Continuous Glucose Monitoring Initiation at Hospital Discharge

Washington University School of Medicine20 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years of age or older 2. Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus) 3. Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness 4. Able and willing to sign informed consent form 5. Have a valid telephone number 6. Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available) Exclusion Criteria: 1. Unable to sign informed consent form 2. Have altered mental status 3. Unable to manage diabetes independently at home 4. Have utilized CGM in the past 5. Pregnancy 6. New steroid-induced hyperglycemia 7. Unwilling to participate in the study 8. Have kidney disease requiring hemodialysis 9. Taking high doses of vitamin C daily (greater than 500 mg every day)

Outcomes

Primary Outcomes

To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital Discharge

Starting and continuing to use a CGM at this critical time is feasible. Feasibility is defined as at least 20 percent of patients with diabetes referred for diabetes education meet inclusion criteria to participate and at least 75 percent participate. From those who participate, at least 50 percent continue using the CGM at 3 months.

Time frame: At 3 months

Secondary Outcomes

Percentage of Patients That Discontinue the CGM

Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.)

Time frame: At 6 months

Mean Time in Range Outcomes

Mean and SD of Time below target, in target and above target at 1 month and 3 months

Time frame: At 1 month and 3 months

Mean Change in Self-efficacy at 3 Months

Using the Diabetes self-management Questionnaire (DMSQ), the investigators will measure the mean change and SD in the score (pre- and post- intervention) score is 0-48, higher scores mean a better outcome

Time frame: Baseline and 3 months