Continuous Glucose Monitoring Initiation at Hospital Discharge

  • STATUS
    Recruiting
  • days left to enroll
    15
  • participants needed
    100
  • sponsor
    Washington University School of Medicine
Updated on 30 April 2021

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.

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)

Details
Condition Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), Insulin dependent diabetes mellitus, Diabetes Mellitus, Type 1, Autoimmune disease, Autoimmune disease, Hypoglycemia, Hypocalcemia, Hyperglycemia, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetes Mellitus Types I and II, Hypoglycemia Unawareness, Type2 Diabetes, Diabetes (Pediatric), type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus, hypoglycaemia unawareness, high blood sugar, elevated blood sugar
Treatment CGM4Home
Clinical Study IdentifierNCT04854135
SponsorWashington University School of Medicine
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years of age or older
Have diabetes (type 1 diabetes mellitus, type 2 diabetes mellitus, cystic fibrosis related diabetes mellitus)
Hemoglobin A1c greater than or equal to 8.0% or history of hypoglycemia unawareness
Able and willing to sign informed consent form
Have a valid telephone number
Willing to purchase FreeStyle Libre 2 CGM sensors out of pocket after discharge from hospital (when insurance coverage isn't available)

Exclusion Criteria

Unable to sign informed consent form
Have altered mental status
Unable to manage diabetes independently at home
Have utilized CGM in the past
Pregnancy
New steroid-induced hyperglycemia
Unwilling to participate in the study
Have kidney disease requiring hemodialysis
Taking high doses of vitamin C daily (greater than 500 mg every day)
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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