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NOT YET RECRUITING
NCT07914621
NA

Outpatient Pramlintide Study

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate performance of a non-hybrid, fully automated closed loop system that does not require the person to announce meals to the system, and will utilize the hormone analog pramlintide in combination with insulin to potentially reduce the meal related hyperglycemia and increase the time spent in target range during the daytime.

Official title: An Outpatient Crossover Study to Evaluate Insulin and Pramlintide Versus Insulin Alone Delivery Strategy

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2026-11-02

Completion Date

2027-01-31

Last Updated

2026-11-03

Healthy Volunteers

No

Conditions

Interventions

DEVICE

MPC closed-loop system in insulin only mode

The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer insulin continuously for managing blood sugar.

DEVICE

MPC closed-loop system in Insulin/Pramlintide mode

The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer both insulin and pramlintide continuously for managing blood sugar. The system will deliver pramlintide in a fixed ratio to insulin at 6 mcg of pramlintide delivered for every 1 unit of insulin.