Happy Bob App for Type 1 Diabetes

Overseen By Sophie MacColl

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a phone app called Happy Bob to determine if it helps young people with Type 1 Diabetes manage their condition more effectively. Researchers aim to assess whether the app is user-friendly and enjoyable, and if it aids users in adhering to their treatment plans while providing social support. Participants will use the app for six months and complete surveys about their experience; some will also try remote monitoring by clinic staff. Ideal candidates for this trial have Type 1 Diabetes, use a Dexcom device, and own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management for young people.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the trial focuses on using an app for support.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual diabetes treatment while using the app, but it's best to confirm with the trial organizers.

What prior data suggests that the Happy Bob app is safe for youth with Type 1 Diabetes?

Research has shown that the Happy Bob App aims to make managing Type 1 Diabetes more engaging by using real-time data to create a fun and rewarding experience. However, specific safety information for the app itself is not available.

Since the app provides support and motivation rather than acting as a medical treatment, typical concerns about side effects do not apply as they would with medications or medical devices. The app's goal is to help users by making diabetes management more interactive and enjoyable, potentially leading to better adherence to treatment plans.

While data privacy is important to consider, no evidence suggests any negative effects from using the app. It serves as a tool to make diabetes care more fun and social. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Happy Bob App for Type 1 Diabetes because it introduces a novel approach to managing blood sugar levels through digital technology. Unlike traditional methods that often rely on manual data entry and separate devices, the app uses remote patient monitoring (RPM) to automatically track glucose data and provide real-time feedback. This could make diabetes management more seamless and less burdensome, potentially improving adherence and outcomes. Additionally, the app's engaging and interactive interface aims to enhance user motivation, making diabetes management a more integrated part of daily life.

What evidence suggests that the Happy Bob App is effective for Type 1 Diabetes?

Research has shown that the Happy Bob app can help people with Type 1 Diabetes manage their blood sugar levels more effectively. In this trial, participants will be divided into two groups: one using the Happy Bob app with remote patient monitoring (RPM) and another without RPM. The app uses real-time data from devices that continuously monitor blood sugar to offer playful reminders, making the process more like a game. Studies have found that people using the app spend more time with their blood sugar levels in a healthy range. This suggests that Happy Bob can make managing diabetes more engaging and effective. The app sends fun, personalized messages and notifications to encourage users to keep track of their condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for young people with Type 1 Diabetes who use a Dexcom device and a smartphone. It's designed to see if the Happy Bob app helps them manage their diabetes by providing peer support and monitoring.

Inclusion Criteria

I have Type 1 Diabetes and use a Dexcom with a smartphone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Happy Bob app and complete surveys at the start, middle, and end of the 6-month period

6 months

3 survey completions (start, middle, end), 2 remote monitoring sessions for some participants

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Happy Bob App

Trial Overview The study tests the Happy Bob app, focusing on its user-friendliness, how well it's liked, and its effectiveness in improving treatment adherence and social support over six months, including some remote patient monitoring sessions.

How Is the Trial Designed?

Group I: RPM (remote patient monitoring) Experimental Treatment 2 Interventions

Group II: Non-RPM Active Control 1 Intervention

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

A pilot trial involving six patients with type 1 diabetes demonstrated that a computer model could effectively simulate blood glucose levels based on self-reported data, helping to suggest alternative insulin doses and meal sizes to minimize the risk of hypo- and hyperglycemia.

Participants found the system helpful, but challenges with data entry limited its usage, indicating that user experience improvements are needed for better implementation in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Internet to optimize self-management of type 1 diabetes: preliminary experience with DiasNet. Cavan, DA., Everett, J., Plougmann, S., et al.[2007]

The open-source AndroidAPS (AAPS) hybrid closed-loop system significantly improved the percentage of time in range (TIR) for participants with type 1 diabetes, increasing it by 18.6% compared to stand-alone insulin pump therapy (76.6% vs. 58.0%).

The AAPS system demonstrated comparable safety to traditional pump therapy, with no serious adverse events or severe hypoglycemia reported, indicating it is a safe option for managing blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes. Nanayakkara, N., Sharifi, A., Burren, D., et al.[2023]

The open-source automated insulin delivery system, AndroidAPS, demonstrated high safety and feasibility in managing blood glucose levels, maintaining control 95% of the time with only 0.72% of the time spent in hypoglycemia below 3 mmol/L during a study involving 16 adolescents with type 1 diabetes.

The hybrid closed loop (HCL) scenario resulted in a slightly higher time spent in hypoglycemia compared to meal announcement only (MA) and full closed loop (FCL) scenarios, but overall, all methods effectively maintained similar average blood glucose levels, suggesting that FCL could be a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study. Petruzelkova, L., Neuman, V., Plachy, L., et al.[2023]

The smartphone-based automated insulin delivery (AID) system was found to be safe for use in 20 pediatric participants with type 1 diabetes, with minimal instances of low blood glucose and no adverse events reported during a 48-hour trial.

The AID system maintained a similar percentage of time in the target glucose range compared to traditional sensor-augmented pump therapy, while also showing improved overnight glucose stability, indicating its efficacy in managing blood sugar levels in children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes. Deshpande, S., Weinzimer, SA., Gibbons, K., et al.[2022]

A study involving 43 children and adolescents with type 1 diabetes showed that after participating in a virtual educational camp and using the Control-IQ closed-loop control system, there were significant improvements in positive emotions, with 67% reporting increased positive feelings immediately and 65% six months later.

The use of the Control-IQ system also led to a notable increase in time in range (TIR) for blood glucose levels, rising from 64% to 75% over six months, indicating improved glucose management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant and persistent improvements in time in range and positive emotions in children and adolescents with type 1 diabetes using a closed-loop control system after attending a virtual educational camp. Rabbone, I., Savastio, S., Pigniatiello, C., et al.[2022]

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar&#174; in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

A virtual educational camp (vEC) significantly improved glucose control in children and adolescents with type 1 diabetes, with over 75% of participants achieving a target range of glucose levels after the camp.

The study, involving 43 participants aged 7-16 years, showed a notable increase in the percentage of time in the target glucose range from 64% to 76% and a decrease in HbA1c by 0.5%, all without any severe hypoglycemia or diabetic ketoacidosis events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: A prospective, multicentre, real-life study. Cherubini, V., Rabbone, I., Berioli, MG., et al.[2021]

The development of automated insulin dosing systems, like the Medtronic MiniMed 670G and 780G, represents significant advancements in managing type 1 diabetes by aiming to 'close the loop' between glucose monitoring and insulin delivery.

DIY artificial pancreas systems, such as OpenAPS, AndroidAPS, and Loop, have emerged from the #WeAreNotWaiting movement, allowing patients and caregivers to create personalized solutions for insulin management, demonstrating real-world benefits in self-management for users across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do-It-Yourself (DIY) Artificial Pancreas Systems for Type 1 Diabetes: Perspectives of Two Adult Users, Parent of a User and Healthcare Professionals. Ahmed, SH., Ewins, DL., Bridges, J., et al.[2021]

The New-Onset Diabetes Educator (NODE) web application significantly improved diabetes knowledge among child/caregiver dyads, with post-intervention scores showing a medium effect size (Δ=0.56) compared to standard education methods.

NODE was found to be user-friendly and feasible, suggesting it could be an effective tool for enhancing diabetes self-management education at the time of diagnosis, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. Bernier, A., Fedele, D., Guo, Y., et al.[2023]

The #WeAreNotWaiting movement has led to the development of do-it-yourself artificial pancreas systems (DIYAPS) by motivated individuals in the diabetes community, which integrate continuous glucose monitoring and insulin pumps to improve glycemic control and quality of life for people with type 1 diabetes.

While DIYAPS show promising improvements in diabetes management based on anecdotal evidence and observational studies, their unregulated nature raises safety concerns, and there are significant barriers to acceptance among healthcare professionals and regulatory bodies due to ethical, legal, and funding issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Do-It-Yourself Artificial Pancreas: A Comprehensive Review. Kesavadev, J., Srinivasan, S., Saboo, B., et al.[2021]

The use of the AndroidAPS automated insulin delivery system significantly improved glycemic control in young children with type 1 diabetes, with time in range increasing and HbA1c levels decreasing after switching from a sensor-augmented pump.

No severe hypoglycemia or diabetic ketoacidosis (DKA) events were reported during the use of AndroidAPS, indicating a safe profile, along with reported improvements in quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Petruzelkova, L., Jiranova, P., Soupal, J., et al.[2022]

The Diabeo software, which allows for personalized insulin dose adjustments and includes telemedicine support, significantly reduced HbA1c levels in poorly controlled type 1 diabetes patients, achieving a mean HbA1c of 8.41% compared to 9.10% in the usual care group.

Patients using the Diabeo system experienced a 0.91% improvement in HbA1c over controls without an increase in hypoglycemic episodes or additional medical time, making it a cost-effective option for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Charpentier, G., Benhamou, PY., Dardari, D., et al.[2022]

The Glucobeeb (Gb) web-based tool significantly improved metabolic control in teenagers with type 1 diabetes, as evidenced by a decrease in average HbA1c levels over 6 months compared to standard care.

After 12 months, both groups showed an increase in HbA1c, but the intervention group maintained better control, indicating that the Gb tool can effectively support diabetes management in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telecare for teenagers with type 1 diabetes: a trial. Cadario, F., Binotti, M., Brustia, M., et al.[2022]

Citations

1. adces.org adces.org/education/danatech/apps-dtx/find-apps-tools/product-detail/happy-bob

Happy Bob Happy Bob engages users with their diabetes data, creating a gamified experience. The smartphone app notifies users of glucose trends and motivates them ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06412601

Happy Bob App: A Preliminary Evaluation of Its Use in ... 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 ...

3. happybob.app happybob.app/

Happy Bob App turns diabetes data into rewarding experiences Happy Bob uses real-time CGM data and turns diabetes management into more rewarding, playful moments that help keeping blood sugar more stable.

4. withpower.com withpower.com/trial/phase-diabetes-mellitus-6-2024-fad3f

Happy Bob App for Type 1 Diabetes · Info for Participants 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 ...

5. childrensmercy.org childrensmercy.org/departments-and-clinics/endocrinology/rising-t1de-alliance/evidence/abstract-youth-with-type-1-diabetes-t1d-improve-time-in-range-by-use-of-a-relational-agent-embedded-in-a-smart-phone-app/

Youth with Type 1 Diabetes (T1D) Improve Time in Range ... The Happy Bob (HB) app uses Dexcom Continuous Glucose Monitor (CGM) data with personified nudges to gamify engagement for users in BG monitoring. Methods ...

6. happybob.app happybob.app/privacy-policy/

Privacy policy We also ask users information about their country, diabetes type, gender and age. This data is used to analyze which user groups benefit from the Happy Bob use.