What side effects are associated with this type of intervention?

Behavioral interventions for Type 2 Diabetes, such as those involving exercise and dietary changes, generally have minimal side effects, including muscle soreness, fatigue, and potential injury. Pharmacological treatments like metformin can cause gastrointestinal issues such as nausea and diarrhea. Sulfonylureas may lead to hypoglycemia and weight gain. GLP-1 receptor agonists, such as semaglutide, often cause gastrointestinal side effects like nausea, vomiting, and diarrhea, and in rare cases, pancreatitis.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 2 Diabetes, focusing on both pharmacologic and behavioral interventions. Pharmacologic treatments include oral antihyperglycemic agents like metformin, sulfonylureas, and newer classes such as SGLT2 inhibitors and GLP-1 receptor agonists. Behavioral interventions, while not always FDA-approved as standalone treatments, are integral to diabetes management. Programs like the Diabetes Prevention Program (DPP) have shown that lifestyle interventions, including diet and exercise, significantly improve clinical outcomes. The Home DM-BAT trial aligns with these approaches by using behavioral activation delivered by trained diabetes nurse educators to enhance clinical and behavioral outcomes in T2DM patients.

What other types of research exist?

Promising, novel alternatives to Home DM-BAT for T2DM patients include: 1) VoiceDiab, a smartphone application with automatic speech recognition and insulin dosage calculation, which has shown efficacy in managing blood glucose levels. 2) Reinforcement Learning-Based Adaptive Insulin Advisor, which uses machine learning to optimize insulin therapy for patients on multiple daily injections. 3) Mindfulness-Based Cognitive Therapy (MBCT), which has shown mixed but potentially beneficial results in managing diabetes-related stress and improving behavioral outcomes. 4) Exercise interventions, which have been effective in improving glycemic control and overall health in T2DM patients.

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Home-Based Behavioral Therapy for Type 2 Diabetes (HOME DM-BAT Trial)

N/A

Waitlist Available

Led By Leonard E Egede, MD, MS

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

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

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in baseline quality of life measure at 12 months post intervention follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a telephone-based support program for low-income, ethnic minority seniors with poorly controlled diabetes. The program aims to improve their health by educating them about diabetes, promoting healthy behaviors, and addressing social challenges.

Who is the study for?

This trial is for low-income seniors aged 65 or older with poorly controlled Type 2 Diabetes (T2DM), specifically those who are Black/African American or Hispanic, living in Milwaukee area senior housing or communities. Participants must have an HbA1c level of at least 8% and be able to communicate in English or Spanish. Those with active psychosis, severe mental disorders, substance abuse issues, participation in other diabetes studies, significant dementia, or a life expectancy under one year cannot join.

What is being tested?

The study tests Home DM-BAT—a culturally-tailored home and phone-based intervention by nurse educators—against supportive therapy control. It aims to improve clinical outcomes like blood sugar levels (hemoglobin A1c), blood pressure, cholesterol; behavioral aspects such as glucose monitoring, dieting habits; exercise routines; medication adherence; and overall quality of life over a period of 12 months.

What are the potential side effects?

Since the interventions involve educational support rather than medications there may not be direct side effects like drugs cause. However participants might experience stress due to lifestyle changes recommended during the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline self-care behaviors at 12 months post intervention follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline self-care behaviors at 12 months post intervention follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline self-care behaviors at 12 months post intervention follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Glycemic control (HbA1c)

LDL-Cholesterol

Systolic and Diastolic Blood Pressure

Secondary study objectives

Quality of Life as measured by SF-12

Self-Care Behaviors

Other study objectives

Quality Adjusted Life Years as measured by EQ-5D

Resource Utilization and Cost

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: Home DM-BAT InterventionExperimental Treatment1 Intervention

A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.

Group II: Control Group (GHE+ST)Active Control1 Intervention

Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.

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

Behavioral interventions for Type 2 Diabetes, such as the Home DM-BAT, focus on improving self-management behaviors through education, motivation, and support. These interventions aim to enhance patients' adherence to medication, diet, exercise, and blood glucose monitoring. By addressing lifestyle factors and promoting consistent self-care practices, these treatments help to improve glycemic control, reduce complications, and enhance overall quality of life. The involvement of trained diabetes nurse educators ensures that patients receive personalized guidance and support, which is crucial for sustaining long-term behavioral changes and achieving better clinical outcomes.

Behavioral interventions to improve self-management in Iranian adults with type 2 diabetes: a systematic review and meta-analysis.Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial.Meta-analysis of randomized educational and behavioral interventions in type 2 diabetes.