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

Area of Science:

• Endocrinology
• Metabolic Diseases
• Artificial Pancreas Technology

Background:

• Type 1 diabetes (T1D) in pregnancy requires careful glucose management to ensure maternal and fetal well-being.
• Traditional insulin therapy and continuous glucose monitoring (CGM) augmented pump therapy present challenges in achieving optimal glycemic control during pregnancy.
• Closed-loop control (CLC) systems offer a potential solution for improved glucose management in pregnant individuals with T1D.

Purpose of the Study:

• To evaluate the feasibility and effectiveness of a pregnancy-specific zone model predictive control (zone-MPC) algorithm for closed-loop insulin delivery.
• To assess glucose control metrics, including time in range, and postprandial glucose levels in pregnant women with T1D using the zone-MPC system.
• To compare glucose control during CLC with a baseline run-in period in a supervised outpatient setting.

Main Methods:

• A multicenter, supervised outpatient study involving pregnant women with T1D (14-32 weeks gestation) using CGM-augmented pump therapy.
• Evaluation of a pregnancy-specific zone-MPC algorithm integrated with the interoperable artificial pancreas system (iAPS) on a smartphone.
• Comparison of CGM data over a 2-day CLC period against a 1-week run-in period, with unrestricted meals and activities.

Main Results:

• The CLC system significantly increased the percentage of time in the target glucose range (63-140 mg/dL) compared to the run-in period (81.5% vs. 64%, P=0.007).
• CLC resulted in significantly less time with glucose levels above 140 mg/dL (16.5% vs. 30.8%, P=0.029) and below 63 mg/dL (2.0% vs. 5.2%, P=0.039).
• Overnight glucose control showed reduced time above 250 mg/dL (0% vs. 3.9%, P=0.030) and a lower glucose standard deviation (23.8 mg/dL vs. 42.8 mg/dL, P=0.007) during CLC.

Conclusions:

• The pregnancy-specific zone-MPC algorithm is feasible for closed-loop insulin delivery in pregnant women with T1D.
• The system demonstrated improved glycemic control, including reduced hyperglycemia and hypoglycemia, compared to standard therapy.
• These findings contribute to the limited data on CLC system use during pregnancy, supporting further research in this area.