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.
Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm
Özaslan, Başak , Kudva, Yogish C. , Pinsker, Jordan E. , O’Malley, Grenye , Kaur, Ravinder Jeet , Castorino, Kristin , Levister, Camilla, Trinidad, Mari Charisse, Desjardins, Donna, Church, Mei Mei , Plesser, Mitchell, McCrady-Spitzer, Shelly , Ogyaadu, Selassie, Nelson, Kristen L., Reid, Corey, Kremers, Walter K. , Rosenn, Barak, Dassau, Eyal , Kudva, Yogish C. , Doyle, Francis J , Dassau, Eyal , Kremers, Walter K , Levy, Carol J. , Nelson, Kristen, Deshpande, Sunil , Doyle, Francis J.
Diabetes Technology & Therapeutics | March 1, 2022 | Volume: 24 | Issue: 7 | Pages: 471-480
Objective: Evaluating the feasibility of closed-loop insulin delivery with a zone model predictive control (zone-MPC) algorithm designed for pregnancy complicated by type 1 diabetes (T1D). Research Design and Methods: Pregnant women with T1D from 14 to 32 weeks gestation already using continuous glucose monitor (CGM) augmented pump therapy were enrolled in a 2-day multicenter supervised outpatient study evaluating pregnancy-specific zone-MPC based closed-loop control (CLC) with the interoperable artificial pancreas system (iAPS) running on an unlocked smartphone. Meals and activities were unrestricted. The primary outcome was the CGM percentage of time between 63 and 140 mg/dL compared with participants' 1-week run-in period. Early (2-h) postprandial glucose control was also evaluated. Results: Eleven participants completed the study (age: 30.6 ± 4.1 years; gestational age: 20.7 ± 3.5 weeks; weight: 76.5 ± 15.3 kg; hemoglobin A1c: 5.6% ± 0.5% at enrollment). No serious adverse events occurred. Compared with the 1-week run-in, there was an increased percentage of time in 63–140 mg/dL during supervised CLC (CLC: 81.5%, run-in: 64%, P = 0.007) with less time >140 mg/dL (CLC: 16.5%, run-in: 30.8%, P = 0.029) and time <63 mg/dL (CLC: 2.0%, run-in:5.2%, P = 0.039). There was also less time <54 mg/dL (CLC: 0.7%, run-in:1.6%, P = 0.030) and >180 mg/dL (CLC: 4.9%, run-in: 13.1%, P = 0.032). Overnight glucose control was comparable, except for less time >250 mg/dL (CLC: 0%, run-in:3.9%, P = 0.030) and lower glucose standard deviation (CLC: 23.8 mg/dL, run-in:42.8 mg/dL, P = 0.007) during CLC. Conclusion: In this pilot study, use of the pregnancy-specific zone-MPC was feasible in pregnant women with T1D. Although the duration of our study was short and the number of participants was small, our findings add to the limited data available on the use of CLC systems during pregnancy (NCT04492566).