Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers
NCT ID: NCT07063420
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
18 participants
INTERVENTIONAL
2025-10-28
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)
Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) PCM-DSS
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.
Continuous Glucose Monitor (CGM) + Usual Care
Continuous Glucose Monitor (CGM) + Usual Care (Physician)
Interventions
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Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)
Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) PCM-DSS
Continuous Glucose Monitor (CGM) + Usual Care
Continuous Glucose Monitor (CGM) + Usual Care (Physician)
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months.
3. Hemoglobin A1c (HbA1c) ≥ 7.0%.
4. Currently using an approved long-acting insulin for at least 3 months (e.g., insulin glargine, insulin degludec).
5. Treated or about to be treated with multi-drug therapies for T2D.
6. If using a CGM, willingness to wear an additional study CGM during the duration of the study.
7. Access to the internet and willingness to upload data during the study as needed.
8. 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.
Exclusion Criteria
2. Currently being treated for a seizure disorder.
3. 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:
1. Seizure disease
2. Decompensated cardiac disease
4. Inpatient psychiatric treatment in the past 6 months
5. Presence of a known adrenal disorder
6. Currently pregnant or intent to become pregnant during the trial.
7. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
18 Years
ALL
No
Sponsors
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Daniel Chernavvsky, MD
OTHER
University of Virginia
OTHER
Responsible Party
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Daniel Chernavvsky, MD
Investigator
Principal Investigators
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Ralf Nass, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Center for Diabetes Technology
Locations
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University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Ralf Nass, MD
Role: primary
Other Identifiers
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302621
Identifier Type: -
Identifier Source: org_study_id