NCT04443153

Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes

Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Personalized Feedback	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.
DEVICE	Decision Support System	CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
DEVICE	Sensor Augmented Mode	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.

Timeline

• Start date: 2020-09-04
• Primary completion: 2024-09-19
• Completion: 2024-09-19
• First posted: 2020-06-23
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study