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Diabetes Management Intervention for Diabetes
N/A
Waitlist Available
Led By Nadia Islam, PhD
Research Sponsored by NYU Langone Health
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
Study Summary
This trial will test a new way to help South Asians with uncontrolled diabetes by using a combination of electronic health records, community health workers, and referrals to culturally relevant resources.
Who is the study for?
This trial is for South Asian individuals who have had diabetes for at least a year, seen their primary care physician in the last 12 months, and have an HbA1c level over 7. It aims to help those struggling with uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests a multi-level intervention combining health coaching by Community Health Workers (CHW), use of electronic health records (EHR) to identify patients, referral to relevant resources, and coordinated care between CHWs and healthcare teams.See study design
What are the potential side effects?
Since this trial involves non-drug interventions like health coaching and care coordination rather than medications, typical drug side effects are not expected. However, participants may experience changes in lifestyle or diet.
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
Percent of patients that experience a reduction in HbA1c of >0.5%
Secondary outcome measures
Average reduction HDL (High density lipoprotein cholesterol)
Average reduction LDL (Low density lipoprotein cholesterol)
Average reduction in BMI (Body Mass Index)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: HIT-enabled & CHW ledExperimental Treatment1 Intervention
Supportive care enabled by mobile devices.
Group II: CHW-led health coachingExperimental Treatment1 Intervention
Group sessions
Group III: CHW & Physician FeedbackExperimental Treatment2 Interventions
Patient setting progress communicated to physician via PHI
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
838,862 Total Patients Enrolled
17 Trials studying Diabetes
19,393 Patients Enrolled for Diabetes
Nadia Islam, PhDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
4,044 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with diabetes for over a year.I have seen a doctor for a regular check-up in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: CHW & Physician Feedback
- Group 2: HIT-enabled & CHW led
- Group 3: CHW-led health coaching
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Can individuals over the age of eighty-five participate in this research study?
"As detailed in the study's enrollment criteria, only individuals between 21 and 75 years old can take part."
Answered by AI
Am I eligible to participate in this experiment?
"This medical trial is striving to recruit 859 volunteers who are between 21 and 75 years old. Moreover, they must have a glucose level (HbA1c) that meets the criteria outlined in the study design."
Answered by AI
Is there presently an opportunity for individuals to participate in this scientific experiment?
"Clinicaltrials.gov provides evidence that this medical trial is no longer actively recruiting patients, having been initially posted on July 11th 2019 and last updated on September 1st 2022. However, 1275 other trials are still in need of individuals willing to participate in research efforts."
Answered by AI
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