Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06291766

The Impact of Continuous Glucose Monitoring on Pregnancy Outcome in Women With Gestational Diabetes and a History of Gastric Bypass Surgery

Led by Region Skane · Updated on 2025-08-22

120

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating gestational diabetes in women who have previously undergone gastric bypass surgery. The study aims to understand how continuous glucose monitoring affects treatment and pregnancy outcomes compared to regular capillary glucose measurements during the last trimester. This research focuses on glucose variability and its impact on pregnancy complications such as large for gestational age infants and small for gestational age infants, which are concerns in this group. Participants will be randomly assigned to one of two groups: one using continuous glucose monitoring with the FreeStyle Libre 3 device and associated apps, and the other receiving standard care with 7-point capillary glucose measurements. Both groups will receive standard medical care, including visits to a specialized maternity care unit and weekly follow-ups with a diabetologist. Continuous glucose monitoring allows for detailed tracking of glucose fluctuations, including time in target range and episodes of high or low glucose. Throughout the study, participants will have regular glucose assessments from gestational weeks 28 to 42, with monitoring of pharmacological treatments and pregnancy outcomes such as birthweight and week of delivery. The main outcome is adverse pregnancy events measured up to five days postpartum. This study also evaluates how glucose measurements relate to treatment approaches and pregnancy health in women with gestational diabetes after gastric bypass surgery.

CONDITIONS

Brief Title

Gestational Diabetes After Gastric Bypass Surgery

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Understands written and spoken Swedish
  • Previous gastric bypass surgery
  • Diagnosed with gestational diabetes according to local criteria
  • Planned follow-up at the Specialized Maternity Ward at Skane University Hospital
  • Understands and is willing to use continuous glucose monitoring
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Other kinds of bariatric surgery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From gestational week 28 to delivery (up to approximately 14 weeks)

Participants receive either continuous glucose monitoring using FreeStyle Libre 3 or standard care with 7-point capillary glucose measurement during the last trimester of pregnancy, alongside standard medical care including weekly follow-up visits by the diabetologist.

Weekly visits (in-person) for follow-up during treatment

Follow-up

Duration - From delivery up to 5 days postpartum

Participants are monitored for pregnancy outcomes including delivery and up to 5 days postpartum to assess the effects of glucose monitoring on pregnancy and infant health.

Approximately 1 to 2 visits around delivery and postpartum

Trial Site Locations

Total: 1 location

1

Region Skane

Lund, Sweden, 221 85

Actively Recruiting

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Research Team

U

Ulrika Moll, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Pregnancy outcome in women with gestational diabetes - A longitudinal study of changes in demography and treatment modalities.

Ulrika Moll, Mona Landin-Olsson, Charlotta Nilsson...

https://pubmed.ncbi.nlm.nih.gov/31654523