Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Hyperglycemia; Type 2 Diabetes Mellitus (T2DM); Type 1 Diabetes Mellitus (T1DM)

Treatments: Device: Libre 3 Plus Continuous Glucose Monitor; Device: Dexcom G7 Continuous Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06852950

242071

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Libre 3 Plus Continuous Glucose Monitor

Experimental group

Description:

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

Treatment:

Device: Libre 3 Plus Continuous Glucose Monitor

Dexcom G7 Continuous Glucose Monitor

Experimental group

Description:

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

Treatment:

Device: Dexcom G7 Continuous Glucose Monitor