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Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
386
Participants Needed
14
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of continuous glucose monitoring (CGM) in women diagnosed with gestational diabetes (GDM), including those with early onset GDM, to better understand its impact on pregnancy outcomes. This open-label randomized controlled trial involves 14 centers in Belgium and compares continuous CGM use to self-monitoring of blood glucose (SMBG) using a glucometer. The study aims to assess a composite of pregnancy outcomes and ends with a postpartum oral glucose tolerance test (OGTT) conducted 6 to 24 weeks after delivery to screen for glucose intolerance. At the start, all women diagnosed with GDM receive education on managing their condition through lifestyle changes and glucose monitoring. Participants are randomly assigned to either continuous real-time CGM with the Freestyle Libre 3 device or to continue routine SMBG using a glucometer, with frequency depending on treatment needs. During pregnancy, all women wear a blinded CGM sensor for specific periods to collect glucose data, with different schedules for early and late GDM diagnosis. After delivery, participants undergo a postpartum OGTT and wear a blinded CGM sensor during the final study visit. Throughout the study, participants will attend multiple visits to monitor glucose levels using CGM devices and glucometers, complete questionnaires on treatment satisfaction, quality of life, dietary intake, physical activity, and symptoms of anxiety and depression. Researchers will measure various glucose-related outcomes during pregnancy and postpartum, including time spent in specific glucose ranges, episodes of low blood sugar, and insulin treatment details. Safety and pregnancy outcomes such as cesarean section rates, neonatal hypoglycemia, and birth weight are also monitored. The total participation duration spans from diagnosis through delivery and postpartum follow-up up to 24 weeks after birth.
CONDITIONS
Brief Title
Continuous Glucose Monitoring for Women With Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of signing the Informed Consent Form
- Singleton pregnancy
- Diagnosed with gestational diabetes before 29.6 weeks of pregnancy
- Able to understand and speak Dutch, French, or English
- Have access to email
You will not qualify if you...
- History of type 1 or type 2 diabetes, or presence of auto-immune antibodies for type 1 diabetes
- Physical or psychological disease likely to interfere with the study
- Use of medication significantly affecting blood sugar, such as high-dose glucocorticoids or diabetes medications like metformin
- Participation in another interventional trial with investigational medicinal product or device
- Multiple pregnancy
- History of bariatric surgery
- Known allergy to adhesives used in continuous glucose monitoring devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 1 week
Participants will use a blinded continuous glucose monitor (CGM) for about 1 week after gestational diabetes diagnosis to establish baseline glucose monitoring.
1 visit to start blinded CGM use
Duration - From diagnosis of gestational diabetes until delivery
Participants are randomized to either continuous use of real-time CGM until delivery or intermittent blinded CGM use at specified pregnancy time points while managing gestational diabetes with lifestyle and glucose monitoring.
CGM use for 2 weeks at 20.0-23.9 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks for intermittent group; continuous CGM use until delivery for intervention group
Duration - 6 to 24 weeks postpartum
After delivery, participants undergo postpartum glucose screening and wear a blinded CGM to monitor glucose levels during the postpartum period.
1 postpartum visit including 75g oral glucose tolerance test and CGM wear
Trial Site Locations
Total: 14 locations
1
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium, 9300
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2
UZA
Antwerp, Belgium
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3
ZNA Antwerpen
Antwerp, Belgium
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4
Imelda Bonheiden
Bonheiden, Belgium, 2820
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5
AZ St Jan Brugge
Bruges, Belgium, 8000
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6
Erasme
Brussels, Belgium
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7
UZ Gent
Ghent, Belgium, 9000
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8
AZ St Lucas Gent
Ghent, Belgium
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9
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8510
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10
UZ Leuven
Leuven, Belgium
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11
CHU de Liège
Liège, Belgium
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12
AZ St Maarten Mechelen
Mechelen, Belgium
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13
AZ Oostende
Ostend, Belgium
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14
Vitaz
Sint-Niklaas, Belgium
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Research Team
K
Katrien Benhalima, 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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