Hope App for Type 2 Diabetes

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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the Hope App treatment for Type 2 Diabetes?

Research suggests that diabetes apps, like the Hope App, can positively impact health by improving blood sugar control, body weight, and health behaviors in people with Type 2 diabetes. Personalizing these apps and involving users in their development can enhance their effectiveness. ^{1 2 3 4 5}

How does the Hope App treatment for Type 2 Diabetes differ from other treatments?

The Hope App is unique because it focuses on reducing the practical, cognitive, and emotional burdens of managing Type 2 Diabetes by providing personalized coaching, reminders, and emotional support, which are not typically addressed by traditional treatments. ^{1 3 6 7 8}

What is the purpose of this trial?

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 those who receive diabetes education (10 educational modules and monthly health coaching) through the research program with those who receive care as usual.

Research Team

Suzanne Mitchell, MD, MS

Principal Investigator

See Yourself Health LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Mobile applications for management of Type 2 diabetes]. [2022]

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

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes. [2023]

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

Rapid Evidence Review of Mobile Applications for Self-management of Diabetes. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Attitudes and experiences of registered diabetes specialists in using health apps for managing type 2 diabetes: results from a mixed-methods study in Germany 2021/2022. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. [2022]

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

A Mobile App for Diabetes Management: Impact on Self-Efficacy Among Patients with Type 2 Diabetes at a Community Hospital. [2022]

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

What Do Adults with Type 2 Diabetes Want from the "Perfect" App? Results from the Second Diabetes MILES: Australia (MILES-2) Study. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Popular Diabetes Apps and the Impact of Diabetes App Use on Self-Care Behaviour: A Survey Among the Digital Community of Persons With Diabetes on Social Media. [2020]