CSII Versus MDI in Pregnant Women With Type 2 Diabetes

Status Not yet recruiting

Clinical Trial Summary

The primary objective of the study is to determine if continuous subcutaneous insulin infusion (CSII) can improve glycemic control in women with type 2 diabetes (T2D) who are pregnant.

Clinical Trial Description

In women with diabetes, hyperglycemia is associated with increased rates of maternal and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, deterioration of proteinuria and caesarean sections. Infants of mothers with diabetes have increased rates of congenital anomalies, premature delivery, macrosomia, stillbirth and NICU admissions, as well as increased risks of shoulder dystocia, birth injury, hypoglycemia, hyperbilirubinemia, respiratory distress syndrome, asphyxia and death in the neonatal period. Several studies have shown that pregnancy outcomes can be improved along with better glycemic control. Theoretically CSII could achieve better glycemic control due to its flexibility in adjusting both basal rate and bolus insulin infusion. Several randomized controlled studies have compared the ability of CSII with multiple daily injection (MDI) in glycemic control and improvement of pregnancy outcomes in patients with type 1 diabetes (T1D). However, there is a lack of similar studies in women with T2D. We hypothesize that CSII will assist women with T2D achieve better glycemic control during pregnancy compared to MDI users. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05001815
Study type	Interventional
Source	Peking University Third Hospital
Contact	Haining Wang, MD and Ph.D
Phone	+86-18211087263
Email	hainingmail@bjmu.edu.cn
Status	Not yet recruiting
Phase	N/A
Start date	December 15, 2021
Completion date	October 1, 2023

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