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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Treated With Insulin

• Registration Number: NCT07063420
• Lead Sponsor: Anas El Fathi

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical efficacy	22 weeks	Measured by improved glycemic control (HbA1c reduction and CGM-derived metrics).

Trial Locations

Locations (1)

University of Virginia Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States