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Completed

NCT Number: NCT06229236

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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)

    Time frame: 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 outcomes

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

    Time frame: 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)

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

    Time frame: 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)

  3. Change in the Diabetes Technology Use Score (DTUS)

    Time frame: 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.

  4. Changes in continuous glucose monitor (CGM) "Time in Range"

    Time frame: 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.

  5. HbA1c change

    Time frame: Baseline, 3 months, 6 months

    Hemoglobin A1c measured as a continuous variable at baseline, 3-months and 6-months.

Other outcomes

  1. Change in General Technology and Diabetes Technology Attitudes score

    Time frame: Baseline and 6 months

    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

  2. Change in the Glucose Monitoring Satisfaction Survey score

    Time frame: Baseline and 6 months

    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.

  3. Change in CGM Benefits and Barriers Scale

    Time frame: Baseline and 6 months

    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.

  4. Change in the Diabetes Distress Scale score

    Time frame: Baseline and 6 months

    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

  5. Changes in the INSPIRE survey scores

    Time frame: Baseline and 6 months

    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)

  6. Participant reported Acceptability of Intervention Measure (AIM)

    Time frame: 6 months

    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.

  7. Participant reported Intervention Appropriateness Measure (IAM)

    Time frame: 6 months

    The total score ranges from 4 to 20. Higher scores indicate greater appropriateness.

  8. Participant reported Feasibility of Intervention Measure (FIM)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: IMPACT-T1D

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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