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

NCT07063420 | Recruiting

• 1 other identifier: 302621
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Patient Centered Multi-Agent Decision Support System (PCM-DSS); Continuous Glucose Monitor (CGM); Insulin pen

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy

  Measured by improved glycemic control (HbA1c change and CGM-derived metrics).

  22 weeks

Other Outcomes (1)

• Patient satisfaction

  22 weeks

Study Arms (2)

CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2)

EXPERIMENTAL

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.

Other: Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)

CGM + Usual Care (Physician)

PLACEBO COMPARATOR

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.

Other: Continuous Glucose Monitor (CGM) + Usual Care

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

CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2)

Continuous Glucose Monitor (CGM) + Usual Care OTHER

Continuous Glucose Monitor (CGM) + Usual Care (Physician)

CGM + Usual Care (Physician)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Currently using rapid insulin for at least three 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:
• Seizure disease
• Decompensated cardiac disease
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• Currently pregnant or intent to become pregnant during the trial.
• Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.

Sponsors & Collaborators

• Daniel Chernavvsky, MD: lead
• University of Virginia: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Ralf Nass, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlene Alix

CONTACT

(434) 249-8961; UAX8YX@uvahealth.org

Laura Kollar, RN

CONTACT

(434) 982-6479; LLK7M@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 14, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after the publication of the manuscript.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team

Locations

US (1)