Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04443153
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Decision Support System — DEVICE
    CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
  • 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.

Study Details

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.

Key Dates

Start date
Sep 4, 2020
Status verified
Oct 2025
Primary completion
Sep 19, 2024
Completion
Sep 19, 2024

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: De-escalation
    Subjects randomized to this arm will proceed from DSS to PF to SAM
  • Experimental: Escalation
    Subjects randomized to this arm will proceed from SAM to PF to DSS

Primary Outcome Measure

Glycemic Outcomes [ Time Frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Center for Diabetes TechnologyCharlottesvilleVirginia22903-

Find similar trials in Charlottesville, VA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Virginia Center for Diabetes Technology· Charlottesville, VA

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