Continuous Glucose Monitoring Initiation at Hospital Discharge

NCT04854135 | Terminated Results FDA Device

• 1 other identifier: 202101175
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type2 Diabetes; Hyperglycemia; Hypoglycemia; Hypoglycemia Unawareness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Patients That Discontinue the CGM

  At 6 months

• Mean Time in Range Outcomes

  At 1 month and 3 months

• Mean Change in Self-efficacy at 3 Months

  Baseline and 3 months

Study Arms (1)

CGM Intervention

EXPERIMENTAL

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

Device: CGM4Home

Interventions

CGM4Home DEVICE

FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott

CGM Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital/ Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• 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.

  PMID: 15251567 BACKGROUND

• 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.

  PMID: 31740472 BACKGROUND

• 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.

  PMID: 11889147 BACKGROUND

• 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.

  PMID: 28828487 BACKGROUND

• 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.

  PMID: 21722581 BACKGROUND

• 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.

  PMID: 18701183 BACKGROUND

• 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.

  PMID: 31661077 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Paulina Cruz Bravo, MD
• Organization: Washington University in St. Louis

pcruz@wustl.edu

314-922-8620

Study Officials

• Paulina Cruz Bravo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 22, 2021
• Study Start: April 13, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)