RESCUE INSULIN INITIATION AFTER NON-INSULIN GLUCOSE-LOWERING THERAPY IN PREGNANCY: A RETROSPECTIVE COHORT STUDY IN CHINA
Author(s)
Linfeng Jiang, MSc1, Nan Peng, PhD2, ruolan wei, Msc1, guoxian Lu, Msc1, Dongning Yao, Ph.D.1.
1School of Pharmacy, Nanjing Medical University, Nanjing, China, 2School of Pharmaceutical Science and Technology,Tianjin University, Tianjin, China.
1School of Pharmacy, Nanjing Medical University, Nanjing, China, 2School of Pharmaceutical Science and Technology,Tianjin University, Tianjin, China.
OBJECTIVES: Hyperglycemia in pregnancy (HIP) is associated with adverse maternal and neonatal outcomes. Evidence on real-world patterns of rescue insulin initiation after non-insulin glucose-lowering therapy remains limited. This study aimed to evaluate the incidence and predictors of rescue insulin initiation among Chinese women with HIP.
METHODS: A retrospective cohort study was conducted using electronic medical records from a provincial healthcare database in eastern China. Women diagnosed with HIP between January 2018 and October 2025 who initiated non-insulin glucose-lowering therapy during pregnancy were included. Participants were categorized into four groups: biguanide monotherapy, novel glucose-lowering agent monotherapy, other non-insulin monotherapy, and combination therapy. The primary outcome was rescuing insulin initiation, defined as addition of or switch to insulin therapy during pregnancy. Kaplan-Meier analysis with log-rank tests (reference: biguanide group) compared cumulative incidence. Cox proportional hazards models identified associated factors.
RESULTS: A total of 634 women were included, including 126 (19.9%) with pregestational diabetes. Rescue insulin was initiated in 20.5% of the biguanide group, 50.0% of the novel agent group, 36.4% of the other monotherapy group, and 75.9% of the combination therapy group. Kaplan-Meier analysis showed significantly higher cumulative incidence in the novel agent and combination therapy groups versus biguanide (P<0.05 for both). In multivariable analysis, higher baseline HbA1c (HR=1.33, 95% CI: 1.18-1.51) and pregestational diabetes (HR=1.97, 95% CI: 1.30-2.99) were associated with increased risk, whereas later gestational age (HR=0.98, 95% CI: 0.96-1.00), employment (HR=0.68, 95% CI: 0.48-0.96), and polycystic ovary syndrome (HR=0.43, 95% CI: 0.23-0.82) were protective (P<0.05 for all).
CONCLUSIONS: Novel glucose-lowering agents and combination therapy were associated with higher rates of rescue insulin initiation compared with biguanide monotherapy. Higher baseline HbA1c and pregestational diabetes were significant predictors of rescue insulin use. Early identification of high-risk patients may support individualized glycemic management during pregnancy.
METHODS: A retrospective cohort study was conducted using electronic medical records from a provincial healthcare database in eastern China. Women diagnosed with HIP between January 2018 and October 2025 who initiated non-insulin glucose-lowering therapy during pregnancy were included. Participants were categorized into four groups: biguanide monotherapy, novel glucose-lowering agent monotherapy, other non-insulin monotherapy, and combination therapy. The primary outcome was rescuing insulin initiation, defined as addition of or switch to insulin therapy during pregnancy. Kaplan-Meier analysis with log-rank tests (reference: biguanide group) compared cumulative incidence. Cox proportional hazards models identified associated factors.
RESULTS: A total of 634 women were included, including 126 (19.9%) with pregestational diabetes. Rescue insulin was initiated in 20.5% of the biguanide group, 50.0% of the novel agent group, 36.4% of the other monotherapy group, and 75.9% of the combination therapy group. Kaplan-Meier analysis showed significantly higher cumulative incidence in the novel agent and combination therapy groups versus biguanide (P<0.05 for both). In multivariable analysis, higher baseline HbA1c (HR=1.33, 95% CI: 1.18-1.51) and pregestational diabetes (HR=1.97, 95% CI: 1.30-2.99) were associated with increased risk, whereas later gestational age (HR=0.98, 95% CI: 0.96-1.00), employment (HR=0.68, 95% CI: 0.48-0.96), and polycystic ovary syndrome (HR=0.43, 95% CI: 0.23-0.82) were protective (P<0.05 for all).
CONCLUSIONS: Novel glucose-lowering agents and combination therapy were associated with higher rates of rescue insulin initiation compared with biguanide monotherapy. Higher baseline HbA1c and pregestational diabetes were significant predictors of rescue insulin use. Early identification of high-risk patients may support individualized glycemic management during pregnancy.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO145
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)