Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pregnancy in Diabetics
- Type 1 Diabetes Mellitus
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
Description
This is an observational study. Data collected will include records of continuous glucose monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG), and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be used to: (1) develop and r...
This is an observational study. Data collected will include records of continuous glucose monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG), and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be used to: (1) develop and refine algorithms for an AP system tailored to the needs of pregnant women with type 1 diabetes, (2) to serve as a comparator group for concurrent AP protocols, (3) describe Dexcom G6 CGM data throughout the pregnancy, and (4) describe insulin changes which occur in pregnancy.
Tracking Information
- NCT #
- NCT03761615
- Collaborators
- Harvard University
- Mayo Clinic
- Icahn School of Medicine at Mount Sinai
- Investigators
- Principal Investigator: Eyal Dassau, PhD Harvard University Principal Investigator: Carol Levy, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Yogish C Kudva, MD Mayo Clinic Principal Investigator: Jordan E Pinsker, MD Sansum Diabetes Research Institute Principal Investigator: Barak Rosenn, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Kristin Castorino, DO Sansum Diabetes Research Institute Principal Investigator: Grenye O'Malley, MD Icahn School of Medicine at Mount Sinai