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CGM4Home: Continuous Glucose Monitoring Initiation at Hospital Discharge

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04854135
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
16.6
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CGM4Home
 N/A

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)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Continuous Glucose Monitoring Initiation at Hospital Discharge: A Feasibility Pilot Study
Actual Study Start Date :
Apr 13, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CGM Intervention

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

Device: CGM4Home
FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott

Outcome Measures

Primary Outcome Measures

  1. To determine the feasibility of initiating a continuous glucose monitoring in patients with diabetes at hospital discharge [At 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

  1. Percentage of patients that discontinue the CGM [At 6 months]

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

  2. Mean Time in range outcomes [At 1 month and 3 months]

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

  3. Mean change in self-efficacy at 3 months [Baseline 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barnes Jewish Hospital/ Washington University Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Paulina Cruz Bravo, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Paulina Cruz Bravo, Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT04854135
Other Study ID Numbers:
  • 202101175
First Posted:
Apr 22, 2021
Last Update Posted:
Apr 22, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Hypoglycemia
Hyperglycemia

Study Results

No Results Posted as of Apr 22, 2021