Continuous Glucose Monitoring Initiation at Hospital Discharge (CGM4Home)

The Washington University

Status: Terminated

Conditions: Hypoglycemia; Hyperglycemia; Type 1 Diabetes; Type2 Diabetes; Hypoglycemia Unawareness

Treatments: Device: CGM4Home

Study type: Interventional

Funder types: Other

Identifiers

NCT04854135

202101175

Details and patient eligibility

About

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.

Full 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)

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CGM Intervention

Experimental group

Description:

All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.

Treatment:

Device: CGM4Home