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

NCT06229236 | Completed

• 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)

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

  Diabetes Technology Utilization Score is calculated based on CGM and Insulin pump use ranging from 0-4, 4 indicating optimal technology use and 0 indicating no use of technology. Measured from baseline to 3 months as a binary outcome (yes/no question)

  Baseline, 3 months

Secondary Outcomes (5)

• Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (90 days of data)

  Baseline, 3 months

• Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases at 3 months and stays the same or increases at 6 months.

  Baseline, 3 months, 6 months

• Change in the Diabetes Technology Use Score (DTUS)

  Baseline, 3 months and 6 months

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

  Baseline, 3 months, 6 months

• HbA1c change

  Baseline, 3 months, 6 months

Other Outcomes (8)

• Change in General Technology and Diabetes Technology Attitudes score

  Baseline and 6 months

• Change in the Glucose Monitoring Satisfaction Survey score

  Baseline and 6 months

• Change in CGM Benefits and Barriers Scale

  Baseline and 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

Study Officials

• Nestoras Mathioudakis, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

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: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)