Continuous Glucose Monitoring Initiation at Hospital Discharge (CGM4Home)
Primary Purpose
Type 1 Diabetes, Type2 Diabetes, Hyperglycemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CGM4Home
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes
Eligibility Criteria
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)
Sites / Locations
- Barnes Jewish Hospital/ Washington UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CGM Intervention
Arm Description
All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.)
Mean Time in range outcomes
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 months
Using the Diabetes self-management Questionnaire (DMSQ), the investigators will measure the mean change and SD in the score (pre- and post- intervention)
Full Information
NCT ID
NCT04854135
First Posted
April 14, 2021
Last Updated
April 20, 2021
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04854135
Brief Title
Continuous Glucose Monitoring Initiation at Hospital Discharge
Acronym
CGM4Home
Official Title
Continuous Glucose Monitoring Initiation at Hospital Discharge: A Feasibility Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Type2 Diabetes, Hyperglycemia, Hypoglycemia, Hypoglycemia Unawareness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CGM Intervention
Arm Type
Experimental
Arm Description
All eligible patients will receive a Continuous Glucose Monitor (CGM) prior to hospital discharge after signing an informed consent.
Intervention Type
Device
Intervention Name(s)
CGM4Home
Intervention Description
FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
Primary Outcome Measure Information:
Title
To determine the feasibility of initiating a continuous glucose monitoring in patients with diabetes at hospital discharge
Description
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.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Percentage of patients that discontinue the CGM
Description
Discontinuation rate, measured by percentage of patients that discontinue the CGM at 6 months with wearing device, use, costs, getting refills, etc.)
Time Frame
At 6 months
Title
Mean Time in range outcomes
Description
Mean and SD of Time below target, in target and above target at 1 month and 3 months
Time Frame
At 1 month and 3 months
Title
Mean change in self-efficacy at 3 months
Description
Using the Diabetes self-management Questionnaire (DMSQ), the investigators will measure the mean change and SD in the score (pre- and post- intervention)
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melisa R Moore, FNP
Phone
314-374-3173
Email
melisa.r.moore@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Recklein, RN
Phone
314-503-4574
Email
carol.recklein@bjc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Cruz Bravo, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Jewish Hospital/ Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulina Cruz Bravo, MD
Phone
314-922-8620
Email
pcruz@wustl.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15251567
Citation
Graber AL, Davidson FA, Brown MS, Gaume JA, McRae MD, Wolff K. Hospitalization of patients with diabetes. Endocr Pract. 1995 Nov-Dec;1(6):399-403. doi: 10.4158/EP.1.6.399.
Results Reference
background
PubMed Identifier
31740472
Citation
Mattishent K, Lane K, Salter C, Dhatariya K, May HM, Neupane S, Loke YK. Continuous glucose monitoring in older people with diabetes and memory problems: a mixed-methods feasibility study in the UK. BMJ Open. 2019 Nov 18;9(11):e032037. doi: 10.1136/bmjopen-2019-032037.
Results Reference
background
PubMed Identifier
11889147
Citation
Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.
Results Reference
background
PubMed Identifier
28828487
Citation
Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.
Results Reference
background
PubMed Identifier
21722581
Citation
Ehrhardt NM, Chellappa M, Walker MS, Fonda SJ, Vigersky RA. The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. J Diabetes Sci Technol. 2011 May 1;5(3):668-75. doi: 10.1177/193229681100500320.
Results Reference
background
PubMed Identifier
18701183
Citation
Yoo HJ, An HG, Park SY, Ryu OH, Kim HY, Seo JA, Hong EG, Shin DH, Kim YH, Kim SG, Choi KM, Park IB, Yu JM, Baik SH. Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract. 2008 Oct;82(1):73-9. doi: 10.1016/j.diabres.2008.06.015. Epub 2008 Aug 12.
Results Reference
background
PubMed Identifier
31661077
Citation
Whelan ME, Orme MW, Kingsnorth AP, Sherar LB, Denton FL, Esliger DW. Examining the Use of Glucose and Physical Activity Self-Monitoring Technologies in Individuals at Moderate to High Risk of Developing Type 2 Diabetes: Randomized Trial. JMIR Mhealth Uhealth. 2019 Oct 28;7(10):e14195. doi: 10.2196/14195.
Results Reference
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Continuous Glucose Monitoring Initiation at Hospital Discharge
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