What is the mechanism of action of this treatment?

The most common treatments for Type 2 Diabetes include metformin, sulfonylureas, GLP-1 receptor agonists, and SGLT2 inhibitors. Metformin works by reducing glucose production in the liver and improving insulin sensitivity. Sulfonylureas increase insulin secretion from the pancreas. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in urine. Understanding these mechanisms is crucial for patients as it helps them comprehend how their medications control blood sugar levels, which can be particularly beneficial when using a mobile app like My Diabetes Care (MDC) to track and manage their condition effectively.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, and insulin therapy. Metformin is generally well-tolerated but can cause gastrointestinal issues like nausea and diarrhea. Sulfonylureas may lead to hypoglycemia and weight gain. DPP-4 inhibitors are associated with a low risk of hypoglycemia but can cause nasopharyngitis and headaches. SGLT2 inhibitors can lead to urinary tract infections and an increased risk of amputations. Insulin therapy, while effective, can cause hypoglycemia and weight gain. Mobile app management, such as the My Diabetes Care (MDC) application, helps in monitoring these treatments to optimize efficacy and minimize side effects.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of Type 2 Diabetes, including GLP-1 receptor agonists such as exenatide (Byetta, Bydureon BCise) and dulaglutide, which have demonstrated efficacy in improving glycemic control. Metformin, a widely used oral antihyperglycemic agent, is also approved for both adult and pediatric use. Extended-release exenatide has been specifically approved for pediatric patients aged 10 to 17 years. These medications, along with lifestyle interventions, form the cornerstone of Type 2 Diabetes management.

What other types of research exist?

Promising alternatives to the My Diabetes Care (MDC) mobile application for Type 2 Diabetes management include: 1) MyDiabetesMyWay (MDMW), an award-winning national electronic personal health record and self-management platform in Scotland, which integrates multiple data sources for comprehensive patient care. 2) Smart Glucose Manager (SGM), which has shown efficacy in improving glycemic control in Sri Lankan patients with diabetes. Both platforms offer robust features for diabetes self-management and have demonstrated positive outcomes in real-world settings.

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MDC Mobile App for Diabetes

N/A

Waitlist Available

Led By William Martinez, MD, MS

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month follow-up (t1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mobile app called My Diabetes Care (MDC) for adults with type 2 diabetes. The app helps users understand their health data using simple graphics and gives personalized advice for managing their condition. MDC is designed to help patients better understand their diabetes health data and support self-care.

Who is the study for?

This trial is for adults aged 18-75 with Type 2 Diabetes who are on medication and attend Vanderbilt Medical Center or Brigham and Women's Hospital. Participants must be able to use English or Spanish, have a smartphone or tablet with internet, and an active patient web portal account.

What is being tested?

The study is testing the 'My Diabetes Care' mobile app for people with Type 2 Diabetes. It aims to understand how users interact with the app, evaluate their experience, and identify any technical issues before a larger-scale trial.

What are the potential side effects?

Since this trial involves using a mobile application rather than medication, traditional side effects are not applicable. However, participants may experience frustration or difficulty if they encounter usability issues with the app.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month follow-up (t1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month follow-up (t1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month follow-up (t1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

System Usage

Usability

User Experience - Acceptance

Secondary study objectives

Change in Diabetes Distress

Change in Diabetes Knowledge

Change in Diabetes Readiness for Change

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: My Diabetes Care (MDC) MobileExperimental Treatment1 Intervention

Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 2 Diabetes include metformin, sulfonylureas, GLP-1 receptor agonists, and SGLT2 inhibitors. Metformin works by reducing glucose production in the liver and improving insulin sensitivity. Sulfonylureas increase insulin secretion from the pancreas. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in urine. Understanding these mechanisms is crucial for patients as it helps them comprehend how their medications control blood sugar levels, which can be particularly beneficial when using a mobile app like My Diabetes Care (MDC) to track and manage their condition effectively.

A Mobile App to Improve Self-Management of Individuals With Type 2 Diabetes: Qualitative Realist Evaluation.SCORE-IT (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes): a systematic review of registered trials.