Type 1 Diabetes MellitusNCT03534193
Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
A study testing Molly Center Diabetes Care Guide (Paper-based) and Tablet based interactive diabetes education modules in people with Type 1 Diabetes Mellitus, run by Hackensack Meridian Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Molly Center Diabetes Care Guide (Paper-based) and Tablet based interactive diabetes education modules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- New diagnosed Type 1 Diabetes admitted to the Joseph M. Sanzari Children's Hospital
- Patient/Caretaker/Family willing to complete questionnaires
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, 07601
About this study
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).
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Molly Center Diabetes Care Guide (Paper-based), Tablet based interactive diabetes education modules
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molly Center Diabetes Care Guide (Paper-based)Other
Diabetes education with Registered Nurse in addition to Paper based education modules
Tablet based interactive diabetes education modulesOther
Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
| Study group | Role | What they receive |
|---|---|---|
| Standard Diabetic Education | Other | Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based) Receives: Other: Molly Center Diabetes Care Guide (Paper-based) |
| Standard Diabetes Education and Tablet | Experimental | Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules Receives: Other: Molly Center Diabetes Care Guide (Paper-based); Other: Tablet based interactive diabetes education modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Test will be completed on day 3 (+/- 2 days)
Secondary outcomes (3)
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
Measured: Assessements will occur at 3 months
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
Measured: Assessements will occur at 3 months
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
Measured: Assessements will occur at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start17 Apr 2017
- Primary completion30 Apr 2019
- Study completion8 Apr 2025
Why it stopped: Site resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Verizon Foundation
- Responsible party
- Sponsor
- Investigators
- Steven Ghanny, MD, Principal investigator, Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534193
- Sponsor's protocol ID
- PRO 2016-0713
- Status last verified
- Dec 2025
- First submitted
- 9 May 2018
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03534193
- Acronym / sponsor ID
- PRO 2016-0713
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Site resources
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Verizon Foundation
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard Diabetic Education | Other | Other: Molly Center Diabetes Care Guide (Paper-based)Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based) |
| Standard Diabetes Education and Tablet | Experimental | Other: Molly Center Diabetes Care Guide (Paper-based), Other: Tablet based interactive diabetes education modulesParticipants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- New diagnosed Type 1 Diabetes admitted to the Joseph M. Sanzari Children's Hospital
- Patient/Caretaker/Family willing to complete questionnaires
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molly Center Diabetes Care Guide (Paper-based)Diabetes education with Registered Nurse in addition to Paper based education modules | Other | Standard Diabetes Education and Tablet, Standard Diabetic Education |
| Tablet based interactive diabetes education modulesMolly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet. | Other | Standard Diabetes Education and Tablet |
Primary outcome
Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes
Time frame: Test 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.
3 secondary outcomes
Improved Subject Compliance With Glucose Monitoring A1 Levels
Time frame: Assessements will occur at 3 months
Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes
Time frame: Assessements will occur at 3 months
Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose Monitoring
Time frame: Assessements will occur at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Ghanny, MD principal investigator
Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molly Center Diabetes Care Guide (Paper-based) and Tablet based interactive diabetes education modules in people with Type 1 Diabetes Mellitus, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes (time frame: Test will be completed on day 3 (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.