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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
No Placebo-Only Group
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 belowSelect...
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
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DH-Spanish InterventionExperimental Treatment1 Intervention
Behavioral treatment by a diabetes wellness coach.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes Homelessness Medication Support Program in Spanish
2023
N/A
~20
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.
Participant experiences in the Diabetes REmission Clinical Trial (DiRECT).Motivational interventions in the management of HbA1c levels: a systematic review and meta-analysis.
Find a Location
Who is running the clinical trial?
Hennepin Healthcare Research InstituteLead Sponsor
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National Institutes of Health (NIH)NIH
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
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University of MinnesotaOTHER
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Katherine D Vickery, MDPrincipal InvestigatorHennepin Healthcare Research Institute
1 Previous Clinical Trials
8 Total Patients Enrolled