Trial Outcomes & Findings for Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes (NCT NCT03534193)
NCT ID: NCT03534193
Last Updated: 2025-12-17
Results Overview
Effectiveness of tablet education modules as measured by a diabetic knowledge post-test questionnaire. Total score ranges from 0-100%, with a higher percentage on the scale indicating a better outcome/knowledge.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Test will be completed on day 3 (+/- 2 days)
Results posted on
2025-12-17
Participant Flow
Participant milestones
| Measure |
Standard Diabetes Education
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
|
Standard Diabetes Education and Tablet
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Standard Diabetes Education
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
|
Standard Diabetes Education and Tablet
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Standard Diabetes Education
n=14 Participants
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
|
Standard Diabetes Education and Tablet
n=14 Participants
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=6 Participants
|
14 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.78 years
n=6 Participants
|
8.85 years
n=5 Participants
|
9.31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=6 Participants
|
14 participants
n=5 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Test will be completed on day 3 (+/- 2 days)Population: post-education test score (percentile of questions answered correctly)
Effectiveness of tablet education modules as measured by a diabetic knowledge post-test questionnaire. Total score ranges from 0-100%, with a higher percentage on the scale indicating a better outcome/knowledge.
Outcome measures
| Measure |
Standard Diabetes Education
n=13 Participants
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
|
Standard Diabetes Education and Tablet
n=11 Participants
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
|
|---|---|---|
|
Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes
|
83 percentage of questions answered correct
Interval 70.0 to 90.0
|
86 percentage of questions answered correct
Interval 70.0 to 90.0
|
SECONDARY outcome
Timeframe: Assessements will occur at 3 monthsPopulation: lower HbA1C comparing to baseline
Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by Lower Hemoglobin A1C at initial follow up visit
Outcome measures
| Measure |
Standard Diabetes Education
n=13 Participants
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
|
Standard Diabetes Education and Tablet
n=11 Participants
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
|
|---|---|---|
|
Improved Subject Compliance With Glucose Monitoring A1 Levels
|
8 percentage change in HbA1C
Interval 7.1 to 14.0
|
8.06 percentage change in HbA1C
Interval 5.9 to 10.1
|
SECONDARY outcome
Timeframe: Assessements will occur at 3 monthsPopulation: number of Hypoglycemic Episodes
Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by lower number of hypoglycemic episodes before initial follow up visit
Outcome measures
| Measure |
Standard Diabetes Education
n=13 Participants
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
|
Standard Diabetes Education and Tablet
n=11 Participants
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
|
|---|---|---|
|
Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes
|
4.2 number of Hypoglycemic Episodes
Interval 0.0 to 15.0
|
1 number of Hypoglycemic Episodes
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Assessements will occur at 3 monthsPopulation: Number of times blood sugar was checked. Data was not collected as patients did not report it for either group.
Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by compliance with daily blood glucose monitoring at initial follow up visit
Outcome measures
Outcome data not reported
Adverse Events
Standard Diabetes Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Diabetes Education and Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place