Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies
NCT ID: NCT06229236
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2024-02-13
2025-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Diabetes Navigator
Support and guidance of Diabetes Navigator in addition to standard care
Diabetes Navigator
Participants in the Diabetes Navigator (DN) arm will receive support from a trained navigator to help them improve progression (improving use/optimization) in use of advanced diabetes technology. The Diabetes Navigator will engage with participants immediately after randomization, throughout the duration of study, using a predefined toolkit, educational resources and interventions to assist them in optimizing use of advanced diabetes technology.
Standard of Care
Standard care provided by the healthcare staff during routine diabetes clinic visits.
No interventions assigned to this group
Interventions
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Diabetes Navigator
Participants in the Diabetes Navigator (DN) arm will receive support from a trained navigator to help them improve progression (improving use/optimization) in use of advanced diabetes technology. The Diabetes Navigator will engage with participants immediately after randomization, throughout the duration of study, using a predefined toolkit, educational resources and interventions to assist them in optimizing use of advanced diabetes technology.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 1 diabetes
* Patient of Johns Hopkins Medicine adult or pediatric diabetes clinics
* Not using or not optimally using diabetes technology.
* Planned Diabetes technology intensification by diabetes provider.
* If already on diabetes technology - must be using the specific device for a minimum of 14 days.
Exclusion Criteria
* Pregnancy or lactation or planned pregnancy in the next 12 months.
* 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)
* Active participant of any other research study that may interfere with diabetes management.
5 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Nestoras Mathioudakis, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Countries
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References
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Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
Kanbour S, Jones M, Abusamaan MS, Nass C, Everett E, Wolf RM, Sidhaye A, Mathioudakis N. Racial Disparities in Access and Use of Diabetes Technology Among Adult Patients With Type 1 Diabetes in a U.S. Academic Medical Center. Diabetes Care. 2023 Jan 1;46(1):56-64. doi: 10.2337/dc22-1055.
Other Identifiers
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IRB00398788
Identifier Type: -
Identifier Source: org_study_id
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