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Two Way Crossover Closed Loop MPC vs Control IQ

NCT05799781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-03-06

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

MPC closed-loop system

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.

DEVICE

t:slim X2 pump with Dexcom G6 CGM and Control IQ

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.

Sponsors & Collaborators

Principal Investigators

  • Leah Wilson, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2024-12-27
Completion
2025-01-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799781 on ClinicalTrials.gov