At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study

Abstract

OBJECTIVE There are no commercially available hybrid closed-loop insulin delivery systems customized to achieve pregnancy-specific glucose targets in the U.S. This study aimed to evaluate the feasibility and performance of at-home use of a zone model predictive controller–based closed-loop insulin delivery system customized for pregnancies complicated by type 1 diabetes (CLC-P). RESEARCH DESIGN AND METHODS Pregnant women with type 1 diabetes using insulin pumps were enrolled in the second or early third trimester. After study sensor wear collecting run-in data on personal pump therapy and 2 days of supervised training, participants used CLC-P targeting 80–110 mg/dL during the day and 80–100 mg/dL overnight running on an unlocked smartphone at home. Meals and activities were unrestricted throughout the trial. The primary outcome was the continuous glucose monitoring percentage of time in the target range 63–140 mg/dL versus run-in. RESULTS Ten participants (HbA1c 5.8 ± 0.6%) used the system from mean gestational age of 23.7 ± 3.5 weeks. Mean percentage time in range increased 14.1 percentage points, equivalent to 3.4 h per day, compared with run-in (run-in: 64.5 ± 16.3% versus CLC-P: 78.6 ± 9.2%; P = 0.002). During CLC-P use, there was significant decrease in both time over 140 mg/dL (P = 0.033) and the hypoglycemic ranges of less than 63 mg/dL and 54 mg/dL (P = 0.037 for both). Nine participants exceeded consensus goals of above 70% time in range during CLC-P use. CONCLUSIONS The results show that the extended use of CLC-P at home until delivery is feasible. Larger, randomized studies are needed to further evaluate system efficacy and pregnancy outcomes.

Effect of artificial pancreas system use on glycaemic control among pregnant women with type 1 diabetes mellitus: A meta‐analysis of randomized controlled trials

“…We excluded inappropriate publication types, animal experiments, and unrelated research topics and then identified six studies on APS use among pregnant women with T1DM for eligibility. Upon full‐text assessment, two non‐RCTs 29,30 were excluded, and a total of four RCTs 25–28 were ultimately included. The PRISMA flow diagram is shown in Figure 1.…”

“…Until now, most studies on APS use in pregnant women with T1DM have been case reports, 12–24 with only a few available randomized controlled trials (RCTs) 25–28 and non‐RCTs that have small sample sizes 29,30 . We conducted the present meta‐analysis of the few RCTs to assess the efficacy of APS use among pregnant women with T1DM.…”

The Benefits Of Continuous Glucose Monitoring In Pregnancy

“…However, only 36% of that study population reached the HbA1c targets of <6.5% in the 1st trimester and 70% reached the target in the 2nd and 3rd trimesters despite the use of CGM. To achieve glycemic targets and lower the risk of diabetes-related complications during pregnancy in patients with type 1 diabetes, other advanced technology, such as automated insulin delivery systems, needs to be combined [ 30 , 31 ]. Ongoing studies such as automated insulin delivery amongst pregnant women with type 1 diabetes (AiDAPT) [ 32 ], and closed-loop insulin delivery in type 1 diabetes pregnancies (CIRCUIT, NCT04902378) are expected to demonstrate the advantages of a closed-loop system in pregnancy.…”