Recruiting

Closed Loop AID

Sponsor:

Oregon Health and Science University

Code:

NCT06676657

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

iPancreas automated insulin delivery system

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes

Study ID

NCT06676657

Start date

Nov 22, 2024

Status verified date

Apr, 2025

Completion date

Aug 30, 2025

Anticipated

Primary completion date

Jul 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus for at least 1 year.
  • Male or female participants 18 and older.
  • HbA1c or GMI ≥ 7.0% at screening.
  • Physically willing and able to perform 30 min of exercise (as determined by the investigator after reviewing the participant's activity level).
  • Current use of an FDA-approved hybrid closed loop system for ≥3 months.
  • 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 OHSU
  • Total daily insulin requirement is less than 139 units/day.
  • Able to read, write and understand spoken English
  • 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.

Exclusion Criteria:

  • GMI or A1c <6.5% or >10.5%
  • Sensor glucose shows < 2% of time above 250 mg/dl in last 30 days.
  • Individual 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.
  • Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
  • Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the OHSU 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 6 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 (example skin infection requiring antibiotics)
  • Known or suspected abuse of alcohol, narcotics, or illicit drugs.
  • Seizure disorder.
  • Active foot ulceration.
  • Peripheral arterial disease.
  • 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).
  • Bleeding disorder or platelet count below 50,000.
  • Allergy to Fiasp insulin
  • Current administration of oral or parenteral corticosteroids.
  • Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
  • Use of beta blockers or non-dihydropyridine calcium channel blockers.
  • Current use of any medication that can lower glucose other than insulin (ex. Wegovy, Jardiance) with the exception of metformin if dose has been stable for ≥3 months and patient willing to not change dose during study.
  • Gastroparesis
  • Diet consisting of less than 50 grams of carbohydrates per day.
  • A positive response to any of the questions from the Physical Activity Readiness Questionnaire with one exception: participant will not be excluded if he/she takes a single blood pressure medication that doesn't impact heart rate and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
  • Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
  • Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

iPancreas automated insulin delivery 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. 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.

Primary outcome measure

  • Percent of time with sensor glucose less than 70 mg/dl [ Time Frame: entire 4 week study ]
  • Percent of time with sensor glucose less than 54 mg/dl [ Time Frame: entire 4 week study ]
  • Percent of time the pattern evaluation windows occurred [ Time Frame: entire 4 week study ]
  • Percent of time with sensor glucose greater than 250 mg/dl [ Time Frame: entire 4 week study ]

Central Contacts and Locations

Central contacts

Leah Wilson, MD

503-494-3273wilsolea@ohsu.edu

Deborah Branigan

5034189070branigad@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Leah Wilson, MD

503-494-3273wilsolea@ohsu.edu

Deborah Branigan

503-418-9070branigad@ohsu.edu

Principal Investigator:

Peter Jacobs, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Keywords

  • automated insulin delivery systems
  • glucose sensor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-04-11.