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

Type 1 Diabetes Clinical Trial

— ONBOARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672655
• Other study ID #: 56922
• Secondary ID: 1K23DK119470-01
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: Molly Tanenbaum, PhD
• Phone: (650) 725-3955
• Email: mollyt[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) and increase readiness for closed loop.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Subject is age 18-50 years at time of enrollment

2. Subject must not have been using CGM regularly for past 6 months

3. Subject has a clinical diagnosis of type 1 diabetes

4. Subject comprehends spoken and written English

Exclusion Criteria:

1. Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.

2. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Molly Tanenbaum	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c (HbA1c) over time	Glycemic control	baseline, month 3, month 6, month 12
Secondary	Time in glucose target range	Percent of glucose readings from CGM system between 70-180 mg/dL per unit of time All time points taken together are needed to evaluate this outcome measure	baseline, month 3, month 6, month 12
Secondary	Percent days wearing CGM	We will use date from CGM to calculated % of days while participating in the study that participants wear the device All time points taken together are needed to evaluate this outcome measure	baseline, month 3, month 6, month 12
Secondary	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.; Minimum score=1; Maximum score=6; higher scores indicate more distress (worse outcome) All time points taken together are needed to evaluate this outcome measure	baseline, month 3, month 6, month 12
Secondary	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.; Minimum score=1; Maximum score=5; higher scores indicate greater satisfaction (better outcome) All time points taken together are needed to evaluate this outcome measure	baseline, month 3, month 6, month 12