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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
Must not have
Other types of diabetes (type 2 diabetes, Maturity Onset Diabetes in Youth, cystic fibrosis-related diabetes, steroid-induced diabetes, post total pancreatectomy, transplant-related diabetes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a type of diabetes that is not type 1.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data)
Secondary study objectives
Change in the Diabetes Technology Use Score (DTUS)
Changes in continuous glucose monitor (CGM) "Time in Range"
HbA1c change
+2 more
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,662 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,271 Total Patients Enrolled
Nestoras Mathioudakis, MDPrincipal InvestigatorJohns Hopkins University
~15 spots leftby Jan 2025
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