Hope App for Type 2 Diabetes

Not currently recruiting at 1 trial location

Overseen By Suzanne Mitchell, MD, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: See Yourself Health LLC

Disqualifiers: Type 1 diabetes, Dialysis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called the Hope App, designed to help older adults with type 2 diabetes manage their condition more effectively. Participants will either use the app, which provides diabetes education and health coaching, or continue with their usual care before gaining access to the app. The trial seeks English-speaking adults aged 65 or older who have type 2 diabetes, a specific blood sugar level (HbA1c of 7.5%), and internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

Do I have to stop taking 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 medications, but please confirm with the study team.

What prior data suggests that the Hope App is safe for older adults with diabetes?

Research has shown that mobile health apps, like the Hope App, are generally safe for people with type 2 diabetes. These apps assist users in managing their condition by offering education and tools to track their health. Studies on similar apps indicate they can help control diabetes without causing harm.

The Hope App is a new tool designed to teach older adults how to manage their diabetes effectively. Current and past studies have reported no negative effects from using the Hope App, suggesting it is likely safe for users.

Overall, using a digital app to manage diabetes is considered safe. The main focus is on education and support, which helps users take better care of their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hope App for managing Type 2 Diabetes because it offers a new way for older adults to engage with their health. Unlike traditional treatments that often focus on medication and in-person clinic visits, the Hope App uses an immersive learning and telehealth platform to deliver personalized diabetes care and self-management education. This approach allows users to access support conveniently from their homes, making it easier for them to stay informed and proactive about their health. By integrating technology with healthcare, the Hope App aims to improve engagement and outcomes for people with diabetes.

What evidence suggests that the Hope App is effective for diabetes care?

Research has shown that mobile health apps, such as the Hope App, which participants in this trial may receive, can assist in managing type 2 diabetes by supporting self-care and education. Studies have found that these apps can improve blood sugar control. Specifically, diabetes self-management education and support can reduce A1C levels—a key measure of blood sugar—by about 0.45–0.57% compared to usual care. These apps provide personalized guidance, simplifying condition management. This approach is widely recognized as a valuable tool in the diabetes community. ^{2 6 7 8 9}

Who Is on the Research Team?

Suzanne Mitchell, MD, MS

Principal Investigator

See Yourself Health LLC

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 and above who have type 2 diabetes with a baseline blood sugar value (HbA1c) of at least 7.5%. Participants must have Internet access, be able to speak English, and are looking to improve their diabetes care skills.

Inclusion Criteria

I am 65 years old or older.

I have been diagnosed with type 2 diabetes.

You have access to the internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Immediate Treatment Group participants receive access to the Hope App for diabetes care and self-management education for 6 months

6 months

3 visits (baseline, 3 months, 6 months)

Wait List Control

Wait List Control participants receive care as usual for 6 months, then gain access to the Hope App

6 months

3 visits (baseline, 3 months, 6 months)

Follow-up

Participants are monitored for changes in glycemic control, anxiety, depressive symptoms, and other health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hope App

Trial Overview The Hope App study is testing an immersive learning and telehealth platform designed for diabetes education. It compares the effectiveness of using the app's educational modules and monthly health coaching against standard diabetes care practices.

How Is the Trial Designed?

Group I: Immediate Treatment Group (ITG) Experimental Treatment 1 Intervention

ITG participants receive access to the Hope App, a newly designed immersive learning and telehealth application designed to deliver engaging diabetes care and self-management education and support for older adults with diabetes. ITG participants also complete data collection (surveys and HbA1c measurements) at baseline, 3 months after baseline, and 6 months after baseline.

Group II: Wait List Control (WLC) Active Control 1 Intervention

WLC participants receive care as usual for 6 months. They will complete data collection (surveys and HbA1c measurements) at baseline, 3 months after baseline, and 6 months after baseline. After 6 months, WLC participants will gain access to the Hope App and receive diabetes programming and health coaching for the remaining 6 months.

Who Is Running the Clinical Trial?

See Yourself Health LLC

Lead Sponsor

Trials

1

Recruited

150+

University of Louisville

Collaborator

Trials

353

Recruited

76,400+

Published Research Related to This Trial

A systematic review of diabetes mobile applications found that while usability ratings from users and experts ranged from 38% to 80%, significant usability issues such as complex navigation and limited functionality were common.

Despite these usability challenges, diabetes apps showed some clinical effectiveness, with reductions in HbA1c levels between 0.15% and 1.9%, indicating potential for improving glycemic control in adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. Fu, H., McMahon, SK., Gross, CR., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947812/

Mobile Health Apps for the Control and Self-management of ... The research showed that mobile health apps provide support for diabetes control and self-management in patients with T2DM.

2. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Based on recent data (13,14,16), DSMES results in an average A1C reduction of 0.45–0.57% when compared with usual care for people with type 2 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1976131724000355

Automated Personalized Self-care Program for Patients ... This study aimed to assess the feasibility of the Automated Personalized Self-Care program among type 2 diabetes patients and evaluate its preliminary ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140636/

Diabetes Care and Education: A Look Backward ... The importance of self-management and education is now generally known and accepted in the diabetes community.

5. researchprotocols.org researchprotocols.org/2022/6/e31652/

The Impact of Mobile Health Use on the Self-care ... This study aims to determine the impact of mobile app use on self-care in patients with type 2 diabetes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05729516

Study Details | NCT05729516 | The Hope App Study This research study will test how a computer program (called the Hope App) teaches diabetes care skills for older adults with diabetes. The study will compare ...

7. diva-portal.org diva-portal.org/smash/get/diva2:1568177/FULLTEXT01.pdf

HOPE Platform Digital Tool for Type 2 Diabetes The results showed that important features were documentation of blood glucose measurements, patient education, data transfer, communication and care plan ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133075/

Understanding Device Integrations Within Diabetes Apps Diabetes management involves a large degree of data collection and self-care in order to accurately administer insulin.

9. diabetesjournals.org diabetesjournals.org/care/article/43/1/250/35864/Diabetes-Digital-App-Technology-Benefits

Diabetes Digital App Technology: Benefits, Challenges, and ... An example is WellDoc's BlueStar Rx mobile app, which was cleared by the FDA as a prescription-only app to support the management of type 2 diabetes.