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

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Diabetes Navigator

• Registration Number: NCT06229236
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Navigator	Diabetes Navigator	Support and guidance of Diabetes Navigator in addition to standard care

Primary Outcome Measures

Name	Time	Method
Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data)	Baseline, 3 months	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)

Secondary Outcome Measures

Name	Time	Method
HbA1c change	Baseline, 3 months, 6 months	Hemoglobin A1c measured as a continuous variable at baseline, 3-months and 6-months.
Change in the Diabetes Technology Use Score (DTUS)	Baseline, 3 months and 6 months	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 and from baseline to 6 months. Change measured in difference in points.
Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (90 days of data)	Baseline, 3 months	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. A higher score is better.; Measured from baseline to 3 months as a binary outcome (yes/no question)
Changes in continuous glucose monitor (CGM) "Time in Range"	Baseline, 3 months, 6 months	Percentage of time blood glucose ranges from 70-180 mg/dL based on CGM data; Measured as a continuous variable at baseline, 3-months and 6-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	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 at 6 months as a binary outcome (yes/no question)

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States