Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring

Study Overview
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Brief Summary
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The objective of this study is to evaluate a virtual diabetes clinic model, for adults with either T1D or T2D, that supports integration of CGM into diabetes self-management and use of decision support technology.

Detailed Description
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Although demand for endocrinology care continues to grow, access to specialized care may be impacted by geographic isolation and a shortage in the number of endocrinologists in the United States. CGM use has been endorsed for individuals with T1D by the American Diabetes Association, the American Association of Clinical Endocrinologists, the Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes. Despite these recommendations and the compelling evidence of the benefits of CGM, many individuals with T1D or insulin-using T2D have not incorporated CGM into their diabetes management. The study was designed to assess feasibility and efficacy of establishing a virtual diabetes clinic with a focus on introduction and training related to use of CGM technology and ongoing CGM use to minimize such rate-limiting factors as geography, cost and access to specialty care. The virtual diabetes clinic model will include a comprehensive care team with support for diabetes technology such as CGM and decision support to align with current recommendations in diabetes care. The virtual diabetes clinic model will also include mental health screening and support services, particularly for diabetes-related issues.

Official Title
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Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Other: Virtual Clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old Diagnosis of type 1 diabetes or type 2 diabetes and using insulin therapy (at least 3 injections of insulin per day or insulin pump that is compatible with Tidepool software); Multiple daily injection (MDI) users must be willing to use a device provided by the study that records the injection dosages and/or enter insulin dosing information through an app See a healthcare provider at least once a year Resident of United States and plan to reside in the U.S. for the duration of the study (This requirement is due to virtual clinic license requirements and U.S. use restrictions for some study software and devices. Not all U.S. states may be eligible for inclusion due to virtual clinic license status.) Use either an Android or iOS smartphone that is compatible with app requirements that are needed for the study Access to a compatible computer with internet Understand written and spoken English Willing and able to follow the study procedures as instructed Exclusion Criteria: Current use of a closed loop system where an insulin pump and CGM share information and insulin dose is automatically adjusted based on glucose reading Current CGM use where Time in Range is ≥60.0% or Time <54% is ≤1.0%. Current use of any off-label glucose-lowering medications for diabetes type (Example: T1D use of non-insulin, anti-diabetic medications including SGLT2 inhibitors). Use of such medications during the study will also be prohibited. Females who are pregnant, intending to become pregnant, or breastfeeding during the study Current renal dialysis or plan to begin renal dialysis during the study Active cancer treatment Extreme visual or hearing impairment that would impair ability to use real-time CGM Known adhesive allergy/prior skin reaction or skin reaction identified during the blinded CGM use phase that would preclude continued CGM use Participation in a different diabetes management study during the study Planned relocation to a state other than current state of residence during the study if virtual clinic is not licensed in the new state. Individuals working routinely in a state other than current state of residence in the next six months are also ineligible if the virtual clinic is not licensed in that state.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Participants<br>All participants will be provided with a commercially available CGM system. Training and data collection for the study will be completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) has been completed, participants will continue to be followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires are administered at enrollment and during follow up. The virtual clinical team member will follow up with the study participant if there is an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decide to continue to use CGM will be asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants will be able to contact the virtual clinic with questions or to request assistance as needed. | Other: Virtual Clinic<br>* CGM, Clinical Care Support and Behavioral Health Support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range (TIR) | TIR 70-180 mg/dL | 26 weeks | 
| Time in Range (TIR) | TIR 70-180 mg/dL | 52 weeks |