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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04443153
Study groupRoleWhat they receive
De-escalationExperimentalSubjects randomized to this arm will proceed from DSS to PF to SAM
Receives: Device: Personalized Feedback; Device: Decision Support System; Device: Sensor Augmented Mode
EscalationExperimentalSubjects 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Average Glycemia

    average of CGM values

    Measured: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention

  7. 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

  8. 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.

  1. First posted23 Jun 2020
  2. Study start4 Sep 2020
  3. Primary completion19 Sep 2024
  4. Study completion19 Sep 2024

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Pending

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?

On the ClinicalTrials.gov record for NCT04443153.

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.

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