NCT06291766

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
116mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2024Dec 2035

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

August 22, 2025

Status Verified

February 1, 2025

Enrollment Period

4.9 years

First QC Date

February 5, 2024

Last Update Submit

August 18, 2025

Conditions

Diabetes, GestationalGastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the PuerperiumPregnancy in DiabeticBlood Glucose Self Monitoring

Outcome Measures

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

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

Secondary Outcomes (11)

  • Glucose values

    Gestational week 28-42

  • Glucose values

    Gestational week 28-42

  • Glucose values

    Gestational week 28-42

  • Glucose values

    Gestational week 28-42

  • Glucose values

    Gestational week 28-42

  • +6 more secondary outcomes

Study Arms (2)

Continous glucose measurement

OTHER

Use of FreeStyle Libre 3, with Libre Link app and Glooko app for measurement and review of glucose measurements.

Device: FreeStyle Libre 2, continous glucose monitoring

Capillary glucose measurement

NO INTERVENTION

Standard care, including capillary glucose measurements and Glooko app for review of glucose measurements.

Interventions

FreeStyle Libre 2, continous glucose monitoringDEVICE

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

Continous glucose measurement

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Understands the use of CGM and is willing to use the system
  • Have signed informed consent

You may not qualify if:

  • Other kinds of bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Skane

Lund, 221 85, Sweden

RECRUITING

Related Publications (1)

  • Moll U, Landin-Olsson M, Nilsson C, Ursing D, Strevens H. Pregnancy outcome in women with gestational diabetes - A longitudinal study of changes in demography and treatment modalities. Acta Obstet Gynecol Scand. 2020 Mar;99(3):333-340. doi: 10.1111/aogs.13758. Epub 2019 Dec 22.

    PMID: 31654523BACKGROUND

MeSH Terms

Conditions

Diabetes, GestationalPregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ulrika Moll, MD, PhD

    Region Skane

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrika Moll, MD, PhD

CONTACT

+46733307170ulrika.moll@skane.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 4, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2035

Last Updated

August 22, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)