Feasibility and Performance of Continuous Glucose Monitoring to Guide Computerized Insulin Infusion Therapy in Non-ICU Patients Receiving Corticosteroid Therapy and Specialized Nutrition

NCT07194642 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 0144-25-FB
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this pilot study is to assess the feasibility and performance of real-time CGM for titrating CII via: (1) evaluation of CGM glucose accuracy in oncology and post-transplant population receiving IV insulin therapy, and (2) assessing both nursing acceptance/convenience and patient satisfaction with CGM use. A randomized prospective trial model will be used comparing glucose control (glucometrics hypoglycemia), patient experience and nursing satisfaction in cancer patients receiving IV insulin therapy where monitoring is done via: a) hybrid protocol originally developed by Faulds et al. integrating CGM with periodic POC-BG tests to monitor and ensure the ongoing accuracy of CGM measurements (available at http://www.covidindiabetes.org). b) standard care with hourly POC testing and blinded professional CGM.Inclusion criteria: Eligible patients include oncology and post-transplant patients receiving IV insulin therapy while on corticosteroid treatment and receiving specialized nutrition. Exclusion criteria: medically instable patients receiving pressor therapy and ICU level of care. Outcome evaluation; Patients' characteristics were collected through the EHR. Glucometrics will be collected throughout the study to include mean BS, % in range ( 80-180) , patient day hypoglycemia , patient stay hypoglycemia . Nursing surveys: Survey will be provided for nurses to assess nursing burden, acceptability. Nurses will complete a survey before starting the project and again after being involved in the initial and ongoing validation phases of CGM at the end of the project. The purpose is to report their convenience with using CGM and their preferred glucose monitoring method, which included POC arterial blood, POC finger sticks, and CGM. Nursing surveys will be administrated electronically to nursing staff and the results will be uploaded automatically. Patient survey: Patients will be approached by the team members to inquire about the willingness to provide feedback. The questionnaire will assess their experiences of care with CGM (options: very good, good, fair, poor), glucose check without pain and disruptions of sleep (yes/no), and overall confidence of care with CGM process (very confident, quite confident, somewhat confident, little confident). Patient surveys will handed out by the team members, and the results were subsequently entered into database (See both nursing and patient surveys in Supplementary Material.)

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Non-inferiority for TIR (Time in Range)

  Participant characteristics will be collected through the EHR. Descriptive analyses will be conducted to summarize patient characteristics, POC-BG, CGM data and survey data.

  12 Months

Study Arms (2)

Unblinded CGM

OTHER

Nursing staff will compare CGM and POC-BG readings every 1 to 2 hours using institutional blood glucose meters. Validated CII calculator will be utilized. Validation will be considered successful when two consecutive CGM readings were within 20% of the POC-BG when BG exceeded 100 mg/dL, or within 20 mg/dL if the POC-BG was below 100 mg/dL. The electronic health records (EHR) will utilize the CGM glucose value entered in the patient flowsheet row for comparison with POC-BG results using the published algorithm above to calculate, confirm, and record the success of the validation. \- Ongoing validation phase for the sustained use of CGM. After the initial CGM validation, POC-BG checks and the CGM validation will be reduced to every 6 hours, and CII titration in the interim was guided by CGM values until the next POC-BG assessment.

Other: Dexcom G7 CGM

Blinded CGM

OTHER

After CGMs are placed (on the abdomen in all participants) and have completed their warm-up period, the nursing staff will proceed with standard of care POC finger sticks. The blinded CGM data will not be visible to the participant, nursing staff, or other care providers. The blinded CGM data will be used for data analysis following the completion of the participant's participation.

Other: Dexcom G7 CGM

Interventions

Dexcom G7 CGM OTHER

The Dexcom G7 is a continuous glucose monitor, FDA 510K cleared (K213919) for people with diabetes. Worn for 10 days at a time, the device monitors the glucose levels of interstitial fluid and, via bluetooth, transmits data every 5 minutes to a receiver.

Blinded CGM; Unblinded CGM

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>19 years old
• Patients with diabetes or stress induced hyperglycemia requiring continuous insulin infusion therapy, with anticipated duration of this therapy being \> 24 hours. Specifically, we will include
• Patients with Type 2 diabetes; or if not previously diagnosed as having diabetes, HbA1c \>7.0% (laboratory-measured at or since hospital admission or within prior 3-months).
• Type 1 diabetes, as well as atypical forms of diabetes (including pancreatectomy and pancreatitis) and
• Stress hyperglycemia defined as at least 1 blood glucose measurement \>180 mg/dL since admission in a patient without history of diabetes, if CII is indicated per treating physician
• Insulin drip (CII) already initiated since admission or planned to be initiated
• Non-critical hospitalization with expected duration of CII \> 24 hours at time of randomization
• Oncology and post-transplant population receiving IV insulin therapy

You may not qualify if:

• Inability to provide written consent
• Medically unstable patients receiving pressor therapy and ICU level of care.
• Patients transferred from ICU with an expected requirement for CII \> 24 hours on a non-ICU floor are eligible)
• For women of childbearing potential: currently pregnant or breastfeeding
• Hypoxia (O2 saturation \< 90 %) present at time of potential enrollment
• Hemoglobin \< 7 mg/dL;
• Anasarca present at time of potential enrollment
• Use of hydroxyurea or high dose acetaminophen use of \>4g daily as those are substances known to interfere with CGM system.
• eGFR \< 20 mL/min or dialysis being received or planned
• Known allergy to medical grade adhesives or a skin condition that may impact CGM performance per investigator discretion
• Admission for Diabetic ketoacidosis or hyperosmolar hyperglycemic state
• Nurse Participants:
• Adults aged 19 and older involved in the routine care of the patient participants
• Adequate proficiency to understand and provide informed consent in English

Sponsors & Collaborators

• University of Nebraska: lead

Related Publications (9)

• Tian T, Aaron RE, Yeung AM, Huang J, Drincic A, Seley JJ, Wallia A, Gilbert G, Spanakis EK, Masharani U, Faulds E, Hirsch IB, Dawood GE, Espinoza JC, Mendez CE, Kerr D, Klonoff DC. Use of Continuous Glucose Monitors in the Hospital: The Diabetes Technology Society Hospital Meeting Report 2023. J Diabetes Sci Technol. 2023 Sep;17(5):1392-1418. doi: 10.1177/19322968231186575. Epub 2023 Aug 9.

  PMID: 37559371 BACKGROUND

• Nair BG, Dellinger EP, Flum DR, Rooke GA, Hirsch IB. A Pilot Study of the Feasibility and Accuracy of Inpatient Continuous Glucose Monitoring. Diabetes Care. 2020 Nov;43(11):e168-e169. doi: 10.2337/dc20-0670. Epub 2020 May 11. No abstract available.

  PMID: 32393587 BACKGROUND

• Dillmann C, Amoura L, Fall Mostaine F, Coste A, Bounyar L, Kessler L. Feasibility of Real-Time Continuous Glucose Monitoring Telemetry System in an Inpatient Diabetes Unit: A Pilot Study. J Diabetes Sci Technol. 2022 Jul;16(4):955-961. doi: 10.1177/1932296821994586. Epub 2021 Mar 4.

  PMID: 33660531 BACKGROUND

• Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.

  PMID: 19502209 BACKGROUND

• Stewart NH, Arora VM. Sleep in Hospitalized Older Adults. Sleep Med Clin. 2018 Mar;13(1):127-135. doi: 10.1016/j.jsmc.2017.09.012. Epub 2017 Nov 10.

  PMID: 29412979 BACKGROUND

• Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987 Sep-Oct;10(5):622-8. doi: 10.2337/diacare.10.5.622.

  PMID: 3677983 BACKGROUND

• Faulds ER, Jones L, McNett M, Smetana KS, May CC, Sumner L, Buschur E, Exline M, Ringel MD, Dungan K. Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill Patients With COVID-19. Endocr Pract. 2021 Apr;27(4):354-361. doi: 10.1016/j.eprac.2021.01.011. Epub 2021 Jan 27.

  PMID: 33515756 BACKGROUND

• Faulds ER, Boutsicaris A, Sumner L, Jones L, McNett M, Smetana KS, May CC, Buschur E, Exline MC, Ringel MD, Dungan K. Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4007-e4016. doi: 10.1210/clinem/dgab409.

  PMID: 34100545 BACKGROUND

• Ang L, Lin YK, Schroeder LF, Huang Y, DeGeorge CA, Arnold P, Akanbi F, Knotts S, DuBois E, Desbrough N, Qu Y, Freeman R, Esfandiari NH, Pop-Busui R, Gianchandani R. Feasibility and Performance of Continuous Glucose Monitoring to Guide Computerized Insulin Infusion Therapy in Cardiovascular Intensive Care Unit. J Diabetes Sci Technol. 2024 May;18(3):562-569. doi: 10.1177/19322968241241005. Epub 2024 Apr 2.

  PMID: 38563491 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Andjela Drincic, MD

CONTACT

4025596276; andjela.drincic@unmc.edu

Aditya Chandlekar, MS

CONTACT

4025597083; achandlekar@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: he blinded CGM data will not be visible to the participant, nursing staff, or other care providers. The blinded CGM data will be used for data analysis following the completion of the participant's participation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Inpatient patients meeting inclusion criteria and not exclusion criteria will be approached and consented by personnel listed in section I. Enrolled participants will be randomized to one of two arms: 1. hybrid protocol originally developed by Faulds et al. integrating CGM with periodic POC-BG tests to monitor and ensure the ongoing accuracy of CGM measurements (available at http://www.covidindiabetes.org). 2. standard care with hourly POC testing with blinded professional CGM for data analysis

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 26, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05