NCT04854135

Continuous Glucose Monitoring Initiation at Hospital Discharge

Continuous Glucose Monitoring Initiation at Hospital Discharge: A Feasibility Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at feasibility (the likelihood) of continued use of the FreeStyle Libre 2 Continuous glucose monitor (CGM) when started at the time of hospital discharge in patients with poorly controlled diabetes and to look at the effects of CGM use on blood glucose control and quality of life. Additional information will be collected to determine the barriers to continuing CGM use after discharge. The investigators will also collect information to see how well blood glucose has been controlled after discharge while utilizing the CGM.

Detailed description

VISIT/PHONE CALL WHAT WILL HAPPEN? (estimated time) \[window\] Screening Visit (\~45 minutes) Review consent form and obtain consent Complete questionnaire, obtain diabetes history Day of Discharge (\~1 hour) Complete FreeStyle Libre 2 CGM education Attach FreeStyle Libre 2 CGM sensor to arm Within 1-3 weeks from discharge Phone Call (\~30 minutes) Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Adverse Events Reminder to take FreeStyle Libre 2 CGM sensor prescription to pharmacy to be filled 1 \& 3 Month Phone Call (\~45 minutes) \[+/- 5 days\] Questions regarding use of FreeStyle Libre 2 CGM Current diabetes regimen Complete questionnaire Adverse Events 6 Month Phone Call (\~15 minutes) \[+/- 10 days\] Questions regarding use of FreeStyle Libre 2 CGM Barriers to FreeStyle Libre 2 CGM use Validated Instruments: Diabetes self-management Questionnaire (DMSQ)

Conditions

• Type 1 Diabetes
• Type2 Diabetes
• Hyperglycemia
• Hypoglycemia
• Hypoglycemia Unawareness

Interventions

Type	Name	Description
DEVICE	CGM4Home	FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-06-13
• Completion: 2022-06-13
• First posted: 2021-04-22
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study