Closed Loop Context Aware AID

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06676657
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • iPancreas automated insulin delivery system — 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 MPC has a new feature called hyperglycemia pattern detection and dosing algorithm that will analyze problem patterns associated with high blood sugar and automatically calculate and deliver a correction dose.

Study Details

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a high blood sugar detection and dosing algorithm for use within an AP control system. If a high blood sugar pattern is detected, correction insulin will be calculated and delivered. The investigators will test how well the new algorithm manages glucose compared to the AP control system without high blood sugar detection and dosing. This type of algorithm may improve glucose control for high risk patient populations.

Key Dates

Start date
Nov 22, 2024
Status verified
Apr 2025
Primary completion
Jul 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iPancreas automated insulin delivery system
    Participants will use the iPancreas automated insulin delivery system for 4 weeks at home. After 3 weeks of collecting high blood sugar pattern data, the high blood sugar pattern detection and dosing feature will be turned on.

Primary Outcome Measure

Percent of time with sensor glucose less than 70 mg/dl [ Time Frame: entire 4 week study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239
Leah Wilson, MD
[email protected]
503-494-3273
Deborah Branigan
[email protected]
503-418-9070
Peter Jacobs, PhD (PRINCIPAL_INVESTIGATOR)

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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