Type 1 DiabetesNCT06412601
Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes
A study testing RPM and app in people with Type 1 Diabetes, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years to 215 monthsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- RPM and app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 years to 215 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone
Who cannot join
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- RPM, app
- 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.
RPMBehavioural
remote patient monitoring by clinic staff
appBehavioural
use of Happy Bob phone app
| Study group | Role | What they receive |
|---|---|---|
| RPM (remote patient monitoring) | Experimental | Not described Receives: Behavioral: RPM; Behavioral: app |
| Non-RPM | Active comparator | Not described Receives: Behavioral: app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Happy Bob App User Metrics
time spent in Happy Bob,
Measured: 6 months
Type 1 Diabetes and Life (T1DAL) Measure
quality of life scale
Measured: 0,3,6 months
Positive and Negative Affect Schedule (PANAS)
mood scale
Measured: 0,3,6 months
Diabetes Treatment Satisfaction Questionnaire
intervention satisfaction
Measured: 0,3,6 months
Social Support Questionnaire for Children (SSQC)
social quality of life
Measured: 0,3,6 months
Health Information Technology Usability Evaluation Scale (Health-ITUES)
usability scale
Measured: 0,3,6 months
Secondary outcomes (2)
Self Efficacy for Diabetes (SED) Scale
efficacy scale
Measured: 0,3,6 months
Diabetes Treatment Outcomes
TIR,
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start30 Jul 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Redel, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412601
- Sponsor's protocol ID
- STUDY00002907
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2024
- Last updated
- 19 Oct 2026
- Results posted
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes
- ClinicalTrials.gov ID
- NCT06412601
- Acronym / sponsor ID
- STUDY00002907
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPM (remote patient monitoring) | Experimental | Behavioral: RPM, Behavioral: app |
| Non-RPM | Active comparator | Behavioral: app |
Who may qualify
- Ages
- 13 years to 215 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone
Key exclusion criteria (1 listed)
- Non-English Speaking
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 |
|---|---|---|
| RPMremote patient monitoring by clinic staff | Behavioural | RPM (remote patient monitoring) |
| appuse of Happy Bob phone app | Behavioural | Non-RPM, RPM (remote patient monitoring) |
Primary outcome
Happy Bob App User Metrics
Time frame: 6 months
time spent in Happy Bob,
Type 1 Diabetes and Life (T1DAL) Measure
Time frame: 0,3,6 months
quality of life scale
Positive and Negative Affect Schedule (PANAS)
Time frame: 0,3,6 months
mood scale
Diabetes Treatment Satisfaction Questionnaire
Time frame: 0,3,6 months
intervention satisfaction
Social Support Questionnaire for Children (SSQC)
Time frame: 0,3,6 months
social quality of life
Health Information Technology Usability Evaluation Scale (Health-ITUES)
Time frame: 0,3,6 months
usability scale
2 secondary outcomes
Self Efficacy for Diabetes (SED) Scale
Time frame: 0,3,6 months
Diabetes Treatment Outcomes
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RPM and app in people with Type 1 Diabetes, run by Children's Mercy Hospital Kansas City 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Happy Bob App User Metrics (time frame: 6 months). The study lists 6 primary outcomes in all. 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 19 Oct 2026.