NCT06628453

Brief Summary

The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are:

  1. 1.Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose?
  2. 2.Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose?
  3. 3.What other factors increase the risk of maternal and infant complications?
  4. 4.Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery
  5. 5.Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis
  6. 6.Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits
  7. 7.Have umbilical cord blood collected at delivery for analysis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
564

participants targeted

Target at P75+ for not_applicable

Timeline
39mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Apr 2025Jul 2029

First Submitted

Initial submission to the registry

September 25, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3.8 years

First QC Date

September 25, 2024

Last Update Submit

June 11, 2025

Conditions

Type 2 Diabetes Mellitus (T2DM)Pregnancy

Keywords

DiabetesPregnancyCGM

Outcome Measures

Primary Outcomes (2)

  • Time in Range (TIR) at 34 weeks gestation

    Percentage of time spent within target range (63-140mg/dL) on Continuous Glucose Monitoring at 34 weeks gestation

    33 to 35 weeks gestation

  • Composite Neonatal Morbidity

    Composite morbidity of the neonate including one or more of preterm birth (delivery less than 37 weeks for any indication), birth trauma (shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to resolve), hypoglycemia (requiring treatment with dextrose gel or IV within 24 hours of birth), hyperbilirubinemia (requiring phototherapy within 72 hours of birth), large-for-gestational-age infant (birthweight greater than the 90th percentile for gestational age), and miscarriage, stillbirth or neonatal death prior to hospital discharge.

    From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Secondary Outcomes (30)

  • Preterm birth

    Delivery

  • Birth trauma

    Delivery

  • Neonatal hypoglycemia

    Delivery to 24 hours of life

  • Hyperbilirubinemia

    Delivery to 72 hours of life

  • Large-for-gestational-age (LGA) neonate

    Delivery

  • +25 more secondary outcomes

Study Arms (2)

Continuous Glucose Monitoring

EXPERIMENTAL

Real-time continuous glucose monitoring

Device: CGM

Self-Monitoring of Blood Glucose

NO INTERVENTION

Self-monitoring of blood glucose (standard of care)

Interventions

CGMDEVICE

Real-time continuous glucose monitoring

Continuous Glucose Monitoring

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater
  • Pregnant with viable fetus at 6 to less than 23 weeks gestation
  • Maternal age 18-50 years old

You may not qualify if:

  • Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions
  • Multiple gestation
  • Major fetal anomaly or two or more minor fetal anomalies
  • Planned delivery outside study consortium
  • Participating in another conflicting interventional study
  • Participation in this trial in a previous pregnancy
  • Patient unable to consent
  • Physician refusal for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of California at San Diego

San Diego, California, 92121, United States

RECRUITING

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97213, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Padgett CE, Ye Y, Champion ML, Fleenor RE, Orfanakos VB, Casey BM, Battarbee AN. Continuous Glucose Monitoring for Management of Type 2 Diabetes and Perinatal Outcomes. Obstet Gynecol. 2024 Nov 1;144(5):677-683. doi: 10.1097/AOG.0000000000005609. Epub 2024 May 23.

    PMID: 38781595BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ashley Battarbee, MD, MSCR

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Battarbee, MD, MSCR

CONTACT

205-975-2361anbattarbee@uabmc.edu

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
Associate Professor

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 8, 2024

Study Start

April 8, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

All data produced in the course of the project will be preserved and shared including: 1. Recruitment rates, reasons for refusal, adherence, loss to follow up 2. Demographics and clinical data 3. Glucose and laboratory values 4. Satisfaction and survey responses

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be made available at the time of publication or the end of the funding period, whichever comes first.
Access Criteria
Deidentified individual patient data will be deposited in the NICHD DASH repository with public access. There is no planned requirement for data use agreements at this time; however, we will monitor the sensitive nature of study data collected at each of the participating sites and revise if needed during the conduct of the trial.

Locations

US(7)