Two Way Crossover Closed Loop MPC vs Control IQ

NCT05799781 | Completed Results DMC FDA Device

• 1 other identifier: OHSU24218
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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

Type 1 Diabetes

Keywords

automated insulin delivery systems; glucose sensor

Outcome Measures

Primary Outcomes (1)

• Percent of Time With Sensed Glucose Between 70-180 mg/dl

  Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across both arms.

  7 days in each treatment arm

Secondary Outcomes (6)

• Percent of Time With Sensed Glucose < 54 mg/dl

  7 days in each treatment arm

• Percent of Time With Sensed Glucose < 70 mg/dl

  7 days in each treatment arm

• Percent of Time With Sensed Glucose > 180 mg/dl

  7 days in each treatment arm

• Mean Sensed Glucose

  7 days in each treatment arm

• Coefficient of Variation of Glucose (Unitless)

  7 days in each treatment arm

Study Arms (2)

MPC Arm

EXPERIMENTAL

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.

Device: MPC closed-loop system

Control IQ arm

ACTIVE COMPARATOR

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.

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

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.

MPC Arm

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.

Control IQ arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Age 18 years and older.
• Current use of a t:slim X2 insulin pump with Dexcom G6 with the use of Control IQ for at least 12 weeks.
• Willingness to use Fiasp insulin during intervention study
• Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system.
• Lives within 40 miles of enrollment site.
• HbA1c ≥ 7.5% at screening.
• Total daily insulin requirement is less than 139 units/day.
• Current use of a smartphone so can be contacted by study staff off-campus
• Willingness to follow all study procedures, including attending all clinic visits.
• Willingness to sign informed consent and HIPAA documents.

You may not qualify if:

• Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• HbA1c \>10% at screening.
• Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the site laboratory).
• Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
• History of diabetes ketoacidosis during the prior 6 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
• Adrenal insufficiency.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Seizure disorder.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Major surgical operation within 30 days prior to screening.
• Use of an investigational drug within 30 days prior to screening.
• Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Washington: collaborator

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Leah Wilson
• Organization: Oregon Health & Science University

wilsolea@ohsu.edu

5034943273

Study Officials

• Leah Wilson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: March 13, 2023
• Primary Completion: December 27, 2024
• Study Completion: January 28, 2025
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Locations

US (2)