Diabetes Mellitus, Type 1DSS-2NCT04443153
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
A study testing Personalized Feedback, Decision Support System and Sensor Augmented Mode in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Personalized Feedback, Decision Support System and Sensor Augmented Mode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2020to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least one year
- HbA1c 6.0-11.0%, inclusive
- Demonstration of proper mental status and cognition for the study
- If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3 months and willingness not to alter the therapy for the study duration.
- For females, not currently known to be pregnant
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- If female and sexually active, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Subjects must have Internet access and a computer system that meets the requirements for uploading the study equipment and ability to participate in video conferencing.
- Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
Who cannot join
- NPH (neutral protamine hagedorn) insulin
- Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
- Current treatment of a primary seizure disorder
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
- Hemophilia or any other bleeding disorder
- A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk such as the following examples:
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- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Abnormal liver function test results (Transaminase >3 times the upper limit of normal)
- Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2).
- Active gastroparesis requiring medical therapy
- Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L).
- Abuse of alcohol or recreational drugs
- Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg).
- Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
- Not familiar with smart phone technology
- Current use of the following drugs and supplements:
- Oral steroids
- Any other medication that the investigator believes is a contraindication to the subject's participation
- Participation in another pharmaceutical or device trial at the time of enrollment or during the 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: Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes
This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.
Read the detailed description
Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort will continue for ~7 months. Following recruitment, screening, and a run-in period of SAM, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4 weeks used to assess glucose variability (GV) from CGM data.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Personalized Feedback, Decision Support System, Sensor Augmented Mode
- Keywords
- Behavior, Continuous Glucose Monitor (CGM), Insulin Pump, Decision Support System (DSS), Personalized Feedback (PF), Sensor Augmented Pump therapy (SAP), Multiple Daily Injections (MDI), Sensor Augmented Mode (SAM), Continuous Subcutaneous Insulin Infusion (CSII)
- Medical subject headings
- Diabetes Mellitus, Type 1, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized FeedbackDevice
Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support SystemDevice
CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented ModeDevice
A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
| Study group | Role | What they receive |
|---|---|---|
| De-escalation | Experimental | Subjects randomized to this arm will proceed from DSS to PF to SAM Receives: Device: Personalized Feedback; Device: Decision Support System; Device: Sensor Augmented Mode |
| Escalation | Experimental | Subjects randomized to this arm will proceed from SAM to PF to DSS Receives: Device: Personalized Feedback; Device: Decision Support System; Device: Sensor Augmented Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Outcomes
Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Secondary outcomes (8)
Percent Time in Clinical Hypoglycemia
Percentage of time blood glucose was below 54mg/dL as per CGM
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Below Recommended Threshold
Percentage of time blood glucose was below 70mg/dL as per CGM
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time in Target Range
Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Above Range
Percentage of time blood glucose was above 180mg/dL as per CGM
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Above 250 mg/dL
Percentage of time blood glucose was above 250mg/dL as per CGM
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Average Glycemia
average of CGM values
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Low Blood Glucose Index
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia.
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
High Blood Glucose Index
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start4 Sep 2020
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Breton, University of Virginia
- Investigators
- Marc Breton, PhD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443153
- Sponsor's protocol ID
- 200007
- Other IDs
- 2R01DK051562-19A1
- Acronym
- DSS-2
- Status last verified
- Oct 2025
- First submitted
- 20 Jun 2020
- Last updated
- 28 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Pending
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04443153
- Acronym / sponsor ID
- DSS-2 / 200007
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Behavior, Continuous Glucose Monitor (CGM), Insulin Pump, Decision Support System (DSS), Personalized Feedback (PF), Sensor Augmented Pump therapy (SAP), Multiple Daily Injections (MDI), Sensor Augmented Mode (SAM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Posted 28 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.
Detailed description
Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort will continue for ~7 months. Following recruitment, screening, and a run-in period of SAM, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4 weeks used to assess glucose variability (GV) from CGM data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-escalation | Experimental | Device: Personalized Feedback, Device: Decision Support System, Device: Sensor Augmented ModeSubjects randomized to this arm will proceed from DSS to PF to SAM |
| Escalation | Experimental | Device: Personalized Feedback, Device: Decision Support System, Device: Sensor Augmented ModeSubjects randomized to this arm will proceed from SAM to PF to DSS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years and older
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least one year
- HbA1c 6.0-11.0%, inclusive
- Demonstration of proper mental status and cognition for the study
- If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3 months and willingness not to alter the therapy for the study duration.
Key exclusion criteria (22 listed)
- NPH (neutral protamine hagedorn) insulin
- Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
- Current treatment of a primary seizure disorder
- Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
- Hemophilia or any other bleeding 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 |
|---|---|---|
| Personalized FeedbackProvides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user. | Device | De-escalation, Escalation |
| Decision Support SystemCGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges | Device | De-escalation, Escalation |
| Sensor Augmented ModeA mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes. | Device | De-escalation, Escalation |
Primary outcome
Glycemic Outcomes
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.
8 secondary outcomes
Percent Time in Clinical Hypoglycemia
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Below Recommended Threshold
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time in Target Range
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Above Range
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Above 250 mg/dL
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Average Glycemia
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Low Blood Glucose Index
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
High Blood Glucose Index
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Pending
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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.
Marc Breton, PhD 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 Personalized Feedback, Decision Support System and Sensor Augmented Mode in people with Diabetes Mellitus, Type 1, run by University of Virginia 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 9 inclusion and 22 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: finished, as of the sponsor's last update on 28 Oct 2025. 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. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Outcomes (time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention). 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 28 Oct 2025.