Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies (IMPACT-T1D)

Johns Hopkins University

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Diabetes Navigator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06229236

R01DK134955 (U.S. NIH Grant/Contract)

IRB00398788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 5 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

Diabetes Navigator

Experimental group

Description:

Support and guidance of Diabetes Navigator in addition to standard care

Treatment:

Behavioral: Diabetes Navigator

Standard of Care

No Intervention group

Description:

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