Case series of a hybrid closed-loop system used in pregnancies in clinical practice.

Abstract

Hybrid closed-loop (HCL) therapy is rarely studied in pregnancy. We present three cases of women with type 1 diabetes who used the Medtronic 670G HCL system for most or all of gestation. The Medtronic 670G system has a manual mode (no automated insulin delivery) and an auto mode (AM, HCL therapy). Women in this case series used AM off-label in gestation. Case 1 started HCL therapy in the second trimester, her sensor glucose time spent <3.9 and >10 mmol/L improved thereafter. Case 1 had average sensor glucose (ASG) levels of 6.4 ± 2.4 mmol/L in the first trimester, 7.0 ± 2.7 mmol/L in the second trimester before HCL use, 7.1 ± 2.1 mmol/L in the second trimester after HCL use, and 6.8 ± 1.9 mmol/L in the third trimester. Case 1 continued AM during operative delivery and post-partum. Cases 2 and 3 used HCL therapy throughout gestation but with inconsistent time in AM. When they increased time in AM their glycaemic indices improved. Case 2 had ASG of 9.5 ± 3.4, 8.6 ± 2.9, and 7.9 ± 2.5 mmol/L in the first through third trimesters, respectively. Case 3 had ASG of 11.1 ± 4.8 and 3.9 to 10 mmol/L in the first and second trimesters, respectively. Case 2 continued HCL therapy post-partum, Case 3 did not. CareLink® Clinical Software only reports the non-pregnant time in range. Nonetheless, this represents the first report of HCL therapy in pregnancy with a system approved by the Food and Drug Administration in non-pregnant populations.