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Diabetes Navigator for Type 1 Diabetes (IMPACT-T1D Trial)

N/A

Recruiting

Led By Nestoras Mathioudakis, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Diagnosis of type 1 diabetes

Not using or not optimally using diabetes technology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Awards & highlights

IMPACT-T1D Trial Summary

This trial aims to find out if having a Diabetes Navigator to help patients with type 1 diabetes is better than the usual care in improving the use of advanced diabetes technology.

Who is the study for?

This trial is for individuals with type 1 diabetes who are interested in potentially improving their management of the condition. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health conditions and agree to follow the study procedures.Check my eligibility

What is being tested?

The trial is testing whether having a Diabetes Navigator—a specialized guide—helps patients with type 1 diabetes better adopt and use advanced technologies for managing their disease compared to standard care without such support.See study design

What are the potential side effects?

Since this trial involves a non-medical intervention (a Diabetes Navigator), there are no direct medical side effects associated with drugs or devices. However, any changes in diabetes management could affect blood sugar levels.

IMPACT-T1D Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with type 1 diabetes.

Select...

I am not using diabetes technology or not using it well.

IMPACT-T1D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data)

Secondary outcome measures

Change in the Diabetes Technology Use Score (DTUS)

Changes in continuous glucose monitor (CGM) "Time in Range"

HbA1c change

+2 more

Other outcome measures

Change in CGM Benefits and Barriers Scale

Change in General Technology and Diabetes Technology Attitudes score

Change in the Diabetes Distress Scale score

+8 more

IMPACT-T1D Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diabetes NavigatorExperimental Treatment1 Intervention

Support and guidance of Diabetes Navigator in addition to standard care

Group II: Standard of CareActive Control1 Intervention

Standard care provided by the healthcare staff during routine diabetes clinic visits.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,349 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,444 Total Patients Enrolled

Nestoras Mathioudakis, MDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

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

Is this medical study currently open for enrollment?

"As per the current information on clinicaltrials.gov, this trial is not actively seeking participants. The trial was initially posted on February 5th, 2024 and had its most recent update on January 19th, 2024. It should be noted that despite this specific trial no longer accepting patients, there are currently a total of 1219 other trials actively recruiting participants at this time."

Answered by AI

Is the age requirement for participating in this medical study limited to individuals below 40 years old?

"As outlined in the study's eligibility criteria, individuals as young as 5 years old and up to the age of 75 are eligible for enrollment."

Answered by AI

Is it possible for me to participate in this clinical trial?

"To be eligible for enrollment in this research study, potential participants must have a confirmed diagnosis of type 1 diabetes and fall within the age range of 5 to 75 years old. The trial aims to recruit a total of 148 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies

2024. "Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229236.

All > Type 1 Diabetes