Clinical trial NCT06852950: Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
Official title: Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Type 1 Diabetes Mellitus (T1DM)
Hyperglycemia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system
timeFrame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
measure: Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care
timeFrame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
measure: Questionnaire responses regarding patient familiarity with continuous glucose monitoring
timeFrame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
Secondary outcomes:
measure: Degree of Average Change in Hemoglobin A1C from Start to End of Study
timeFrame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
measure: Degree of Average Change in Glucose Management Indicator (GMI)
timeFrame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
measure: Number of Participants with 30-day Readmissions Related to Glycemic Control
timeFrame: From enrollment until follow-up telephone visit 2-3 weeks after discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: