CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Automated Insulin Deliverydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04492566
NCT04492566N/ACompleted
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Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

Sansum Diabetes Research Institute·interventional·Posted Jul 30, 2020·Updated Aug 4, 2023

In Brief

A clinical study evaluating Automated Insulin Delivery for Type 1 Diabetes and Pregnancy. Completed, enrolled 10 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Pregnancy
CountriesUnited States
CollaboratorsMayo Clinic, Harvard University, Icahn School of Medicine at Mount Sinai

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 30, 2020
Enrollment StartJul 27, 2020
Primary CompletionOct 5, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.9 years ago

Interventions

Automated Insulin Deliverydevice

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.