CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
The Omnipod 5/Horizon HCL systemdevice
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/NCT04714216
NCT04714216N/ACompleted
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Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study

Emory University·interventional·Posted Jan 19, 2021·Updated Apr 23, 2024

In Brief

A clinical study evaluating The Omnipod 5/Horizon HCL system for Diabetes Mellitus. Completed, enrolled 22 participants across 3 sites.

Detailed Summary

This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited States
CollaboratorsInsulet Corporation, Jaeb Center for Health Research

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 19, 2021
Enrollment StartJun 29, 2021
Primary CompletionAug 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.5 years ago

Interventions

The Omnipod 5/Horizon HCL systemdevice

The Omnipod 5/Horizon HCL system, consists of a disposable insulin infusion pump (or "pod"), a built-in model predictive control (MPC) insulin dosing algorithm, and a remote Personal Diabetes Manager (PDM) interface, that interact with a Dexcom G6 continuous glucose monitor (CGM) to automatically control insulin delivery based upon real-time glucose values. The PDM component also enables remote interaction with the system, including glucose monitoring as well as insulin dosing management and adjustments.