RECRUITING

Closed Loop Context Aware AID

Conditions

Type 1 Diabetes automated insulin delivery systems glucose sensor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-22

Study Completion:2025-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06676657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \<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.

Inclusion Criteria

Exclusion 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 \<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.

Contacts and Locations

Study Contact

Leah Wilson, MD

CONTACT

503-494-3273

wilsolea@ohsu.edu

Deborah Branigan

CONTACT

5034189070

branigad@ohsu.edu

Principal Investigator

Leah Wilson, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health and Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22

Study Completion Date2025-02-28

Study Record Updates

Study Start Date2024-11-22

Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

automated insulin delivery systems
glucose sensor

Additional Relevant MeSH Terms

Type 1 Diabetes