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

NCT04765358 | Completed Results

• 1 other identifier: VDiSC
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C (HbA1c)

  Percentage of red blood cells with glucose coated hemoglobin

  26 weeks

Secondary Outcomes (1)

• Time Spent With Glucose 70-180 mg/dL

  26 weeks

Study Arms (1)

All Participants

OTHER

All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed.

Other: Virtual Clinic

Interventions

Virtual Clinic OTHER

CGM, Clinical Care Support and Behavioral Health Support

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead

Study Sites (1)

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Related Publications (1)

• Hood KK, Bergenstal RM, Cushman T, Gal RL, Raghinaru D, Kruger D, Johnson ML, McArthur T, Bradshaw A, Olson BA, Oser SM, Oser TK, Kollman C, Weinstock RS, Beck RW, Aleppo G. Patient-Reported Outcomes Improve with a Virtual Diabetes Care Model that Includes Continuous Glucose Monitoring. Telemed J E Health. 2025 Jan;31(1):75-84. doi: 10.1089/tmj.2024.0093. Epub 2024 Aug 21.

  PMID: 39166322 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Robin Gal
• Organization: Jaeb Center for Health Research

rgal@jaeb.org

813-975-8690

Study Officials

• Grazia Aleppo, MD

  Northwestern University Feinberg School of Medicine

  STUDY CHAIR

• Robin L Gal, MSPH

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 21, 2021
• Study Start: August 24, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-04

Locations

US (1)