Status:
COMPLETED
Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this pilot study is to test the safety and feasibility of using two or three research modules in conjunction with an automated insulin delivery device (AID).
Detailed Description
This concept is implemented in the Adaptive Biobehavioral Control (ABC) system - ABC will use human-machine co-adaptation of AID, recognizing both the necessity for the control algorithm to adapt to c...
Eligibility Criteria
Inclusion
- Age ≥18.0 and ≤70 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using insulin pump for at least six months
- Currently using insulin for at least six months
- Currently using or anticipated to be using the t:slim X2 insulin pump with Control-IQ technology at the start of the run-in phase (Visit 1).
- Using or willing to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
- Willing to use an app on a smart phone during the study.
- For females, not currently known to be pregnant or breastfeeding
- If female, sexually active, and of childbearing potential, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to use only insulin analogs approved for use in the t:slim X2 pump such as lispro (Humalog) or aspart (Novolog) and not use ultra-rapid acting insulin analogs (e.g. FiAsp) during the study
- Total daily insulin dose (TDD) at least 10 units per day
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, and sulfonylureas)
- An understanding and willingness to follow the protocol and signed informed consent
Exclusion
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
- A condition, which in the opinion of the investigator or designee, would put the participant at risk or interfere with the completion of the protocol.
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Currently being treated for a seizure disorder
- Hemophilia or any other bleeding disorder
- Planned surgery during study duration
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (e.g. study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
Key Trial Info
Start Date :
July 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04784637
Start Date
July 23 2021
End Date
December 24 2021
Last Update
November 7 2024
Active Locations (1)
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1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903