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Automated Insulin Delivery in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

NCT04492566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-04

Study results available
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Summary

This clinical trial is a safety and feasibility study to assess the performance of an artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the iAPS platform for pregnant patients with type 1 diabetes (T1D).

Conditions

Interventions

DEVICE

Automated Insulin Delivery

Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session. For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy.

Sponsors & Collaborators

Principal Investigators

  • Eyal Dassau, PhD · Harvard University John A Paulson School of Engineering and Applied Sciences

  • Yogish Kudva, MD · Mayo Clinic

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

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

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

  • Kristin Castorino, DO · Sansum Diabetes Research Institute

  • Jordan Pinsker, MD · Sansum Diabetes Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2022-10-05
Completion
2022-10-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04492566 on ClinicalTrials.gov