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New treatment option for Type 1 Diabetes
Official title Closed Loop Context Aware AID
ClinicalTrials.gov ID: NCT06676657
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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.
You likely can't join if
- GMI or A1c \ 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...
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure...
- 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.
See the full eligibility 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.
- GMI or A1c \ 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 /...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.