Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Daniel Chernavvsky, MD
Study ID
NCT07063420
Status
Recruiting
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Conditions

  • Type 2 Diabetes Treated With Insulin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) — OTHER
    Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) PCM-DSS
  • Continuous Glucose Monitor (CGM) + Usual Care — OTHER
    Continuous Glucose Monitor (CGM) + Usual Care (Physician)

Study Details

Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).

Key Dates

Start date
Oct 28, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2)
    Participants will use their personal insulin pen and study continuous glucose monitor (CGM). Participants will adjust therapy guided by the study physician who receives the TREAT2D Report for a 16-week period. TREAT2D Report is generated by the Patient Centered Multi-Agent Decision Support System (PCM-DSS). Participant will then complete a 2-week Maintenance Phase where therapy established during the Intervention Phase will be maintained.
  • Placebo Comparator: CGM + Usual Care (Physician)
    Participants will use a study CGM and their personal insulin pen. They will have their insulin therapy guided by the study physician for a 16-week period. Participants will be contacted by study personnel as per standard care to adjust their therapy if needed. Participants will then complete a 2-week Maintenance Phase where therapy established during the Intervention Phase will be maintained.

Primary Outcome Measure

Clinical efficacy [ Time Frame: 22 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Center for Diabetes TechnologyCharlottesvilleVirginia22903
Ralf Nass, MD
[email protected]
Anas El Fathi, PhD (SUB_INVESTIGATOR)
Daniel Cherñavvsky, MD (SUB_INVESTIGATOR)
Mohammadreza Ganjiarjenaki (SUB_INVESTIGATOR)

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By research site
University of Virginia Center for Diabetes Technology· Charlottesville, VA

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