Actively Recruiting
Closed Loop Context Aware AID
Led by Oregon Health and Science University · Updated on 2025-04-11
10
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Closed Loop Context Aware AID
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female participants 18 and older.
- HbA1c or GMI 7.0% or higher at screening.
- Physically willing and able to perform 30 minutes of exercise as determined by the investigator.
- Current use of an FDA-approved hybrid closed loop system for 3 months or more.
- Lives with another person age 18 or older who sleeps in the house at night and can attend training.
- Lives within 40 miles of OHSU.
- Total daily insulin requirement is less than 139 units per day.
- Able to read, write, and understand spoken English.
- Current use of a smartphone for off-campus contact by study staff.
- Willingness to follow all study procedures and attend all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
You will not qualify if you...
- GMI or A1c less than 6.5% or greater than 10.5%.
- Sensor glucose shows less than 2% of time above 250 mg/dl in the last 30 days.
- Individuals of childbearing potential who are pregnant, intending to become pregnant, breastfeeding, or not using adequate contraceptive methods.
- Any cardiovascular disease including significant EKG abnormalities, stroke, heart failure, myocardial infarction, angina, coronary bypass, angioplasty, heart block, or arrhythmias.
- Renal insufficiency with GFR less than 60 ml/min.
- Liver failure, cirrhosis, or other liver diseases compromising function.
- History of severe hypoglycemia or hypoglycemia unawareness in the past 6 months.
- History of diabetic ketoacidosis in the past 6 months.
- Adrenal insufficiency.
- Any active infection requiring antibiotics.
- Known or suspected substance abuse.
- Seizure disorder.
- Active foot ulceration.
- Peripheral arterial disease.
- Major surgery within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic use of immunosuppressive medication.
- Bleeding disorder or platelet count below 50,000.
- Allergy to Fiasp insulin.
- Current use of oral or parenteral corticosteroids.
- Any life-threatening disease including recent malignant neoplasms except basal or squamous cell skin cancer.
- Use of beta blockers or non-dihydropyridine calcium channel blockers.
- Use of glucose-lowering medications other than insulin with exceptions.
- Gastroparesis.
- Diet with less than 50 grams of carbohydrates per day.
- Positive response to Physical Activity Readiness Questionnaire except controlled blood pressure on a single medication.
- Chest discomfort with physical activity.
- Any clinically significant disease or disorder judged by investigator to jeopardize safety or compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
L
Leah Wilson, MD
CONTACT
D
Deborah Branigan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here