PACTAID App for Diabetes

(PACTAID Trial)

Overseen By Corey Kurek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Insulin

Must not be taking: Anti-hyperglycemics, Chemotherapy, Immunosuppressants, others

Disqualifiers: Pregnancy, Hypertension, COPD, others

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

Compensation: Varies

Number of Visits: 12

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called PACTAID, which assists people with type 1 diabetes in managing exercise while using an automated insulin delivery system. The goal is to enhance blood sugar control during and after exercise and to reduce heart-related risks. Individuals who have managed type 1 diabetes with an insulin pump for at least three months and do not have significant heart issues might be suitable candidates. Participants will use the app for eight weeks to assess its impact on their health and diabetes management. As an unphased trial, this study provides an opportunity to contribute to innovative diabetes management research and potentially improve personal health outcomes.

Will I have to stop taking my current medications?

The trial requires that you do not take anti-hyperglycemic drugs other than insulin, including metformin. If you are on any medication affecting heart rate or certain other medications, you may need to stop them, but the protocol does not specify all medications that must be stopped.

What prior data suggests that the PACTAID App is safe for managing exercise in adults with type 1 diabetes?

Research has shown that mobile apps can assist people with diabetes in managing their condition. One study examined various apps that support adherence to diabetes treatment plans and found that these apps can improve blood sugar control. Another study investigated the impact of mobile apps on individuals with Type 2 diabetes, revealing that these apps can enhance medication adherence and blood sugar management.

Specific safety information about the PACTAID App is not available. However, as it is designed to aid in diabetes management, it is likely safe to use. Apps generally pose a low risk of harm since they do not involve medication or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PACTAID App is unique because it offers a digital approach to managing diabetes, unlike traditional methods such as medication, insulin therapy, or lifestyle changes alone. This app is designed to actively engage users with personalized support and real-time feedback, which can enhance self-management skills and improve adherence to diabetes care plans. Researchers are excited about this treatment because it leverages technology to empower patients, potentially leading to better blood sugar control and overall health outcomes.

What evidence suggests that the PACTAID App is effective for managing type 1 diabetes?

Research shows that mobile apps can help people with diabetes manage their condition effectively. In this trial, participants in the intervention group will use the PACTAID app, designed for adults with type 1 diabetes to manage exercise routines while using automated insulin delivery systems. The app tracks blood sugar levels and offers advice before, during, and after exercise to maintain control. Early findings suggest that using an app like this can improve diabetes management and reduce heart disease risks. Although data on the PACTAID app is limited, similar apps have demonstrated positive results in enhancing diabetes care. ^{6 7 8 9 10}

Who Is on the Research Team?

Yogish Kudva, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with type 1 diabetes who are using automated insulin delivery systems. It aims to help them manage their blood sugar levels and cardiovascular risk factors during and after exercise.

Inclusion Criteria

CGM and insulin pump data available for > 70% for last 2 weeks

HbA1c ≤10%

Willing to wear study devices

Exclusion Criteria

Pregnancy or contemplating pregnancy in study

My thyroid levels are abnormal and I haven't been treated for it.

Baseline exercise status - vigorous exercise such as 1 hour per day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants use the PACTAID app to manage exercise while on an automated insulin delivery system

4 weeks

Baseline, 4 weeks

App Refinement

The PACTAID app is refined based on feedback from Phase 1

2-4 weeks

Phase 2 Treatment

Participants use the refined PACTAID app to manage exercise while on an automated insulin delivery system

4 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PACTAID App

Trial Overview

The PACTAID smartphone app is being tested to see if it can improve the management of type 1 diabetes in relation to exercise, by potentially enhancing glycemic control and other health aspects.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will utilize the PACTAID app for 8 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Published Research Related to This Trial

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]

Mobile applications for diabetes self-management can significantly aid patients in adhering to complex treatment regimens, which include medication, blood sugar monitoring, diet, and exercise.

The rapid increase in available diabetes management apps highlights the need for patients and healthcare providers to stay informed about effective options, as previous reviews have shown varying outcomes in app effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we know about mobile applications for diabetes self-management? A review of reviews. Hood, M., Wilson, R., Corsica, J., et al.[2022]

Diabetes apps, including companion apps for insulin pumps and glucose monitors, have become essential tools for managing diabetes, especially during the COVID-19 pandemic when many appointments shifted to telemedicine.

A consensus report from diabetes organizations emphasizes the need to understand both the benefits and potential drawbacks of these apps to ensure informed decisions by patients, healthcare professionals, and policymakers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and risks of apps for patients. Ahn, DT.[2021]

Mobile health care applications, like the Healthy-note app, can enhance adherence to self-management activities in diabetes patients, showing promise in improving diabetes management.

However, the effectiveness of these mobile apps may vary among patients, indicating a need for further research to boost patient engagement and optimize the use of mobile interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Management via a Mobile Application: a Case Report. Jo, IY., Yoo, SH., Lee, DY., et al.[2020]

A systematic review of seven clinical trials involving 649 type 2 diabetes patients found that mobile app-based interventions generally improved medication adherence, with three studies showing statistically significant results.

Despite the positive outcomes, the studies had varying designs and sample sizes, making it difficult to pinpoint specific app features that enhance adherence, highlighting the need for more systematically planned research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App Interventions to Improve Medication Adherence Among Type 2 Diabetes Mellitus Patients: A Systematic Review of Clinical Trials. Shrivastava, TP., Goswami, S., Gupta, R., et al.[2023]

The smartphone app significantly improved asthma control in 60 adults over a 4-month period, with Asthma Control Test scores increasing from 16.6 to 20.5, indicating better management of their condition.

Patients also experienced a 7.9% increase in lung function (FEV1) and a reduction in the use of systemic corticosteroids, demonstrating the app's effectiveness in enhancing asthma management while requiring minimal user input.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. Cook, KA., Modena, BD., Simon, RA.[2023]

Out of 346 diabetes management apps evaluated, only 16 from Apple and 19 from Google Play met the criteria for inclusion, highlighting the limited options available for effective diabetes self-management tools.

Most apps focused on basic features like reminders and data reporting, with only a few providing personalized education or therapeutic support, indicating a need for better app design that addresses patients' needs for comprehensive diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content Analysis of Mobile Health Applications on Diabetes Mellitus. Izahar, S., Lean, QY., Hameed, MA., et al.[2019]

The Pro-Active Call Center Treatment Support (PACCTS) program significantly improved glycemic control in individuals with type 2 diabetes, showing an overall reduction in HbA1c levels by 0.31% compared to usual care in a study of 591 participants over one year.

For patients with higher baseline HbA1c levels (>7%), the improvement was even greater at 0.49%, and PACCTS also increased the likelihood of achieving a reduction of at least 1% in HbA1c by 10% overall, indicating its effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Young, RJ., Taylor, J., Friede, T., et al.[2022]

The smartphone-based mDiabetes system significantly reduced HbA1c levels in patients with type 2 diabetes by an average of 0.40%, compared to only 0.06% in the traditional paper logbook group, over a 24-week trial involving 172 participants.

Patients using mDiabetes were more likely to achieve HbA1c levels below 7.0% without experiencing hypoglycemia, indicating that this digital intervention is both effective and safe for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Kim, EK., Kwak, SH., Jung, HS., et al.[2022]

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