Type 1 DiabetesVDiSCNCT04765358
Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
A study testing Virtual Clinic in people with Type 1 Diabetes and Type 2 Diabetes, run by Jaeb Center for Health Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Virtual Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jaeb Center for Health Research
Tampa, Florida, 33647
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Virtual Clinic
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual ClinicOther
CGM, Clinical Care Support and Behavioral Health Support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1c)
Percentage of red blood cells with glucose coated hemoglobin
Measured: 26 weeks
Secondary outcomes (1)
Time Spent With Glucose 70-180 mg/dL
Percentage of 24 hour period with blood glucose in target range of 70-180 mg/dL
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start24 Aug 2020
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grazia Aleppo, MD, Study chair, Northwestern UniversityRobin L Gal, MSPH, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765358
- Sponsor's protocol ID
- VDiSC
- Acronym
- VDiSC
- Status last verified
- Apr 2024
- First submitted
- 15 Jan 2021
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39166322
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT04765358
- Acronym / sponsor ID
- VDiSC / VDiSC
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Other: Virtual ClinicAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual ClinicCGM, Clinical Care Support and Behavioral Health Support | Other | All Participants |
Primary outcome
Hemoglobin A1C (HbA1c)
Time frame: 26 weeks
Percentage of red blood cells with glucose coated hemoglobin
1 secondary outcome
Time Spent With Glucose 70-180 mg/dL
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39166322Hood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grazia Aleppo, MD study chair
Northwestern University
Robin L Gal, MSPH principal investigator
Jaeb Center for Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Clinic in people with Type 1 Diabetes and Type 2 Diabetes, run by Jaeb Center for Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (HbA1c) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.