Continuous Glucose Monitoring of Hospitalized Patients With Diabetes

NCT04230694 | Completed DMC FDA Device

• 1 other identifier: 018-601
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been found to be helpful for reducing hypoglycemia in some studies while less so in others, however, these studies were performed with earlier generation glucose monitoring devices(5). ICU studies have confirmed accuracy of CGM measurements compared with capillary glucose even in settings with use of vasopressors and large-volume resuscitation. A limited number of studies have evaluated glycemic outcomes in the inpatient non-ICU setting. Studies of non-ICU patients (6-10) are limited by very small sample size, short study duration, and use of older CGM devices. There is, therefore, a critical need to systematically investigate the use of CGM in the inpatient care of patients with diabetes mellitus who are receiving care in a hospital setting that is typical of inpatient care.

Conditions

Glucose, Low Blood; Diabetes; Diabetes Mellitus; Glucose, High Blood

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Hypoglycemia Events during hospitalization

  Dexcom Gen6 readings

  Up to 10 days

Secondary Outcomes (1)

• Number of Hyperglycemia Events during hospitalization

  Up to 10 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay.

Device: Dexcom Generation 6 CGM (Dexcom Gen6) device

Treatment Group

EXPERIMENTAL

Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks.

Device: Dexcom Generation 6 CGM (Dexcom Gen6) device

Interventions

Dexcom Generation 6 CGM (Dexcom Gen6) device DEVICE

Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings.

Also known as: CGM

Control Group; Treatment Group

Eligibility Criteria

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

You may qualify if:

• Patients with Type 1 and Type 2 diabetes.
• Subjects 18 years of age or older with diabetes.
• Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)
• Subjects with expected hospital length-of-stay of 2 or more days beyond the time of enrollment.
• Subjects willing to wear CGM device.

You may not qualify if:

• Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.
• Subjects with greater than 4gm use of Tylenol/24 hr.
• Surgical patients or patients with pre-planned surgery or procedure in the next 48 hours.
• Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.
• Patients who may potentially require IV insulin.
• Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
• Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
• Patients who have had organ transplant.
• Patients with any severe medical conditions such as end-stage renal disease on dialysis, status post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic support, Ejection Fraction (EF) \< 15 % or severe sepsis.
• Any condition for which, in the opinion of the investigators, it would not be in the best interest of the participant.
• Legally protected subjects (under judicial protection, guardianship, or supervision), persons deprived of their liberty, mental or language barriers rendering the subject unable to understand the nature, scope and possible consequences of the study.
• Subjects with active substance abuse.
• Subjects with infaust prognosis.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

Location

Related Publications (12)

• Levetan CS, Passaro M, Jablonski K, Kass M, Ratner RE. Unrecognized diabetes among hospitalized patients. Diabetes Care. 1998 Feb;21(2):246-9. doi: 10.2337/diacare.21.2.246.

  PMID: 9539990 BACKGROUND

• Mendez CE, Mok KT, Ata A, Tanenberg RJ, Calles-Escandon J, Umpierrez GE. Increased glycemic variability is independently associated with length of stay and mortality in noncritically ill hospitalized patients. Diabetes Care. 2013 Dec;36(12):4091-7. doi: 10.2337/dc12-2430. Epub 2013 Oct 29.

  PMID: 24170754 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

• Rubin DJ, Golden SH. Hypoglycemia in non-critically ill, hospitalized patients with diabetes: evaluation, prevention, and management. Hosp Pract (1995). 2013 Feb;41(1):109-16. doi: 10.3810/hp.2013.02.1016.

  PMID: 23466973 BACKGROUND

• van Steen SC, Rijkenberg S, Limpens J, van der Voort PH, Hermanides J, DeVries JH. The Clinical Benefits and Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients-A Systematic Scoping Review. Sensors (Basel). 2017 Jan 14;17(1):146. doi: 10.3390/s17010146.

  PMID: 28098809 BACKGROUND

• Gomez AM, Umpierrez GE, Munoz OM, Herrera F, Rubio C, Aschner P, Buendia R. Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. J Diabetes Sci Technol. 2015 Aug 31;10(2):325-9. doi: 10.1177/1932296815602905.

  PMID: 26330394 BACKGROUND

• Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.

  PMID: 25927357 BACKGROUND

• Levitt DL, Silver KD, Spanakis EK. Inpatient Continuous Glucose Monitoring and Glycemic Outcomes. J Diabetes Sci Technol. 2017 Sep;11(5):1028-1035. doi: 10.1177/1932296817698499. Epub 2017 Mar 14.

  PMID: 28290224 BACKGROUND

• Levitt DL, Silver KD, Spanakis EK. Mitigating Severe Hypoglycemia by Initiating Inpatient Continuous Glucose Monitoring for Type 1 Diabetes Mellitus. J Diabetes Sci Technol. 2017 Mar;11(2):440-441. doi: 10.1177/1932296816664538. Epub 2016 Aug 20. No abstract available.

  PMID: 27543272 BACKGROUND

• Spanakis EK, Levitt DL, Siddiqui T, Singh LG, Pinault L, Sorkin J, Umpierrez GE, Fink JC. The Effect of Continuous Glucose Monitoring in Preventing Inpatient Hypoglycemia in General Wards: The Glucose Telemetry System. J Diabetes Sci Technol. 2018 Jan;12(1):20-25. doi: 10.1177/1932296817748964. Epub 2017 Dec 13.

  PMID: 29237288 BACKGROUND

• Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. doi: 10.1186/1477-7525-5-57.

  PMID: 17927832 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Tresa McNeal, MD

  Baylor Scott & White Medical Center - Temple

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dexcom Generation 6 CGM (Dexcom Gen6) device

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: September 20, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)