Closed Loop Context Aware AID for Type 1 Diabetes

This study is testing a new feature for the iPancreas automated insulin delivery system, which is a type of artificial pancreas (AP) that automatically delivers insulin. The new feature is an algorithm (a set of rules for a computer) designed to detect and correct high blood sugar patterns. Researchers want to see how well this new algorithm manages blood sugar compared to the iPancreas system without this feature. You might be able to join if you are 18 or older, have had type 1 diabetes for at least a year, have an HbA1c or GMI of 7.0% or higher, can exercise for 30 minutes, and have been using an FDA-approved hybrid closed-loop system for at least 3 months. Success in this study will be measured by how much time participants spend with their blood sugar levels within a healthy range.

Study design: This is an interventional study with 10 participants. It is testing a new algorithm within an automated insulin delivery system.
What's involved: You would be on the study for about 4 weeks. This includes an initial clinic visit, followed by 3 weeks of data collection at home, a virtual visit, and then one more week using the new algorithm.
Compensation: Not stated in the trial record.
Follow-up: The primary outcomes, such as time with sensor glucose less than 70 mg/dl, are measured over the entire 4-week study period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Closed Loop Context Aware AID

Recruiting

NAAges 18+InterventionalTreatment

Oregon Health and Science University

~10 participants

Updated 2025-04-11 on ClinicalTrials.gov

What's tested:iPancreas automated insulin delivery system

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percent of time with sensor glucose less than 70 mg/dl

Measured over entire 4 week study

+3 more outcomes measured

Conditions

Type 1 Diabetes

Where it's being run

1 sites across 1 states

Oregon1

Study leadership

Leah Wilson, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Leah Wilson, MD

[email protected]

503-494-3273

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Percent of time with sensor glucose less than 70 mg/dlentire 4 week study
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl comparing first 3 weeks vs. last week
Percent of time with sensor glucose less than 54 mg/dlentire 4 week study
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl comparing first 3 weeks vs. last week
Percent of time the pattern evaluation windows occurredentire 4 week study
To assess the hyperglycemia pattern detection and dosing feature by evaluating the percent time that the feature is active in detecting hyperglycemic patterns during the pattern evaluation windows calculated as: (minutes in pattern evaluation window) / (total minutes) \* 100
Percent of time with sensor glucose greater than 250 mg/dlentire 4 week study
Assess the percent of time that the Dexcom G6 reported sensor glucose values more than 250 mg/dl comparing first 3 weeks vs. last week

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