Automated insulin delivery system for managing high blood sugar in type 1 diabetes

Assessment of a Fully-closed Loop AID System With a Context-aware Hyperglycemia Pattern Detection and Dosing Algorithm in People With Type 1 Diabetes

This study tests a new automated insulin delivery system for people with type 1 diabetes to see if it can better manage high blood sugar compared to a standard system.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Oregon Health and Science University (other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06676657 on ClinicalTrials.gov

What this trial studies

This study evaluates a new algorithm for an artificial pancreas that automatically delivers insulin based on high blood sugar detection. Participants will use an Omnipod insulin delivery system and a Dexcom G6 continuous glucose monitor (CGM) to collect glucose data. Over a four-week period, the system will learn from participants' glucose patterns and activity data to improve insulin dosing. The effectiveness of this new algorithm will be compared to a standard automated insulin delivery system without high blood sugar detection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes, an HbA1c of 7.0% or higher, and currently using a hybrid closed loop insulin delivery system.

Not a fit: Patients with well-controlled diabetes (HbA1c below 6.5%) or those with severe hyperglycemia (HbA1c above 10.5%) may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better glucose control and reduced complications for patients with type 1 diabetes.

How similar studies have performed: Other studies have shown promise with automated insulin delivery systems, but this specific algorithm is a novel approach.

Eligibility criteria

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.

Where this trial is running

Portland, Oregon

• Oregon Health and Science University — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Leah Wilson, MD — Oregon Health and Science University
• Study coordinator: Leah Wilson, MD

Conditions: Type 1 Diabetes, automated insulin delivery systems, glucose sensor