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Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes

Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03534193
Enrollment
28
Registered
2018-05-23
Start date
2017-04-17
Completion date
2025-04-08
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

This is a prospective, randomized trial to evaluate the effectiveness of using educational modules accessed through a bedside tablet in patients newly diagnosed with Type 1 Diabetes as an adjunct to \*standard Children's Hospital- Molly Center diabetes education in comparison to \*standard Children's Hospital- Molly Center diabetes education. (standard diabetes education consists of paper based reading material and nursing education).

Detailed description

Type I diabetes is one of the most common diseases of childhood and its incidence has been increasing worldwide. By age 18, 1 in 300 children will be affected by Type 1 Diabetes1. Not only are children diagnosed with diabetes met with significant morbidity due to their disease, but they are also expected to be active participants in daily often complicated treatment regimens. As children with Type 1 diabetes grow older and eventually spend time away from their parents or caregivers, they are forced to manage their own care. Over the last several years, health systems in the United States have become more patient-centered and have focused on autonomy and patient preference. With the advent of technology that makes self-directed education possible, this patient-centered approach needs to be applied to children diagnosed with Type I diabetes. When clinicians are at the center of educating patients with diabetes, they often communicate more directly with parents, who then use the information they receive to manage their child's care. This model, however, does not account for the fact that children with diabetes will one day need to manage their own care and that patients who are active participants and who understand their disease process will be more likely to cooperate with treatment regimens and lifestyle interventions. It is often difficult for any patient, child or adult, to process educational information provided verbally in a physician's office, especially immediately after they have been diagnosed with a life-long disease. Educational tools therefore need to focus on incorporating methods that best serve the patients being educated. Since individuals learn in different ways and at different paces, interactive educational tools can help patients and their families learn in a way that can be individualized and private and can also be fun and creative. As our patients are growing up surrounded by technology, the use of this technology for education might provide a sense of normalcy to children and teenagers already overwhelmed by processes that are often difficult for them to identify with or understand. We hope that patients and families who are given the opportunity to learn independently will become better equipped to manage self-care and will develop a sense of involvement in their treatment. Interactive tools will also help patients and families become more actively engaged in understanding their disease process and can help them to become more active participants in their care.

Interventions

OTHERMolly Center Diabetes Care Guide (Paper-based)

Diabetes education with Registered Nurse in addition to Paper based education modules

OTHERTablet based interactive diabetes education modules

Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.

Sponsors

Verizon Foundation
CollaboratorOTHER
Hackensack Meridian Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Participants will be randomized to one of 2 arms: Group 1 - standard Diabetic education-consisting of one on one education with a Registered Nurse in addition to the Molly Center Diabetes Care Guide (paper based) Group 2 - standard Diabetic education plus Bedside tablet with interactive Diabetic modules

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion criteria

* New diagnosed Type 1 Diabetes admitted to the Joseph M. Sanzari Children's Hospital * Patient/Caretaker/Family willing to complete questionnaires

Exclusion criteria

* Patients with previous history of Diabetes * Patients with no plans to follow up at The Joseph M. Sanzari Children's Hospital - Molly's Center for Children with Diabetes and Endocrine Disorders after hospital discharge * Non English speaking patients/family/caretaker

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of Tablet Education in Newly Diagnosed Type 1 DiabetesTest will be completed on day 3 (+/- 2 days)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.

Secondary

MeasureTime frameDescription
Improved Subject Compliance With Glucose Monitoring A1 LevelsAssessements will occur at 3 monthsSubjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by Lower Hemoglobin A1C at initial follow up visit
Improved Subject Compliance With Glucose Monitoring - Hypoglycemic EpisodesAssessements will occur at 3 monthsSubjects 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
Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose MonitoringAssessements will occur at 3 monthsSubjects 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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
14
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.
14
Total28

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up13

Baseline characteristics

CharacteristicStandard Diabetes Education and TabletStandard Diabetes EducationTotal
Age, Categorical
<=18 years
14 Participants14 Participants28 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous8.85 years9.78 years9.31 years
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants5 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants7 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants5 Participants
Race (NIH/OMB)
White
11 Participants8 Participants19 Participants
Region of Enrollment
United States
14 participants14 participants28 participants
Sex: Female, Male
Female
6 Participants9 Participants15 Participants
Sex: Female, Male
Male
8 Participants5 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 11
other
Total, other adverse events
0 / 130 / 11
serious
Total, serious adverse events
0 / 130 / 11

Outcome results

Primary

Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes

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.

Time frame: Test will be completed on day 3 (+/- 2 days)

Population: post-education test score (percentile of questions answered correctly)

ArmMeasureValue (MEAN)
Standard Diabetes EducationEffectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes83 percentage of questions answered correct
Standard Diabetes Education and TabletEffectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes86 percentage of questions answered correct
Secondary

Improved Subject Compliance With Glucose Monitoring A1 Levels

Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by Lower Hemoglobin A1C at initial follow up visit

Time frame: Assessements will occur at 3 months

Population: lower HbA1C comparing to baseline

ArmMeasureValue (MEAN)
Standard Diabetes EducationImproved Subject Compliance With Glucose Monitoring A1 Levels8 percentage change in HbA1C
Standard Diabetes Education and TabletImproved Subject Compliance With Glucose Monitoring A1 Levels8.06 percentage change in HbA1C
Secondary

Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose Monitoring

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

Time frame: Assessements will occur at 3 months

Population: Number of times blood sugar was checked. Data was not collected as patients did not report it for either group.

Secondary

Improved Subject Compliance With Glucose Monitoring - 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

Time frame: Assessements will occur at 3 months

Population: number of Hypoglycemic Episodes

ArmMeasureValue (MEAN)
Standard Diabetes EducationImproved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes4.2 number of Hypoglycemic Episodes
Standard Diabetes Education and TabletImproved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes1 number of Hypoglycemic Episodes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026