Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy, Type 1 Diabetes (T1D). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Estimating Insulin Sensitivity Fluctuations Across Pregnancies With Type 1 Diabetes
Overview
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.
Primary outcome measures
- Percent Time in Target Range [Time frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum]
Secondary outcome measures (2)
- Percent Time Below Range [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Northwestern Memorial Hospital — Chicago
- UVA Health — Charlottesville
Identifiers
NCT: NCT07351318 · 20254424 · 2-APF-2025-1678-A-N