NCT05001815

CSII Versus MDI in Pregnant Women With Type 2 Diabetes

Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injection in Pregnant Women With Type 2 Diabetes: A Single-center Open Label Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes
• Pregnancy in Diabetic

Interventions

Type	Name	Description
DEVICE	Continuous subcutaneous insulin infusion (CSII)	The CSII device used in this study has access to mobile phone, however, without CGM enhanced function
DEVICE	Multiple daily insulin injection (MDI)	Patients with indication will receive MDI treatment with at least one basal insulin injection plus 2 to 3 prandial insulin injection.

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-08-01
• Completion: 2023-10-01
• First posted: 2021-08-12
• Last updated: 2021-11-30

Locations

1 site across 1 country: China