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

ConditionType 2 Diabetes Treated With Insulin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaniel Chernavvsky, MD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18.0 years old at time of consent.

Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months.

Hemoglobin A1c (HbA1c) ≥ 7.0%.

Currently using an approved long-acting insulin for at least 3 months (e.g., insulin glargine, insulin degludec).

Disqualifiers

Currently using rapid insulin for at least three months (e.g., insulin aspart, insulin lispro, insulin regular).

Currently being treated for a seizure disorder.

Seizure disease

Decompensated cardiac disease

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

  • Continuous Glucose Monitor (CGM) + Usual Care

    Other intervention

    Continuous Glucose Monitor (CGM) + Usual Care (Physician)

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2)Experimental treatment 1 intervention
Group B: CGM + Usual Care (Physician)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical efficacy

Measured by improved glycemic control (HbA1c change and CGM-derived metrics).

Time frame
22 weeks

Secondary outcomes

Other outcomes

1

Patient satisfaction

Patient satisfaction which will be assessed through Diabetes Distress Scale Survey (DDS) questionnaire, measured after Screening and at End of Study, and the Participant Satisfaction Survey (PSS) measured at End of Study. DDS asks the participant to consider the degree distress they felt to 17 items during the past month. PSS is six questions asking the participant about the experience in this study.

Time frame
22 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniel Chernavvsky, MD

Lead sponsor

University of Virginia

Sponsor institution

University of Virginia

Collaborator

Source ClinicalTrials.gov
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