Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05981547 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Patterns and Glycaemic Endpoints for Diagnosing Gestational Diabetes

Study acronym: PAGED-GDM
StatusCompleted
PhaseNot specified
Started2023-11-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-18
notable
Trial completed
Final enrollment: 180 participants (planned 400)
Primary completion confirmed: May 2026 (last estimated June 2026)
2025-12-16
notable
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-09-30→2026-06-21
Completion date2025-11-30→2026-06-21
Study sitesdetails revised at 1 of 1 site
2025-07-14
minor
Study Status, Oversight v6
Primary completion date2025-05-31→2025-09-30
2025-05-27
minor
Study Status v5
Primary completion date2024-11→2025-05-31
Completion date2024-11→2025-11-30
2024-07-01
minor
Study Status v4
Primary completion date2024-05→2024-11
Completion date2024-08→2024-11
Show 3 earlier versions
2024-04-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-11-22
Study sites0→1
2023-11-15
minor
Study Status v2
Start date2023-08→2023-11
2023-08-17
minor
Study Status, Eligibility, Contacts/Locations v1
Re-verified, no change to tracked fields
2023-07-31
minor
Original filing
Gestational diabetes (GDM) develops during pregnancy and is becoming increasingly common. The condition is associated with adverse outcomes for mother and baby during both the pregnancy and delivery period. This study compares glucose variability (recorded by a continuous glucose monitoring (CGM) sensor) in pregnant women who have been diagnosed with GDM with pregnant woman who do not have the diagnosis but are at high risk. The sensors will be applied to 400 participants around the time of their standard test for GDM, with a randomly selected 60 of these patients forming a sub-group later in the study to assess for progression of high blood glucose. At present, a positive oral glucose tolerance test (OGTT) is used to confirm the diagnosis of GDM but the test can be unreliable leading to potential diagnostic error. CGM devices are used extensively in the management of Type 1 diabetes and GDM, and have also shown potential to be used in the diagnosis of Type 2 diabetes. If this study can demonstrate similar trends in glucose variability between OGTT positive patients and those who are OGTT negative but are at high risk for the condition, then further research into the utility of CGM as a diagnostic alternative or supplement to the OGTT would be indicated. The investigators will recruit 400 patients at high risk for GDM, give them a blinded CGM device, and compare the CGM glucose data with their OGTT result, their initial risk factors for GDM, their pregnancy outcome and their need for treatment. The investigators will use the data to test our hypothesis that a positive OGTT result does not predict hyperglycaemia in pregnancy.
Trial Details
NCT Number NCT05981547
Lead Sponsor Portsmouth Hospitals NHS Trust
Collaborators: Abbott
Conditions Gestational Diabetes
Enrollment 180 participants
Start Date 2023-11-22
Primary Completion 2026-05-08 (estimated)
Study Completion 2026-05-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-17