Citations 2
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.
Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial
Brown, Sue A. , Beck, Roy W. , Raghinaru, Dan, Buckingham, Bruce A. , Laffel, Lori M. , Kudva, Yogish C. , Pinsker, Jordan E. , Dassau, Eyal , Ambler-Osborn, Louise, Anderson, Stacey M. , Church, Mei Mei , Ekhlaspour, Laya , Forlenza, Gregory P. , Levister, Camilla, Simha, Vinaya , Breton, Marc D. , Kollman, Craig, Lum, John W. , Kovatchev, Boris , Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Isganaitis, Elvira , Flint, Emily, Kim, Kenny, Roethke, Lindsay, André, Camille , Piper, Molly, Lam, David W. , O’Malley, Grenye , Ogyaadu, Selassie, Lovett, Jessica, Dadlani, Vikash, McCrady-Spitzer, Shelly , Reid, Corey, Slover, Robert H., Jost, Emily , Berget, Cari , Towers, Lindsey, Rossick-Solis, Alex, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen , Keller, Jordan, Salas, Evalina, Passman, Samantha, Campos, Tiffany, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas L., Green, Neal, Reznik, Yves , Janicek, Robert, Gabrielson, Deanna, Belle, Steven H., Castle, Jessica R. , Legault, Laurent , Wysham, Carol , Kudva, Yogish C. , Pinsker, Jordan E , Dassau, Eyal , Doyle, Francis J , Ekhlaspour, Laya , Forlenza, Gregory P , Breton, Marc D , Lum, John , Kovatchev, Boris , Buckingham, Bruce , Beck, Roy W , Wadwa, R Paul , Levy, Carol J. , Doyle, Francis J. , Kollman, Craig , Oliveri, Mary Clancy , Kumari, Kanchan , Alonso, G. Todd , Messer, Laurel H , Renard, Eric , Cobelli, Claudio , Green, Jennifer Greif , Willi, Steven Matthew
Diabetes Care | May 30, 2020 | Volume: 43 | Issue: 8 | Pages: 1822-1828
OBJECTIVE Limited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system. RESEARCH DESIGN AND METHODS After 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14–72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70–180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study. RESULTS All 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = −6.0%; 95% CI −8.4%, −3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI −0.05%, 0.13%; P = 0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference −0.34% [−3.7 mmol/mol]; 95% CI −0.57% [−6.2 mmol/mol], −0.11% [1.2 mmol/mol]; P = 0.0035). CONCLUSIONS Following 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.