfinancial support from Dexcom, nonfinancial support from Roche Diagnostics, grants from the National Institute of Health, during the conduct of the study; grants and nonfinancial support from Tandem Diabetes Care, nonfinancial support from Dexcom, nonfinancial support from Roche Diagnostics, grants from Insulet, grants from Tolerion, outside the submitted work.
Source: PubMed