CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Personalized Feedback +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04443153
NCT04443153N/ACompleted
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Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes

University of Virginia·interventional·Posted Jun 23, 2020·Updated Oct 28, 2025

In Brief

A clinical study evaluating Personalized Feedback, Decision Support System, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 23, 2020
Enrollment StartSep 4, 2020
Primary CompletionSep 19, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.0 years ago

Interventions

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.