CClinicalTrials.gg
Active, not recruitingNCT07063420TREAT2DUpdated Sep 25, 2026

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

An interventional study of Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) and Continuous Glucose Monitor (CGM) + Usual Care in Type 2 Diabetes Treated With Insulin, sponsored by Daniel Chernavvsky, MD. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Daniel Chernavvsky, MD · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

The purpose of this study is to test the safety and feasibility of using a patient centered decision support system (software) aim for healthcare providers to treat people with type 2 diabetes under multi antidiabetic drug therapy.

02

Conditions studied

  • Type 2 Diabetes Treated With Insulin

Keywords

  • Patient Centered Multi-Agent Decision Support System (PCM-DSS)
  • Continuous Glucose Monitor (CGM)
  • Insulin pen
03

In context

Lead sponsor

Daniel Chernavvsky, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18.0 years old at time of consent.
  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

Exclusion Criteria:

  1. Currently using rapid insulin for at least three months (e.g., insulin aspart, insulin lispro, insulin regular).
  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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study 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.

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

  • 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.

    Other: Continuous Glucose Monitor (CGM) + Usual Care

Interventions

  • OtherContinuous 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

  • OtherContinuous Glucose Monitor (CGM) + Usual Care

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

06

What researchers measure

Primary outcomes

  1. Clinical efficacy

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

    Time frame: 22 weeks

Other outcomes

  1. Patient satisfaction

    Patient satisfaction which will be assessed through Diabetes Distress Scale Survey (DDS) questionnaire, measured after Screening and at End of Study, and the Participant Satisfaction Survey (PSS) measured at End of Study. DDS asks the participant to consider the degree distress they felt to 17 items during the past month. PSS is six questions asking the participant about the experience in this study.

    Time frame: 22 weeks

07

Study locations

1 site
  • University of Virginia Center for Diabetes Technology
    Charlottesville, Virginia 22903, United States
08

References and documents

Individual participant data

Plan to share: Yes — Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Sep 25, 2026
Primary completion
Jul 31, 2026→Nov 15, 2026
Sep 25, 2026
Study completion
Jul 31, 2026→Nov 17, 2026
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Recruiting→Active, not recruiting
    Primary completion Jul 31, 2026→Nov 15, 2026
    Study completion Jul 31, 2026→Nov 17, 2026
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07063420
Lead sponsor
Daniel Chernavvsky, MD
Collaborators
University of Virginia
Responsible party
Daniel Chernavvsky, MD (Investigator, University of Virginia) — Sponsor-investigator
First posted
Jul 14, 2025
Start date
Oct 28, 2025
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 17, 2026 (estimated)
Last update
Sep 25, 2026

Study contacts

Ralf Nass, MD
principal investigator · University of Virginia Center for Diabetes Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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