NCT06412601

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jul 2024Sep 2026

First Submitted

Initial submission to the registry

April 18, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.2 years

First QC Date

April 18, 2024

Last Update Submit

October 15, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Self Efficacy for Diabetes (SED) Scale

    0,3,6 months

  • Diabetes Treatment Outcomes

    6 months

Study Arms (2)

RPM (remote patient monitoring)

EXPERIMENTAL
Behavioral: RPMBehavioral: app

Non-RPM

ACTIVE COMPARATOR
Behavioral: app

Interventions

RPMBEHAVIORAL

remote patient monitoring by clinic staff

RPM (remote patient monitoring)
appBEHAVIORAL

use of Happy Bob phone app

Non-RPMRPM (remote patient monitoring)

Eligibility Criteria

Age13 Years - 215 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

You may not qualify if:

  • Non-English Speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 18, 2024

First Posted

May 14, 2024

Study Start

July 30, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations