TY - JOUR
T1 - Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm
AU - Ozaslan, Basak
AU - Levy, Carol J.
AU - Kudva, Yogish C.
AU - Pinsker, Jordan E.
AU - O'malley, Grenye
AU - Kaur, Ravinder Jeet
AU - Castorino, Kristin
AU - Levister, Camilla
AU - Trinidad, Mari Charisse
AU - Desjardins, Donna
AU - Church, Mei Mei
AU - Plesser, Mitchell
AU - Mccrady-Spitzer, Shelly
AU - Ogyaadu, Selassie
AU - Nelson, Kristen
AU - Reid, Corey
AU - Deshpande, Sunil
AU - Kremers, Walter K.
AU - Doyle, Francis J.
AU - Rosenn, Barak
AU - Dassau, Eyal
N1 - Funding Information:
Financial support for this study was provided by the National Institutes of Health (R01DK120358). Product support was provided by Dexcom, Inc. (AP-2020-014). REDCap data management was supported by the Research Computing Facility grant (UL1TR002377).
Funding Information:
The work of the LOIS-P Diabetes and Pregnancy Consortium is dedicated to the memory of Dr. Lois Jovanovi≤c, a pioneer in the field of diabetes and pregnancy, a tireless advocate for her patients, and a mentor to many of the coauthors. Statistical support was provided by Byron Smith, Mayo Clinic, and data science specialist Steven Worthington, at the Institute for Quantitative Social Science, Harvard University. The authors thank Clara Bakus for her help during the supervised CLC sessions at Sansum Diabetes Research Institution.
Publisher Copyright:
© 2022, Mary Ann Liebert, Inc., publishers 2022.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - 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).
AB - 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).
KW - Artificial pancreas
KW - Closed loop control
KW - Glucose control
KW - Outpatient
KW - Pregnancy
KW - Type 1 diabetes
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U2 - 10.1089/dia.2021.0521
DO - 10.1089/dia.2021.0521
M3 - Article
C2 - 35230138
AN - SCOPUS:85133663990
SN - 1520-9156
VL - 24
SP - 471
EP - 480
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
IS - 7
ER -