What is the mechanism of action of this treatment?

The most common treatments for Type 2 Diabetes include metformin, sulfonylureas, insulin, and lifestyle modifications. Metformin works by reducing glucose production in the liver and improving insulin sensitivity, making it easier for cells to absorb glucose. Sulfonylureas stimulate the pancreas to release more insulin. Insulin therapy directly provides the hormone that helps cells take in glucose from the bloodstream. Lifestyle modifications, such as diet and exercise, help reduce blood sugar levels and improve insulin sensitivity. These treatments are crucial for managing Type 2 Diabetes as they help maintain blood glucose levels within a target range, reducing the risk of complications. For homeless individuals, support for medication adherence and management is vital to ensure consistent treatment and better health outcomes.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, sulfonylureas, insulin, GLP-1 receptor agonists, and SGLT2 inhibitors. Metformin is generally well-tolerated but can cause gastrointestinal issues like nausea and diarrhea. Sulfonylureas may lead to hypoglycemia and weight gain. Insulin therapy, while effective, also carries a risk of hypoglycemia and potential weight gain. GLP-1 receptor agonists can cause gastrointestinal side effects such as nausea and vomiting, and are often expensive. SGLT2 inhibitors may lead to urinary tract infections and, in some cases, an increased risk of amputations. These side effects should be carefully managed, especially in vulnerable populations such as homeless individuals.

What prior FDA approvals exist?

Several pharmacological treatments for Type 2 Diabetes have received FDA approval, including GLP-1 receptor agonists like exenatide and liraglutide, which help lower blood glucose levels and have cardiovascular benefits. SGLT2 inhibitors, such as canagliflozin, are also approved and work by preventing glucose reabsorption in the kidneys. DPP-4 inhibitors like sitagliptin enhance the body's incretin levels, which help regulate insulin. Insulin therapies, including long-acting and premixed formulations, are essential for managing blood glucose levels in more severe cases. These treatments are relevant to the Diabetes Homeless Medication Support trial, which focuses on improving medication adherence and management in homeless individuals with diabetes.

What other types of research exist?

Promising alternatives for supporting medication adherence and management in homeless individuals with Type 2 Diabetes include: 1) Use of Sodium-glucose cotransporter-2 inhibitors (SGLT2i), which have shown benefits in managing diabetes and renal outcomes. 2) Implementation of telehealth platforms for remote monitoring and support, which can help maintain continuity of care. 3) Collaboration with community organizations to ensure consistent access to medications and nutritional support. 4) Utilization of mobile health clinics to provide on-site medical care and medication management. 5) Integration of digital health tools, such as mobile apps for medication reminders and glucose monitoring, to enhance self-management.

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Medication Support Program for Diabetes in Spanish Speakers (DH-Spanish Trial)

N/A

Waitlist Available

Led By Katherine D Vickery, MD

Research Sponsored by Hennepin Healthcare Research Institute

Eligibility Criteria Checklist

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

Must have

Self-reported diagnosis of type 2 diabetes, later verified in medical record

Age 18 yrs or older

Must not have

Patients who choose to opt out of research

Active psychosis or intoxication precluding ability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 16 weeks

Awards & highlights

Summary

This trial tests a support program for Spanish-speaking homeless people with diabetes. The program includes counseling, education, and emotional support to help them manage their diabetes better. It aims to improve their medication adherence and overall health.

Who is the study for?

This trial is for Spanish-speaking adults with type 2 diabetes who have experienced significant housing instability or homelessness. Participants should be willing to improve medication adherence and self-care, plan to stay local or reachable by phone for 16 weeks, and not be pregnant or lactating.

What is being tested?

The study tests a support program designed specifically for homeless, Spanish-speaking individuals with type 2 diabetes. It aims to understand how participants perceive the program and its feasibility over a single-arm trial involving 12 people.

What are the potential side effects?

Since this trial focuses on a support program rather than a medical intervention, traditional side effects are not applicable. However, participants may experience stress or emotional discomfort when discussing personal health issues.

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.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I choose not to participate in any research studies.

Select...

I am mentally clear and able to understand and agree to the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 16 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

Acceptability of intervention

Secondary study objectives

Change in glycemic control

Diabetes medication adherence

Health-related quality of life

Trial Design

1Treatment groups

Experimental Treatment

Group I: DH-Spanish InterventionExperimental Treatment1 Intervention

Behavioral treatment by a diabetes wellness coach.

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

The most common treatments for Type 2 Diabetes include metformin, sulfonylureas, insulin, and lifestyle modifications. Metformin works by reducing glucose production in the liver and improving insulin sensitivity, making it easier for cells to absorb glucose. Sulfonylureas stimulate the pancreas to release more insulin. Insulin therapy directly provides the hormone that helps cells take in glucose from the bloodstream. Lifestyle modifications, such as diet and exercise, help reduce blood sugar levels and improve insulin sensitivity. These treatments are crucial for managing Type 2 Diabetes as they help maintain blood glucose levels within a target range, reducing the risk of complications. For homeless individuals, support for medication adherence and management is vital to ensure consistent treatment and better health outcomes.

Participant experiences in the Diabetes REmission Clinical Trial (DiRECT).Motivational interventions in the management of HbA1c levels: a systematic review and meta-analysis.

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Who is running the clinical trial?

Hennepin Healthcare Research InstituteLead Sponsor

91 Previous Clinical Trials

77,415 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,783 Previous Clinical Trials

8,138,367 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,424 Previous Clinical Trials

4,324,923 Total Patients Enrolled

~5 spots leftby Oct 2025

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