What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulfonylureas, insulin, and lifestyle interventions such as diet and exercise. Metformin can cause gastrointestinal issues like diarrhea and nausea. Sulfonylureas may lead to hypoglycemia and weight gain. Insulin therapy can also result in hypoglycemia and weight gain. Lifestyle interventions, while generally safe, can sometimes cause musculoskeletal injuries or nutritional deficiencies if not properly managed. Addressing unmet basic needs can help improve adherence to these treatments and potentially mitigate some side effects by promoting better overall health and self-care.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of Type 2 Diabetes focus on improving self-care and health behaviors, which can lead to better health outcomes and reduced HbA1c levels. These include GLP-1 receptor agonists (e.g., liraglutide, exenatide) and SGLT2 inhibitors (e.g., canagliflozin, dapagliflozin), which not only lower blood glucose levels but also have benefits for weight management and cardiovascular health. Additionally, DPP-4 inhibitors (e.g., sitagliptin) and thiazolidinediones (e.g., pioglitazone) are associated with low risk of hypoglycemia, making them suitable for patients with varying needs. These medications, when combined with lifestyle interventions and addressing basic needs, can significantly improve diabetes management and overall quality of life.

What other types of research exist?

Promising novel alternatives to Basic Needs Navigation for Type 2 Diabetes patients include: 1) Health Coaching, which has been shown to reduce HbA1c levels through personalized support and behavior change strategies. 2) Mobile Phone-Based Diabetes Support Interventions, which provide education, encouragement, and self-care monitoring through digital platforms. 3) Diabetes Self-Management Support (DSMS) programs facilitated by community health workers, which combine resource navigation with structured diabetes education sessions.

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Basic Needs Navigation for Type 2 Diabetes

Phase 2

Waitlist Available

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Age 18-75 years old

Diagnosed with type 2 diabetes

Must not have

Have cognitive or hearing impairments that significantly impede participation in telephone-based survey and intervention protocols

Individuals not living independently (e.g., nursing homes, rehab or correctional facilities)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if having someone to help with basic needs like food and housing can improve diabetes management in low-income adults. The study focuses on adults with type 2 diabetes who struggle with basic needs. By addressing these needs, the trial aims to see if participants can better manage their diabetes and improve their health.

Who is the study for?

This trial is for adults aged 18-75 with type 2 diabetes and Medicaid, who have at least one unmet basic need like food or housing. They must have had a HbA1c test recently and not be in case management, pregnant, living in care facilities, or have significant cognitive or hearing impairments.

What is being tested?

The study compares a 'basic needs navigation' intervention to usual care among those with type 2 diabetes on Medicaid. It aims to see if helping with needs like food and housing can improve blood sugar control (HbA1c levels) and overall health outcomes.

What are the potential side effects?

Since the intervention involves social support rather than medication, typical drug side effects are not expected. However, participants may experience changes in stress levels or emotional well-being due to the nature of receiving additional support.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

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

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I have significant hearing or cognitive issues affecting phone communication.

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I do not live independently due to being in a nursing home, rehab, or correctional facility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

HbA1c

Secondary study objectives

Health-related Quality of Life

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: Basic needs navigationExperimental Treatment1 Intervention

Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.

Group II: Usual careActive Control1 Intervention

Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.

0 / 4Eligibility 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

Common treatments for Type 2 Diabetes include lifestyle modifications, metformin, and insulin therapy. Lifestyle modifications, such as diet and exercise, improve insulin sensitivity and promote weight loss, thereby reducing blood glucose levels. Metformin decreases hepatic glucose production and increases insulin sensitivity. Insulin therapy directly lowers blood glucose levels by facilitating cellular glucose uptake. These treatments are essential for Type 2 Diabetes patients as they address both physiological and behavioral aspects of the disease, leading to better glycemic control and overall health outcomes.

Systematic Review and Meta-Analysis of Good Self-Care Practice among People Living with Type 2 Diabetes Mellitus in Ethiopia: A National Call to Bolster Lifestyle Changes.Defining Usual Care in Clinical Trials.Effectiveness of lay-led, group-based self-management interventions to improve glycated hemoglobin (HbA1c), self-efficacy, and emergency visit rates among adults with type 2 diabetes: A systematic review and meta-analysis.