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Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

NCT03761615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-04-12

Study results available
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Summary

The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose \<63 mg/dL.

Conditions

  • Type 1 Diabetes Mellitus
  • Pregnancy in Diabetics

Interventions

DEVICE

Dexcom G6 CGM

All women in the study will be given Dexcom G6 CGM and a study glucometer.

Sponsors & Collaborators

Principal Investigators

  • Eyal Dassau, PhD · Harvard University

  • Carol Levy, MD · Icahn School of Medicine at Mount Sinai

  • Yogish C Kudva, MD · Mayo Clinic

  • Jordan E Pinsker, MD · Sansum Diabetes Research Institute

  • Barak Rosenn, MD · Icahn School of Medicine at Mount Sinai

  • Kristin Castorino, DO · Sansum Diabetes Research Institute

  • Grenye O'Malley, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2021-06-09
Completion
2021-06-09

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761615 on ClinicalTrials.gov