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NCT05083559 · ClinicalTrials.gov registry record · NA

Two Way Crossover Closed Loop Study R-AP vs MPC

A NA study, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
15
Enrollment target

NCT05083559: Completed NA study, sponsored by Oregon Health and Science University.

NCT05083559 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05083559, a NA study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target

Study Summary

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. The robust R-AP system used in this protocol has been designed to handle a variety of real-world scenarios that are critical to a high-risk patient population. The investigators will test how well the new algorithm handles missed or inaccurate meal announcements. This type of algorithm may significantly improve glucose control over the standard model predictive control (MPC) closed-loop algorithm without these new algorithm features for patients with type 1 diabetes.

Primary Outcome

Incremental AUC of postprandial glucose in the 4 hours following the start of first meal. AUC (mg/dL\*hr) will be calculated using a trapezoidal method, which sums all CGM values taken every 5 minutes in the 4 hour period following the meal above the starting glucose. This yields a maximum of 48 data points for the calculation.

Interventions

  • DEVICE MPC AP algorithm
  • DEVICE Robust R-AP algorithm

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-12-08
Est. Completion 2022-03-03
Phase NA

What the finished NCT05083559 record still lists

NCT05083559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which MPC AP algorithm is the first listed.

NCT05083559 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05083559 about?

NCT05083559 is a clinical study titled "Two Way Crossover Closed Loop Study R-AP vs MPC". An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. The robust R-AP system used in this protocol has been designed to handle a variety of real-world scenarios t...

What is the current status of trial NCT05083559?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2021-12-08. Estimated completion is 2022-03-03.

What interventions are being tested in trial NCT05083559?

The interventions under investigation include: MPC AP algorithm (DEVICE), Robust R-AP algorithm (DEVICE).

Who is sponsoring clinical trial NCT05083559?

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

How this trial's enrollment target compares

Where NCT05083559's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05083559, the US trial registry maintained by the National Library of Medicine. NCT05083559 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.