Type 1 DiabetesONBOARDNCT04672655
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
A study testing ONBOARD in people with Type 1 Diabetes, run by Molly Tanenbaum at 1 site in United States.
Trial summary
This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with T1D the skills to maximize benefit and minimize daily interference from barriers associated with Continuous Glucose Monitoring (CGM)… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- ONBOARD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is age 18-50 years at time of enrollment
- Subject must not have been using CGM regularly for past 6 months
- Subject has a clinical diagnosis of type 1 diabetes
- Subject comprehends spoken and written English
Who cannot join
- Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
- Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with T1D the skills to maximize benefit and minimize daily interference from barriers associated with Continuous Glucose Monitoring (CGM) and increase readiness for closed loop.
Read the detailed description
The investigators will enroll 178 adults with T1D between 18-50 years of age. Participants must not have been using CGM regularly for past 6 months. Once consented and enrolled, baseline demographic and psychosocial data will be obtained. Participants will receive 12 weeks of CGM supplies at no cost to them and provided with initial standard CGM introduction and education. Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). Hemoglobin A1c values, CGM usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.
- Conditions
- Type 1 Diabetes
- Being tested
- ONBOARD
- 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.
ONBOARDBehavioural
Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM \& social situations; Session 4: Building trust with your CGM
| Study group | Role | What they receive |
|---|---|---|
| ONBOARD Intervention Group | Experimental | Those randomized to the ONBOARD group will receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They will also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart. Receives: Behavioral: ONBOARD |
| CGM Only Group | No intervention | Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. They will only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c) Over Time
Glycated hemoglobin
Measured: baseline, month 3, month 6, month 12
Secondary outcomes (4)
Change in Time in Glucose Target Range
14 days of CGM data were used to calculate the change in the percentage glucose readings from CGM system between 70-180 mg/dL per unit of time at each time point. All time points taken together are needed to evaluate this outcome measure.
Measured: baseline, month 3, month 6, month 12
Change in Percent CGM Wear Time
14 days of CGM data were used to calculate the change in percentage of time wearing CGM at each time point. All time points taken together are needed to evaluate this outcome measure.
Measured: baseline, month 3, month 6, month 12
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
The T1-DDS is a 28-item self-report scale that assesses multiple dimensions of diabetes distress. Each item is scored from 1 to 6, then items scores are summed and average to calculate a total score (1 to 6): higher item and total scores indicate more distress (worse outcome). All time points taken together are needed to evaluate this outcome measure
Measured: baseline, month 3, month 6, month 12
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
The GMSS-T1D is a 15-item self-report scale that assesses attitudes towards one's current glucose monitoring system. Overall score range is 1 to 5: higher total scores indicate greater satisfaction (better outcome). All time points taken together are needed to evaluate this outcome measure
Measured: baseline, month 3, month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Feb 2021
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 3 weeks).
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molly Tanenbaum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Molly Tanenbaum, Stanford University
- Investigators
- Molly Tanenbaum, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672655
- Sponsor's protocol ID
- 56922
- Other IDs
- 1K23DK119470-01
- Acronym
- ONBOARD
- Status last verified
- Aug 2025
- First submitted
- 11 Dec 2020
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
- ClinicalTrials.gov ID
- NCT04672655
- Acronym / sponsor ID
- ONBOARD / 56922
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Molly TanenbaumUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 5 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with T1D the skills to maximize benefit and minimize daily interference from barriers associated with Continuous Glucose Monitoring (CGM) and increase readiness for closed loop.
Detailed description
The investigators will enroll 178 adults with T1D between 18-50 years of age. Participants must not have been using CGM regularly for past 6 months. Once consented and enrolled, baseline demographic and psychosocial data will be obtained. Participants will receive 12 weeks of CGM supplies at no cost to them and provided with initial standard CGM introduction and education. Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). Hemoglobin A1c values, CGM usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 3 weeks).
| Arm | Type | Receives |
|---|---|---|
| ONBOARD Intervention Group | Experimental | Behavioral: ONBOARDThose randomized to the ONBOARD group will receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They will also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart. |
| CGM Only Group | No intervention | –Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. They will only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is age 18-50 years at time of enrollment
- Subject must not have been using CGM regularly for past 6 months
- Subject has a clinical diagnosis of type 1 diabetes
- Subject comprehends spoken and written English
Key exclusion criteria (2 listed)
- Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
- Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
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 |
|---|---|---|
| ONBOARDSession 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM \& social situations; Session 4: Building trust with your CGM | Behavioural | ONBOARD Intervention Group |
Primary outcome
Change in Hemoglobin A1c (HbA1c) Over Time
Time frame: baseline, month 3, month 6, month 12
Glycated hemoglobin
4 secondary outcomes
Change in Time in Glucose Target Range
Time frame: baseline, month 3, month 6, month 12
Change in Percent CGM Wear Time
Time frame: baseline, month 3, month 6, month 12
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
Time frame: baseline, month 3, month 6, month 12
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
Time frame: baseline, month 3, month 6, month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Molly Tanenbaum, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONBOARD in people with Type 1 Diabetes, run by Molly Tanenbaum 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 4 inclusion and 2 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 5 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 5 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Hemoglobin A1c (HbA1c) Over Time (time frame: baseline, month 3, month 6, month 12). 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 5 Sep 2025.