What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include GLP-1 analogues (e.g., semaglutide, exenatide), SGLT-2 inhibitors (e.g., empagliflozin), and lifestyle interventions. GLP-1 analogues can cause gastrointestinal issues such as nausea, vomiting, and diarrhea, and may also lead to weight loss. SGLT-2 inhibitors are associated with an increased risk of genital and urinary tract infections, dehydration, and, in rare cases, diabetic ketoacidosis. Lifestyle interventions, while generally safe, can sometimes lead to musculoskeletal injuries or nutritional deficiencies if not properly managed. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes, including GLP-1 receptor agonists (e.g., exenatide, liraglutide), SGLT2 inhibitors (e.g., dapagliflozin), and DPP-4 inhibitors (e.g., sitagliptin). These medications help manage blood glucose levels through various mechanisms, such as enhancing insulin secretion, reducing glucose reabsorption in the kidneys, and increasing insulin sensitivity. The DECIDE/eDECIDE program focuses on improving decision-making and problem-solving skills for diabetes management, which can be particularly beneficial when choosing among these treatment options.

What other types of research exist?

Promising alternatives to the DECIDE/eDECIDE program for Type 2 Diabetes patients include: 1) Digital health interventions that offer continuous support and personalized educational content, which have shown improvements in glycemic control. 2) Telemedicine approaches, which provide low-cost, effective management of chronic diseases and have demonstrated clinical and cost-effectiveness in diabetes care. 3) Computerized decision-support tools that assist healthcare professionals and patients in making informed decisions about diabetes management. 4) Patient-oriented treatment decision aids that facilitate shared decision-making and improve patient engagement in their care.

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DECIDE Program for Type 2 Diabetes (eDECIDE Trial)

N/A

Waitlist Available

Led By Michelle L Redmond, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Diagnosis of Type 2 Diabetes per one of the following

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to create an online version of the DECIDE program, called eDECIDE, to help people with type 2 diabetes manage their condition. The program teaches practical skills for dealing with everyday issues related to diabetes, making it easier to keep blood sugar levels stable.

Who is the study for?

This trial is for African American individuals who speak English, have daily internet access, can read at a 5th-grade level or higher, and have been diagnosed with Type 2 Diabetes based on specific blood sugar levels or HbA1c percentage.

What is being tested?

The study is testing the eDECIDE web-based intervention against the traditional face-to-face DECIDE curriculum. It aims to see if managing diabetes through an online program is as effective as in-person education.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, there are no direct medical side effects. However, participants may experience stress or frustration related to technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Type 2 Diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Task Analysis Wireframe Development part 1

Task Analysis Wireframe Development part 2

Task Analysis study process chart

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: eDECIDE Web-based Intervention GroupExperimental Treatment1 Intervention

Participants randomized to the eDECIDE arm will use the online version of the program through the eDECIDE study portal. Participants in this group will receive bi-weekly calls from their health coach to mark their progress with the program.

Group II: DECDIE Traditional GroupActive Control1 Intervention

Participants randomized to the DECIDE group will receive a copy of the curriculum via mail and will be a self-study group where they go through the curriculum on their own with 4 calls from their health coach.

0 / 1Eligibility criteria met

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 lifestyle modifications, metformin, GLP-1 receptor agonists, and SGLT2 inhibitors. Lifestyle modifications, such as diet and exercise, help reduce blood glucose levels and improve insulin sensitivity. Metformin decreases hepatic glucose production and increases insulin sensitivity. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps control blood sugar levels. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine. These treatments are crucial for Type 2 Diabetes patients as they target different aspects of glucose regulation, helping to achieve better glycemic control and reduce the risk of complications.

Development and Evaluation of a Prediabetes Decision Aid in Primary Care: Examining Patient-Reported Outcomes by Language Preference and Educational Attainment.Patient decisional needs when considering treatment intensification for type 2 diabetes: A qualitative study in China.