Clinical trial NCT06229236: Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies
Official title: Assessing Effectiveness of a Diabetes Navigator in Increasing Progression (Improving Uptake and/or Optimization) of Advanced Diabetes Technologies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-01-29
Enrollment: 148
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (90 days of data)
timeFrame: Baseline, 3 months
measure: Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases at 3 months and stays the same or increases at 6 months.
timeFrame: Baseline, 3 months, 6 months
measure: Change in the Diabetes Technology Use Score (DTUS)
timeFrame: Baseline, 3 months and 6 months
measure: Changes in continuous glucose monitor (CGM) "Time in Range"
timeFrame: Baseline, 3 months, 6 months
measure: HbA1c change
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Change in General Technology and Diabetes Technology Attitudes score
timeFrame: Baseline and 6 months
measure: Change in the Glucose Monitoring Satisfaction Survey score
timeFrame: Baseline and 6 months
measure: Change in CGM Benefits and Barriers Scale
timeFrame: Baseline and 6 months
measure: Change in the Diabetes Distress Scale score
timeFrame: Baseline and 6 months
measure: Changes in the INSPIRE survey scores
timeFrame: Baseline and 6 months
measure: Participant reported Acceptability of Intervention Measure (AIM)
timeFrame: 6 months
measure: Participant reported Intervention Appropriateness Measure (IAM)
timeFrame: 6 months
measure: Participant reported Feasibility of Intervention Measure (FIM)
timeFrame: 6 months
measure: Provider reported Acceptability of Intervention Measure (AIM)
timeFrame: 6 months
measure: Provider reported Intervention Appropriateness Measure (IAM)
timeFrame: 6 months
measure: Provider reported Feasibility of Intervention Measure (FIM)
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Nestoras Mathioudakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.