Actively Recruiting
Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study
Led by Daniel Chernavvsky, MD · Updated on 2025-11-13
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Daniel Chernavvsky, MD
Lead Sponsor
U
University of Virginia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a patient-centered decision support system (software) designed to help healthcare providers manage multi antidiabetic drug therapy for people with type 2 diabetes who use insulin. The study aims to test the safety and feasibility of this software in guiding treatment. This pilot study focuses on adults with type 2 diabetes treated with insulin and receiving multiple diabetes medications. Participants will be randomly assigned to one of two groups. One group will use their personal insulin pen along with a continuous glucose monitor (CGM) and have their therapy guided by the Patient Centered Multi-Agent Decision Support System (PCM-DSS) through a TREAT2D Report for 16 weeks. The other group will also use a CGM and their personal insulin pen but receive usual care from their physician for the same 16-week period. Both groups will then complete a 2-week maintenance phase where the therapy established during the intervention phase is maintained. During the study, participants will wear a CGM and adjust their insulin therapy under physician guidance. Data will be uploaded via the internet as needed. Researchers will monitor clinical efficacy over 22 weeks to assess the impact of the decision support system compared to usual care. Safety and feasibility will also be evaluated through ongoing monitoring and follow-up throughout the study duration.
CONDITIONS
Brief Title
Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Clinical diagnosis of type 2 diabetes for at least 6 months
- Hemoglobin A1c (HbA1c) of 7.0% or higher
- Using an approved long-acting insulin for at least 3 months
- Treated or about to be treated with multiple drugs for type 2 diabetes
- Willingness to wear an additional study continuous glucose monitor (CGM) if already using one
- Access to the internet and willingness to upload data as needed
- If female and sexually active, agreement to use contraception and negative pregnancy test; pregnancy during study requires discontinuation
You will not qualify if you...
- Currently using rapid-acting insulin for at least 3 months
- Being treated for a seizure disorder
- Medical conditions that may interfere with study completion, such as seizure disease or decompensated cardiac disease
- Inpatient psychiatric treatment in the past 6 months
- Known adrenal disorder
- Currently pregnant or intending to become pregnant during the trial
- Anticipated surgery, interventional procedures, or prolonged fasting during the study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive therapy guided by study physicians using either the Patient Centered Multi-Agent Decision Support System or usual care while wearing a continuous glucose monitor and using their personal insulin pen.
Regular contacts and therapy adjustments as per study physician guidance
Duration - 2 weeks
Participants maintain the therapy established during the Treatment phase.
1 maintenance phase visit
Trial Site Locations
Total: 1 location
1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
C
Carlene Alix
L
Laura Kollar, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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