Decision support to help providers manage insulin-treated type 2 diabetes
Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study
NA · University of Virginia · NCT07063420
This trial will test a software decision-support tool used by healthcare providers, together with continuous glucose monitoring, to help adults with insulin-treated type 2 diabetes who are on multiple diabetes medicines manage their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07063420 on ClinicalTrials.gov |
What this trial studies
This interventional study tests the safety and feasibility of a patient-centered multi-agent decision support software (PCM-DSS) used by healthcare providers alongside continuous glucose monitoring. Eligible adults with type 2 diabetes on long-acting insulin and multi-drug therapy will be assigned to CGM plus PCM-DSS-supported care or to CGM plus usual care. Participants will wear a study CGM, upload data via the internet, and have treatment decisions informed either by the PCM-DSS or by standard practice. The primary focus is on operational safety and feasibility of integrating the tool into clinical care for complex antidiabetic regimens.
Who should consider this trial
Good fit: Adults (≥18) with type 2 diabetes for at least 6 months, HbA1c ≥7.0%, using a long-acting insulin for ≥3 months and treated or about to be treated with multiple diabetes drugs, who can wear a study CGM and upload data.
Not a fit: People not on insulin, with HbA1c <7%, pregnant or planning pregnancy, unwilling to wear a CGM or upload data, or those with type 1 diabetes are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the tool could help providers make safer, more personalized medication adjustments that improve blood sugar control and reduce low blood sugar episodes.
How similar studies have performed: Previous studies combining CGM with decision-support tools have shown improved glucose metrics in some settings, but a provider-facing multi-agent PCM-DSS for complex multi-drug regimens is relatively novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charlottesville, Virginia
- University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Ralf Nass, MD — University of Virginia Center for Diabetes Technology
- Study coordinator: Carlene Alix
- Email: UAX8YX@uvahealth.org
- Phone: (434) 249-8961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Treated With Insulin, Patient Centered Multi-Agent Decision Support System, Continuous Glucose Monitor, Insulin pen