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NCT04771403 · ClinicalTrials.gov registry record · NA

Two Way Crossover Closed Loop Study MPC vs FMPD

A NA study of Type 1 Diabetes, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT04771403 is a NA study of Type 1 Diabetes that has completed, run by Oregon Health and Science University. The registered enrollment target is 25 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04771403, a NA study of Type 1 Diabetes, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

An artificial pancreas (AP) is a control system for automatic insulin delivery. Our group has implemented a fading memory proportional derivative controller (FMPD) for use within an AP control system which has been evaluated in clinical studies. However, the long action of insulin (90 minutes for peak action) makes it challenging to control insulin with a classical proportional derivative system. The study described within this protocol is designed to test the effectiveness of a new model-predictive control (MPC) AP that modulates insulin delivery based on estimated activity level. The potential benefit of this type of AP is that it handles exercise not as a discrete event, but it automatically adjusts insulin delivery based on estimated activity level calculated at every 5 minute cycle. This type of algorithm may significantly improve glucose control over our FMPD AP, which is designed only to detect exercise when activity level goes above a threshold for a specific duration of 45 minutes.

Conditions Studied

Interventions

  • DEVICE FMPD AP algorithm
  • DEVICE MPC AP system
  • DEVICE Dexcom G6 Continuous Glucose Monitoring (CGM) System

Study Locations (1)

Oregon

  • Oregon Health and Science University - Portland

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2021-02-23
Est. Completion 2022-03-10
Phase NA

What the Registry Record Tells You About NCT04771403

The ClinicalTrials.gov registry entry for NCT04771403 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which FMPD AP algorithm is the first listed.

NCT04771403 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT04771403 about?

NCT04771403 is a clinical study titled "Two Way Crossover Closed Loop Study MPC vs FMPD". An artificial pancreas (AP) is a control system for automatic insulin delivery. Our group has implemented a fading memory proportional derivative controller (FMPD) for use within an AP control system which has been evaluated in clinical studies. However, the long action of insulin (90 minutes for pe...

What is the current status of trial NCT04771403?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2021-02-23. Estimated completion is 2022-03-10.

What conditions does trial NCT04771403 study?

This clinical trial studies the following conditions: Type 1 Diabetes.

What interventions are being tested in trial NCT04771403?

The interventions under investigation include: FMPD AP algorithm (DEVICE), MPC AP system (DEVICE), Dexcom G6 Continuous Glucose Monitoring (CGM) System (DEVICE).

Who is sponsoring clinical trial NCT04771403?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04771403 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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