Decision Support Software for Insulin-Dependent Diabetes

(TREAT2D Trial)

Overseen By Laura Kollar, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Chernavvsky, MD

Must be taking: Long-acting insulin

Must not be taking: Rapid insulin

Disqualifiers: Seizure disorder, Cardiac disease, others

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new software tool designed to help manage type 2 diabetes (T2D) for individuals who rely on insulin. The software, called the Patient Centered Multi-Agent Decision Support System (PCM-DSS), aims to improve multi-drug therapy by providing personalized reports to guide treatment adjustments. Participants will either use the software along with a continuous glucose monitor (CGM) or follow usual care with a CGM for a 16-week period. This trial suits those who have had type 2 diabetes for at least six months, use long-acting insulin, and are open to trying new technology to manage their condition. As an unphased trial, this study offers an opportunity to explore innovative technology that could enhance diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be using a long-acting insulin and cannot be using rapid insulin for at least three months before joining.

What prior data suggests that this decision support software is safe for use in type 2 diabetes?

Research has shown that decision support systems (DSS) for diabetes can be safe and helpful. In one study, a DSS tested over 12 weeks showed promising results in managing blood sugar levels. Most studies have found that these systems help improve blood sugar, blood pressure, and cholesterol levels in people with diabetes.

The Patient Centered Multi-Agent Decision Support System (PCM-DSS) is a type of DSS. Although specific safety data for PCM-DSS is limited, the widespread use of DSSs suggests they are generally well-tolerated. This system aims to improve diabetes management by aiding in better insulin use decisions.

No serious side effects have been reported so far. However, like any new tool, monitoring its use is important. Participants should feel comfortable asking questions and reporting any issues during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Centered Multi-Agent Decision Support System (PCM-DSS) for insulin-dependent diabetes because it offers a personalized approach to managing insulin therapy. Unlike standard care, which relies on regular physician guidance and patient self-management, PCM-DSS uses advanced decision support software to generate tailored recommendations for insulin adjustments. This system aims to optimize glucose control by analyzing continuous glucose monitor (CGM) data and providing precise, data-driven insights, which could lead to more effective and efficient diabetes management.

What evidence suggests that this decision support software is effective for type 2 diabetes?

Research has shown that decision support systems (DSS) can significantly aid in managing diabetes. Studies have demonstrated improvements in blood sugar levels in 71% of cases, blood pressure in 67%, and cholesterol levels in 38%. This indicates that such software can enhance control over these critical health factors for people with diabetes. In this trial, participants in one arm will use the Patient Centered Multi-Agent Decision Support System (PCM-DSS) alongside a continuous glucose monitor (CGM) to optimize treatment for type 2 diabetes. Early results from similar systems suggest they can effectively tailor diabetes treatment plans to individual needs. ^{3 4 6 7 8}

Who Is on the Research Team?

Ralf Nass, MD

Principal Investigator

University of Virginia Center for Diabetes Technology

Are You a Good Fit for This Trial?

Adults over 18 with type 2 diabetes for at least 6 months, HbA1c ≥7.0%, on long-acting insulin like glargine or degludec for 3+ months, and using multiple diabetes drugs can join. They must have internet access to upload data and if female, use contraception to prevent pregnancy during the study.

Inclusion Criteria

I have been using a long-acting insulin like glargine or degludec for over 3 months.

My HbA1c level is 7.0% or higher.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Tempo™ Personalized Diabetes Management Platform or study CGM with insulin therapy guided by the study physician for a 16-week period

16 weeks

Maintenance

Therapy established during the Intervention Phase is maintained for a 2-week period

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Centered Multi-Agent Decision Support System (PCM-DSS)

Trial Overview The trial is testing a new software designed to help healthcare providers manage patients taking various antidiabetic medications. Participants will be randomly assigned to either use this experimental decision support system or continue with standard care.

How Is the Trial Designed?

Group I: CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2) Experimental Treatment 1 Intervention

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.

Group II: CGM + Usual Care (Physician) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Daniel Chernavvsky, MD

Lead Sponsor

Trials

1

Recruited

30+

Anas El Fathi

Lead Sponsor

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07063420?term=302621&rank=1

Patient Centered Multi-Agent Decision Support System ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746969/

Applications of Clinical Decision Support Systems in Diabetes ... CDSSs significantly improved patients' blood glucose, blood pressure, and lipid profiles in 71% (45/63), 67% (12/18), and 38% (8/21) of the studies, ...

3. nature.com nature.com/articles/s41467-025-63671-0

A Bayesian decision support system for automated insulin ... We report results from a 12-week, open-label, randomized controlled trial evaluating a decision support system (DSS) consisting of a mobile ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0010482524010862

A knowledge-based decision support system to ... This work presents a prototypical ontology-based clinical Decision Support System (OnT2D- DSS) aimed at assisting general practice doctors in managing T2D ...

5. karger.com karger.com/hrp/article/98/4/384/928484/Enhancing-Care-in-Type-1-Diabetes-with-Artificial

Enhancing Care in Type 1 Diabetes with Artificial ... The availability of objective data on minute-by-minute glucose levels and insulin dosing information creates an opportunity for the development ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07063420?term=diabetes

Patient Centered Multi-Agent Decision Support System (PCM ... TREAT2D Report is generated by the Patient Centered Multi-Agent Decision Support System (PCM-DSS). Participant will then complete a 2-week Maintenance Phase ...

7. meddatax.com meddatax.com/clinical-trials/NCT07063420

Patient Centered Multi-Agent Decision Support System (PCM ... The purpose of this study is to test the safety and feasibility of using a patient centered decision support system (software) aim for ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0933365723002634

Advanced decision support system for individuals with ... A novel learning algorithm to optimally calculate mealtime and correction insulin boluses. Tested in a validated simulator and in a real-world clinical data.