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Healthy Food Vouchers for Type 2 Diabetes (VOUCH4DIABETES Trial)
Phase 3
Recruiting
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
VOUCH4DIABETES Trial Summary
This trial tests if giving low-income people with diabetes/high blood sugar access to healthy food can lower their blood sugar. #diabetes
Who is the study for?
This trial is for low-income individuals with type 2 diabetes or prediabetes who struggle to afford food and have a Hemoglobin A1c level between 6.0 to 11.0. It's not open to those living with another participant, with severe food allergies, on total parenteral nutrition, a life expectancy under six months, or certain blood conditions.Check my eligibility
What is being tested?
The study tests if giving out vouchers for healthy foods can lower blood sugar levels in people with type 2 diabetes or prediabetes. Participants are randomly chosen to receive these vouchers and their effects on blood glucose control are measured.See study design
What are the potential side effects?
Since the intervention involves providing healthy food vouchers rather than medication, there are no direct medical side effects expected from participating in this trial.
VOUCH4DIABETES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemoglobin A1c
Secondary outcome measures
Carotenoid level
Financial security ("Do you have trouble making ends meet at the end of the month?")
Food insecurity measured by 6 questions from Household Food Security Survey
+3 moreVOUCH4DIABETES Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Food voucherExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
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Who is running the clinical trial?
Unity Health TorontoLead Sponsor
535 Previous Clinical Trials
446,693 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need nutrition through an IV.Your Hemoglobin A1c level is higher than 11.You have trouble getting enough food or money to support yourself.Your Hemoglobin A1c level is between 6.0 and 11.0.You have severe allergies to many common foods that could be life-threatening.You are expected to live for less than six months.You have a blood condition that makes it hard to understand your hemoglobin A1c levels.
Research Study Groups:
This trial has the following groups:- Group 1: Food voucher
- Group 2: Control
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could utilizing Food vouchers pose a potential hazard to individuals?
"As the trial has traversed to its third stage, evidence of efficacy and safety have been corroborated multiple times; thus, our team at Power assigns Food voucher a score of 3."
Answered by AI
Are there currently any openings to join this experiment?
"According to the clinicaltrials.gov records, this particular medical experiment is no longer recruiting patients. Initially published on March 1st 2023 and last updated on the 16th of that same month, there are presently 1042 other trials actively looking for volunteers."
Answered by AI
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