DREAM Intervention for Type 1 Diabetes

(DREAM Trial)

Recruiting at 2 trial locations

Overseen By Jenise C Wong, MD, PhD

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: 0

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Diabetes technology, such as insulin pumps and continuous glucose monitoring devices, can help improve glucose control for people with type 1 diabetes (T1D), which keeps them at lower risk for diabetes complications, but many Latinx adolescents, who make up the largest marginalized ethnic group of youth with T1D in California, use these devices less often and have less optimal glucose control compared to White youth. In phase 1 of this project, we worked directly with Latinx youth, their families, and diabetes care team members in California to develop DREAM, Device use Reimagined through Education And Mentorship, a virtual peer group (VPG) intervention that will encourage and support the use of diabetes devices in Latinx adolescents with T1D. The goals for phase 2 (intervention) of this project are to evaluate the feasibility and acceptability of the stakeholder-informed VPG intervention, and evaluate clinical and person-centered outcomes.

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 data supports the effectiveness of the DREAM intervention treatment for Type 1 Diabetes?

Research shows that improving sleep can help manage blood sugar levels in people with Type 1 Diabetes. Studies have found that focusing on better sleep habits can lead to better diabetes control, which suggests that the DREAM intervention, which includes education and mentorship, might be effective in helping people manage their diabetes. ^{1 2 3 4 5}

Is the DREAM Intervention for Type 1 Diabetes safe for humans?

The research articles provided do not contain specific safety data for the DREAM Intervention or its related names. They focus on other aspects of diabetes management and do not address the safety of this particular treatment. ^{1 4 6 7 8}

How is the DREAM Intervention treatment for Type 1 Diabetes different from other treatments?

The DREAM Intervention is unique because it combines device use with education and mentorship to improve diabetes self-management, focusing on sleep health and glycemic control, which is not typically addressed in standard treatments for Type 1 Diabetes. ^{4 5 9 10 11}

Research Team

Jenise Wong, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Virtual peer groups (VPGs) Six different VPGs topics will be offered on two dates (same topic) every 4-6 weeks, with topics rotating at 4-6 week intervals during their 12-month study participation period. In-Person Events Quarterly in-person events will be offered during their 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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Extending sleep to improve glycemia: The Family Routines Enhancing Adolescent Diabetes by Optimizing Management (FREADOM) randomized clinical trial protocol. [2023]

2. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus. [2021]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Exploring Sleep Health in Young Adults with Type 1 Diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Involvement of Racially and Ethnically Minoritized Youths in Behavioral Type 1 Diabetes Interventions: A Systematic Review. [2023]

6. United States 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. [2022]

7. Denmark 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. [2021]

8. United States 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]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep in Type 1 Diabetes: Implications for Glycemic Control and Diabetes Management. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Sleep Self-Management Intervention for Young Adults With Type 1 Diabetes (NCT04975230). [2023]

11. Ireland 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. [2020]