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

Launched by ANAS EL FATHI · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new computer program designed to help healthcare providers make better decisions when managing treatment for people with type 2 diabetes who use insulin. The software aims to support doctors in choosing the best combination of diabetes medicines to keep blood sugar under control. Right now, the study is not yet recruiting participants.

Adults aged 18 and older with type 2 diabetes for at least six months may be eligible if their blood sugar levels are higher than recommended (measured by a test called HbA1c) and they have been using a long-acting insulin for at least three months. Participants should also be using or planning to use multiple diabetes medicines. People who use a continuous glucose monitor (CGM) may need to wear an extra one provided by the study and upload their health data online. Women who can become pregnant must agree to use birth control during the study and will have pregnancy tests to ensure safety. The study excludes people using rapid-acting insulin or those with certain medical or mental health conditions. Participants can expect to work closely with their healthcare team and share information through the program to help improve their diabetes treatment.

Gender

ALL

Eligibility criteria

• 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.