Gestational Diabetes After Gastric Bypass Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorRegion Skane

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • FreeStyle Libre 2, continous glucose monitoring

    Device

    The use of FreeStyle Libre 3 sensors and Libre Link app and Glooko app for analysing glucose control in pregnancy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Continous glucose measurementOther 1 intervention
Group B: Capillary glucose measurementNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
During delivery and postpartum (measured up to 5 days postpartum)

Secondary outcomes

1

Glucose values

Mean/median glucose values (mmol/l)

Time frame
Gestational week 28-42
2

Glucose values

Glucose variability (SD)

Time frame
Gestational week 28-42
3

Glucose values

% Time in Target (3,5-7,8 mmol/l)

Time frame
Gestational week 28-42
4

Glucose values

% Time below target

Time frame
Gestational week 28-42

Other outcomes

Sponsors and contacts

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