Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06422325
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MPC closed-loop system in insulin only mode — DEVICE
    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.
  • MPC closed-loop system in insulin/pramlintide mode — DEVICE
    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.

Study Details

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.

Key Dates

Start date
Jul 12, 2024
Status verified
Feb 2026
Primary completion
Jan 4, 2025
Completion
Jan 28, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin Only Arm
    Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
  • Experimental: Insulin and Pramlintide Arm
    Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

Primary Outcome Measure

Incremental Area Under the Curve of Postprandial Glucose Following the First Meal [ Time Frame: 6 hours following first meal ]

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239-

Find similar trials in Portland, OR

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Oregon Health and Science University· Portland, OR

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