About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Understands written and spoken Swedish
Previous Gastric Bypass surgery
Diagnosed with gestational diabetes according to our local criteria
Planned follow up at the Specialized Maternity Ward at Skane University Hospital
Disqualifiers
Other kinds of bariatric surgery
Trial design
Parallel
Treatments tested in this trial
FreeStyle Libre 2, continous glucose monitoring
DeviceThe use of FreeStyle Libre 3 sensors and Libre Link app and Glooko app for analysing glucose control in pregnancy
Treatment groups
Trial outcomes
Primary outcomes
Adverse Pregnancy Outcome
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
Secondary outcomes
Glucose values
Mean/median glucose values (mmol/l)
Glucose values
Glucose variability (SD)
Glucose values
% Time in Target (3,5-7,8 mmol/l)
Glucose values
% Time below target
Sponsors and contacts
Click on the lead sponsor to view all of their trials.