Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial

Part of paid clinical trials in Stanford, California.

Sponsor
Molly Tanenbaum
Study ID
NCT04672655
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • ONBOARD — BEHAVIORAL
    Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM \& social situations; Session 4: Building trust with your CGM

Study Details

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.

Key Dates

Start date
Feb 17, 2021
Status verified
Aug 2025
Primary completion
Sep 16, 2024
Completion
Sep 16, 2024

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ONBOARD Intervention Group
    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.
  • No Intervention: CGM Only Group
    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.

Primary Outcome Measure

Change in Hemoglobin A1c (HbA1c) Over Time [ Time Frame: baseline, month 3, month 6, month 12 ]

Locations (1)

FacilityCityStateZIP
Stanford UniversityStanfordCalifornia94305

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