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Multicenter Study
. 2022 Jul;24(7):471-480.
doi: 10.1089/dia.2021.0521. Epub 2022 Apr 26.

Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm

Basak Ozaslan  1   2 , Carol J Levy  3 , Yogish C Kudva  4 , Jordan E Pinsker  2 , Grenye O'Malley  3 , Ravinder Jeet Kaur  4 , Kristin Castorino  2 , Camilla Levister  3 , Mari Charisse Trinidad  4 , Donna Desjardins  4 , Mei Mei Church  2 , Mitchell Plesser  3 , Shelly McCrady-Spitzer  4 , Selassie Ogyaadu  3 , Kristen Nelson  2 , Corey Reid  4 , Sunil Deshpande  1   2 , Walter K Kremers  4 , Francis J Doyle , III  1 , Barak Rosenn  5 , Eyal Dassau  1
Affiliations
Multicenter Study

Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm

Basak Ozaslan et al. Diabetes Technol Ther. 2022 Jul.

Abstract

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).

Keywords: Artificial pancreas; Closed loop control; Glucose control; Outpatient; Pregnancy; Type 1 diabetes.

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Conflict of interest statement

C.J.L. has received research support from Insulet, Abbott Diabetes, Tandem Diabetes and Dexcom paid to her institution, and has received consulting fees from Dexcom. J.E.P. is currently an employee and shareholder of Tandem Diabetes Care, Inc., The work presented in the article was performed as part of his academic appointment at Sansum Diabetes Research Institute and is independent of his employment with Tandem Diabetes Care. G.O. receives research support from Tandem Diabetes, Insulet, Dexcom, and Abbot paid to her institution. K.C. receives research support provided to her institution from Dexcom, Abbott, Medtronic, Novonordisk, and Insulet. S.O. receives research support from Insulet, Dexcom, and Abbot paid to her institution. W.K.K. receives research funding from the NIH, DOD, AstraZeneca, Roche and Biogen all unrelated to this study. F.J.D. reports equity, licensed IP, and is a member of the Scientific Advisory Board of Mode AGC. Y.C.K. reports product support from Roche Diabetes, Dexcom, Tandem Diabetes and consulting fees from Novo Nordisk. E.D. reports receiving grants from JDRF, NIH, and Helmsley Charitable Trust, personal fees from Roche and Eli Lilly, patents on artificial pancreas technology, and product support from Dexcom, Insulet, Tandem, and Roche. E.D. is currently an employee and shareholder of Eli Lilly and Company. The work presented in this article was performed as part of his academic appointment and is independent of his employment with Eli Lilly and Company. No other conflict of interest was reported.

Figures

FIG. 1.
FIG. 1.
(A) Comparison of CGM glucose levels between CLC therapy (solid traces and green area) and participants' standard therapy (dashed traces and yellow area), (B) individual breakdown of time spent in the target range on the y-axis and time spent above the target range is represented by circles, (C) individual breakdown of mean CGM glucose on the y-axis and time spent below the target range is represented by circles. CGM, continuous glucose monitor; CLC, closed-loop control.
FIG. 2.
FIG. 2.
CLC session glucose, meal, and insulin delivery of (A) the participant with highest CGM time in the target 63–140 mg/dL range (100%) and low carbohydrate intake (125 g), and (B) the participant with highest carbohydrate intake (472 g). For both participants, the top figure shows the glucose on the left axis and carbohydrate intake amounts on the right axis; the bottom figure shows the controller decided micro-bolus deliveries on the left axis and the user requested boluses (i.e., meal and additional correction) are presented on the right axis. Note that participant numbers are assigned arbitrarily.
See this image and copyright information in PMC

References

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