US Health and Science University is about to start Two Way Crossover Closed Loop Study MPC vs FMPD
Oregon Health and Science University is recruiting patients for the clinical trial of 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 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.
The researchers plan that February 23, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in December 31, 2022.
Among the criteria that allow participation, the following are indicated:
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female participants 21 to 50 years of age.
- Physically willing and able to perform aerobic exercise (as determined by the investigator after reviewing the participant's activity level).
- Current use of an insulin pump for at least 3 months with stable insulin pump settings for >2 weeks.
- Lives with another person age 18 or older who will be present while participant exercises at home and that can attend the training on using the system.
- Lives within 40 miles of OHSU main campus.
- HbA1c ≤ 10% at screening.
- Total daily insulin requirement is less than 139 units/day.
- Current use of a phone or other device so can be contacted by study staff off-campus.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04771403
