What is the mechanism of action of this treatment?

The most common treatments for Type 2 Diabetes include education, lifestyle modification, and family support. Education empowers patients with knowledge about their condition and management strategies, which is crucial for adherence to treatment plans. Lifestyle modification, including dietary changes and increased physical activity, helps improve insulin sensitivity and glycemic control, reducing the need for medication. Family support provides emotional and practical assistance, enhancing the patient's ability to maintain healthy behaviors. These non-pharmacologic approaches are foundational because they address the root causes of hyperglycemia and can significantly improve long-term outcomes. Pharmacologic treatments, such as metformin, work by decreasing hepatic glucose production and improving insulin sensitivity, while other medications like SGLT2 inhibitors and GLP1 receptor agonists help lower blood glucose levels through different mechanisms. Combining these strategies can lead to better overall management of Type 2 Diabetes.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as education, lifestyle modification, and family support, generally have minimal side effects. Lifestyle modifications, including diet and exercise, can sometimes lead to temporary discomfort such as muscle soreness or hunger. However, these interventions are generally safe and beneficial. Oral hypoglycemic agents, like sulfonylureas and DPP-4 inhibitors, can cause side effects such as hypoglycemia, gastrointestinal issues, and weight gain. Insulin therapy, while effective, carries risks of hypoglycemia and potential weight gain. Overall, lifestyle interventions are considered safe and are often recommended as first-line treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that align with the principles of education, lifestyle modification, and family support. Notably, glucagon-like peptide-1 (GLP-1) receptor agonists such as exenatide (Bydureon BCise) and dulaglutide have been approved for their efficacy in improving glycemic control when combined with lifestyle interventions. These drugs have shown significant benefits in clinical trials, including improved A1C levels and weight management, which are crucial for comprehensive diabetes care. Additionally, the TODAY study highlights the importance of combination pharmacotherapy with metformin and lifestyle interventions, emphasizing the need for early and sustained management strategies in youth with Type 2 Diabetes.

What other types of research exist?

Promising, novel alternatives to Family-Based Diabetes Management Programs for Type 2 Diabetes patients include: 1) Mobile lifestyle management programs like GlycoLeap, which offer online lessons and app-based support. 2) Web-based diabetes self-management education, providing flexibility and accessibility. 3) Participatory group-based education programs, such as Next Education, which engage patients actively in their learning process. These alternatives emphasize the use of technology and interactive learning to enhance diabetes management.

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TOD Program for Type 2 Diabetes (TOD Trial)

N/A

Waitlist Available

Led By Melissa Walls, PhD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

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

Must have

ADULT: Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)

ADULT: Have a completed verification form from a healthcare provider indicating a confirmed diagnosis of type 2 diabetes

Must not have

YOUTH: Do not have an enrolled Adult caregiver

YOUTH: Do not fall within the specified age range of 10-16 years at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, month 3, month 6, month 12, month 18, and month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the TOD program, which helps American Indian families manage type 2 diabetes through home-based coaching on healthy living. It targets adults with diabetes and their children, aiming to improve their health by promoting good habits and reducing stress. The Together on Diabetes (TOD) program was developed through community-based participatory research and has been tested in multiple studies involving American Indian youth and their families.

Who is the study for?

This trial is for American Indian adult caregivers with type 2 diabetes and their children aged 10-16. Adults must be over 18, speak English, live near participating reservations, and have a confirmed diabetes diagnosis. Children must also speak English and be willing to participate in the study.

What is being tested?

The 'Together Overcoming Diabetes' program is being tested. It's a family-based intervention delivered at home by health coaches over six months. Participants are randomly assigned to start immediately or after two years, with regular assessments of health outcomes.

What are the potential side effects?

Since this is a behavioral intervention focusing on diabetes management rather than medication or medical procedures, there may not be direct side effects like those associated with drugs; however, lifestyle changes could potentially cause stress or require significant adjustments.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can understand and sign forms and see well enough to complete tasks.

Select...

I have a form from my doctor confirming my type 2 diabetes diagnosis.

Select...

I can read, understand, and sign forms and complete tests by myself.

Select...

I am between 10 and 16 years old.

Select...

I live within 30 miles of a participating reservation.

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a young participant without an adult caregiver enrolled in the study.

Select...

I am not between the ages of 10 and 16.

Select...

I cannot follow the study's required procedures.

Select...

I do not have type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, month 3, month 6, month 12, month 18, and month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, month 3, month 6, month 12, month 18, and month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, month 3, month 6, month 12, month 18, and month 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Adult Participant Fasting HbA1c

Secondary study objectives

Change in BMI/zBMI - Adult and Youth participants

Change in Depression and Depressive symptoms - Adult and Youth participants

Other study objectives

Change in Communal Mastery - Adult and Youth participants

Change in Diabetes Empowerment - Adult participants

Change in Physical Activity - Adult and Youth participants

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: Together Overcoming Diabetes (TOD) curriculumExperimental Treatment1 Intervention

A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD). Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.

Group II: Waitlist ControlActive Control1 Intervention

A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months. Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.

0 / 10Eligibility 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 education, lifestyle modification, and family support. Education empowers patients with knowledge about their condition and management strategies, which is crucial for adherence to treatment plans. Lifestyle modification, including dietary changes and increased physical activity, helps improve insulin sensitivity and glycemic control, reducing the need for medication. Family support provides emotional and practical assistance, enhancing the patient's ability to maintain healthy behaviors. These non-pharmacologic approaches are foundational because they address the root causes of hyperglycemia and can significantly improve long-term outcomes. Pharmacologic treatments, such as metformin, work by decreasing hepatic glucose production and improving insulin sensitivity, while other medications like SGLT2 inhibitors and GLP1 receptor agonists help lower blood glucose levels through different mechanisms. Combining these strategies can lead to better overall management of Type 2 Diabetes.