Type 1 DiabetesONBOARDNCT04161131
Overcoming Barriers and Obstacles to Adopting Diabetes Devices
A study testing ONBOARD in people with Type 1 Diabetes, run by Molly Tanenbaum at 1 site in United States.
Trial summary
This study will create a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with type 1 diabetes (T1D) the skills to maximize benefit and minimize daily interference from barriers associated with continuous… 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 22 Oct 2020
- 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 screening
- Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the 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
Official title: A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D
This study will create a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with type 1 diabetes (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 proposed research will create and refine the ONBOARD intervention for CGM use. Participants will be tracked using metrics of A1c, time in glucose target range, number of days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress, and technology attitudes. The investigators will examine whether ONBOARD leads to improved diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of CGM and increase readiness for closed loop adoption.
- 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; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
| Study group | Role | What they receive |
|---|---|---|
| ONBOARD Intervention | Experimental | ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers. Receives: Behavioral: ONBOARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
Glycated haemoglobin (HbA1c)
Measured: baseline, month 3
Secondary outcomes (15)
Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study
The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition
Measured: Duration of study participation (up to three months)
Number of Eligible Individuals Who Agree to Participate in the Study
Number of eligible individuals who agree to participate in the study out of all those approached during recruitment
Measured: During screening visit (up to 50 minutes)
Satisfaction With Intervention Survey
Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction.
Measured: Month 3
Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL
Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl
Measured: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Diabetes Distress Scale for Type 1 Diabetes
Unabbreviated Scale Title: Diabetes Distress Scale for Type 1 Diabetes (T1-DDS) is a 28-item self-report scale that highlights seven critical dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friends/family distress. A total score is calculated using the mean of all item scores. Subscale scores are calculated using the means of specific items for each subscale.
Min Value: 1 Max Value: 6 Higher scores mean worse outcome/more distress
Measured: baseline, month 3
Glucose Monitoring System Satisfaction Survey (GMSS-T1D)
Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome
Measured: baseline, month 3
Percentage of CGM Data Downloaded and Available for Analysis
Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses.
Measured: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Mean Glucose Level
Mean glucose level from continuous glucose monitoring data at baseline and month 3
Measured: baseline, month 3
Barriers to Diabetes Device Use Survey
Title: Barriers to Diabetes Device Use is a 19-item list of barriers to diabetes device use. Participants can select between 0 and 19 barriers. Examples of barriers are: cost, insurance, lack of family support, lack of support from the diabetes care team, and not liking devices on the body.
Min: 0 Max: 19 higher scores mean a worse outcome
Measured: baseline, month 3
Diabetes Technology Attitudes Survey
Title: Diabetes Technology Attitudes Survey, a 6-item survey that asks about general attitudes about the role diabetes technology in one's life and the extent to which someone finds technology helpful for managing diabetes.
Min: 1 Max: 5 Mean Score, higher score means better outcome
Measured: Baseline, Month 3
Fear of Hypoglycemia - Worry Survey
Scale Title: Hypoglycemia Fear Survey II - Worry Subscale is an 18-item subscale that presents a list of concerns people with diabetes sometimes have about low blood sugar. Respondents answer based on their level of worry about each item for the past 6 months. A total score is calculated by summing individual item scores.
Min: 0 Max: 4 Higher score indicates worse outcome
Measured: baseline, month 3
Hypoglycemia Confidence Scale
Title: Hypoglycemia Confidence Scale is a 9-item scale that asks about how confident the respondent is in managing problems with hypoglycemia in a range of situations. A total score is calculated using the mean of all item scores.
Min: 1 Max: 4 Higher score means better outcome/more confidence
Measured: baseline, month 3
Technology Use For Diabetes Problem Solving Scale
Scale: Technology Use For Diabetes Problem Solving Scale is a 9-item scale that asks participants to rate how often they use different types of technology (eg phone, websites, looking at graphs of their glucose data) in managing their diabetes, solving problems and finding answers to questions that arise in managing diabetes. A total score is calculated by summing all items.
Min: 0 Max: 5 Higher score means a better outcome
Measured: baseline, month 3
INSPIRE Survey
Title: INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a 31-item survey that assesses perceived benefits and burdens of automated insulin delivery systems. A total score is calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100.
Min: 1 Max: 5 High score means more positive outcome
Measured: baseline, month 3
Frequency of Blood Glucose Monitoring
Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start9 Dec 2019
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT04161131
- Sponsor's protocol ID
- 47667
- Other IDs
- K23DK119470, P30DK116074
- Acronym
- ONBOARD
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2019
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanenbaum ML, Ngo J, Hanes SJ, Basina M, Buckingham BA, Hessler D, Maahs DM, Mulvaney S, Hood KK. ONBOARD: A Feasibility Study of a Telehealth-Based Continuous Glucose Monitoring Adoption Intervention for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):818-827. doi: 10.1089/dia.2021.0198.
PubMed 34270351Tanenbaum ML, Messer LH, Wu CA, Basina M, Buckingham BA, Hessler D, Mulvaney SA, Maahs DM, Hood KK. Help when you need it: Perspectives of adults with T1D on the support and training they would have wanted when starting CGM. Diabetes Res Clin Pract. 2021 Oct;180:109048. doi: 10.1016/j.diabres.2021.109048. Epub 2021 Sep 14.
PubMed 34534592
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D
- ClinicalTrials.gov ID
- NCT04161131
- Acronym / sponsor ID
- ONBOARD / 47667
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Molly TanenbaumUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will create a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with type 1 diabetes (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 proposed research will create and refine the ONBOARD intervention for CGM use. Participants will be tracked using metrics of A1c, time in glucose target range, number of days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress, and technology attitudes. The investigators will examine whether ONBOARD leads to improved diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of CGM and increase readiness for closed loop adoption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONBOARD Intervention | Experimental | Behavioral: ONBOARDONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers. |
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 screening
- Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the 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; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions) | Behavioural | ONBOARD Intervention |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: baseline, month 3
Glycated haemoglobin (HbA1c)
15 secondary outcomes
Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study
Time frame: Duration of study participation (up to three months)
Number of Eligible Individuals Who Agree to Participate in the Study
Time frame: During screening visit (up to 50 minutes)
Satisfaction With Intervention Survey
Time frame: Month 3
Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL
Time frame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Diabetes Distress Scale for Type 1 Diabetes
Time frame: baseline, month 3
Glucose Monitoring System Satisfaction Survey (GMSS-T1D)
Time frame: baseline, month 3
Percentage of CGM Data Downloaded and Available for Analysis
Time frame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Mean Glucose Level
Time frame: baseline, month 3
Barriers to Diabetes Device Use Survey
Time frame: baseline, month 3
Diabetes Technology Attitudes Survey
Time frame: Baseline, Month 3
Fear of Hypoglycemia - Worry Survey
Time frame: baseline, month 3
Hypoglycemia Confidence Scale
Time frame: baseline, month 3
Technology Use For Diabetes Problem Solving Scale
Time frame: baseline, month 3
INSPIRE Survey
Time frame: baseline, month 3
Frequency of Blood Glucose Monitoring
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34270351Tanenbaum ML, Ngo J, Hanes SJ, Basina M, Buckingham BA, Hessler D, Maahs DM, Mulvaney S, Hood KK. ONBOARD: A Feasibility Study of a Telehealth-Based Continuous Glucose Monitoring Adoption Intervention for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):818-827. doi: 10.1089/dia.2021.0198.
- Results publication: PubMed 34534592Tanenbaum ML, Messer LH, Wu CA, Basina M, Buckingham BA, Hessler D, Mulvaney SA, Maahs DM, Hood KK. Help when you need it: Perspectives of adults with T1D on the support and training they would have wanted when starting CGM. Diabetes Res Clin Pract. 2021 Oct;180:109048. doi: 10.1016/j.diabres.2021.109048. Epub 2021 Sep 14.
- 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 13 Sep 2022. 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 8 Jun 2021). 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?
Hemoglobin A1c (HbA1c) (time frame: baseline, month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161131, which also lists 2 linked publications.
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 13 Sep 2022.