Recruiting

Observational Study

Sponsor:

Louise Reagan

Code:

NCT05286892

Conditions

Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diabetes LIVE JustICE

Enhanced Education

Study Details

Brief summary:

The proposed study will use a randomized clinical trial design with non-equivalent control group and longitudinal design to evaluate the feasibility, acceptability, and preliminary effects of the Diabetes LIVE JustICE application. The design will incorporate repeated measures at 0, 6, and 12 weeks. Outcome variables will include recruitment assessments, participation, engagement, user experience, and measures proximally related to behavior change - e.g., diabetes knowledge, diabetes-related distress, diabetes self-care, and social support and clinical outcomes -e.g., glycemic control. Focus group interviewing will be conducted to evaluate acceptability among intervention group participants.

Conditions

Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2

Study ID

NCT05286892

Start date

Apr 30, 2023

Status verified date

Jul, 2025

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individuals will be eligible to participate if they:

1. have Type 1 or 2 diabetes
2. are age 18 and older
3. can speak and understand English
4. have been released directly from one of five Connecticut prisons to supervised community housing or parole

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Control

Participants randomized to the control group will receive enhanced pre-release diabetes education with registered or licensed practical nurse-delivered diabetes education about medications and insulin administration supplemented with the literacy tailored diabetes education packets used in the principal investigator's prior research.

experimental: Intervention

Because eight avatars plus the educator avatar are allowed in the VE classroom at one time, we will cap enrollment for the feasibility study to allow for CHW and CDE training and the opportunity to work together during LIVE JustICE sessions. The DSMES will consist of six synchronous 1-hour education sessions and an hour support session for participants living in supervised community housing in the experimental group. We will run the six-week series sequentially a total of eleven times over 18 months. LIVE JustICE sessions will be held conveniently for participants, and days/times rotated if needed.

Interventions

Diabetes LIVE JustICE

Diabetes LIVE JustICE will be an adaptation of the current Diabetes LIVE persistent multi-user online virtual environment built on the Unreal Engine (Epic Games, Inc., Cary, NC) that allows users to talk to each other in real-time and participate in instructor-led synchronous sessions. Users can access the virtual environment through IOS/Android devices. Instructors can show learning material such as Google Docs and PowerPoint. The LIVE JustICE community will contain a community center, a tranquility center, and a message board. This will be an interactive community where participants will communicate in real-time on their mobile device or, if preferred, using their computer via text or audio chat. Access to LIVE will allow participants to utilize resources and links in the application, leave a message on the message board for the diabetes educators, or engage with other participants. Research team members will add and trial gaming activities to the VE during this feasibility study.

Enhanced Education

See control group description above

Primary outcome measure

  • Demographics [ Time Frame: baseline ]
  • Potential Confounding Effects [ Time Frame: week 1 ]
  • Potential Confounding Effects [ Time Frame: week 2 ]
  • Potential Confounding Effects [ Time Frame: week 3 ]
  • Potential Confounding Effects [ Time Frame: week 4 ]
  • Potential Confounding Effects [ Time Frame: week 5 ]
  • Potential Confounding Effects [ Time Frame: week 6 ]
  • Metabolic Indicator [ Time Frame: baseline ]
  • Metabolic Indicator [ Time Frame: week 12 ]
  • Diabetes Knowledge [ Time Frame: baseline ]
  • Diabetes Knowledge [ Time Frame: week 6 ]
  • Diabetes Knowledge [ Time Frame: week 12 ]
  • Diabetes-Related Emotional Distress [ Time Frame: baseline ]
  • Diabetes-Related Emotional Distress [ Time Frame: week 6 ]
  • Diabetes-Related Emotional Distress [ Time Frame: week 12 ]
  • Self-management behaviors [ Time Frame: baseline ]
  • Self-management behaviors [ Time Frame: week 6 ]
  • Self-management behaviors [ Time Frame: week 12 ]
  • Perceived Support for Diabetes Management [ Time Frame: baseline ]
  • Perceived Support for Diabetes Management [ Time Frame: week 6 ]
  • Perceived Support for Diabetes Management [ Time Frame: week 12 ]
  • Perceived Competence Scale [ Time Frame: baseline ]
  • Perceived Competence Scale [ Time Frame: week 6 ]
  • Perceived Competence Scale [ Time Frame: week 12 ]

Central Contacts and Locations

Central contacts

Lousie Reagan, PhD

860-486-0593louise.reagan@uconn.edu

Stephen Walsh, ScD

860-486-0544stephen.walsh@uconn.edu

Locations

University of Connecticut

Recruiting

Storrs, Connecticut, United States, 06269

Contacts

Louise A Reagan, PhD

18608745644louise.reagan@uconn.edu

Stephen J Walsh, ScD

8608745644louise.reagan@uconn.edu

Principal Investigator:

Louise A Reagan, PhD

University of Connecticut

Recruiting

Storrs Mansfield, Connecticut, United States, 06269-0001

Contacts

Louise A Reagan, PhD

8608745644louise.reagan@uconn.edu

More Information

Sponsor

Louise Reagan

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Keywords

  • Vulnerable Population
  • Diabetes Self-Management Education and Support (DSMES)
  • Diabetes Survival Skills (DSS)
  • innovation
  • technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louise Reagan on 2025-07-28.