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Behavioral Intervention

Comprehensive Diabetes Management for Diabetes (IDEA Trial)

N/A

Recruiting

Research Sponsored by Sinai Health System

Eligibility Criteria Checklist

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

Must have

A diagnosis of type 1 or type 2 diabetes

18+ years of age

Must not have

Be suffering from a severe form of cardiovascular disease (NYHA Class III and IV)

Diagnosis of gestational diabetes (without type 1 or type 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (time = 0); 6 months (time = 1); 12 months (time = 2)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test different combinations & sequences of 3 diabetes treatments to find the best one for patients in Chicago. Participants will be randomly assigned, then rerandomized after 6 months. Results will show best combination & sequence for improved A1c.

Who is the study for?

This trial is for African American/Black or Latinx adults with Type 1 or Type 2 diabetes, an HbA1c level over 7%, and access to a smartphone. They must be current patients who've completed at least one Center appointment and not already using remote glucose monitoring or working with a community health worker.

What is being tested?

The study tests how well different combinations of diabetes care enhancements work together. It starts with either self-management training or remote glucose monitoring, then adds tailored support after six months based on A1c changes. The goal is to find the best sequence for improving blood sugar control.

What are the potential side effects?

Potential side effects are not directly from treatments but may include stress due to frequent monitoring, potential data privacy concerns with app usage, and possible reliance on technology for managing health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diabetes.

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I am 18 years old or older.

Exclusion Criteria

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

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I have severe heart disease that limits my daily activities.

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I have been diagnosed with diabetes during pregnancy.

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I have designated someone as my Power of Attorney.

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I have advanced kidney disease or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (time = 0); 6 months (time = 1); 12 months (time = 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (time = 0); 6 months (time = 1); 12 months (time = 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time = 0); 6 months (time = 1); 12 months (time = 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in A1c

Secondary study objectives

Active Usage of RGM

CHW Support Adherence

DSMT Attendance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW)Experimental Treatment2 Interventions

Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support.

Group II: Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM)Experimental Treatment1 Intervention

Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group.

Group III: Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT)Experimental Treatment2 Interventions

Group IV: Diabetes Self-Management Training > Standard of Care (DSMT->SOC)Experimental Treatment1 Intervention

Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care.

Group V: Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM)Experimental Treatment2 Interventions

Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM.

Group VI: Diabetes Self-Management Training > Community Health Worker (DSMT->CHW)Experimental Treatment2 Interventions

0 / 6Eligibility criteria met