8 Participants Needed

PACTAID App for Diabetes

(PACTAID Trial)

CK
Overseen ByCorey Kurek
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this trial is to test and refine the PACTAID smart phone application in adults with type 1 diabetes mellitus to help manage exercise while on automated insulin delivery systems with the goal of improving glycemic control during and after exercise as well as improving multiple other cardiovascular risk factors.

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.

How is the PACTAID App treatment for diabetes different from other treatments?

The PACTAID App is unique because it leverages mobile technology to support diabetes self-management, offering features like tracking blood glucose levels and medication, which can improve adherence to diabetes care. Unlike traditional treatments, it provides a digital platform for patients to actively manage their condition, potentially enhancing engagement and outcomes.12345

What data supports the effectiveness of the PACTAID App treatment for diabetes?

Research shows that mobile apps can help people with diabetes manage their condition better by improving their adherence to self-care activities. For example, a study on a similar app called mDiabetes found it helped patients monitor their glucose levels, diet, and physical activity effectively.46789

Who Is on the Research Team?

Yogish C. Kudva, M.B.B.S. - Doctors and ...

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
Willing to wear study devices
I have type 1 diabetes and no heart-related artery disease.
See 9 more

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
See 22 more

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?
1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention

Find a Clinic Near You

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

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.
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.
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 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.
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]

Citations

Diabetes Management via a Mobile Application: a Case Report. [2020]
Mobile App Interventions to Improve Medication Adherence Among Type 2 Diabetes Mellitus Patients: A Systematic Review of Clinical Trials. [2023]
Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. [2022]
The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. [2022]
Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. [2023]
An evaluation of diabetes self-management applications for Android smartphones. [2017]
Benefits and risks of apps for patients. [2021]
What do we know about mobile applications for diabetes self-management? A review of reviews. [2022]
Content Analysis of Mobile Health Applications on Diabetes Mellitus. [2019]
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