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

NCT ID: NCT06229236

Last Updated: 2025-10-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-13

Study Completion Date

2025-09-26

Brief Summary

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The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.

Detailed Description

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This study will recruit 148 individuals, 74 adults (ages 21-75) and 74 youth (ages 5-20) with type 1 diabetes. Participants will be randomized to standard care (usual diabetes care) or the intervention arm in which the participants will receive additional support from a Diabetes Navigator. Participants in the intervention group will receive assistance from a Diabetes Navigator who will help the participants address challenges in acquiring and optimally using advanced diabetes technology. The investigators will compare the group receiving Diabetes Navigator support with the standard care group to see if the additional support improves progression (increases uptake and/or optimization) in use of advanced diabetes technology and, consequently, improves glycemic control among patients.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Patients will be masked until randomization. Outcomes Assessor will be masked.

Study Groups

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Diabetes Navigator

Support and guidance of Diabetes Navigator in addition to standard care

Group Type EXPERIMENTAL

Diabetes Navigator

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 5 to 75 years.
* 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

* Optimally using Diabetes Technology
* 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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 36223197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36378855 (View on PubMed)

Other Identifiers

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R01DK134955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00398788

Identifier Type: -

Identifier Source: org_study_id

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