Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18.0 years old at time of consent.

• Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months.

• Hemoglobin A1c (HbA1c) ≥ 7.0%.

• Currently using an approved long-acting insulin for at least 3 months (e.g., insulin glargine, insulin degludec).

• Treated or about to be treated with multi-drug therapies for T2D.

• 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.

Locations
United States
Virginia
University of Virginia Center for Diabetes Technology
RECRUITING
Charlottesville
Contact Information
Primary
Carlene Alix
UAX8YX@uvahealth.org
(434) 249-8961
Backup
Laura Kollar, RN
LLK7M@virginia.edu
(434) 982-6479
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 18
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Virginia
Leads: Daniel Chernavvsky, MD

This content was sourced from clinicaltrials.gov

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