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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2) | Experimental | 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. |
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| CGM + Usual Care (Physician) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) | Other | Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) PCM-DSS |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy | Measured by improved glycemic control (HbA1c change and CGM-derived metrics). | 22 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlene Alix | Contact | (434) 249-8961 | UAX8YX@uvahealth.org | |
| Laura Kollar, RN | Contact | (434) 982-6479 | LLK7M@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ralf Nass, MD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Recruiting | Charlottesville | Virginia | 22903 | United States |
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Data will be made available after the publication of the manuscript.
The Data Sharing Agreements will be formulated by the study team
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| Continuous Glucose Monitor (CGM) + Usual Care | Other | Continuous Glucose Monitor (CGM) + Usual Care (Physician) |
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| 22 weeks |
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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