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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test if helping people with type 2 diabetes meet their basic needs makes it easier for them to manage their diabetes and results in better health outcomes.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HbA1c

Secondary outcome measures

Health-related Quality of Life

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,940 Previous Clinical Trials

2,302,922 Total Patients Enrolled

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

2,364 Previous Clinical Trials

4,314,929 Total Patients Enrolled

Louisiana Healthcare ConnectionsUNKNOWN

1 Previous Clinical Trials

1,460 Total Patients Enrolled

Media Library

Basic needs navigation Clinical Trial Eligibility Overview. Trial Name: NCT03940209 — Phase 2

Type 2 Diabetes Research Study Groups: Usual care, Basic needs navigation

Type 2 Diabetes Clinical Trial 2023: Basic needs navigation Highlights & Side Effects. Trial Name: NCT03940209 — Phase 2

Basic needs navigation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03940209 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people aged 40 and up participate in this research project?

"This specific clinical trial is for patients aged 18-75. Out of the 2,514 similar trials, 195 are for patients younger than the age of majority and 1,119 are for patients that are senior citizens."

Answered by AI

If I am eligible, how can I sign up for this experiment?

"Up to 473 patients with type 2 diabetes mellitus will be accepted for this clinical trial, as long as they are between 18 and 75 years old and meet the other requirements, which are being a member of Louisiana Healthcare Connections."

Answered by AI

Are investigators still looking for eligible participants for this research?

"The clinical trial in question is not recruiting patients at this time. This can be deduced from the clinicaltrials.gov listing, which indicates that the last date the study was edited was on September 8th, 2020. Although this specific study is not looking for candidates, there are 1448 other trials that are currently recruiting patients."

Answered by AI

Has the FDA cleared Basic needs navigation for use?

"This intervention has only been studied in a Phase 2 trial, so there is some data supporting its safety but none yet demonstrating its efficacy. For this reason, our team at Power rates the safety of this intervention as a 2."

Answered by AI