Trial Outcomes & Findings for Overcoming Barriers and Obstacles to Adopting Diabetes Devices (NCT NCT04161131)
NCT ID: NCT04161131
Last Updated: 2022-09-13
Results Overview
Glycated haemoglobin (HbA1c)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
baseline, month 3
Results posted on
2022-09-13
Participant Flow
Participants were recruited through the Stanford Research Database, at the Stanford Endocrinology Clinic, and through online type 1 diabetes social media platforms. 81 participants were screened for eligibility. Participation was online. Once the participants provided their consent they were prompted to complete baseline surveys and then scheduled to receive the four intervention sessions.
Participant milestones
| Measure |
ONBOARD Intervention
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to Continuous Glucose Monitor (CGM) use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
Completed Baseline Surveys
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27
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Overall Study
Received Intervention
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22
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
ONBOARD Intervention
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to Continuous Glucose Monitor (CGM) use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Overall Study
Ineligible
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2
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Overall Study
Lost to Follow-up
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4
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Baseline Characteristics
Only 20 participants in the study are insulin pump users
Baseline characteristics by cohort
| Measure |
ONBOARD Intervention
n=26 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=26 Participants
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Age, Categorical
Between 18 and 65 years
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26 Participants
n=26 Participants
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Age, Categorical
>=65 years
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0 Participants
n=26 Participants
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Age, Continuous
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31.48 years
STANDARD_DEVIATION 8.34 • n=26 Participants
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Sex: Female, Male
Female
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16 Participants
n=26 Participants
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Sex: Female, Male
Male
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10 Participants
n=26 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=26 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=26 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=26 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=26 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=26 Participants
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Race (NIH/OMB)
White
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22 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=26 Participants
|
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Region of Enrollment
United States
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26 Participants
n=26 Participants
|
|
Marital Status
Single
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11 Participants
n=26 Participants
|
|
Marital Status
Married
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9 Participants
n=26 Participants
|
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Marital Status
Separated
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1 Participants
n=26 Participants
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Marital Status
Living with someone
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5 Participants
n=26 Participants
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Education
Some College
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6 Participants
n=26 Participants
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Education
College graduate
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11 Participants
n=26 Participants
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Education
Graduate degree
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9 Participants
n=26 Participants
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Annual Family Income
<$25,000
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3 Participants
n=26 Participants
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Annual Family Income
$25,000-50,000
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2 Participants
n=26 Participants
|
|
Annual Family Income
$51,000 - 75,000
|
5 Participants
n=26 Participants
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|
Annual Family Income
$76,000 - 100,000
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4 Participants
n=26 Participants
|
|
Annual Family Income
$101,000 - 125,000
|
5 Participants
n=26 Participants
|
|
Annual Family Income
$126,000 -150,000
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1 Participants
n=26 Participants
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|
Annual Family Income
$151,000 -175,000
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3 Participants
n=26 Participants
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|
Annual Family Income
>$175,000
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2 Participants
n=26 Participants
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|
Annual Family Income
Unknown/Declined to state
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1 Participants
n=26 Participants
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Currently Using Insulin (%)
Yes
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20 Participants
n=26 Participants
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Currently Using Insulin (%)
No
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6 Participants
n=26 Participants
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Length of insulin pump use
<0.5 year
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3 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Length of insulin pump use
0.5-<1 year
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1 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Length of insulin pump use
1-<2 years
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0 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Length of insulin pump use
2-<5 years
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1 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Length of insulin pump use
>5 years
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15 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Pump Brand
Medtronic
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9 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Pump Brand
Tandem
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7 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Pump Brand
Insulet
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4 Participants
n=20 Participants • Only 20 participants in the study are insulin pump users
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Currently using CGM
Yes
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23 Participants
n=26 Participants
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Currently using CGM
No
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3 Participants
n=26 Participants
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Length of CGM use
<0.5 years
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10 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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Length of CGM use
0.5-1 year
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10 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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Length of CGM use
1-2 years
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1 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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Length of CGM use
>5 years
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2 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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CGM brand
Dexcom
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19 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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CGM brand
Medtronic
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1 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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CGM brand
Abbott (Freestyle)
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3 Participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
|
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Chronic conditions other than diabetes
Yes
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9 Participants
n=26 Participants
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|
Chronic conditions other than diabetes
No
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17 Participants
n=26 Participants
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|
Frequency of CGM use in the past month (per participant)
1 day
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1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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Frequency of CGM use in the past month (per participant)
5 days
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1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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Frequency of CGM use in the past month (per participant)
14 days
|
1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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|
Frequency of CGM use in the past month (per participant)
15 days
|
1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
|
|
Frequency of CGM use in the past month (per participant)
19 days
|
1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
|
|
Frequency of CGM use in the past month (per participant)
21 days
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2 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
|
|
Frequency of CGM use in the past month (per participant)
25 days
|
1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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|
Frequency of CGM use in the past month (per participant)
29 days
|
1 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
|
|
Frequency of CGM use in the past month (per participant)
30 days
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14 participants
n=23 Participants • Only 23 participants in the study were using a CGM at baseline
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PRIMARY outcome
Timeframe: baseline, month 3Population: Participants with measurement at baseline and month 3 are included in the analysis
Glycated haemoglobin (HbA1c)
Outcome measures
| Measure |
ONBOARD Intervention
n=10 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Hemoglobin A1c (HbA1c)
baseline
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7.27 percentage of HbA1c
Standard Deviation 2.18
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Hemoglobin A1c (HbA1c)
month 3
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6.73 percentage of HbA1c
Standard Deviation 2
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SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
ONBOARD Intervention
n=28 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study
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6 Participants
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SECONDARY outcome
Timeframe: During screening visit (up to 50 minutes)Population: 81 individuals were assessed for eligibility
Number of eligible individuals who agree to participate in the study out of all those approached during recruitment
Outcome measures
| Measure |
ONBOARD Intervention
n=81 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Number of Eligible Individuals Who Agree to Participate in the Study
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28 Participants
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SECONDARY outcome
Timeframe: Month 3Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction.
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Satisfaction With Intervention Survey
Q1. Overall, how helpful was the ONBOARD program for you?
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2.95 score on a scale
Standard Deviation 0.84
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Satisfaction With Intervention Survey
Q2.Overall, how satisfied were you with the ONBOARD program?
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3.5 score on a scale
Standard Deviation 0.86
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Satisfaction With Intervention Survey
Q3.Overall, how satisfied were you with receiving the ONBOARD program online?
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3.55 score on a scale
Standard Deviation 0.86
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Satisfaction With Intervention Survey
Q4. I would recommend the ONBOARD program
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3.5 score on a scale
Standard Deviation 0.51
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Satisfaction With Intervention Survey
Q5. Overall, how satisfied were you with the number of sessions?
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3.32 score on a scale
Standard Deviation 0.72
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Satisfaction With Intervention Survey
Q6. Overall, how satisfied were you with the length of the sessions?
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3.32 score on a scale
Standard Deviation 0.89
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SECONDARY outcome
Timeframe: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)Population: 19 participants had CGM data available for both measurements
Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl
Outcome measures
| Measure |
ONBOARD Intervention
n=19 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL
Pre-intervention
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71.4 percentage of time in range
Standard Deviation 19.4
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Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL
Post-intervention
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75.1 percentage of time in range
Standard Deviation 20
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SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol are included in the analysis.
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
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Diabetes Distress Scale for Type 1 Diabetes
baseline
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2.27 score on a scale
Standard Deviation .66
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Diabetes Distress Scale for Type 1 Diabetes
month 3
|
2.02 score on a scale
Standard Deviation .60
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SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol and with data for the respective timepoints are included in the analysis.
Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome
Outcome measures
| Measure |
ONBOARD Intervention
n=21 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Glucose Monitoring System Satisfaction Survey (GMSS-T1D)
baseline
|
3.88 score on a scale
Standard Deviation .56
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Glucose Monitoring System Satisfaction Survey (GMSS-T1D)
month 3
|
3.93 score on a scale
Standard Deviation .44
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SECONDARY outcome
Timeframe: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)Population: 19 participants provided CGM data for both measurements
Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses.
Outcome measures
| Measure |
ONBOARD Intervention
n=19 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Percentage of CGM Data Downloaded and Available for Analysis
Pre-Intervention
|
76.4 percentage of CGM wear data available
Standard Deviation 29.6
|
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Percentage of CGM Data Downloaded and Available for Analysis
Post-Intervention
|
81.3 percentage of CGM wear data available
Standard Deviation 23.4
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SECONDARY outcome
Timeframe: baseline, month 3Population: 20 participants provided mean glucose values at baseline and month 3
Mean glucose level from continuous glucose monitoring data at baseline and month 3
Outcome measures
| Measure |
ONBOARD Intervention
n=20 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Mean Glucose Level
Baseline
|
149.04 mg/dL
Standard Deviation 33.02
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Mean Glucose Level
month 3
|
147.03 mg/dL
Standard Deviation 35.26
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SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol are included in the analysis.
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
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Barriers to Diabetes Device Use Survey
baseline
|
5.45 score on a scale
Standard Deviation 2.28
|
|
Barriers to Diabetes Device Use Survey
month 3
|
5.5 score on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Participants who completed the protocol are included in the analysis.
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
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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|---|---|
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Diabetes Technology Attitudes Survey
baseline
|
3.97 score on a scale
Standard Deviation .3
|
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Diabetes Technology Attitudes Survey
month 3
|
4.23 score on a scale
Standard Deviation .61
|
SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol are included in the analysis.
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
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
|
|---|---|
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Fear of Hypoglycemia - Worry Survey
baseline
|
.87 score on a scale
Standard Deviation .47
|
|
Fear of Hypoglycemia - Worry Survey
month 3
|
.89 score on a scale
Standard Deviation .49
|
SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol are included in the analysis.
Title: Hypoglycemia Confidence Scale is a 9-item scale that asks about how confident the respondent is in managing problems with hypoglycemia in a range of situations. A total score is calculated using the mean of all item scores. Min: 1 Max: 4 Higher score means better outcome/more confidence
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
|
|---|---|
|
Hypoglycemia Confidence Scale
baseline
|
3.43 score on a scale
Standard Deviation .47
|
|
Hypoglycemia Confidence Scale
month 3
|
3.44 score on a scale
Standard Deviation .51
|
SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol are included in the analysis.
Scale: Technology Use For Diabetes Problem Solving Scale is a 9-item scale that asks participants to rate how often they use different types of technology (eg phone, websites, looking at graphs of their glucose data) in managing their diabetes, solving problems and finding answers to questions that arise in managing diabetes. A total score is calculated by summing all items. Min: 0 Max: 5 Higher score means a better outcome
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
|
|---|---|
|
Technology Use For Diabetes Problem Solving Scale
baseline
|
2.36 score on a scale
Standard Deviation .71
|
|
Technology Use For Diabetes Problem Solving Scale
month 3
|
2.35 score on a scale
Standard Deviation .8
|
SECONDARY outcome
Timeframe: baseline, month 3Population: Participants who completed the protocol are included in the analysis.
Title: INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a 31-item survey that assesses perceived benefits and burdens of automated insulin delivery systems. A total score is calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100. Min: 1 Max: 5 High score means more positive outcome
Outcome measures
| Measure |
ONBOARD Intervention
n=22 Participants
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
|
|---|---|
|
INSPIRE Survey
baseline
|
1.96 score on a scale
Standard Deviation .66
|
|
INSPIRE Survey
month 3
|
1.92 score on a scale
Standard Deviation .68
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data were not collected for this outcome measure
Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter
Outcome measures
Outcome data not reported
Adverse Events
ONBOARD Intervention
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ONBOARD Intervention
n=28 participants at risk
ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to CGM use: physical, data, social, and trust. Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise. Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
ONBOARD: Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
|
|---|---|
|
Endocrine disorders
diabetic ketoacidosis (DKA)
|
3.6%
1/28 • Up to 5 months
|
|
Infections and infestations
Ascites
|
3.6%
1/28 • Up to 5 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place