Diabetes LIVE JustICE for Type 1 and Type 2 Diabetes

This study is testing a new program called Diabetes LIVE JustICE. This program uses a virtual environment to help people with Type 1 or Type 2 diabetes learn how to manage their condition. It's designed for individuals who have recently left prison and are reentering the community. The study wants to see if this program is practical, acceptable to users, and if it helps improve diabetes knowledge, self-care, and blood sugar control. You can join if you are 18 or older, have Type 1 or 2 diabetes, speak English, and have been released from one of five Connecticut prisons to supervised housing or parole. The study is currently unclear on its recruitment status.

Study design
This study is an interventional trial with a planned enrollment of 128 participants. It uses a randomized design, meaning participants will be assigned to either the Diabetes LIVE JustICE program or an enhanced education control group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks, with measurements taken at 0, 6, and 12 weeks.

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NCT05286892

Diabetes Learning in Virtual Environments Just in Time for Community Reentry

Recruiting
NAAges 18+InterventionalSupportive care
Louise Reagan
~128 participants
Updated 2025-07-28 on ClinicalTrials.gov
What's tested:Diabetes LIVE JustICEEnhanced Education

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demographics
Measured over baseline
+23 more outcomes measured
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
2 sites across 1 states
Connecticut2
  • Lousie Reagan, PhD · PRINCIPAL_INVESTIGATOR · University of Connecticut

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  • Demographicsbaseline

    Demographic data (race/ethnicity, marital status, income (categorical), educational attainment, employment, age, sex, and disease duration).

  • Potential Confounding Effectsweek 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)

  • Potential Confounding Effectsweek 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)

  • Potential Confounding Effectsweek 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)

  • Potential Confounding Effectsweek 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)

  • Potential Confounding Effectsweek 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)

  • Potential Confounding Effectsweek 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)

  • Metabolic Indicatorbaseline

    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).

  • Metabolic Indicatorweek 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).

  • Diabetes Knowledgebaseline

    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.

  • Diabetes Knowledgeweek 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.

  • Diabetes Knowledgeweek 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.

  • Diabetes-Related Emotional Distressbaseline

    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.

  • Diabetes-Related Emotional Distressweek 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.

  • Diabetes-Related Emotional Distressweek 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.

  • Self-management behaviorsbaseline

    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

  • Self-management behaviorsweek 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

  • Self-management behaviorsweek 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

  • Perceived Support for Diabetes Managementbaseline

    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

  • Perceived Support for Diabetes Managementweek 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

  • Perceived Support for Diabetes Managementweek 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

  • Perceived Competence Scalebaseline

    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.

  • Perceived Competence Scaleweek 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.

  • Perceived Competence Scaleweek 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.