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

80 Participants Needed

Trial Summary

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 data supports the idea that Happy Bob App for Type 1 Diabetes is an effective treatment?

The available research does not provide specific data on the effectiveness of the Happy Bob App for Type 1 Diabetes. However, it mentions other treatments like the Diabeo software and closed-loop control systems, which have shown improvements in managing diabetes. For example, the Diabeo software, combined with telemedicine support, improved blood sugar control in patients. This suggests that technology-based treatments can be effective, but specific data on the Happy Bob App is not available in the provided information. ^{1 2 3 4 5}

What data supports the effectiveness of the Happy Bob App treatment for Type 1 Diabetes?

Research shows that using technology, like apps and software, can help people with type 1 diabetes manage their condition better. For example, the Diabeo software, which helps adjust insulin doses, improved blood sugar control in patients. This suggests that similar apps, like Happy Bob, might also be effective. ^{1 2 3 4 5}

What safety data exists for the Happy Bob App for Type 1 Diabetes?

The provided research does not contain specific safety data for the Happy Bob App or any treatment under the name Happy Bob. The studies focus on closed-loop control systems, do-it-yourself artificial pancreas systems, and educational tools for diabetes management, but none mention the Happy Bob App directly. Therefore, no safety data for the Happy Bob App is available in the provided research. ^{2 6 7 8 9}

Is the Happy Bob App a promising treatment for Type 1 Diabetes?

The Happy Bob App is a promising treatment for Type 1 Diabetes because it offers a new way to help people manage their condition. It uses technology to make it easier for patients to monitor their blood sugar levels and manage their insulin, which can improve their daily lives. ^{8 10 11 12 13}

How does the Happy Bob App treatment for Type 1 Diabetes differ from other treatments?

The Happy Bob App is unique because it likely integrates technology to assist in managing Type 1 Diabetes, potentially offering a novel approach compared to traditional insulin delivery systems. While other treatments focus on automated insulin delivery, this app may provide additional support or motivation through its interface, making diabetes management more engaging and personalized. ^{7 10 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 #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 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 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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of the Internet to optimize self-management of type 1 diabetes: preliminary experience with DiasNet. [2007]

2. Germany 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. [2022]

3. United States 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). [2022]

4. United States 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. [2020]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Do-It-Yourself Artificial Pancreas: A Comprehensive Review. [2021]

7. Denmark 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. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Hybrid Closed Loop Using a Do-It-Yourself Artificial Pancreas System in Adults With Type 1 Diabetes. [2023]

10. United States 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study. [2023]

13. Italy pubmed.ncbi.nlm.nih.gov

Telecare for teenagers with type 1 diabetes: a trial. [2022]