NCT04161131

Brief 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 glucose monitoring (CGM) and increase readiness for closed loop.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 8, 2021

Completed
Last Updated

September 13, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

November 8, 2019

Results QC Date

March 24, 2021

Last Update Submit

August 24, 2022

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c (HbA1c)

    Glycated haemoglobin (HbA1c)

    baseline, month 3

Secondary Outcomes (15)

  • Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study

    Duration of study participation (up to three months)

  • Number of Eligible Individuals Who Agree to Participate in the Study

    During screening visit (up to 50 minutes)

  • Satisfaction With Intervention Survey

    Month 3

  • Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL

    two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)

  • Diabetes Distress Scale for Type 1 Diabetes

    baseline, month 3

  • +10 more secondary outcomes

Study Arms (1)

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.

Behavioral: ONBOARD

Interventions

ONBOARDBEHAVIORAL

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)

ONBOARD Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

  • 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.

    PMID: 34270351RESULT

  • Tanenbaum 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.

    PMID: 34534592RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Molly Tanenbaum
Organization
Stanford University
mollyt@stanford.edu
650-725-3955

Study Officials

  • Molly Tanenbaum, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 13, 2019

Study Start

December 9, 2019

Primary Completion

October 22, 2020

Study Completion

October 22, 2020

Last Updated

September 13, 2022

Results First Posted

June 8, 2021

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)