Gestational Diabetes After Gastric Bypass Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

FreeStyle Libre 2, continous glucose monitoring: The use of FreeStyle Libre 3 sensors and Libre Link app and Glooko app for analysing glucose control in pregnancy

Study summary

The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.

The main question it aims to answer is:

How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.

Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups.

Eligibility

Primary outcome measure(s)

• Adverse Pregnancy Outcome — During delivery and postpartum (measured up to 5 days postpartum)
  ANY: Caesarian section (Y/N), instrumental delivery (Y/N), preeclampsia (Y/N), premature birth before week 37 (Y/N), Macrosomia (\>4000g) (Y/N), Large for gestational age infant (Y/N), small for gestational age infant (Y/N), shoulder dystocia (Y/N), neonatal hypoglycemia (Y/N) (\<4 hours after birth: \<1.4 mmol/L; 4 to \<24 hours after birth: \<1.9 mmol/L; 24 to \<48 hours after birth: \<2.8 mmol/L, ≥48 hours after birth: 3.3 mmol/L

Trial sites (1)

More Region Skane trials in Sweden