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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ONBOARD
Sponsored by
Molly Tanenbaum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ONBOARD Intervention Group

CGM Only Group

Arm Description

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.

Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. There 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.

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c (HbA1c) over time
Glycemic control

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
December 11, 2020
Last Updated
August 29, 2023
Sponsor
Molly Tanenbaum
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04672655
Brief Title
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Acronym
ONBOARD
Official Title
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Molly Tanenbaum
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ONBOARD Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
CGM Only Group
Arm Type
No Intervention
Arm Description
Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. There 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.
Intervention Type
Behavioral
Intervention Name(s)
ONBOARD
Intervention Description
Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c (HbA1c) over time
Description
Glycemic control
Time Frame
baseline, month 3, month 6, month 12
Secondary Outcome Measure Information:
Title
Time in glucose target range
Description
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
Time Frame
baseline, month 3, month 6, month 12
Title
Percent days wearing CGM
Description
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
Time Frame
baseline, month 3, month 6, month 12
Title
Change in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)
Description
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
Time Frame
baseline, month 3, month 6, month 12
Title
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
Description
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
Time Frame
baseline, month 3, month 6, month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Tanenbaum, PhD
Phone
(650) 725-3955
Email
mollyt@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lydia Liu, BS
Phone
(650) 498-7634
Email
onboardstudy@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly Tanenbaum, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Tanenbaum, PhD
Phone
650-725-3955
Email
mollyt@stanford.edu
First Name & Middle Initial & Last Name & Degree
Lydia Liu
Phone
650-498-7634
Email
onboardstudy@stanford.edu
First Name & Middle Initial & Last Name & Degree
Korey Hood, PhD
First Name & Middle Initial & Last Name & Degree
Marina Basina, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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