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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
Sponsor:
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Other: Virtual Clinic Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
All Participants
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




Primary Outcome Measures :
  1. Time in Range (TIR) [ Time Frame: 26 weeks ]
    TIR 70-180 mg/dL

  2. Time in Range (TIR) [ Time Frame: 52 weeks ]
    TIR 70-180 mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years old
  2. 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
  3. See a healthcare provider at least once a year
  4. 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.)
  5. Use either an Android or iOS smartphone that is compatible with app requirements that are needed for the study
  6. Access to a compatible computer with internet
  7. Understand written and spoken English
  8. Willing and able to follow the study procedures as instructed

Exclusion Criteria:

  1. Use of real-time CGM (including Abbott Libre or integrated pump system) in last 12 months (interval blinded CGM use is acceptable)
  2. 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.
  3. Females who are pregnant, intending to become pregnant, or breastfeeding during the study
  4. Current renal dialysis or plan to begin renal dialysis during the study
  5. Active cancer treatment
  6. Extreme visual or hearing impairment that would impair ability to use real-time CGM
  7. Known adhesive allergy/prior skin reaction or skin reaction identified during the blinded CGM use phase that would preclude continued CGM use
  8. Participation in a different diabetes management study during the study
  9. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Robin L Gal, MSPH 813-975-8690 ext 5113 rgal@jaeb.org

Locations
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United States, Florida
Jaeb Center for Health Research Recruiting
Tampa, Florida, United States, 33647
Contact: Vanessa Oduah    813-975-8690    vdisc@jaeb.org   
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
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Study Chair: Grazia Aleppo, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Robin L Gal, MSPH Jaeb Center for Health Research
  Study Documents (Full-Text)

Documents provided by Jaeb Center for Health Research:
Study Protocol  [PDF] December 1, 2020
Informed Consent Form  [PDF] December 1, 2020

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT04765358    
Other Study ID Numbers: VDiSC
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases