Status:
RECRUITING
Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fa...
Detailed Description
The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study will be performed at the University of Virginia (UVA), with screening procedures taking place either virtuall...
Eligibility Criteria
Inclusion
- Age ≥18.0 years old at time of consent.
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
- HbA1c ≥ 7.5%.
- Currently using an approved long-acting insulin for at least two months (e.g., insulin glargine, insulin degludec)
- If using a CGM, willingness to wear an additional study CGM during the duration of the study.
- Access to the internet and willingness to upload data during the study as needed.
- If female and sexually active, 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 who self-report that they are 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 remain on same dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals).
Exclusion
- Currently using an approved intermediate (e.g., insulin NPH) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).
- Currently being treated for a seizure disorder.
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Uncontrolled thyroid disease
- Currently pregnant or intent to become pregnant during the trial.
- Currently breastfeeding.
- Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
- History of hypoglycemia unawareness.
- On a non-stable dose of non-insulin glucose-lowering agent prior to the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals) as defined by study physician.
Key Trial Info
Start Date :
June 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06024928
Start Date
June 18 2024
End Date
December 31 2025
Last Update
October 3 2025
Active Locations (2)
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1
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
2
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903