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Digital PRO Tool for Type 2 Diabetes

N/A
Waitlist Available
Led By Antoinette Schoenthaler
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient Group: Be > 18 years of age
Patient Group: Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12
Awards & highlights

Study Summary

This trial will compare a new program to usual care to see if it helps reduce diabetes risk in people with Type 2 diabetes.

Who is the study for?
Adults over 18 with Type 2 diabetes for at least 6 months, who are fluent in English or Spanish, can text, and have a history of high HbA1c levels. Excluded are those planning to leave their clinic soon, unable to consent, with significant mental health or substance issues, pregnant women, participants in other diabetes studies, or patients with severe kidney problems.Check my eligibility
What is being tested?
The trial is testing iMatter2—a mobile tool for reporting patient outcomes—against usual care to see if it better reduces long-term blood sugar levels (HbA1c) in people with Type 2 diabetes after one year.See study design
What are the potential side effects?
Since this trial involves a digital tool rather than medication, traditional side effects aren't expected. However, users may experience stress or frustration if they encounter technical difficulties or find the app difficult to use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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My type 2 diabetes is uncontrolled with HbA1c over 7% in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hemoglobin A1C (HbA1c)
Secondary outcome measures
Mean Number of EHR Reports Viewed by Providers
Mean Number of PRO Messages Responded To by Patients
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: iMatter2Experimental Treatment1 Intervention
All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.
Group II: Usual Care (UC)Active Control1 Intervention
All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,368 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,995 Total Patients Enrolled
Antoinette SchoenthalerPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

iMatter2 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05884775 — N/A
Type 2 Diabetes Research Study Groups: iMatter2, Usual Care (UC)
Type 2 Diabetes Clinical Trial 2023: iMatter2 Highlights & Side Effects. Trial Name: NCT05884775 — N/A
iMatter2 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884775 — N/A

Frequently Asked Questions

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

Are participants currently being accepted for this study?

"According to clinical trials.gov, this medical research is not currently recruiting any more patients and was last updated on May 23rd 2023. Despite the closure of enrollment for this trial, 1288 other studies are presently seeking participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
2025. "Novel Digital Patient-Reported Outcomes Tool for Diabetes Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05884775.
~235 spots leftby Feb 2028
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