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ONBOARD Program for Type 1 Diabetes (ONBOARD Trial)

N/A
Recruiting
Led By Molly Tanenbaum, PhD
Research Sponsored by Molly Tanenbaum
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is age 18-50 years at time of enrollment
Subject has a clinical diagnosis of type 1 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, month 6, month 12
Awards & highlights

ONBOARD Trial Summary

This trial will help adults with Type 1 diabetes overcome common barriers to using Continuous Glucose Monitoring (CGM) and increase readiness for closed loop systems.

Who is the study for?
The ONBOARD trial is for English-speaking adults aged 18-50 with type 1 diabetes who haven't been using Continuous Glucose Monitoring (CGM) regularly in the past 6 months. It's not suitable for those with medical or neurological disorders that could affect their participation as judged by the study team.Check my eligibility
What is being tested?
ONBOARD is a behavioral intervention designed to help adults with type 1 diabetes overcome barriers to using CGM devices and prepare them for closed loop systems, which automate insulin delivery based on glucose levels.See study design
What are the potential side effects?
As ONBOARD is a behavioral intervention rather than a medication, it may not have typical side effects. Participants might experience stress or discomfort from lifestyle changes or device use.

ONBOARD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.
Select...
I have been diagnosed with type 1 diabetes.

ONBOARD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 6, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 6, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hemoglobin A1c (HbA1c) over time
Secondary outcome measures
Change in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)
Diabetes Mellitus, Insulin-Dependent
Percent days wearing CGM
+1 more

ONBOARD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ONBOARD Intervention GroupExperimental Treatment1 Intervention
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.
Group II: CGM Only GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONBOARD
2019
N/A
~30

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,317 Total Patients Enrolled
Molly TanenbaumLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
Molly Tanenbaum, PhDPrincipal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

ONBOARD Clinical Trial Eligibility Overview. Trial Name: NCT04672655 — N/A
Type 1 Diabetes Research Study Groups: CGM Only Group, ONBOARD Intervention Group
Type 1 Diabetes Clinical Trial 2023: ONBOARD Highlights & Side Effects. Trial Name: NCT04672655 — N/A
ONBOARD 2023 Treatment Timeline for Medical Study. Trial Name: NCT04672655 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current scope of enrollment into this clinical trial?

"Correct. According to the details available on clinicaltrials.gov, this clinical trial has been publicly advertised since February 17th 2021 and is actively looking for participants - it hopes to recruit a total of 178 from 1 site."

Answered by AI

Does this research encompass elderly adults aged 70 and over?

"This trial is recruiting individuals aged 18 to 50 years old."

Answered by AI

Is it feasible for new participants to join this experiment?

"Affirmative. As indicated on clinicaltrials.gov, this medical trial is still enrolling patients; it was first posted on February 17th 2021 and the latest update to its details occurred August 24th 2022. The study seeks 178 participants from one single site."

Answered by AI

Are my qualifications satisfactory for participation in this research project?

"This clinical trial seeks 178 people aged 18 to 50, with diabetes mellitus. To be eligible for enrollment in the study, participants must have refrained from using CGM (continuous glucose monitoring) over the past 6 months and meet the age criteria of being between 18-50 years old at time of enrolment."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Molly Tanenbaum 2021. "Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04672655.
~9 spots leftby Jul 2024
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