Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Libre 3 Plus Continuous Glucose Monitor
DeviceSubjects in this arm will start using the Libre 3 Plus continuous glucose monitor.
Dexcom G7 Continuous Glucose Monitor
DeviceSubjects in this arm will start using the Dexcom G7 continuous glucose monitor.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Libre 3 Plus Continuous Glucose MonitorExperimental treatment 1 intervention
Group B: Dexcom G7 Continuous Glucose MonitorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment until follow-up telephone visit 2-3 weeks after discharge2
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.
Time frame
From enrollment until follow-up telephone visit 2-3 weeks after discharge3
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.
Time frame
From enrollment until follow-up telephone visit 2-3 weeks after dischargeSecondary outcomes
1
Degree of Average Change in Hemoglobin A1C from Start to End of Study
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 discharge2
Degree of Average Change in Glucose Management Indicator (GMI)
Degree of average change in glucose management indicator (GMI)
Time frame
From enrollment until follow-up telephone visit 2-3 weeks after discharge3
Number of Participants with 30-day Readmissions Related to Glycemic Control
Number of participants with 30-day Readmissions Related to Glycemic Control (hyperglycemia, hypoglycemia, or diabetic ketoacidosis)
Time frame
From enrollment until follow-up telephone visit 2-3 weeks after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov