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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: Completed NA study of Type 1 Diabetes, sponsored by Oregon Health and Science University.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across the duration of the 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD).
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
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2022-03-10 |
| Phase | NA |
What the finished NCT04771403 record still lists
NCT04771403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04771403's enrollment target sits among peer trials
25 136th of 198 higher than 59 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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.
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