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

NCT03534193 | Terminated Results

• 1 other identifier: PRO 2016-0713
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Improved Subject Compliance With Glucose Monitoring A1 Levels

  Assessements will occur at 3 months

• Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes

  Assessements will occur at 3 months

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

  Assessements will occur at 3 months

Study Arms (2)

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)

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

Other: Molly Center Diabetes Care Guide (Paper-based); Other: Tablet based interactive diabetes education modules

Interventions

Molly Center Diabetes Care Guide (Paper-based) OTHER

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

Standard Diabetes Education and Tablet; Standard Diabetic Education

Tablet based interactive diabetes education modules OTHER

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

Standard Diabetes Education and Tablet

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Verizon Foundation: collaborator

Study Sites (1)

Joseph M. Sanzari Children's Hospital

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The team experienced difficulties in collecting the number of blood sugar checks from the patients who did not report it for either group.

Results Point of Contact

• Title: Steven Ghanny, MD
• Organization: Hackensack Meridian Health

steven.ghanny@hmhn.org

5519965329

Study Officials

• Steven Ghanny, MD

  Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 23, 2018
• Study Start: April 17, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 8, 2025
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)