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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can help teens and young adults with type 2 diabetes better manage their blood sugar levels. Participants will use the app to track their blood sugar and daily habits, such as exercise and diet. Some will receive focused prompts about their physical activity or diet, while others will not. The study will also explore whether checking in with participants when data is missing helps maintain their engagement. Those who have had type 2 diabetes for a while and are stable on their medication might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management for many.

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 prior data suggests that this smartphone app is safe for adolescents and young adults with Type 2 Diabetes?

Research shows that smartphone apps can safely help manage type 2 diabetes (T2D) for many people. These apps track blood sugar levels, diet, and exercise, often prompting users to reflect on their daily health habits, which can enhance diabetes management.

Studies have found that apps like WellDoc's BlueStar Rx, approved by the FDA, are considered safe for managing T2D. Although the trial under consideration does not involve BlueStar, it demonstrates that apps can safely assist in diabetes management.

The apps in this trial focus on physical activity and diet. Research indicates that many diabetes apps are well-received and effectively track exercise and food intake without causing harm. However, some studies suggest that not all exercise plans from apps are safe for everyone with T2D. Following healthcare professionals' advice when using these apps is crucial.

Overall, most digital health apps for diabetes are safe and serve as useful tools in managing the condition. They provide real-time feedback on health behaviors, which can improve overall diabetes management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how smartphone apps can help people with Type 2 Diabetes manage their condition more effectively. Unlike current treatments, which often focus on medication and lifestyle changes, this approach uses personalized app prompts to engage users in reflecting on their diet and physical activity in relation to their blood glucose levels. This method leverages technology for real-time feedback and self-awareness, potentially empowering individuals to make more informed decisions about their health. Additionally, the trial examines the effects of proactive outreach for missing data, which could enhance the reliability and completeness of health tracking. This innovative approach could transform how people with Type 2 Diabetes manage their health, making it more interactive and personalized.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research shows that smartphone apps can help people manage type 2 diabetes by promoting more exercise and healthier eating. In this trial, researchers will assign participants to different app prompt groups. The Physical Activity Focused App Prompt will inquire about participants' physical activity in relation to their blood glucose levels, while the Diet Focused App Prompt will concentrate on dietary habits. Some studies found that apps designed to increase walking didn't always lead to more activity, but other research suggests they can enhance overall exercise. For diet-focused apps, evidence indicates they can improve dietary quality and reduce heart health risks. These apps can also assist people in taking their medication on time and maintaining stable blood sugar levels. Overall, using smartphone apps for diabetes care has shown positive effects on managing type 2 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Mary Ellen Vajravelu, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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: Outreach for Missing Data Experimental Treatment 1 Intervention

Participants will be randomized to receive proactive outreach by the study team in the case of 3 or more days of missing CGM data, versus no proactive outreach

Group III: No App Prompt Experimental Treatment 1 Intervention

No app prompt will be sent to the participant

Group IV: 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+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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