T1D Pregnancy & Me

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Jaeb Center for Health Research
Study ID
NCT06959316
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hybrid closed loop insulin delivery system — DEVICE
    Hybrid closed loop insulin delivery system is a system that uses a continuous glucose monitor (CGM) to send blood glucose values to an insulin pump that automatically provides insulin based on the blood glucose value and anticipated future level.

Study Details

T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.

Key Dates

Start date
Apr 25, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: HCL Use
    Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy
  • Arm: HCL Non-Use
    Pregnant individuals with type 1 diabetes (T1D) not using HCL systems for glycemic management in pregnancy

Primary Outcome Measure

CGM Outcome (BG 63-140 mg/dl) [ Time Frame: Up to 37 weeks gestation ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
[email protected]
205-934-7993
Ashley Battarbee, MD (PRINCIPAL_INVESTIGATOR)
Barbara Davis Center for Diabetes & University of Colorado HealthAuroraColorado80045
Scott Maclean
[email protected]
303-724-8348
Sarit Polsky, MD (PRINCIPAL_INVESTIGATOR)
Lynn Barbour, MD (PRINCIPAL_INVESTIGATOR)
Jaeb Center for Health ResearchTampaFlorida33647
Coordinating Center (Remote Enrollment anywhere in US)
[email protected]
813-975-8690
Indiana UniversityIndianapolisIndiana46202
Sarah Oswalt
[email protected]
317-944-7069
Gula Lala
[email protected]
Christina Scifres, MD (PRINCIPAL_INVESTIGATOR)
Joslin Diabetes CenterBostonMassachusetts02215
[email protected]
617-309-4616
Florence Brown, MD (PRINCIPAL_INVESTIGATOR)
Mass General BrighamBostonMassachusetts02114
[email protected]
617-726-1847
Camille Powe, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Denisa Tamarez
[email protected]
212-241-9089
Carol Levy, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
[email protected]
614-685-3229
Elizabeth Buschur, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
[email protected]
503-494-8748
Amy Valent, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
[email protected]
267-438-2709
Celeste Durnwald, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Alabama at Birmingham· Birmingham, ALBarbara Davis Center for Diabetes & University of Colorado Health· Aurora, COJaeb Center for Health Research· Tampa, FLIndiana University· Indianapolis, INJoslin Diabetes Center· Boston, MAMass General Brigham· Boston, MA

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