Type 2 Diabetes Treated With InsulinTREAT2DNCT07063420
Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers
A study testing Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) in people with Type 2 Diabetes Treated With Insulin, run by Daniel Chernavvsky, MD at 1 site in United States.
Trial summary
Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 17 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
Official title: Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study
Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).
Read the 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.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS), Continuous Glucose Monitor (CGM) + Usual Care
- Keywords
- Patient Centered Multi-Agent Decision Support System (PCM-DSS), Continuous Glucose Monitor (CGM), Insulin pen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Continuous Glucose Monitor (CGM) + Usual CareOther
Continuous Glucose Monitor (CGM) + Usual Care (Physician)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) |
| 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. Receives: Other: Continuous Glucose Monitor (CGM) + Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Measured by improved glycemic control (HbA1c change and CGM-derived metrics).
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start28 Oct 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Chernavvsky, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Sponsor-investigator, Daniel Chernavvsky, MD, University of Virginia
- Investigators
- Ralf Nass, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063420
- Sponsor's protocol ID
- 302621
- Acronym
- TREAT2D
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers: A Pilot Study
- ClinicalTrials.gov ID
- NCT07063420
- Acronym / sponsor ID
- TREAT2D / 302621
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Patient Centered Multi-Agent Decision Support System (PCM-DSS), Continuous Glucose Monitor (CGM), Insulin pen
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Daniel Chernavvsky, MDUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2) | Experimental | Other: Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)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. |
| CGM + Usual Care (Physician) | Placebo comparator | Other: Continuous Glucose Monitor (CGM) + Usual CareParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2) |
| Continuous Glucose Monitor (CGM) + Usual CareContinuous Glucose Monitor (CGM) + Usual Care (Physician) | Other | CGM + Usual Care (Physician) |
Primary outcome
Clinical efficacy
Time frame: 22 weeks
Measured by improved glycemic control (HbA1c change and CGM-derived metrics).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Nass, MD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) in people with Type 2 Diabetes Treated With Insulin, run by Daniel Chernavvsky, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.