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NCT04089202 · ClinicalTrials.gov registry record · NA
Diabetes eConsult Non-Inferiority Study
A NA study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 87
- Enrollment target
NCT04089202 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 87 participants.
The verdict
NCT04089202, a NA study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 87 participants
- Enrollment target
Study Summary
Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. It provides a full 24-hour glucose profile for each day that the sensor is worn and that can be correlated with daily activities, medication administration, food intake, and other factors that are contextually relevant in meeting glycemic goals for an individual patient. In this study, patients referred to Endocrinology for specialty diabetes care will be randomized to an in-person visit as is typically done or to wear the Freestyle Libre Pro placed by staff at their primary care clinic. Patients who wear the Freestyle Libre Pro will have a professional interpretation of their glucose data completed by an endocrinologist as well as a remote eConsult completed using this glucose data and information from their medical record. The recommendations from the eConsult regarding medication and lifestyle adjustment as well as potential referral on to see Endocrinology will be implemented by the primary care physician at their clinical discretion. The investigators will utilize glycemic measures including hemoglobin A1c, number of clinical visits (outpatient, inpatient and emergency department) for diabetes care, patient reported outcomes including self-efficacy, and patient and provider assessments of burden to determine if eConsults utilizing flash glucose monitoring technology are non-inferior to in-person visits with a diabetes specialist.
Interventions
- OTHER Standard of care
- OTHER eConsult
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2022-09-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04089202
The ClinicalTrials.gov registry entry for NCT04089202 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT04089202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04089202 about?
NCT04089202 is a clinical study titled "Diabetes eConsult Non-Inferiority Study". Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. ...
What is the current status of trial NCT04089202?
This trial is currently terminated. It is a NA study. The enrollment target is 87 participants. The study started on 2020-02-03. Estimated completion is 2022-09-27.
What interventions are being tested in trial NCT04089202?
The interventions under investigation include: Standard of care (OTHER), eConsult (OTHER).
Who is sponsoring clinical trial NCT04089202?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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