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Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes

Estimating Insulin Sensitivity Fluctuations Across Pregnancies With Type 1 Diabetes

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07351318
Acronym
EISP
Enrollment
100
Registered
2026-01-20
Start date
2026-02-01
Completion date
2027-03-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Type 1 Diabetes (T1D)

Keywords

pregnancy, type 1 diabetes, diabetes, insulin, insulin sensitivity, gestation

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.

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.

Interventions

None listed

Sponsors

University of Virginia
Lead SponsorOTHER
Northwestern Memorial Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent Time in Target RangeAssessed every 2 weeks from 4 weeks pre-conception to 6 months post partumPercentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM

Secondary

MeasureTime frameDescription
Percent Time Below RangeAssessed every 2 weeks from 4 weeks pre-conception to 6 months post partumPercentage of time blood glucose was below 70mg/dL as per CGM
Percent Time Above RangeAssessed every 2 weeks from 4 weeks pre-conception to 6 months post partumPercentage of time blood glucose was above 180 mg/dl as per CGM

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026