NCT04161131: ONBOARD

Overcoming Barriers and Obstacles to Adopting Diabetes Devices

Completed NA Results posted Last updated 13 September 2022

What this trial tests

NA trial testing ONBOARD in Type 1 Diabetes in 28 participants. Completed in 22 October 2020.

Timeline

9 December 2019

Primary endpoint
22 October 2020

22 October 2020

Quick facts

Lead sponsor	Molly Tanenbaum
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	9 December 2019
Primary completion	22 October 2020
Estimated completion	22 October 2020
Sites	1 location across United States

Drugs / interventions tested

• ONBOARD

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Molly Tanenbaum

Who can join

Adults 18 to 50, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hemoglobin A1c (HbA1c) Primary · baseline, month 3

Glycated haemoglobin (HbA1c)

baseline

Group	Value	95% CI
ONBOARD Intervention	7.27	± 2.18

month 3

Group	Value	95% CI
ONBOARD Intervention	6.73	± 2

Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study Secondary · Duration of study participation (up to three months)

The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition

Group	Value	95% CI
ONBOARD Intervention	6

Number of Eligible Individuals Who Agree to Participate in the Study Secondary · During screening visit (up to 50 minutes)

Number of eligible individuals who agree to participate in the study out of all those approached during recruitment

Group	Value	95% CI
ONBOARD Intervention	28

Satisfaction With Intervention Survey Secondary · Month 3

Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction.

Q1. Overall, how helpful was the ONBOARD program for you?

Group	Value	95% CI
ONBOARD Intervention	2.95	± 0.84

Q2.Overall, how satisfied were you with the ONBOARD program?

Group	Value	95% CI
ONBOARD Intervention	3.5	± 0.86

Q3.Overall, how satisfied were you with receiving the ONBOARD program online?

Group	Value	95% CI
ONBOARD Intervention	3.55	± 0.86

Q4. I would recommend the ONBOARD program

Group	Value	95% CI
ONBOARD Intervention	3.5	± 0.51

Q5. Overall, how satisfied were you with the number of sessions?

Group	Value	95% CI
ONBOARD Intervention	3.32	± 0.72

Q6. Overall, how satisfied were you with the length of the sessions?

Group	Value	95% CI
ONBOARD Intervention	3.32	± 0.89

Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL Secondary · two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)

Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl

Pre-intervention

Group	Value	95% CI
ONBOARD Intervention	71.4	± 19.4

Post-intervention

Group	Value	95% CI
ONBOARD Intervention	75.1	± 20

Diabetes Distress Scale for Type 1 Diabetes Secondary · baseline, month 3

Unabbreviated Scale Title: Diabetes Distress Scale for Type 1 Diabetes (T1-DDS) is a 28-item self-report scale that highlights seven critical dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friends/family distress. A total score is calculated using the mean of all item scores. Subscale scores are calculated using the means of specific items for each subscale. Min Value: 1 Max Value: 6 Higher scores mean worse outcome/more distress

baseline

Group	Value	95% CI
ONBOARD Intervention	2.27	± .66

month 3

Group	Value	95% CI
ONBOARD Intervention	2.02	± .60

Glucose Monitoring System Satisfaction Survey (GMSS-T1D) Secondary · baseline, month 3

Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome

baseline

Group	Value	95% CI
ONBOARD Intervention	3.88	± .56

month 3

Group	Value	95% CI
ONBOARD Intervention	3.93	± .44

Percentage of CGM Data Downloaded and Available for Analysis Secondary · two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)

Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses.

Pre-Intervention

Group	Value	95% CI
ONBOARD Intervention	76.4	± 29.6

Post-Intervention

Group	Value	95% CI
ONBOARD Intervention	81.3	± 23.4

Mean Glucose Level Secondary · baseline, month 3

Mean glucose level from continuous glucose monitoring data at baseline and month 3

Baseline

Group	Value	95% CI
ONBOARD Intervention	149.04	± 33.02

month 3

Group	Value	95% CI
ONBOARD Intervention	147.03	± 35.26

Barriers to Diabetes Device Use Survey Secondary · baseline, month 3

Title: Barriers to Diabetes Device Use is a 19-item list of barriers to diabetes device use. Participants can select between 0 and 19 barriers. Examples of barriers are: cost, insurance, lack of family support, lack of support from the diabetes care team, and not liking devices on the body. Min: 0 Max: 19 higher scores mean a worse outcome

baseline

Group	Value	95% CI
ONBOARD Intervention	5.45	± 2.28

month 3

Group	Value	95% CI
ONBOARD Intervention	5.5	± 2.58

Diabetes Technology Attitudes Survey Secondary · Baseline, Month 3

Title: Diabetes Technology Attitudes Survey, a 6-item survey that asks about general attitudes about the role diabetes technology in one's life and the extent to which someone finds technology helpful for managing diabetes. Min: 1 Max: 5 Mean Score, higher score means better outcome

baseline

Group	Value	95% CI
ONBOARD Intervention	3.97	± .3

month 3

Group	Value	95% CI
ONBOARD Intervention	4.23	± .61

Fear of Hypoglycemia - Worry Survey Secondary · baseline, month 3

Scale Title: Hypoglycemia Fear Survey II - Worry Subscale is an 18-item subscale that presents a list of concerns people with diabetes sometimes have about low blood sugar. Respondents answer based on their level of worry about each item for the past 6 months. A total score is calculated by summing individual item scores. Min: 0 Max: 4 Higher score indicates worse outcome

baseline

Group	Value	95% CI
ONBOARD Intervention	.87	± .47

month 3

Group	Value	95% CI
ONBOARD Intervention	.89	± .49

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ONBOARD Intervention

Serious: 2/28 (7%)

Deaths: 0/28

Serious adverse events (2 terms)

Reaction	System	ONBOARD Intervention
diabetic ketoacidosis (DKA)	Endocrine disorders	—
Ascites	Infections and infestations	—

Most-reported serious reactions: diabetic ketoacidosis (DKA), Ascites.

Data from ClinicalTrials.gov NCT04161131 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.