Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes

The goal of this clinical trial is to evaluate the impact of peer support via the Happy Bob phone app in youth with Type 1 Diabetes.

The main questions it aims to answer are: What is the usability and acceptability of the app? What is the app's efficacy on measures such as treatment adherence and social support? And how are these effects impacted by remote patient monitoring by clinic staff?

Participants will use the Happy Bob app for 6 months and will complete a series of surveys at the start, middle, and end of their use of the app. Some participants will participate in 2 remote patient monitoring sessions when beginning their use of the app.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: RPM; Behavioral: app

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

Exclusion Criteria:

Non-English Speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RPM (remote patient monitoring)	Behavioral: RPM; remote patient monitoring by clinic staff; Behavioral: app; use of Happy Bob phone app
Active Comparator: Non-RPM	Behavioral: app; use of Happy Bob phone app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Happy Bob App User Metrics	time spent in Happy Bob,	6 months
Type 1 Diabetes and Life (T1DAL) Measure	quality of life scale	0,3,6 months
Positive and Negative Affect Schedule (PANAS)	mood scale	0,3,6 months
Diabetes Treatment Satisfaction Questionnaire	intervention satisfaction	0,3,6 months
Social Support Questionnaire for Children (SSQC)	social quality of life	0,3,6 months
Health Information Technology Usability Evaluation Scale (Health-ITUES)	usability scale	0,3,6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Efficacy for Diabetes (SED) Scale	efficacy scale	0,3,6 months
Diabetes Treatment Outcomes	TIR,	6 months

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: STUDY00002907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No