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

NCT06229236 | Completed Results

• 2 other identifiers: IRB00398788R01DK134955
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Glucose Monitor (CGM); Insulin Pumps; Hybrid Closed Loop (HCL); Diabetes Navigator; Diabetes Navigator Toolkit; Advanced Diabetes Technology (ADT)

Outcome Measures

Primary Outcomes (1)

• Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data)

  Participants whose DTUS increased from baseline to 3 months as a binary outcome (yes/no question)

  From baseline to 3 months

Secondary Outcomes (5)

• Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (90 Days of Data)

  From baseline to 3 months

• Participants Whose Diabetes Technology Utilization Score (DTUS) Stays the Same or Increased at 6 Months Among Those Whose DTUS Increased at 3 Months

  From 3 months to 6 months

• Participants Whose Diabetes Technology Use Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data) at 6 Months

  From baseline to 6 months

• Changes in Continuous Glucose Monitor (CGM) Percent Time Active

  From baseline to 3 months

• Change in Glycated Hemoglobin (HbA1c)

  From baseline to 6 months

Other Outcomes (8)

• Change in Diabetes Technology Attitudes Survey Score

  From baseline to 6 months

• Change in the Glucose Monitoring Satisfaction Survey Score

  From baseline to 6 months

• Change in CGM Benefits and Burdens Scale Scores

  From baseline to 6 months

Study Arms (2)

Diabetes Navigator

EXPERIMENTAL

Support and guidance of Diabetes Navigator in addition to standard care

Behavioral: Diabetes Navigator

Standard of Care

NO INTERVENTION

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

Interventions

Diabetes Navigator 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.

Diabetes Navigator

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 36223197 BACKGROUND

• 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.

  PMID: 36378855 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Nestoras Mathioudakis, MD, MHS
• Organization: Johns Hopkins University

nmathio1@jhmi.edu

410-955-3663

Study Officials

• Nestoras Mathioudakis, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be masked until randomization. Outcomes Assessor will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: February 13, 2024
• Primary Completion: August 26, 2025
• Study Completion: September 26, 2025
• Last Updated: September 23, 2026
• Results First Posted: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)