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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK134955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Navigator | Experimental | Support and guidance of Diabetes Navigator in addition to standard care |
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| Standard of Care | No Intervention | Standard care provided by the healthcare staff during routine diabetes clinic visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestoras Mathioudakis, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36223197 | Background | 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. | |
| 36378855 | Background | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Patients will be masked until randomization. Outcomes Assessor will be masked.
|
| 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 |
| 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 |
| 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 |
| HbA1c change | Hemoglobin A1c measured as a continuous variable at baseline, 3-months and 6-months. | Baseline, 3 months, 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Participant reported Intervention Appropriateness Measure (IAM) | The total score ranges from 4 to 20. Higher scores indicate greater appropriateness. | 6 months |
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |