Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring (VDiSC)
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|ClinicalTrials.gov Identifier: NCT04765358|
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Type 2 Diabetes||Other: Virtual Clinic||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring|
|Actual Study Start Date :||August 24, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2022|
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) has been completed, participants will continue to be followed by the virtual clinic team for 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 will no longer be followed by the virtual clinic team but those who decide to continue to use CGM will be asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data.
Other: Virtual Clinic
CGM, Clinical Care Support and Behavioral Health Support
- Time in Range (TIR) [ Time Frame: 26 weeks ]TIR 70-180 mg/dL
- Time in Range (TIR) [ Time Frame: 52 weeks ]TIR 70-180 mg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765358
|Contact: Robin L Gal, MSPH||813-975-8690 ext email@example.com|
|United States, Florida|
|Jaeb Center for Health Research||Recruiting|
|Tampa, Florida, United States, 33647|
|Contact: Vanessa Oduah 813-975-8690 firstname.lastname@example.org|
|Study Chair:||Grazia Aleppo, MD||Northwestern University Feinberg School of Medicine|
|Principal Investigator:||Robin L Gal, MSPH||Jaeb Center for Health Research|