Type 1 DiabetesBEAD-T1DNCT05488119
BEAD-T1D: Building the Evidence to Address Disengagement in Type 1 Diabetes
A study testing Intervention to increase diabetes technology uptake in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Intervention to increase diabetes technology uptake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The investigators will include youth aged 12-21 years in this study. The lower limit of 12 years was selected as this is the age when youth are able to understand and reflect on the topics discussed in the survey measures and focus groups. The upper limit of 21 years was selected as this is the upper limit of public payer coverage (for example, California Children's Services). This aim focuses specifically on the family (youth and parent/guardian) factors that determine diabetes technology use and thus requires that youth are living with their parent/guardian in order to be included in this study. For youth under 18, the investigators will obtain both parental permission and youth assent to participate in the study. For those older than 18, the investigators will obtain consent from the youth alone.
Who cannot join
- Diabetes diagnosis in youth other than type 1
- T1D youth less than the age of 12 or older than 21
- non-public payer insurance
- caregivers not living with the youth with type 1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Outcomes in Pediatric Diabetes: Building the Evidence Base to Inform Effective Diabetes Technology Interventions
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.
Read the detailed description
As diabetes technologies have become more innovative and effective in the management of pediatric type 1 diabetes (T1D), research and usage has not engaged all youth living with T1D . Studies have consistently demonstrated lower rates of diabetes technology use in some youth. Although diabetes technology has the potential to improve in pediatric T1D outcomes. This proposal aims to build an evidence base for data-driven interventions designed to increase uptake and utilization of diabetes innovations by addressing barriers and supporting promoters of diabetes technology use.
Ananta Addala, D.O., M.P.H, is a physician scientist committed to a career as an independent investigator addressing factors associated with in T1D management and outcomes. Dr. Addala's longstanding research and clinical interests are to promote care for youth with T1D. As a physician with a background in pediatric endocrinology, epidemiology, and behavioral health, Dr. Addala is uniquely qualified to address factors associated with diabetes technology use youth with T1D. Dr. Addala has enlisted a multi-disciplinary mentorship team comprised of experts in the fields of pediatric T1D, health disparities, statistics, and mixed method study design to successfully execute this proposal and launch an independent research career in pediatric T1D.
The overall objective of this proposal is to discover factors associated with diabetes technology use in youth with T1D and public insurance and develop a brief intervention, as a means to understand and improve pediatric T1D outcomes. This will be accomplished through two aims. In aim 1, focusing on the family, Dr. Addala will construct an evidence base of barriers and promoters to diabetes technology use in youth with public insurance in order to formulate and test a brief pilot intervention aimed at increasing uptake. In aim 2, this time focusing on the providers, Dr. Addala will construct the evidence base on barriers and promoters to recommending diabetes technology to youth with public insurance in order to formulate and test a brief pilot intervention to increase provider recommendation of diabetes technology.
Taken together, findings from Aims 1 and 2 will result in the development of an intervention aimed at increasing diabetes technology uptake and access in youth, thereby improving T1D outcomes. Dr. Addala will use the K23 mentored award to execute an in-depth training plan which includes formal coursework and structured mentorship by her mentors to advance her understanding of mixed methods research, intervention development, and expertise on statistical methods. This proposal is foundational to a future independent clinical trial to evaluate the efficacy of the interventions developed on promoters and barriers of diabetes technology use in youth with T1D.
- Conditions
- Type 1 Diabetes
- Being tested
- Intervention to increase diabetes technology uptake
- Keywords
- Diabetes Technology, Pediatric Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to increase diabetes technology uptakeBehavioural
The design for this phase is a prospective pilot study. The intervention modules 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. I will recruit 20 families or providers to participate in the delivery of the pilot intervention designed in Phase 1 of the study via a stakeholder advisory board.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Intervention | Experimental | 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. Receives: Behavioral: Intervention to increase diabetes technology uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interviews with you on your feedback on the intervention
The investigators will ask you questions in a 30-minute interview at the end of the four-week intervention. The investigators will as your feedback on ways the intervention could be more effective and what changes can be made to the intervention so that it is most effective. The investigators will ask you if you are likely to change your diabetes management after completing the intervention.
Measured: Upon completion of intervention on week 4
Survey questions on your feedback on the intervention
The investigators will ask you questions in a feedback survey at the end of the four-week intervention. These questions will be developed by the investigators and will ask you ways the intervention could be more effective and what changes can be made to the intervention so that it is most effective. Example questions of what the investigators plan to ask in the survey include:
- Was the study explained appropriately?
- Was it logistically easy to participate in the study? How could it have improved?
- What parts of the intervention were most helpful?
- What parts could be cut?
- What parts need to be added?
- Are there certain types of people who are likely to do better with this intervention?
Measured: Upon completion of intervention on week 4
Tracking people who complete the study
The investigators will also keep track of who enrolled in the study and track how many people completed the intervention.
Measured: Through study completion, an average of one year
Secondary outcomes (1)
Changes in diabetes technology usage
The investigators will ask you survey questions to understand your attitudes towards diabetes technology at the start and end of the study intervention. The investigators will use a validated survey measure called Diabetes Technology Attitudes Survey to assess this in addition to having conversations with you to learn your beliefs about diabetes technology.
Measured: At the start of the study and upon completion of intervention on week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start3 Sep 2025
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ananta Addala, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488119
- Sponsor's protocol ID
- 65313
- Other IDs
- 1K23DK131342
- Acronym
- BEAD-T1D
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Pediatric Diabetes: Building the Evidence Base to Inform Effective Diabetes Technology Interventions
- ClinicalTrials.gov ID
- NCT05488119
- Acronym / sponsor ID
- BEAD-T1D / 65313
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes Technology, Pediatric Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As diabetes technologies have become more innovative and effective in the management of pediatric type 1 diabetes (T1D), research and usage has not engaged all youth living with T1D . Studies have consistently demonstrated lower rates of diabetes technology use in some youth. Although diabetes technology has the potential to improve in pediatric T1D outcomes. This proposal aims to build an evidence base for data-driven interventions designed to increase uptake and utilization of diabetes innovations by addressing barriers and supporting promoters of diabetes technology use.
Ananta Addala, D.O., M.P.H, is a physician scientist committed to a career as an independent investigator addressing factors associated with in T1D management and outcomes. Dr. Addala's longstanding research and clinical interests are to promote care for youth with T1D. As a physician with a background in pediatric endocrinology, epidemiology, and behavioral health, Dr. Addala is uniquely qualified to address factors associated with diabetes technology use youth with T1D. Dr. Addala has enlisted a multi-disciplinary mentorship team comprised of experts in the fields of pediatric T1D, health disparities, statistics, and mixed method study design to successfully execute this proposal and launch an independent research career in pediatric T1D.
The overall objective of this proposal is to discover factors associated with diabetes technology use in youth with T1D and public insurance and develop a brief intervention, as a means to understand and improve pediatric T1D outcomes. This will be accomplished through two aims. In aim 1, focusing on the family, Dr. Addala will construct an evidence base of barriers and promoters to diabetes technology use in youth with public insurance in order to formulate and test a brief pilot intervention aimed at increasing uptake. In aim 2, this time focusing on the providers, Dr. Addala will construct the evidence base on barriers and promoters to recommending diabetes technology to youth with public insurance in order to formulate and test a brief pilot intervention to increase provider recommendation of diabetes technology.
Taken together, findings from Aims 1 and 2 will result in the development of an intervention aimed at increasing diabetes technology uptake and access in youth, thereby improving T1D outcomes. Dr. Addala will use the K23 mentored award to execute an in-depth training plan which includes formal coursework and structured mentorship by her mentors to advance her understanding of mixed methods research, intervention development, and expertise on statistical methods. This proposal is foundational to a future independent clinical trial to evaluate the efficacy of the interventions developed on promoters and barriers of diabetes technology use in youth with T1D.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Intervention | Experimental | Behavioral: Intervention to increase diabetes technology uptakeThe 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The investigators will include youth aged 12-21 years in this study. The lower limit of 12 years was selected as this is the age when youth are able to understand and reflect on the topics discussed in the survey measures and focus groups. The upper limit of 21 years was selected as this is the upper limit of public payer coverage (for example, California Children's Services). This aim focuses specifically on the family (youth and parent/guardian) factors that determine diabetes technology use and thus requires that youth are living with their parent/guardian in order to be included in this study. For youth under 18, the investigators will obtain both parental permission and youth assent to participate in the study. For those older than 18, the investigators will obtain consent from the youth alone.
Key exclusion criteria (4 listed)
- Diabetes diagnosis in youth other than type 1
- T1D youth less than the age of 12 or older than 21
- non-public payer insurance
- caregivers not living with the youth with type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention to increase diabetes technology uptakeThe design for this phase is a prospective pilot study. The intervention modules 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. I will recruit 20 families or providers to participate in the delivery of the pilot intervention designed in Phase 1 of the study via a stakeholder advisory board. | Behavioural | Pilot Intervention |
Primary outcome
Interviews with you on your feedback on the intervention
Time frame: Upon completion of intervention on week 4
The investigators will ask you questions in a 30-minute interview at the end of the four-week intervention. The investigators will as your feedback on ways the intervention could be more effective and what changes can be made to the intervention so that it is most effective. The investigators will ask you if you are likely to change your diabetes management after completing the intervention.
Survey questions on your feedback on the intervention
Time frame: Upon completion of intervention on week 4
The investigators will ask you questions in a feedback survey at the end of the four-week intervention. These questions will be developed by the investigators and will ask you ways the intervention could be more effective and what changes can be made to the intervention so that it is most effective. Example questions of what the investigators plan to ask in the survey include: * Was the study explained appropriately? * Was it logistically easy to participate in the study? How could it have improved? * What parts of the intervention were most helpful? * What parts could be cut? * What parts need to be added? * Are there certain types of people who are likely to do better with this intervention?
Tracking people who complete the study
Time frame: Through study completion, an average of one year
The investigators will also keep track of who enrolled in the study and track how many people completed the intervention.
1 secondary outcome
Changes in diabetes technology usage
Time frame: At the start of the study and upon completion of intervention on week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to increase diabetes technology uptake in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interviews with you on your feedback on the intervention (time frame: Upon completion of intervention on week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.