Continuous Glucose Monitoring Initiation at Hospital Discharge

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Type 1 Diabetes, Type2 Diabetes, Hyperglycemia, Hypoglycemia, Hypoglycemia Unawareness

Intervention / Treatment
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* Device: CGM4Home


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM Intervention<br>All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent. | Device: CGM4Home<br>* FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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 | 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) | Baseline and 3 months |