دورية أكاديمية
Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial
| العنوان: | Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial |
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| المؤلفون: | O'Malley, Grenye, Messer, Laurel, Levy, Carol, Pinsker, Jordan, Forlenza, Gregory, Isganaitis, Elvira, Kudva, Yogish, Ekhlaspour, Laya, Raghinaru, Dan, Lum, John, Brown, Sue, Kovatchev, Boris, Anderson, Stacey, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Oliveri, Mary, Gondor-Fredrick, Linda, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc, Laffel, Lori, Ambler-Osborn, Louise, Flint, Emily, Kim, Kenny, Roethke, Lindsay, Church, Mei Mei, Andre, Camille, Piper, Molly, Lam, David, Levister, Camilla, Ogyaadu, Selassie, Lovett, Jessica, Simha, Vinaya, Dadlani, Vikash, McCrady-Spitzer, Shelly, Reid, Corey, Kumari, Kanchan, Wadwa, R. Paul, Alonso, G. Todd, Slover, Robert, Jost, Emily, Berget, Cari, Towers, Lindsey, Rossick-Solis, Alex, Buckingham, Bruce, Jacobson, Tali, Town, Marissa, Tabatabai, Ideen, Keller, Jordan, Salas, Evalina, Paulson, John, Beck, J.L. Roy, Passman, Samantha, Campos, Tiffany, Kollman, D.R. Craig, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreza-Rubin, Guillermo, Eggerman, Thomas, Green, Neal, Renard, Eric, Cobelli, Claudio, Reznik, Yves, Beck., J.L. Roy |
| المساهمون: | Icahn School of Medicine at Mount Sinai New York (MSSM), University of Colorado Colorado Springs (UCCS), Harvard Medical School Boston (HMS), Mayo Clinic Rochester, University of Virginia Charlottesville |
| المصدر: | ISSN: 1520-9156. |
| بيانات النشر: | HAL CCSD Mary Ann Liebert |
| سنة النشر: | 2021 |
| المجموعة: | Archive ouverte HAL (Hyper Article en Ligne, CCSD - Centre pour la Communication Scientifique Directe) |
| مصطلحات موضوعية: | Automated insulin delivery, Closed-loop control, Continuous glucose monitor, Pump parameters, Type 1 diabetes, MESH: Blood Glucose Self-Monitoring, MESH: Diabetes Mellitus, Type 1, MESH: Humans, MESH: Hypoglycemic Agents, MESH: Insulin, MESH: Insulin Infusion Systems, [SDV]Life Sciences [q-bio] |
| الوصف: | International audience ; 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/33155824; hal-03654244; https://hal.archives-ouvertes.fr/hal-03654244Test; PUBMED: 33155824; PUBMEDCENTRAL: PMC8114941 |
| DOI: | 10.1089/dia.2020.0472 |
| الإتاحة: | https://doi.org/10.1089/dia.2020.0472Test https://hal.archives-ouvertes.fr/hal-03654244Test |
| رقم الانضمام: | edsbas.E9CC37C9 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1089/dia.2020.0472 |
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