Two Way Crossover Closed Loop MPC vs Control IQ

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05799781
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MPC closed-loop 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.
  • t:slim X2 pump with Dexcom G6 CGM and Control IQ — DEVICE
    The t:slim pump is a hybrid closed-loop system available to consumers for automated insulin delivery. Control IQ technology automatically adjusts insulin levels based on continuous glucose monitoring (CGM) readings from Dexcom G6.

Study Details

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. If a meal is detected that was not reported by the user, the system shall calculate the amount of meal insulin that will be dosed and deliver that insulin. The investigators will test how well the new algorithm manages glucose compared to the participant's usual care including the tslim X2 pump with Control IQ enabled. This type of algorithm may improve glucose control for high risk patient populations.

Key Dates

Start date
Mar 13, 2023
Status verified
Feb 2026
Primary completion
Dec 27, 2024
Completion
Jan 28, 2025

Study Design

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

Arms

  • Experimental: MPC Arm
    Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
  • Active Comparator: Control IQ arm
    Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.

Primary Outcome Measure

Percent of Time With Sensed Glucose Between 70-180 mg/dl [ Time Frame: 7 days in each treatment arm ]

Locations (2)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239-
University of WashingtonSeattleWashington98105-

Find similar trials in Portland, OR

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Oregon Health and Science University· Portland, ORUniversity of Washington· Seattle, WA

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