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RecruitingNCT06852950Updated Mar 5, 2026

Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

An interventional study of Libre 3 Plus Continuous Glucose Monitor and Dexcom G7 Continuous Glucose Monitor in Type 2 Diabetes Mellitus (T2DM), Type 1 Diabetes Mellitus (T1DM) and Hyperglycemia, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)
  • Type 1 Diabetes Mellitus (T1DM)
  • Hyperglycemia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Libre 3 Plus Continuous Glucose Monitor

    Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.

    Device: 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.

    Device: Dexcom G7 Continuous Glucose Monitor

Interventions

  • DeviceLibre 3 Plus Continuous Glucose Monitor

    Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor.

  • DeviceDexcom G7 Continuous Glucose Monitor

    Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.

05

What researchers measure

Primary outcomes

  1. Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system

    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.

    Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge

  2. Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care

    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.

    Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge

  3. Questionnaire responses regarding patient familiarity with continuous glucose monitoring

    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.

    Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge

Secondary outcomes

  1. Degree of Average Change in Hemoglobin A1C from Start to End of Study

    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

  2. Degree of Average Change in Glucose Management Indicator (GMI)

    Degree of average change in glucose management indicator (GMI)

    Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge

  3. Number of Participants with 30-day Readmissions Related to Glycemic Control

    Number of participants with 30-day Readmissions Related to Glycemic Control (hyperglycemia, hypoglycemia, or diabetic ketoacidosis)

    Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge

06

Study locations

1 of 1 sites recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    • Angel Morvant, MD · Contact · angel.morvant@vumc.org · (615) 343-8332
    • Angel Morvant, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06852950
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Angel Morvant (Principal Investigator, Vanderbilt University Medical Center) — Principal investigator
First posted
Feb 28, 2025
Start date
Mar 9, 2025
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Mar 5, 2026

Study contacts

Angel Morvant, MD
Contact
angel.morvant@vumc.org
615-343-8332

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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