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

Diabetes Mellitus, Type 1 Clinical Trial

— IMPACT-T1D  

Official title:

Assessing Effectiveness of a Diabetes Navigator in Increasing Progression (Improving Uptake and/or Optimization) of Advanced Diabetes Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229236
• Other study ID #: IRB00398788
• Secondary ID: R01DK134955
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Nestoras Mathioudakis, MD
• Phone: 410-955-3663
• Email: nmathio1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Diabetes Navigator
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in General Technology and Diabetes Technology Attitudes score	Measured using General Technology and Diabetes Technology Attitudes survey, a 6-item survey assessing attitudes and use of various general technologies and diabetes devices as reported by participants.; Min: 1 Max: 5 Mean Score, higher score means better outcome	Baseline and 6 months
Other	Change in the Glucose Monitoring Satisfaction Survey score	Measured using the Glucose Monitoring Satisfaction Survey (GMSS), a 15-item survey with scores ranging from 0 to 60 with higher scores indicating greater satisfaction.	Baseline and 6 months
Other	Change in CGM Benefits and Barriers Scale	This survey measures the benefits and burden of Continuous Glucose Monitor (CGM) use as reported by participants.; Score ranges from 1 (strongly disagree) to 5 (strongly agree). Higher score indicating greater perceived benefits or burdens.	Baseline and 6 months
Other	Change in the Diabetes Distress Scale score	17 items are scored on a 6-point Likert scale from 1 "not a problem" to 6 "very serious problem." Higher scores mean worse outcome/more distress	Baseline and 6 months
Other	Changes in the INSPIRE survey scores	The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems. Score range 0-100, higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree)	Baseline and 6 months
Other	Participant reported Acceptability of Intervention Measure (AIM)	Total of 12-items answered on a Likert scale of 1 = completely disagree to 5 = completely agree. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention.	6 months
Other	Participant reported Intervention Appropriateness Measure (IAM)	The total score ranges from 4 to 20. Higher scores indicate greater appropriateness.	6 months
Other	Participant reported Feasibility of Intervention Measure (FIM)	Feasibility of Intervention Measure includes 4 questions with 5-point likert response options, Completely disagree (1) - Completely agree (5). Higher score, higher agreement of feasibility.	6 months
Other	Provider reported Acceptability of Intervention Measure (AIM)	Total of 12-items answered on a Likert scale of 1 = completely disagree to 5 = completely agree. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention.	6 months
Other	Provider reported Intervention Appropriateness Measure (IAM)	The total score ranges from 4 to 20. Higher scores indicate greater appropriateness.	6 months
Other	Provider reported Feasibility of Intervention Measure (FIM)	Feasibility of Intervention Measure includes 4 questions with 5-point likert response options, Completely disagree (1) - Completely agree (5). Higher score, higher agreement of feasibility.	6 months
Primary	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	Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (90 days of 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. A higher score is better.; Measured from baseline to 3 months as a binary outcome (yes/no question)	Baseline, 3 months
Secondary	Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases at 3 months and stays the same or increases at 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)	Baseline, 3 months, 6 months
Secondary	Change in the Diabetes Technology Use Score (DTUS)	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.	Baseline, 3 months and 6 months
Secondary	Changes in continuous glucose monitor (CGM) "Time in Range"	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.	Baseline, 3 months, 6 months
Secondary	HbA1c change	Hemoglobin A1c measured as a continuous variable at baseline, 3-months and 6-months.	Baseline, 3 months, 6 months