Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:42 AM
Study NCT ID:
NCT07351318
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-02
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Estimating Insulin Sensitivity Fluctuations Across Pregnancies With Type 1 Diabetes
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EISP
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2-APF-2025-1678-A-N | OTHER_GRANT | BreakthroughT1D | View |