Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes

NCT07351318 | Enrolling By Invitation

• 2 other identifiers: 202544242-APF-2025-1678-A-N
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators want to learn how the body's response to insulin changes during pregnancy in people with Type 1 Diabetes. In this study, the investigators will look at information from people who used a Dexcom continuous glucose monitor (CGM) and a Tandem insulin pump while they were pregnant. Participants will fill out an online survey and agree to share their device data. The investigators will use this information to see how insulin sensitivity changes from three months before pregnancy to six months after the baby is born.

Conditions

Pregnancy; Type 1 Diabetes (T1D)

Keywords

pregnancy; type 1 diabetes; diabetes; insulin; insulin sensitivity; gestation

Outcome Measures

Primary Outcomes (1)

• Percent Time in Target Range

  Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM

  Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum

Secondary Outcomes (2)

• Percent Time Below Range

  Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum

• Percent Time Above Range

  Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals with T1D who received pregnancy care within the last 8 years in one of the participating sites: UVA Health (Charlottesville, VA), Northwestern Memorial Hospital (Chicago, IL).

You may qualify if:

• Age \>=18 years old
• Pregnant within the last 8 years
• Diagnosed with type 1 diabetes for at least one year at the time of pregnancy
• Use of a Dexcom CGM system (Dexcom, Inc., CA) and Tandem insulin infusion pump (Tandem Diabetes Care, CA) across gestation, and willing to share data from this pregnancy with study staff.

Sponsors & Collaborators

• Northwestern Memorial Hospital: collaborator
• University of Virginia: lead

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

UVA Health

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)