Recruiting NCT06852950
Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Libre 3 Plus Continuous Glucose Monitor, Dexcom G7 Continuous Glucose Monitor.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Type 1 Diabetes Mellitus (T1DM), Hyperglycemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Libre 3 Plus Continuous Glucose Monitor
Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor. - Device Dexcom G7 Continuous Glucose Monitor
Subjects in this arm will start using the Dexcom G7 continuous glucose monitor.
Primary outcome measures
- Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system [Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge]
- Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care [Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge]
- Questionnaire responses regarding patient familiarity with continuous glucose monitoring [Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge]
Secondary outcome measures (3)
- 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]
- Degree of Average Change in Glucose Management Indicator (GMI) [Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge]
- Number of Participants with 30-day Readmissions Related to Glycemic Control [Time frame: From enrollment until follow-up telephone visit 2-3 weeks after discharge]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT06852950 · 242071