Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Pregnancy
  • Type 1 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age 18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour closed-loop (CL) session in a sup...

The system will be evaluated on up to 21 pregnant adult subjects with type 1 diabetes age 18-45 years old at three clinical sites (Sansum Diabetes Research Institute, Mayo Clinic Rochester MN and Mt Sinai Hospital, New York City). Subjects will complete a 48-60 hour closed-loop (CL) session in a supervised outpatient environment with medical staff present. During the session, subjects will bolus for all meals and snacks, and will perform their usual daily activities while being accompanied by study medical staff.

Tracking Information

NCT #
NCT04492566
Collaborators
  • Mayo Clinic
  • Harvard University
  • Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Eyal Dassau, PhD Harvard University John A Paulson School of Engineering and Applied Sciences Principal Investigator: Yogish Kudva, MD Mayo Clinic Principal Investigator: Carol Levy, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Barak Rosenn, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Grenye O'Malley, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Kristin Castorino, DO Sansum Diabetes Research Institute Principal Investigator: Jordan Pinsker, MD Sansum Diabetes Research Institute
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