CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJaeb Center for Health Research
About this trial
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are:
(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
Eligibility criteria
Qualifiers
Maternal age of 18 years and older
Singleton pregnancy
Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening
HbA1c <6.5% (48 mmol/mol) since onset of pregnancy
Disqualifiers
Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
Planned termination of pregnancy or any indications of miscarriage
Prior gastric bypass surgery
Pregravid diabetes (type 1 or type 2)
Trial design
Treatments tested in this trial
- Diabetes Treatment
- Usual Care Group
Treatment groups
6,000 Participants
are divided into 3 treatment groupsLocations
10United Kingdom
Leeds Teaching Hospitals NHS Trust LeedsLeeds, United Kingdom
Norfolk and Norwich University Hospitals NHS NorwichNorwich, United Kingdom
United States
Alabama
University of Alabama at Birmingham35173, Birmingham United States
Florida
University of Miami33016, Miami United States
Sponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
DexCom, Inc.
Collaborator
Abbott
Collaborator
Source ClinicalTrials.gov