Smartphone App for Type 2 Diabetes

(REFLECT2D Trial)

Overseen By Mary Ellen Vajravelu, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Hydroxyurea

Disqualifiers: Pregnancy, Cognitive impairment, Eating disorder, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your medication use has been stable for at least 3 months before joining.

What data supports the effectiveness of the treatment Focused App Prompt, No App Prompt for Type 2 Diabetes?

Research shows that diabetes apps, especially those with virtual coaching, can improve blood sugar control and encourage healthy behaviors. Mobile health prompts, like notifications, are also effective in supporting behavior change in diabetes prevention programs. ^{1 2 3 4 5}

Is the smartphone app for Type 2 Diabetes safe for humans?

The research does not specifically mention safety concerns for the smartphone app used in managing Type 2 Diabetes, but it highlights the importance of personalizing the app to the user and involving them in its development and testing. ^{6 7 8 9 10}

How does the 'Smartphone App for Type 2 Diabetes' treatment differ from other treatments for this condition?

The 'Smartphone App for Type 2 Diabetes' treatment is unique because it uses a mobile app to provide personalized prompts and support for diabetes management, which can enhance self-care behaviors like diet and exercise. Unlike traditional treatments, this app-based approach can offer real-time feedback and motivation, potentially improving engagement and adherence to diabetes management plans. ^{1 6 11 12 13}

What is the purpose of this trial?

This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.

Research Team

Mary Ellen Vajravelu, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adolescents and young adults with Type 2 Diabetes who are interested in managing their blood sugar levels using technology. Participants should be comfortable using a smartphone app, a Fitbit activity tracker, and Continuous Glucose Monitors (CGM). Specific eligibility criteria were not provided.

Inclusion Criteria

I have type 2 diabetes without any autoimmune or genetic diabetes conditions.

English-speaking (app in English)

My HbA1c level is 7.0% or higher and I've been on the same diabetes medication for at least 3 months.

Exclusion Criteria

I am taking hydroxyurea, which affects my CGM sensor readings.

Current pregnancy

Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management

Timeline

Run-in

Participants engage in initial setup and baseline assessments with a Registered Dietitian and Diabetes Educator to form diet and activity goals

2-4 weeks

Micro-randomized Trial

Participants receive daily prompts focused on physical activity or dietary intake, or no prompt, to reflect on glycemic trends and revise behavioral management goals

12 weeks

Daily virtual interactions via app

Observation

Participants are observed for ongoing use of the Healthmine app and engagement with CGM without prompts

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the observation period

4 weeks

Treatment Details

Interventions

• Focused App Prompt
• No App Prompt

Trial Overview The study tests if an app that prompts users to check real-time blood sugar and health behavior data helps control Type 2 Diabetes better. Half will get these prompts; the other half won't. Everyone's monitored for 90 days then observed for another 90 without prompts.

Participant Groups

Group I: Physical Activity Focused App Prompt Experimental Treatment 1 Intervention

The app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers.

Group II: No App Prompt Experimental Treatment 1 Intervention

No app prompt will be sent to the participant

Group III: Diet Focused App Prompt Experimental Treatment 1 Intervention

The app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

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]

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]

Mobile health (mHealth) prompts, especially text messaging, are widely used in diabetes prevention programs, but their effectiveness on behavior change and diabetes incidence shows mixed results based on a review of 44 studies.

Participants generally received mHealth prompts positively, yet there is a lack of clarity on the theoretical basis for prompt design and timing, indicating a need for more rigorous research to optimize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth prompts within diabetes prevention programs: a scoping review. MacPherson, MM., Merry, KJ., Locke, SR., 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]

Using the Diahome smartphone app for diabetes management led to a significant reduction in fasting blood glucose levels among users, from 156 mg/dl to 129 mg/dl, compared to conventional treatment.

App users also showed a greater percentage improvement in HbA1c levels (15.8%) compared to non-app users (10.4%), indicating that the app may enhance glycaemic control in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India. Raghavan, A., Nanditha, A., Satheesh, K., et al.[2022]

A systematic review of 42 articles identified seven core incentive mechanisms used in mobile health (mHealth) tools for diabetes management, with education being the most common, followed by reminders and feedback.

Despite advancements in technology, the fundamental incentive-driven mechanisms have remained consistent, evolving mainly in terms of content delivery and personalization to enhance user engagement and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on incentive-driven mobile health technology: As used in diabetes management. de Ridder, M., Kim, J., Jing, Y., et al.[2022]

Out of 80 diabetes apps reviewed, only 42 were eligible, with 86% allowing users to record blood glucose levels, but only 26% included a prandial insulin dose calculator, indicating a lack of comprehensive diabetes management tools.

The overall usability of the apps was low, with a mean composite score of 11.3 out of 30, and only four apps scored above 20, suggesting that most apps may not effectively support diabetes management despite some being rated highly, such as Glucool Diabetes and OnTrack Diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of diabetes self-management applications for Android smartphones. Demidowich, AP., Lu, K., Tamler, R., et al.[2017]

References

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

Virtual Coaching to Enhance Diabetes Care. [2020]

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

Patterns of User Engagement with Mobile- and Web-Delivered Self-Care Interventions for Adults with T2DM: A Review of the Literature. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

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

4. China pubmed.ncbi.nlm.nih.gov

mHealth prompts within diabetes prevention programs: a scoping review. [2022]

5. 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]

6. Denmark pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Qualitative assessment of user experiences of a novel smart phone application designed to support flexible intensive insulin therapy in type 1 diabetes. [2018]

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

Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomised controlled trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India. [2022]

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

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

11. England pubmed.ncbi.nlm.nih.gov

A systematic review on incentive-driven mobile health technology: As used in diabetes management. [2022]

12. England pubmed.ncbi.nlm.nih.gov

An evaluation of diabetes self-management applications for Android smartphones. [2017]

13. 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]