DREAM Intervention for Type 1 Diabetes

(DREAM Trial)

Recruiting at 2 trial locations

Overseen By Cristina Acosta Navarro, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Medical, developmental, psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Latinx teens with type 1 diabetes (T1D) use technology like insulin pumps and continuous glucose monitors more effectively. The researchers seek to determine if a virtual peer group (VPG) intervention, called the DREAM intervention (Device Use Reimagined Through Education And Mentorship), can improve glucose control and make using these devices more acceptable and feasible. Teens with T1D who receive care at certain California medical centers and identify as Latinx are ideal candidates. Participants will join virtual groups to discuss various topics, with sessions available in both English and Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management for Latinx teens.

Will I have to stop taking my current medications?

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

What prior data suggests that the DREAM intervention is safe for Latinx adolescents with type 1 diabetes?

Research has shown that the DREAM program is designed to help Latinx teenagers with type 1 diabetes improve their use of diabetes technology, such as insulin pumps and continuous glucose monitors. The program promotes the use of these devices through online peer groups, where participants receive support and motivation from others in similar situations.

Currently, no specific information exists on side effects or problems associated with the DREAM program. However, as a support program rather than a new drug or device, any risks are expected to be low. The program aims to enhance the use of these devices, which is generally safe and beneficial for managing type 1 diabetes.

Overall, available information suggests that most participants should find the DREAM program manageable and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DREAM intervention for Type 1 Diabetes because it offers a fresh, community-focused approach. Unlike traditional treatments that primarily focus on insulin management, this intervention emphasizes support through virtual peer groups (VPGs) and optional in-person events. By fostering community and education among youth and caregivers in both English and Spanish, it aims to improve diabetes management through shared experiences and support. This approach could address the emotional and social challenges of living with Type 1 Diabetes, which are often overlooked by standard medical treatments.

What evidence suggests that the DREAM intervention is effective for improving device use in Latinx adolescents with type 1 diabetes?

Research has shown that the DREAM program, which participants in this trial may receive, aims to help Latinx teenagers with type 1 diabetes (T1D) improve their use of diabetes devices. Studies suggest that combining technology with education and mentorship can simplify diabetes management. The program seeks to increase the use of continuous glucose monitors, which track blood sugar levels, and other diabetes tools. Early results indicate that this approach can lead to better blood sugar control and overall health for participants. By offering support through online peer groups, the program may help fill gaps in diabetes care for these young people. ^{1 2 3 4 6}

Who Is on the Research Team?

Jenise Wong, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for Latinx adolescents with Type 1 Diabetes in California who may benefit from better glucose control through the use of diabetes technology. The study aims to support these youths and their families in using insulin pumps and monitoring devices more effectively.

Inclusion Criteria

I am between 13 and 17 years old, or I am the caregiver of someone in this age group.

I am a teenager with Type 1 Diabetes and get my care at UCSF, CHLA, or UC Davis.

Self-identify as Latina/o/x or other variations such as Hispanic

Exclusion Criteria

Participants who have a medical, developmental, or psychiatric condition that would make peer group participation difficult

Adolescents who are planning to transfer care to a different medical center within the next year, which would prevent assessment of longitudinal outcomes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in virtual peer groups (VPGs) to promote the use of diabetes technology among Latinx adolescents with T1D

12 months

Bi-weekly virtual sessions, quarterly in-person events

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• DREAM intervention

Trial Overview The DREAM intervention, which stands for Device Use Reimagined Through Education And Mentorship, is being tested. It's a virtual peer group program designed to encourage Latinx adolescents with T1D to use diabetes technology more frequently.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Virtual peer groups (VPGs) Six different VPGs topics will be offered. Each VPG topic will be presented separately to youth and caregivers, in Spanish and English. Frequency of scheduling for each VPG will vary on a month-to-month basis depending on the distribution of current enrollees who have not yet discussed that topic and the availability of the relevant facilitators. In-Person Events Optional in-person events may be offered quarterly during the 6-12 month study participation period.

Group II: Comparator Group Active Control 1 Intervention

An equal number of eligible non-enrolled patients at each site will be selected and matched to the enrolled cohort based on age, language, HbA1c, insurance type, and diabetes technology use at a population level.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A study involving 16 young adults with type 1 diabetes revealed that a cognitive behavioral sleep self-management intervention (CB-sleep) is perceived as beneficial for improving sleep knowledge and health goals.

Participants identified various barriers and facilitators to the CB-sleep intervention, suggesting it could be effectively integrated into diabetes self-management programs to enhance both sleep quality and glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Sleep Self-Management Intervention for Young Adults With Type 1 Diabetes (NCT04975230). Griggs, S., Hernandez, E., Bolton, PJ., et al.[2023]

In a study of 86 children and adolescents with type 1 diabetes, those with higher glycated hemoglobin (HbA1c) levels (≥7.5%) experienced more daytime sleepiness and shorter sleep duration during the week.

The research found that a shorter duration since diagnosis of type 1 diabetes also increased the likelihood of daytime sleepiness, indicating that both poor glycemic control and recent diagnosis may negatively impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus. Silva, RAE., Ganen, AP., Fernandes, VFT., et al.[2021]

The study will involve up to 175 adolescents with type 1 diabetes and their caregivers, comparing the effects of a sleep extension intervention against family routines support to improve sleep duration and glycemic control.

It is hypothesized that increasing sleep duration will lead to better glycemic control, measured through continuous glucose monitoring and HbA1c levels, highlighting the importance of sleep in managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. Perfect, MM., Silva, GE., Chin, CN., et al.[2023]

This study will evaluate the effectiveness of a sleep optimization intervention (Sleep-Opt) in improving sleep quality and glycemic control in 120 adults with type 1 diabetes over 12 weeks, focusing on sleep variability, duration, and A1C levels.

The Sleep-Opt intervention combines technology-assisted behavioral strategies, including a wearable sleep tracker and a smartphone app, aiming to enhance self-management behaviors and overall quality of life for individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Martyn-Nemeth, P., Duffecy, J., Quinn, L., et al.[2023]

The automated unified safety system (USS) improved the time children and adolescents with type 1 diabetes spent in the target glucose range (70-150 mg/dL) during overnight closed-loop control, achieving a median of 73% compared to 52% with standard sensor-augmented therapy.

The USS also significantly reduced the occurrence of nocturnal hypoglycemia, with less time spent in low glucose ranges (<50, <60, and <70 mg/dL) during the overnight period, indicating both safety and efficacy in managing diabetes overnight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Ly, TT., Breton, MD., Keith-Hynes, P., et al.[2022]

In a study involving 176 participants with type 1 diabetes, nocturnal hypoglycemia occurred in 8.5% of nights, with a median of 7.4% of nights per subject experiencing these events, indicating that hypoglycemia is a common issue during the night.

The risk of nocturnal hypoglycemia was significantly higher in patients with lower baseline A1C levels and those who had experienced hypoglycemia during a prior blinded continuous glucose monitoring period, suggesting that monitoring can help identify at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged nocturnal hypoglycemia is common during 12 months of continuous glucose monitoring in children and adults with type 1 diabetes. [2022]

A systematic review of 24 studies involving 3,117 youth with type 1 diabetes (T1D) found that while psychosocial interventions show promise for improving glycemic health, only 11 studies included more than 20% racially/ethnically minoritized (REM) youth.

Despite the potential benefits of these interventions, only one study specifically examined their impact on REM youth or addressed racial/ethnic disparities in treatment outcomes, highlighting a significant gap in research that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involvement of Racially and Ethnically Minoritized Youths in Behavioral Type 1 Diabetes Interventions: A Systematic Review. Dimentstein, K., Greenberg, BA., Valenzuela, JM.[2023]

Individuals with type 1 diabetes (T1D) experience more sleep disturbances than those without diabetes, which negatively affects their blood sugar control and overall diabetes management.

Inconsistent sleep timing is linked to poorer glycemic control, suggesting that interventions aimed at improving sleep consistency could enhance diabetes management and psychosocial outcomes for people with T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. Perez, KM., Hamburger, ER., Lyttle, M., et al.[2020]

In a study of 315 adults with type 1 diabetes, poor sleep quality was linked to higher levels of anxiety and depression, indicating that sleep disturbances can negatively impact psychological well-being.

Despite the correlation between sleep quality and psychological health, glycemic variability did not differ between those with poor and good sleep, suggesting that psychological management may be key to improving sleep quality without directly affecting blood sugar control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between sleep disturbances, fear of hypoglycemia and psychological well-being in adults with type 1 diabetes mellitus, data from cross-sectional VARDIA study. Suteau, V., Saulnier, PJ., Wargny, M., et al.[2020]

In a study of 92 youth with type 1 diabetes using the Minimed 670G hybrid closed loop (HCL) system, 30% discontinued use within 6 months, with higher baseline HbA1c levels significantly predicting discontinuation.

The main barriers to continued use of HCL included difficulties with calibrations, frequent alarms, and the overall workload required to manage the system, indicating a need for interventions to support users, especially those with higher HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Messer, LH., Berget, C., Vigers, T., et al.[2021]

In a study involving 35 young adults with type 1 diabetes, two main health goals were identified: promoting better sleep (including quantity, quality, and hygiene) and improving diabetes self-management (like monitoring glucose levels and diet).

The use of sleep data visualization helped participants articulate their health goals, suggesting that this approach could effectively support young adults with type 1 diabetes in achieving better sleep and managing their condition more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Sleep Health in Young Adults with Type 1 Diabetes. Griggs, S., Grey, M., Toly, VB., et al.[2022]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06546930

Device Use Reimagined Through Education And Mentorship The DREAM project's findings will inform future efforts to improve diabetes technology use and T1D health outcomes among Latinx adolescents. If found to be ...

2. reporter.nih.gov reporter.nih.gov/search/Su4yiEmhE06dk_wF_KdnIw/project-details/10746406

RePORT RePORTER - National Institutes of Health (NIH) | This study aims to evaluate the preliminary efficacy of the behavioral intervention to enhance CGM use and resulting T1D health outcomes. Sixty adolescents and ...

3. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-8-2024-f377e

DREAM Intervention for Type 1 Diabetes (DREAM Trial) The DREAM Intervention is unique because it combines device use with education and mentorship ... effective in helping people manage their diabetes.

4. reporter.nih.gov reporter.nih.gov/project-details/7991005

Incentives for Internet-based glucose testing in adolescent ... Optimizing diabetes technology use for Latinx youth through DREAM (Device use Reimagined through Education And Mentorship) virtual peer groups. 504 ...

5. policylab.us policylab.us/clinical-trials/l/california/condition/type-1-diabetes?page=3

Type 1 Diabetes Paid Clinical Trials in California - Policy Lab A listing of 33 Type 1 Diabetes clinical trials in California actively recruiting volunteers for paid trials and research studies in various therapeutic areas.

6. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9ExNjI3MDcx1DcyMjE3MDEwMQ0FHKSy4xMDY1NjexMFKKBQCPOhaB

Save Selected The trial will be an open label, single arm, phase 2 study in 20 participants. The study will assess the tolerability and efficacy of HLX-1502 in ...