Clinical trial NCT06957028: CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
Official title: CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: GDM
CGM
Pregnancy
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: DexCom, Inc.
name: Abbott
First posted: 2025-05-04
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks.

* Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar.
* The blinded CGM sensor data will be evaluated to determine if the following criterion is met: 5% to \<25% of values \>140 mg/dL

  • An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days
* Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation.
* Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is \<6.5% (48 mmol/mol)

Eligibility criteria: Inclusion Criteria

1. Maternal age of 18 years and older
2. Singleton pregnancy
3. Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening

   • Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available
4. HbA1c \<6.5% (48 mmol/mol) since onset of pregnancy

   • If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.
5. No prior history of gestational diabetes mellitus (GDM)
6. Able to read English or Spanish

Exclusion Criteria

1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
2. Planned termination of pregnancy or any indications of miscarriage
3. Prior gastric bypass surgery
4. Pregravid diabetes (type 1 or type 2)
5. Unwillingness/inability to wear CGM sensor
6. Unwillingness to attend routine antenatal obstetric appointments
7. Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening

   • Topical and inhaled corticosteroids are acceptable
8. Use of insulin during the pregnancy prior to enrollment
9. Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
10. Deemed unable to participate for medical reasons identified by their physician

Additional Criteria for RCT Eligibility

1. Screening CGM meeting study criteria for hyperglycemia: 5% to \<25% time \>140 mg/dL
2. Randomization by 16 week 6 days of pregnancy
3. No participation in a separate intervention trial.

Primary outcomes:
measure: Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy
timeFrame: Baseline to 45 weeks
Secondary outcomes:
measure: Composite of Neonatal Complications, Death, and Maternal Complications
timeFrame: Baseline to 45 weeks
Other outcomes:
measure: Small for Gestational Age Birth Weight
timeFrame: Baseline to 45 weeks
measure: CGM-Measured Time Less Than 54 mg/dL
timeFrame: Through study completion, an average of 30 months
measure: Severe Hypoglycemia Events
timeFrame: Through study completion, an average of 30 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Decatur
country: United States
facility: Emory University
state: Georgia
city: Saint Louis Park
country: United States
facility: IDC at Park Nicollet
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS
Study officials:
affiliation: University of Pennsylvania
name: Celeste Durnwald, MD
role: STUDY_CHAIR
References: