Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitor (CGM), Insulin Pumps, Hybrid Closed Loop (HCL), Diabetes Navigator, Diabetes Navigator Toolkit, Advanced Diabetes Technology (ADT)
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.
Interventions
BEHAVIORALDiabetes 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Patients will be masked until randomization. Outcomes Assessor will be masked.
Eligibility
Sex/Gender
ALL
Age
5 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (90 days of data) | 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) |
| Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases at 3 months and stays the same or increases at 6 months. | 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) |
| Change in the Diabetes Technology Use Score (DTUS) | 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. |
| Changes in continuous glucose monitor (CGM) Time in Range | 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. |
| HbA1c change | Baseline, 3 months, 6 months | Hemoglobin A1c measured as a continuous variable at baseline, 3-months and 6-months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant reported Intervention Appropriateness Measure (IAM) | 6 months | The total score ranges from 4 to 20. Higher scores indicate greater appropriateness. |
| Change in General Technology and Diabetes Technology Attitudes score | 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 |
| Participant reported Feasibility of Intervention Measure (FIM) | 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. |
| Change in the Glucose Monitoring Satisfaction Survey score | 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. |
| Change in CGM Benefits and Barriers Scale | 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. |
| Change in the Diabetes Distress Scale score | 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 |
| Changes in the INSPIRE survey scores | 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) |
| Participant reported Acceptability of Intervention Measure (AIM) | 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. |
Countries
United States
Outcome results
None listed