Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes

NCT04443153 | Completed Results FDA Device

• 2 other identifiers: 2000072R01DK051562-19A1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.

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); Continuous Subcutaneous Insulin Infusion (CSII)

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Percent Time in Clinical Hypoglycemia

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

• Percent Time Below Recommended Threshold

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

• Percent Time in Target Range

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

• Percent Time Above Range

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

• Percent Time Above 250 mg/dL

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

Study Arms (2)

De-escalation

EXPERIMENTAL

Subjects randomized to this arm will proceed from DSS to PF to SAM

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

Device: Personalized Feedback; Device: Decision Support System; Device: Sensor Augmented Mode

Interventions

Personalized Feedback DEVICE

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.

De-escalation; Escalation

Decision Support System DEVICE

CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges

De-escalation; Escalation

Sensor Augmented Mode DEVICE

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.

De-escalation; Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: UVA Center for Diabetes Technology

marc.breton@virginia.edu

434-982-6484

Study Officials

• Marc Breton, PhD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: September 4, 2020
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)