- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852950
Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
March 2, 2026 updated by: Angel Morvant, Vanderbilt University Medical Center
This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Angel Morvant, MD
- Phone Number: 615-343-8332
- Email: angel.morvant@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Angel Morvant, MD
- Phone Number: (615) 343-8332
- Email: angel.morvant@vumc.org
-
Principal Investigator:
- Angel Morvant, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Non-pregnant adults, ages greater than or equal to 18 years, admitted to VUMC
- Able to give informed consent
- Hyperglycemia requiring insulin therapy including subcutaneous insulin injection or continuous subcutaneous insulin infusion (patient's own insulin pump) during hospitalization and at the time of discharge
- POC glucose or venous glucose levels in the 24 hours prior to participation need to be 70-350 mg/dL
- Need glucose readings greater than or equal to one time per day
- Mental status and dexterity adequate to use Libre 3 Plus or Dexcom G7 sensors with Libre 3 or Dexcom G7 application on patient's smartphone
Exclusion Criteria:
- Currently using Libre 3 Plus or Dexcom G7 CGMS during hospitalization or have used Libre 3 Plus or Dexcom G7 CGMS in the past 3 months
- Does not have smartphone compatible with Libre 3 App or Dexcom G7 App
- Received chemotherapy during current hospitalization
- Planning on major surgery within 10-15 days
- Hemodialysis or peritoneal dialysis
- Requiring vasopressors, intubation, sedation, or admission to an intensive care unit
- Vitamin C use of more than 500 milligrams per day
- Hydroxyurea use
- Acetaminophen use of more than 4 grams per day or 1 gram every 6 hours
- Significant pitting edema (3+ or greater) i.e. cirrhosis with ascites, congestive heart failure with edema, nephrotic syndrome, or signs of poor perfusion
- Presentation in diabetic ketoacidosis or hyperosmotic nonketotic state
- Skin allergy to adhesives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Libre 3 Plus Continuous Glucose Monitor
Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.
|
Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.
|
|
Experimental: Dexcom G7 Continuous Glucose Monitor
Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.
|
Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system
Time Frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system: regarding how do subjects feel that using CGM impacted their glucose control on a scale of 1-5, with 1=strongly made it worse, 2=somewhat made it worse, 3=did not make it better or worse, 4=somewhat made it better, and 5=strongly made it better?; regarding what is the overall opinion of subject's experience with CGM use on a scale of 1-5, with 1=very negative, 2=negative, 3=neutral, 4=positive, 5=very positive.
|
From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
|
Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care
Time Frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care: regarding how do subjects feel that using CGM impacted the diabetes care overall on a scale of 1-5, with 1=strongly made it worse, 2=somewhat made it worse, 3=did not make it better or worse, 4=somewhat made it better, and 5=strongly made it better.
|
From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
|
Questionnaire responses regarding patient familiarity with continuous glucose monitoring
Time Frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Questionnaire responses regarding patient familiarity with continuous glucose monitoring: regarding degree of familiarity of CGMs in general and the different types of information provided by CGMs, what is the subject's familiarity on a scale of 1-5, with 1=very unfamiliar, 2=unfamiliar, 3=neutral, 4=familiar, 5=very familiar.
|
From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Average Change in Hemoglobin A1C from Start to End of Study
Time Frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Degree of average change in Hemoglobin A1C from start to end of study
|
From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
|
Degree of Average Change in Glucose Management Indicator (GMI)
Time Frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Degree of average change in glucose management indicator (GMI)
|
From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
|
Number of Participants with 30-day Readmissions Related to Glycemic Control
Time Frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Number of participants with 30-day Readmissions Related to Glycemic Control (hyperglycemia, hypoglycemia, or diabetic ketoacidosis)
|
From enrollment until follow-up telephone visit 2-3 weeks after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
February 20, 2025
First Submitted That Met QC Criteria
February 24, 2025
First Posted (Actual)
February 28, 2025
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 242071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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