Citations 2
Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4
Pinsker, Jordan E. , Dassau, Eyal , Deshpande, Sunil , Raghinaru, Dan, Buckingham, Bruce A. , Kudva, Yogish C. , Laffel, Lori M. , Church, Mei Mei , Desrochers, Hannah, Ekhlaspour, Laya , Kaur, Ravinder Jeet , Levister, Camilla, Lum, John W. , Kollman, Craig, Ambler-Osborn, Louise, Freiner, Emily , O’Malley, Grenye , Brooks, Danielle , Ogyaadu, Selassie, Plesser, Mitchell, Simha, Vinaya , Desjardins, Donna, McCrady-Spitzer, Shelly , Nolander, Lisa, Hsu, Liana, Passman, Samantha, Campos, Tiffany, Murphy, Carlos, Patibandla, Nandan, Borgman, Sarah, Arreaza-Rubín, Guillermo , Eggerman, Thomas L., Green, Neal, Belle, Steven H., Castle, Jessica R. , Legault, Laurent , Wysham, Carol , Ekhlaspour, Laya , Lum, John , Doyle, Francis J , Buckingham, Bruce , Levy, Carol J. , Shi, Dawei , Kollman, Craig , Doyle, Francis J. , Isganaitis, Elvira , Beck, Roy W. , Green, Jennifer Greif , Willi, Steven Matthew
Diabetes Technology & Therapeutics | May 12, 2022 | Volume: 24 | Issue: 9 | Pages: 635-642
Background: Automated insulin delivery (AID) systems have proven effective in increasing time-in-range during both clinical trials and real-world use. Further improvements in outcomes for single-hormone (insulin only) AID may be limited by suboptimal insulin delivery settings. Methods: Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive zone model predictive control AID for 13 weeks, then crossed over to the other arm. Each week, the AID insulin delivery settings were sequentially and automatically updated by an adaptation system running on the study phone. Primary outcome was sensor glucose time-in-range 70–180 mg/dL, with noninferiority in percent time below 54 mg/dL as a hierarchical outcome. Results: Thirty-five participants completed the trial (mean age 39 ± 16 years, HbA1c at enrollment 6.9% ± 1.0%). Mean time-in-range 70–180 mg/dL was 66% with SAP versus 69% with AID (mean adjusted difference +2% [95% confidence interval: −1% to +6%], P = 0.22). Median time <70 mg/dL improved from 3.0% with SAP to 1.6% with AID (−1.5% [−2.4% to −0.5%], P = 0.002). The adaptation system decreased initial basal rates by a median of 4% (−8%, 16%) and increased initial carbohydrate ratios by a median of 45% (32%, 59%) after 13 weeks. Conclusions: Automated adaptation of insulin delivery settings with AID use did not significantly improve time-in-range in this very well-controlled population. Additional study and further refinement of the adaptation system are needed, especially in populations with differing degrees of baseline glycemic control, who may show larger benefits from adaptation.
Randomized Controlled Trial of Mobile Closed-Loop Control
Kovatchev, Boris , Anderson, Stacey M. , Raghinaru, Dan, Kudva, Yogish C. , Laffel, Lori M. , Pinsker, Jordan E. , Buckingham, Bruce A. , Doyle, Francis J. , Brown, Sue A. , Church, Mei Mei , Dadlani, Vikash, Dassau, Eyal , Ekhlaspour, Laya , Forlenza, Gregory P. , Isganaitis, Elvira , Lam, David W. , Lum, John W. , Group, iDCL Study, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Ambler-Osborn, Louise, Flint, Emily, Schultz, Alan , Kim, Kenny, Church, Mei Mei, André, Camille , Lam, David W., O’Malley, Grenye , Levister, Camilla, Ogyaadu, Selassie, Simha, Vinaya , McCrady-Spitzer, Shelly , Reid, Corey, Jost, Emily , Berget, Cari , Towers, Lindsey, Buckingham, Bruce, Ekhlaspour, Laya, Hsu, Liana, Loebner, Sarah E., Doyle, Francis J., Campos, Tiffany, Passman, Samantha, Murphy, Carlos, Patibandla, Nandan, Kollman, Craig, Pinsker, Jordan E , Doyle, Francis J , Dassau, Eyal , Ekhlaspour, Laya , Forlenza, Gregory P , Lum, John , Kovatchev, Boris , Buckingham, Bruce , Levy, Carol J. , Wadwa, R Paul , Beck, Roy W. , Group, iDCL Study, Oliveri, Mary Clancy , Church, Mei Mei, Lam, David W., Messer, Laurel H , Buckingham, Bruce, Ekhlaspour, Laya, Doyle, Francis J., Kollman, Craig
Diabetes Care | January 15, 2020 | Volume: 43 | Issue: 3 | Pages: 607-615
OBJECTIVE Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)–measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference −1.7% [95% CI −2.4, −1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference −3.0% [95% CI −6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.