Glucosano App + Coaching for Type 1 Diabetes

Overseen By Julie Hutter, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sarah MacLeish

Must be taking: Insulin

Disqualifiers: Type 2 diabetes, Monogenic diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not have used an automated insulin delivery system in the past 3 months.

What data supports the effectiveness of the Glucosano App + Coaching treatment for Type 1 Diabetes?

Research shows that using diabetes apps with virtual coaching can improve blood sugar control and lead to positive behavior changes. Additionally, a case study of a similar app showed significant improvement in blood sugar levels over time. ^{1 2 3 4 5}

Is the Glucosano App + Coaching safe for humans?

The research does not provide specific safety data for the Glucosano App + Coaching, but similar diabetes-related apps and technologies have been used safely in managing type 1 diabetes, with high levels of satisfaction and no reported safety concerns. ^{3 4 5 6 7}

How does the Glucosano App + Coaching treatment differ from other treatments for type 1 diabetes?

The Glucosano App + Coaching treatment is unique because it combines a mobile app with virtual coaching to help people with type 1 diabetes manage their condition. This approach offers real-time, personalized support and guidance, which can lead to better blood sugar control and improved self-management compared to using an app alone. ^{3 4 5 8 9}

What is the purpose of this trial?

Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.

Eligibility Criteria

This trial is for Black/African American children and young adults with type 1 diabetes who are willing to wear a glucose monitor and consider its continuous use. They must be diagnosed with T1D, treated with insulin, not using an automated insulin delivery system recently, and have English-speaking guardians.

Inclusion Criteria

You are not currently using a device that automatically delivers insulin, and you haven't used one in the last 3 months.

I am willing to wear a glucose monitor for 30 days and consider using one regularly.

I have type 1 diabetes and need insulin.

Exclusion Criteria

Non-English speaking guardians

I have been diagnosed with Type 2 or a specific genetic form of diabetes.

You have used an automated insulin delivery system in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a diabetes dashboard and smartphone app, with support from a community health worker, to optimize glucose management

12 months

Scheduled and as needed visits with a community health worker

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Community Health Worker diabetes technology coach
• Glucosano

Trial Overview The study tests if a new computer program for diabetes teams, along with the Glucosano smartphone app and support from a community health worker can improve the use of diabetes technologies among Black/African American patients.

Participant Groups

Group I: Standard of Care Active Control 1 Intervention

Participants in this arm follow standard of care procedures.

Group II: Diabetes Dashboard and Community Health Worker Active Control 2 Interventions

Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.

Who Is Running the Clinical Trial?

Sarah MacLeish

Lead Sponsor

Trials

1

Recruited

60+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

KeborMed

Collaborator

Trials

1

Recruited

60+

Findings from Research

This trial aims to evaluate the combined effect of digital health self-monitoring and community health worker support on improving blood glucose self-monitoring and glycosylated hemoglobin levels in uninsured or publicly insured individuals with poorly controlled diabetes living in high-poverty urban areas.

The study is designed with a focus on social justice and community engagement, ensuring that the interventions are tailored to the needs of low-income populations, which may enhance the effectiveness of diabetes management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients. Harte, R., Norton, L., Whitehouse, C., et al.[2023]

The study involved 66 participants with Type 2 Diabetes Mellitus who received 3 months of virtual health coaching through the Guru Diabetes application, resulting in significant improvements in diabetes self-management knowledge and quality of life scores.

While the glycemic hemoglobin (HbA1c) levels decreased across all groups, the most notable outcomes were the increased knowledge scores (from 14.97 to 19.07) and quality of life scores (from 54.34 to 60.28), indicating the app's effectiveness in enhancing self-management skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing knowledge of Diabetes self-management and quality of life in people with Diabetes Mellitus by using Guru Diabetes Apps-based health coaching. Jafar, N., Huriyati, E., Haryani, ., et al.[2023]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps alone, addressing common treatment barriers effectively.

Users of these enhanced apps report high satisfaction and prolonged engagement, suggesting that virtual coaching may be a valuable tool in diabetes education, although further research is needed to explore its long-term effects across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. Ramchandani, N.[2020]

The Diabesdagboga smartphone app and Diani web portal allow for comprehensive tracking of diabetes-related data, including blood sugar levels, carbohydrate intake, insulin doses, and physical activity, enhancing patient engagement and data analysis.

A case report of a patient using this system for nearly two years showed a significant improvement in metabolic control, with an 18.6 mmol/mol decrease in HbA1c, indicating better long-term blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. Brož, J., Holubová, A., Mužík, J., et al.[2022]

A study involving 31 diabetes educators in Australia revealed that they found the use of technology in managing type 1 diabetes to be burdensome, indicating a need for better support and training in technology use.

Despite the potential benefits of diabetes-related technologies, care delivery was often fragmented and inconsistent, suggesting that improvements in policy and service structure are necessary to enhance the effectiveness of these tools in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. James, S., Perry, L., Gallagher, R., et al.[2018]

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]

A total of 1019 Android and 1303 iOS apps were identified as relevant for diabetes self-management, but none met all criteria for providing comprehensive and accredited information, highlighting a gap in quality and reliability.

Most diabetes self-management apps are available in Chinese and English, which account for over 80% of the total apps, suggesting a need for more diverse language options and tailored functionalities to better serve users in different regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical relevance of smartphone apps for diabetes management: A global overview. Huang, Z., Soljak, M., Boehm, BO., et al.[2018]

The Sugar Sleuth mobile app, used alongside the FreeStyle Libre™ glucose sensor, led to a significant average reduction in A1c levels by 0.5% over 14 weeks in adults with type 1 diabetes, indicating improved glycemic control.

Participants also reported a decrease in daily carbohydrate intake by an average of 43 grams, suggesting that the app effectively supported dietary management, although no significant changes were observed in other glycemic metrics or insulin dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. Toschi, E., Fisher, L., Wolpert, H., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients. [2023]

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

Enhancing knowledge of Diabetes self-management and quality of life in people with Diabetes Mellitus by using Guru Diabetes Apps-based health coaching. [2023]

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

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. [2018]

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

Virtual Coaching to Enhance Diabetes Care. [2020]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. [2022]

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

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. [2018]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Clinical relevance of smartphone apps for diabetes management: A global overview. [2018]

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

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. [2019]