Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes (EISP)

February 26, 2026 updated by: Jacopo Pavan, University of Virginia

Estimating Insulin Sensitivity Fluctuations Across Pregnancies With Type 1 Diabetes

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The aim of this retrospective observational study is to collect continuous glucose monitor (CGM) and insulin pump data from pregnant individuals with Type 1 Diabetes, from 3 months before conception to 6 months after delivery. This data will be used to estimate how insulin sensitivity (IS) changes across gestation, with the goal of better understanding glucose-insulin dynamics during pregnancy and develop algorithms for adapting insulin administration across gestational ages.

Participants will complete an online survey where they will provide their insulin pump serial number, date of delivery, gestational week at delivery, date of last menstrual cycle (if known), and other optional demographic information. The study team will use this information to retrieve participants' CGM and insulin infusion data from 3 months before conception to 6 months after delivery.

Up to 200 participants will be screened, with the goal of reaching 100 screened participants.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Time in Target Range
Time Frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Time Below Range
Time Frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percentage of time blood glucose was below 70mg/dL as per CGM
Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percent Time Above Range
Time Frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percentage of time blood glucose was above 180 mg/dl as per CGM
Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Northwestern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20254424
  • 2-APF-2025-1678-A-N (Other Grant/Funding Number: BreakthroughT1D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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