Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

Not Applicable

Recruiting

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

• Registration Number: NCT06852950
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Status Verified: 2025-03
• Study Start: 2025-03-09
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system	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.
Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care	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.
Questionnaire responses regarding patient familiarity with continuous glucose monitoring	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.

Secondary Outcome Measures

Name	Time	Method
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 Hemoglobin A1C from start to end of study
Degree of Average Change in Glucose Management Indicator (GMI)	From enrollment until follow-up telephone visit 2-3 weeks after discharge	Degree of average change in glucose management indicator (GMI)
Number of Participants with 30-day Readmissions Related to Glycemic Control	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)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States