Diabetes Learning in Virtual Environments Just in Time for Community Reentry (LIVE JustICE)

July 23, 2025 updated by: Louise Reagan

Diabetes Learning in Virtual Environments Just In Time for Community reEntry (Diabetes LIVE JustICE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Among incarcerated persons, the rate of diabetes is almost 50% higher (9%) than the general population (6.5%) when matched for sex, age, race, and Hispanic origin. The burden of diabetes is carried forward post-incarceration, with 95% of incarcerated persons reentering the community with minimal health-related skills stemming from high-security environments with constrained self-care. These individuals lack critical knowledge and skills for diabetes self-management (DSM) regarding what foods to eat, how to control the formerly incarcerated person's blood sugar, and how and when to take insulin. Furthermore, the Principal Investigator's research in correctional institutions has demonstrated significant diabetes knowledge deficits related to treating potentially life-threatening hypo/hyperglycemia. A1C, a measure of metabolic control and predictive for diabetes complications, was suboptimal for the majority of participants. Furthermore, these returning citizens have cognitive impairment and lower literacy than those living in community households across age, sex, and educational attainment. The formerly incarcerated have higher hospitalization rates for short-term diabetes complications seven days' post-prison release compared to matched controls. Prevention is possible with Diabetes Self-Management Education and Support (DSMES) and diabetes survival skills (DSS). DSS refers to hypoglycemia and sick day management, insulin administration, and consistent nutrition habits, among other behaviors to prevent acute diabetes issues (hypo/hyperglycemia), and hospitalizations. At a minimum, incarcerated persons transitioning to the community have a critical need for DSS and support.

There have been efforts to examine the effect of engaging incarcerated persons in blood glucose monitoring on glycemic control. Still, those released from incarceration have not benefitted from the decades of research that have resulted in improved outcomes. As a first step to filling this gap, the research team developed a literacy-tailored 6-week theory-based DSS intervention. The research team tested the feasibility and acceptability of the DSS intervention in incarcerated men between 6 to 9 months of transitioning from state prisons to supervised community housing or parole. The Principal Investigator found improvements in diabetes knowledge and diabetes-related distress in both groups and outcome expectancy with the treatment group. Analysis of focus group data revealed acceptance of the literacy-tailored DSS education, a need for skill-based videos, and ongoing support upon release. After an analysis of the research team's retention rate and feasibility data, the research team identified the haphazard process of releasing individuals to supervised community housing as a significant contributor to retention for the research team's in-person pre-release DSS intervention.

Consequently, the primary investigator recognized a critical need to make the literacy-tailored DSS and ongoing DSMES widely accessible to returning citizens with diabetes after release to supervised housing via synchronous and asynchronous remote options. Based on the evidence that virtual environments (VE) may lead to superior learning and experience for the participants and can promote social and educational interaction via repetition, practice, feedback, and application,24,25 the research team aims to leverage the research team's collective experience with diabetes Learning in Virtual Environments (LIVE) a diabetes educator-led, DSMES in a VE26-28 to develop the Diabetes LIVE JustICE (Just In time for Community reentry) intervention using an iterative participant engaged process. Because persons living in supervised community housing do not have access to reliable private computers but do have access to mobile devices, the research team will develop Diabetes LIVE JustICE as a mobile application. The Principal Investigator's goal is to recruit a sample of vulnerable incarcerated persons with multimorbidity, including diabetes on the transition to supervised community living to develop and test the feasibility and acceptability of a multi-user virtual diabetes community (Diabetes LIVE JustICE). This platform allows users to talk to each other in real-time and participate in instructor-led education sessions and facilitated support sessions accessed through IOS/Android mobile devices. The specific aims of this study are to:

  1. Examine feasibility and acceptability of the Diabetes LIVE JustICE application by tracking the following outcomes: recruitment rate, participation rates (number of log-ins, time spent in mobile application, retention) engagement (materials accessed), and the user experience (usability, usefulness, satisfaction, and attitudes toward use of Diabetes LIVE JustICE).
  2. Examine the preliminary short-term effects of Diabetes LIVE JustICE compared to usual pre-release diabetes care supplemented with low literacy diabetes education materials on the following outcomes: A1C, diabetes knowledge, diabetes self-care, diabetes-related emotional distress, social support, and perceived competence.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Storrs, Connecticut, United States, 06269
        • Recruiting
        • University of Connecticut
        • Contact:
        • Principal Investigator:
          • Louise A Reagan, PhD
        • Sub-Investigator:
          • Stephen J Walsh, PhD
        • Contact:
      • Storrs Mansfield, Connecticut, United States, 06269-0001
        • Recruiting
        • University of Connecticut
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Enhanced Education
See control group description above
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: baseline
Demographic data (race/ethnicity, marital status, income (categorical), educational attainment, employment, age, sex, and disease duration).
baseline
Potential Confounding Effects
Time Frame: week 1
We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)
week 1
Potential Confounding Effects
Time Frame: week 2
We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)
week 2
Potential Confounding Effects
Time Frame: week 3
We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)
week 3
Potential Confounding Effects
Time Frame: week 4
We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)
week 4
Potential Confounding Effects
Time Frame: week 5
We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)
week 5
Potential Confounding Effects
Time Frame: week 6
We will send weekly text messages to experimental group participants. 1. In the past week, how many minutes did you talk to someone about your diabetes self-management? Multiple choice: minutes 2. Do you have anything else to tell us? (open-ended)
week 6
Metabolic Indicator
Time Frame: baseline
Metabolic control will be measured as glycosylated hemoglobin (HbA1c) through central laboratory measures (Quest Labs) [78], indicating average glucose levels over the prior three months. The reliability and validity of the lab measures are improved by utilizing a central laboratory for sample analysis (Quest Labs).
baseline
Metabolic Indicator
Time Frame: week 12
Metabolic control will be measured as glycosylated hemoglobin (HbA1c) through central laboratory measures (Quest Labs) [78], indicating average glucose levels over the prior three months. The reliability and validity of the lab measures are improved by utilizing a central laboratory for sample analysis (Quest Labs).
week 12
Diabetes Knowledge
Time Frame: baseline
Diabetes knowledge will be measured by the 10 item Spoken Knowledge in Low Literacy for Diabetes scale (SKILLD).51 It takes less than 10 minutes to administer. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder Richardson Coefficient of reliability) When used to evaluate knowledge in a population of incarcerated persons with diabetes, Cronbach's alpha was 0.6520-.0.70 respectively.7,6 Content validity was confirmed in previous research by experts in correctional health.
baseline
Diabetes Knowledge
Time Frame: week 6
Diabetes knowledge will be measured by the 10 item Spoken Knowledge in Low Literacy for Diabetes scale (SKILLD).51 It takes less than 10 minutes to administer. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder Richardson Coefficient of reliability) When used to evaluate knowledge in a population of incarcerated persons with diabetes, Cronbach's alpha was 0.6520-.0.70 respectively.7,6 Content validity was confirmed in previous research by experts in correctional health.
week 6
Diabetes Knowledge
Time Frame: week 12
Diabetes knowledge will be measured by the 10 item Spoken Knowledge in Low Literacy for Diabetes scale (SKILLD).51 It takes less than 10 minutes to administer. Coefficients of internal reliability for the SKILLD have been reported at 0.72 (Kuder Richardson Coefficient of reliability) When used to evaluate knowledge in a population of incarcerated persons with diabetes, Cronbach's alpha was 0.6520-.0.70 respectively.7,6 Content validity was confirmed in previous research by experts in correctional health.
week 12
Diabetes-Related Emotional Distress
Time Frame: baseline
Distress will be measured with PAID (Problem Areas in Diabetes) scale, 52with 20 items using a 6-point Likert scale; higher scores indicate higher levels of distress. Internal consistency >0.902.
baseline
Diabetes-Related Emotional Distress
Time Frame: week 6
Distress will be measured with PAID (Problem Areas in Diabetes) scale, 52with 20 items using a 6-point Likert scale; higher scores indicate higher levels of distress. Internal consistency >0.902.
week 6
Diabetes-Related Emotional Distress
Time Frame: week 12
Distress will be measured with PAID (Problem Areas in Diabetes) scale, 52with 20 items using a 6-point Likert scale; higher scores indicate higher levels of distress. Internal consistency >0.902.
week 12
Self-management behaviors
Time Frame: baseline
Self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) .53 This 11-item questionnaire assesses the frequency of health behaviors over the last week, including diet, exercise, blood sugar testing, foot care, and smoking. The instrument has acceptable internal consistency
baseline
Self-management behaviors
Time Frame: week 6
Self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) .53 This 11-item questionnaire assesses the frequency of health behaviors over the last week, including diet, exercise, blood sugar testing, foot care, and smoking. The instrument has acceptable internal consistency
week 6
Self-management behaviors
Time Frame: week 12
Self-management behaviors will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA) .53 This 11-item questionnaire assesses the frequency of health behaviors over the last week, including diet, exercise, blood sugar testing, foot care, and smoking. The instrument has acceptable internal consistency
week 12
Perceived Support for Diabetes Management
Time Frame: baseline
The 12-item Diabetes Support Scale assesses social support in a diabetes internet intervention and has demonstrated internal consistency 0.90-0.93, and construct validity
baseline
Perceived Support for Diabetes Management
Time Frame: week 6
The 12-item Diabetes Support Scale assesses social support in a diabetes internet intervention and has demonstrated internal consistency 0.90-0.93, and construct validity
week 6
Perceived Support for Diabetes Management
Time Frame: week 12
The 12-item Diabetes Support Scale assesses social support in a diabetes internet intervention and has demonstrated internal consistency 0.90-0.93, and construct validity
week 12
Perceived Competence Scale
Time Frame: baseline
The 4-item PCS assesses the degree to which participants feel confident of meeting the challenges of DSM. A person's score on the PCS is calculated by averaging responses on the four-item 7-poins Likert scale with higher scores indicating higher perceived competence. Alpha reliabilities have been reported as above 0.80.
baseline
Perceived Competence Scale
Time Frame: week 6
The 4-item PCS assesses the degree to which participants feel confident of meeting the challenges of DSM. A person's score on the PCS is calculated by averaging responses on the four-item 7-poins Likert scale with higher scores indicating higher perceived competence. Alpha reliabilities have been reported as above 0.80.
week 6
Perceived Competence Scale
Time Frame: week 12
The 4-item PCS assesses the degree to which participants feel confident of meeting the challenges of DSM. A person's score on the PCS is calculated by averaging responses on the four-item 7-poins Likert scale with higher scores indicating higher perceived competence. Alpha reliabilities have been reported as above 0.80.
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louise Reagan

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Lousie Reagan, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 23, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21-0144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

1. Summary of data outputs and/or resources that the proposed research will generate: The PIs are committed to the open and timely dissemination of research outcomes. We expect that the proposed project will produce the following data:

  1. Raw study data, protocols, processed data, quantitative measures and qualitative self-reported data.
  2. Data analysis programs in the format of SPSS, SAS, and R.

Proposed repository for data sharing: The materials, data, and protocols from the research will be made available to researchers who are interested in reproducing the work and developing original research based on our work. We will prepare our dataset in accordance with the requirements for NIDDK data repository datasets and associated documentation for submission to the NIDDK Information Network(DKnet) in accordance with the Guidelines for NIDDK DKnet data set preparation.

IPD Sharing Time Frame

Data generated from the proposed study would be shared and available to the participating study investigators no later than 6 months post publication or 18 months from the award end date of November 1, 2024.

IPD Sharing Access Criteria

We also intend to make results available to the community of scientists interested in diabetes self-management education and behavioral research, correctional health research, and virtual environments upon request to avoid unintentional duplication of research. Furthermore, we will welcome collaboration with others who could make use of the study protocols developed in the proposed study. Deidentified datasets will be made readily available for sharing with other qualified researchers after major publications have been accepted

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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