Viewing Study NCT04765358


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Study NCT ID: NCT04765358
Status: COMPLETED
Last Update Posted: 2024-04-16
First Post: 2021-01-15
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Sponsor: Jaeb Center for Health Research
Organization:

Study Overview

Official Title: Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VDiSC
Brief Summary: The objective of this study was to evaluate a virtual diabetes clinic model, for adults with either type 1 diabetes or type 2 diabetes, that supports integration of CGM into diabetes self-management and use of decision support technology.
Detailed Description: 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 included 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 also included mental health screening and support services, particularly for diabetes-related issues.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: