Technology Uptake for Type 1 Diabetes

(BEAD-T1D Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-type 1 diabetes, Non-public insurance, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young people with type 1 diabetes use diabetes technology more effectively. The research focuses on understanding factors that prevent or encourage the use of these technologies, which can improve diabetes management. The trial includes a four-week behavioral intervention for diabetes technology uptake, delivered online to ensure accessibility for families nationwide. Youth aged 12-21 with type 1 diabetes, living with their parents or guardians, and having public insurance, are ideal candidates for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to research that could enhance diabetes technology use for young people across the country.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for increasing diabetes technology uptake?

Research has shown that programs designed to help people use diabetes technology are generally safe and easy to handle. These programs can lead to benefits such as reduced family conflict and improved blood sugar control for up to two years. While studies do not always focus on safety details, the positive results suggest these programs work effectively without causing major issues. There are no significant reports of negative side effects, making them a safe choice for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on increasing the uptake of diabetes technology among young people with Type 1 Diabetes. Unlike traditional treatments that mainly involve insulin therapy and glucose monitoring, this intervention aims to enhance the use of advanced diabetes technology, potentially leading to better management of the condition. The intervention is delivered virtually, which is a big plus as it allows for national recruitment and accessibility even during situations like a pandemic. This approach could pave the way for more personalized and effective diabetes management strategies in the future.

What evidence suggests that this intervention is effective for increasing diabetes technology uptake?

This trial will evaluate an intervention designed to increase the uptake of diabetes technology. Research has shown that technology can improve diabetes management. Studies have found that smartphone apps and text message reminders enhance blood sugar control and encourage more frequent use of diabetes devices. One study found that a digital health platform with a Bluetooth glucose meter enhanced diabetes care. Overall, technology appears to make managing diabetes easier and more effective. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young people aged 12-21 with Type 1 Diabetes, especially from low socioeconomic backgrounds. Participants must be living with a parent or guardian if under 18 (with their consent) and can give personal consent if over 18.

Inclusion Criteria

I am between 12 and 21 years old.

Youth must be living with their parent/guardian

Exclusion Criteria

I was diagnosed with diabetes as a youth, but it's not type 1.

Non-public payer insurance

I am either younger than 12 or older than 21 with type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Intervention

Participants receive intervention modules weekly over a four-week period, including pre- and post-intervention assessments of survey measurements.

4 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for changes in diabetes technology usage and provide feedback on the intervention.

4 weeks

1 virtual visit for feedback interview

What Are the Treatments Tested in This Trial?

Interventions

• Intervention to increase diabetes technology uptake

Trial Overview

The BEAD-T1D study aims to increase the use of diabetes technology among disadvantaged youths. It will explore barriers to care, aiming to improve diabetes management and outcomes in this group.

How Is the Trial Designed?

Group I: Pilot Intervention Experimental Treatment 1 Intervention

The design for this phase is a prospective pilot study. The intervention will be delivered weekly over a four-week period and will include pre- and post-intervention assessments of survey measurements. The investigators will also evaluate youth diabetes management and technology use. Families will be compensated in a stepwise fashion. Virtual delivery of the pilot intervention will facilitate national recruitment and allow for recruitment during the pandemic or any ensuing limitations to in-person recruitment.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

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 of 1498 adults with type 1 diabetes identified five distinct personas based on their readiness to adopt diabetes technology, revealing that the 'd-Embracers' had the highest device use and lowest HbA1c levels, indicating better health outcomes.

The findings suggest that understanding these personas can help create targeted interventions to address specific barriers and psychosocial needs, potentially increasing the adoption of beneficial diabetes devices like insulin pumps and continuous glucose monitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Wary Wearers to d-Embracers: Personas of Readiness to Use Diabetes Devices. Tanenbaum, ML., Adams, RN., Iturralde, E., et al.[2019]

Despite significant advancements in diabetes technology, such as insulin pumps and continuous glucose monitoring, barriers to adoption still exist at various levels, including systemic, provider, and individual.

Facilitators for increasing and sustaining the use of these devices include consistent insurance coverage, structured education for users, and accessible support resources, highlighting the need for comprehensive strategies to enhance device adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Diabetes Device Adoption for People with Type 1 Diabetes. Tanenbaum, ML., Commissariat, PV.[2023]

A series of 7 virtual workshops with 32 stakeholders, including patients and healthcare providers, identified key barriers to technology use in type 1 diabetes and co-created solutions to enhance accessibility and support.

Proposed interventions focused on creating equitable systems for technology access, utilizing hands-on education, increasing peer and family support, and aiding in insurance navigation to address disparities in diabetes technology use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solutions to Address Inequity in Diabetes Technology Use in Type 1 Diabetes: Results from Multidisciplinary Stakeholder Co-creation Workshops. Agarwal, S., Crespo-Ramos, G., Leung, SL., et al.[2023]

The study involving 29 women with type 2 diabetes showed that a continuous glucose monitoring intervention combined with problem-solving counseling significantly improved participants' problem-solving skills compared to those receiving general diabetes education.

Participants in the continuous glucose monitoring plus problem-solving group also experienced greater improvements in dietary adherence, moderate physical activity, and weight loss, indicating preliminary efficacy of this intervention in promoting healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A continuous glucose monitoring and problem-solving intervention to change physical activity behavior in women with type 2 diabetes: a pilot study. Allen, N., Whittemore, R., Melkus, G.[2022]

Diabetes self-management technologies, such as continuous glucose monitoring and insulin pump therapy, significantly improve clinical outcomes for type 1 diabetes patients, but their effectiveness is influenced by psychosocial factors and previous self-care behaviors.

While these technologies do not appear to cause adverse psychological outcomes and are associated with high treatment satisfaction, there is a risk of widening health inequalities if access is limited to only motivated patients, highlighting the need for comprehensive education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences on Technology Use and Efficacy in Type 1 Diabetes. Franklin, V.[2018]

A study of 471 parents of youth with type 1 diabetes identified five distinct profiles based on their attitudes toward diabetes technology, which can help tailor support and education for better device uptake.

The majority of parents (50.7%) were categorized as 'Embracers,' indicating a positive attitude towards technology, while smaller groups expressed concerns such as burden, distrust, or minimal engagement, highlighting the need for personalized approaches in promoting insulin pumps and continuous glucose monitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Perspectives: Identifying Profiles of Parental Attitudes and Barriers Related to Diabetes Device Use. Wong, JJ., Barley, RC., Hanes, S., et al.[2021]

Recent advancements in diabetes technology, including insulin pumps and automated insulin delivery systems, have shown significant positive health and psychosocial outcomes for individuals with type 1 diabetes.

Despite these benefits, there are notable barriers to the adoption of these technologies, such as device-related physical burdens, high costs, and inadequate healthcare support, which hinder their utilization among both adults and children with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to Uptake of Insulin Technologies and Novel Solutions. Pauley, ME., Berget, C., Messer, LH., et al.[2021]

Patients with type 1 diabetes are increasingly using various technologies for management, but the impact on health and psychological outcomes varies, with some groups benefiting more than others.

Despite the rise in technology use, patients experience moderate levels of diabetes distress regardless of the technology type, and those using multiple daily injections tend to have less favorable attitudes towards technology compared to other users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. Naranjo, D., Tanenbaum, ML., Iturralde, E., et al.[2018]

The review of 18 studies found that transitioning from traditional diabetes management to advanced technologies like insulin pumps and continuous glucose monitoring (CGM) significantly increased treatment satisfaction, especially when blood glucose levels were consistently below 7.00 mmol/L.

Data logging adherence was positively correlated with age and the use of apps that provided meaningful feedback, indicating that older adults may benefit more from technology in managing their diabetes, although frustrations with device usability were common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Factors and Data Logging Processes With the Use of Advanced Technology for Adults With Type 1 Diabetes: Systematic Integrative Review. Waite, M., Martin, C., Franklin, R., et al.[2020]

A survey of 1,503 adults with type 1 diabetes revealed that the most common barriers to using diabetes devices like insulin pumps and continuous glucose monitors (CGMs) were related to the discomfort of wearing them, with 47% citing hassle and 35% disliking the devices on their bodies.

Younger adults (ages 18-25) showed the lowest uptake of CGMs and insulin pumps, along with the highest levels of diabetes distress and HbA1c, indicating a need for targeted interventions to address their specific barriers and improve device adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets. Tanenbaum, ML., Hanes, SJ., Miller, KM., et al.[2022]

A study involving 31 diabetes educators in Australia revealed that they found the use of technology in managing type 1 diabetes to be burdensome, indicating a need for better support and training in technology use.

Despite the potential benefits of diabetes-related technologies, care delivery was often fragmented and inconsistent, suggesting that improvements in policy and service structure are necessary to enhance the effectiveness of these tools in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. James, S., Perry, L., Gallagher, R., et al.[2018]

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