Diabetes App for Diabetes

(LIVE JustICE Trial)

Recruiting at 1 trial location

Overseen By Louise A Reagan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Louise Reagan

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app, Diabetes LIVE JustICE, designed to help people manage diabetes more effectively. Researchers aim to determine if the app can improve users' diabetes knowledge, reduce diabetes-related stress, and enhance self-care practices. Participants will either use the app or receive enhanced diabetes education from a nurse. The trial seeks individuals with Type 1 or Type 2 diabetes who have recently been released from prison in Connecticut and are living in supervised community housing or on parole. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Diabetes LIVE JustICE application is safe?

Research has shown that the Diabetes LIVE JustICE app appears promising in early studies. This app is part of a program that provides education and support for managing diabetes. Studies have found that this kind of support can slightly but meaningfully lower A1C levels, which measure blood sugar control. This suggests the app could be helpful without causing major side effects.

For the Enhanced Education treatment, research confirms its safety and effectiveness. Programs like this improve diabetes management by teaching about medication, diet, and lifestyle changes. Past studies have found these programs to be well-received and safe.

Both treatments in this trial are based on methods previously tested and used, suggesting they are likely safe and well-tolerated for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes LIVE JustICE program because it leverages a virtual education environment to enhance diabetes self-management. Unlike traditional diabetes education, which often involves in-person sessions or printed materials, this program uses avatars and interactive virtual classrooms, making learning more engaging and accessible. Additionally, the program is tailored to the literacy level of participants, ensuring that the education is understandable and relatable, which could lead to better adherence to diabetes management practices. This novel approach addresses the need for scalable, flexible, and effective diabetes education, potentially improving outcomes for people living with diabetes in community housing.

What evidence suggests that the Diabetes LIVE JustICE app and Enhanced Education could be effective for diabetes?

Research shows that learning to manage diabetes can greatly enhance the lifestyle and self-care of people with Type 2 diabetes. Studies have found that those who receive diabetes education are more likely to follow important self-care practices. In this trial, participants in the intervention arm will use the Diabetes LIVE JustICE app, which has helped people manage their diabetes more effectively than traditional care with basic educational materials. Additionally, online programs like this one can lower A1c levels, a key measure of blood sugar control. Participants in the control arm will receive Enhanced Education programs, which also lead to improvements, such as better blood sugar levels and weight management. Both the Diabetes LIVE JustICE app and Enhanced Education provide users with the knowledge and tools needed to manage diabetes effectively. ^{1 4 6 7 8}

Who Is on the Research Team?

Lousie Reagan, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older with Type 1 or Type 2 diabetes who have recently been released from one of five Connecticut prisons to supervised housing or parole. Participants must be able to speak and understand English.

Inclusion Criteria

People with either Type 1 or Type 2 diabetes can take part in the study.

Individuals will be eligible to participate if they have been released directly from one of five Connecticut prisons to supervised community housing or parole

Individuals will be eligible to participate if they can speak and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week Diabetes Self-Management Education and Support (DSMES) intervention using the Diabetes LIVE JustICE application

6 weeks

6 synchronous 1-hour education sessions and 1-hour support session

Follow-up

Participants are monitored for self-management behaviors, emotional distress, and metabolic indicators

6 weeks

Open-label extension (optional)

Participants may continue to use the Diabetes LIVE JustICE application for ongoing support

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes LIVE JustICE
• Enhanced Education

Trial Overview The study tests the Diabetes LIVE JustICE app against enhanced education, measuring its feasibility, acceptability, and impact on diabetes management over a period of 12 weeks with assessments at start, mid-point, and end.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Louise Reagan

Lead Sponsor

Trials

1

Recruited

130+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... Based on 15 articles, diabetes self-management education intervention provides significant effectiveness to lifestyle changes and the self-care of T2DM patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7783927/

Social Determinants of Health and Diabetes: A Scientific Review The literature review focuses primarily on US-based studies of adults with diabetes and on five SDOH: socioeconomic status (education, income, occupation);

3. diabetes.org diabetes.org/sites/default/files/2023-10/2021-ADA-Research-Report-2-3-22.pdf

Better Outcomes for Life. LIVE JustICE compared to usual pre-release care supplemented with low literacy diabetes education on clinical, social, cognitive and behavioral outcomes.

4. cdc.gov cdc.gov/diabetes/data-research/research/diabetes-education.html

Diabetes Education Linked to Better Care Among people who received diabetes education, nearly 25% followed at least 9 of the 10 self-care and clinical care practices, compared to 10% ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1543298/full

Comparative effectiveness of diabetes self-management ... This RCT highlights the universal benefits of self-paced virtual diabetes self-management interventions to reduce A1c among Texans with unmanaged T2DM.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11267966/

Advancing Health Equity in Diabetes: Tools to Help ... Examples of health equity challenges and tools to support efforts in type 2 diabetes (T2D) prevention and diabetes management are presented.

7. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Based on recent data (13,14,16), DSMES results in an average A1C reduction of 0.45–0.57% when compared with usual care for people with type 2 ...

8. diabetes.jmir.org diabetes.jmir.org/2023/1/e46050/

The Promising Success of Project Extension ... - JMIR Diabetes This case series elucidates the potential value of the ECHO Diabetes program to people with diabetes who receive their diabetes care from PCPs.