Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 8:09 PM
Study NCT ID:
NCT04771403
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Two Way Crossover Closed Loop Study MPC vs FMPD
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
A Randomized, Two-way, Cross-over Study to Assess the Efficacy of an MPC Exercise-enabled Closed-loop System vs FMPD Exercise-enabled Closed-loop System
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Participants will undergo two approximately 76 hour studies. During each of these intervention visits, participants will wear an Omnipod to deliver insulin and a Dexcom G6 CGM to measure glucose. The CGM system will provide sensed glucose data every 5 minutes. Sensed glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 transmitter to the Samsung master controller every five minutes. The smart phone will wirelessly communicate via BTLE to an Omnipod through an Omnipod PDM. During one of the studies, glucose will be controlled using the MPC AP. During another study, glucose will be controlled using the FMPD AP. The AP system will receive activity data through a Polar M600 watch worn by the participant.
Participants will arrive at the clinic at approximately 7am for the inpatient visits. Participants will eat breakfast, lunch and dinner in the clinic. Participants will perform activities of daily living and exercise using an aerobic exercise video. Participants will discharge at 7pm to go home for the remainder of the study visit and perform one exercise video session at home. Participants will return to OHSU on Day 4 for removal of all devices. The exception to this is for the first 8 participants using the MPC AP. These participants will stay at the research clinic during the day and go home to sleep each night (7pm-7am).
Participants will arrive at the clinic at approximately 7am for the inpatient visits. Participants will eat breakfast, lunch and dinner in the clinic. Participants will perform activities of daily living and exercise using an aerobic exercise video. Participants will discharge at 7pm to go home for the remainder of the study visit and perform one exercise video session at home. Participants will return to OHSU on Day 4 for removal of all devices. The exception to this is for the first 8 participants using the MPC AP. These participants will stay at the research clinic during the day and go home to sleep each night (7pm-7am).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: