Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS), Continuous Glucose Monitor (CGM) + Usual Care.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Treated With Insulin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study
Overview
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.
Interventions
- Other Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)
Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) PCM-DSS - Other Continuous Glucose Monitor (CGM) + Usual Care
Continuous Glucose Monitor (CGM) + Usual Care (Physician)
Primary outcome measures
- Clinical efficacy [Time frame: 22 weeks]
Eligibility criteria
Inclusion criteria
- 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).
- Treated or about to be treated with multi-drug therapies for T2D.
- If using a CGM, willingness to wear an additional study CGM during the duration of the study.
- Access to the internet and willingness to upload data during the study as needed.
- 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
- Currently using rapid insulin for at least three months (e.g., insulin aspart, insulin lispro, insulin regular).
- Currently being treated for a seizure disorder.
- 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:
- Seizure disease
- Decompensated cardiac disease
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Currently pregnant or intent to become pregnant during the trial.
- Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Virginia Center for Diabetes Technology — Charlottesville
Identifiers
NCT: NCT07063420 · 302621