Recruiting

Decision Support System

Sponsor:

Daniel Chernavvsky, MD

Code:

NCT07063420

Conditions

Type 2 Diabetes Treated With Insulin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Continuous Glucose Monitor (CGM) + Usual Care

Study Details

Brief summary:

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

Conditions

Type 2 Diabetes Treated With Insulin

Study ID

NCT07063420

Start date

Oct 28, 2025

Status verified date

Nov, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

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.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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)

Primary outcome measure

  • Clinical efficacy [ Time Frame: 22 weeks ]

Central Contacts and Locations

Locations

University of Virginia Center for Diabetes Technology

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Ralf Nass, MD

rmn9a@uvahealth.org

More Information

Sponsor

Daniel Chernavvsky, MD

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Daniel Chernavvsky, MD on 2025-11-13.