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

Trial Summary

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 data supports the effectiveness of the treatment to increase diabetes technology uptake for type 1 diabetes?

Research shows that using diabetes devices like insulin pumps and continuous glucose monitors can improve health and quality of life for people with type 1 diabetes. However, uptake is low, and addressing barriers through psychosocial support and education can help more people benefit from these technologies. ^{1 2 3 4 5}

Is the technology uptake intervention for type 1 diabetes safe for humans?

The research does not provide specific safety data for the intervention, but it discusses barriers and psychological factors related to using diabetes technology, which may indirectly affect user experience and safety. ^{1 4 6 7 8}

How does the treatment to increase diabetes technology uptake differ from other treatments for type 1 diabetes?

This treatment is unique because it focuses on behavioral interventions to increase the use of diabetes technology like insulin pumps and continuous glucose monitors, addressing barriers such as cost, device navigation, and psychosocial factors, rather than directly altering insulin levels or glucose control. ^{3 6 9 10 11}

What is the purpose of this trial?

Youth with public insurance underutilize diabetes care, particularly diabetes technology which is associated with improvement in diabetes-specific outcomes. Thus, we urgently need studies to understand and increase diabetes technology utilization. This proposed research will (1) improve representation of youth in the literature, (2) address the gap in knowledge of barriers and promoters in youth, and (3) identify and address factors associated with diabetes technology uptake and utilization.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

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]

References

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

Diabetes Device Use in Adults With Type 1 Diabetes: Barriers to Uptake and Potential Intervention Targets. [2022]

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

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

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

From Wary Wearers to d-Embracers: Personas of Readiness to Use Diabetes Devices. [2019]

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

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. [2018]

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

Solutions to Address Inequity in Diabetes Technology Use in Type 1 Diabetes: Results from Multidisciplinary Stakeholder Co-creation Workshops. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Barriers to Uptake of Insulin Technologies and Novel Solutions. [2021]

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

Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. [2018]

8. Canada 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. [2020]

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

Parental Perspectives: Identifying Profiles of Parental Attitudes and Barriers Related to Diabetes Device Use. [2021]

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

Barriers and Facilitators to Diabetes Device Adoption for People with Type 1 Diabetes. [2023]

11. United States 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. [2022]