Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

NCT06852950 | Recruiting FDA Device

• 1 other identifier: 242071
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

• 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)

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

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

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

Study Arms (2)

Libre 3 Plus Continuous Glucose Monitor

EXPERIMENTAL

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

Device: Libre 3 Plus Continuous Glucose Monitor

Dexcom G7 Continuous Glucose Monitor

EXPERIMENTAL

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

Device: Dexcom G7 Continuous Glucose Monitor

Interventions

Dexcom G7 Continuous Glucose Monitor DEVICE

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

Dexcom G7 Continuous Glucose Monitor

Libre 3 Plus Continuous Glucose Monitor DEVICE

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

Libre 3 Plus Continuous Glucose Monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Angel Morvant, MD

CONTACT

615-343-8332; angel.morvant@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: March 9, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)