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Continuous Glucose Monitoring Initiation at Hospital Discharge

Not Applicable
Terminated
Conditions
Type2 Diabetes
Type 1 Diabetes
Hypoglycemia
Hyperglycemia
Hypoglycemia Unawareness
Interventions
Device: CGM4Home
Registration Number
NCT04854135
Lead Sponsor
Washington University School of Medicine
Brief 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)

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
20
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
CGM InterventionCGM4HomeAll eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.
Primary Outcome Measures
NameTimeMethod
To Determine the Feasibility of Initiating a Continuous Glucose Monitoring in Patients With Diabetes at Hospital DischargeAt 3 months

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.

Secondary Outcome Measures
NameTimeMethod
Percentage of Patients That Discontinue the CGMAt 6 months

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

Mean Time in Range OutcomesAt 1 month and 3 months

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

Mean Change in Self-efficacy at 3 MonthsBaseline and 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

Trial Locations

Locations (1)

Barnes Jewish Hospital/ Washington University

🇺🇸

Saint Louis, Missouri, United States

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