Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
Phase: NA
Conditions: Hyperglycemia, Hypoglycemia, Critical Illness, Diabetes Mellitus
Sponsor: Malcom Randall VA Medical Center

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RESEARCH PROTOCOL 
 
Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients 
 
NCT05442853 
 
October 20, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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RESEARCH PROTOCOL 
 
1. Project Title: Continuous Glucose Monitoring for Hyperglycemia in Critically Ill 
Patients 
 
 
2. Abstract: 
The investigators intend to conduct prospective, randomized comparative trial of 
patients admitted to the intensive care unit (ICU) at the North Florida/South 
Georgia Veterans Health System who received continuous glucose monitoring 
(CGM) vs standard glucose monitoring. This study will examine several outcomes 
for patients in the ICU with hyperglycemia. The primary outcome of the study 
will be the percentage of time in target range (blood glucose 70-180 mg/dL). 
Secondary outcomes will include percentage of time in clinically significant 
hypoglycemic (BG < 54 mg/dL), hypoglycemic (BG 54-69 mg/dL), hyperglycemic 
(BG 181-250 mg/dL), and clinically relevant hyperglycemic (BG >250 mg/dL) 
ranges; ICU length of stay, ICU mortality, 30-day mortality, costs associated with 
monitoring, mean BG, glucose variability between the two groups (% coefficient 
of variation = SD/mean BG*100%), and patient satisfaction. An evaluation will be 
done to assess the proportions of patients with new infection, acute kidney 
injury (AKI), agitation, delirium, and pain. Correlation between CGM values and 
whole blood values for blood glucose will be evaluated. 
 
3. Background: 
Diabetes mellitus (DM) is a common comorbidity among hospitalized 
patients with over 25% reporting a history of the disease. Furthermore, stress-induced 
hyperglycemia is common in critically ill patients. Among these patients, glucose 
control is a necessity to avoid further complications. Inpatient hyperglycemia has 
been associated with a longer length of stay, increased risk of infection, and increased 
mortality. Hypoglycemia can be more severe in hospitalized patients and can also 
increase length of stay and mortality. The current standard for glucose monitoring 
involves point-of-care (POC) blood glucose finger sticks or arterial/venous whole 
blood sampling. These methods have limitations and continuous glucose monitors 
(CGMs) offer a potential alternative. 
Continuous glucose monitors (CGMs) were originally designed for use in the 
home and outpatient setting, with less data on its application in the hospital or critical 
care settings. Until April 2020, CGMs were not approved for inpatient use. To 
support COVID-19 healthcare efforts, the FDA allowed for the use of continuous 
glucose monitoring (CGM) systems for the treatment of patients in various healthcare 
facilities. This remote glucose monitoring allowed for conservation of personal 
protective equipment (PPE) and reduction of potential exposure of staff from multiple 
point-of-care glucose checks. Compared to the POC checks every one to two hours, 
CGM systems can provide blood glucose readings multiple times each hour, allowing 
for remote monitoring and the ability to detect urgent changes in blood glucose.  
Several studies have evaluated the use of CGM among hospitalized patients 
with DM and have shown positive results when compared to traditional POC glucose 

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monitoring. Most studies have found the use of CGM can help minimize the number 
of hypoglycemia episodes and overall improve patient care. Similar studies have been 
done in the intensive care unit (ICU) with favorable results; however, these studies 
had smaller sample sizes and limited external validity. While there is consensus on 
the superiority of CGM detecting hypoglycemic blood glucose levels, the effects on 
other patient outcomes in the critically ill remain uncertain. 
 
4. Study Purpose: 
The purpose of this study is to compare the use of CGM versus POC glucose 
monitoring in the critical care setting for differences in glycemic control and 
other important ICU outcomes. 
 
5. Research Plan: 
a. Study Design:  
i. Prospective, single-center, randomized comparative trial 
 
b. Study Sample:  
i. Adult patients at North Florida/South Georgia Veterans Health 
System anticipated to be admitted to an ICU for a minimum of 48 
hours after enrollment 
ii. A minimum sample size was calculated to be a total of 88 patients (44 
per group), but will continue to enroll patients for a maximum of 2 
years or a maximum of 300 patients 
1. Anticipated mean POC % time in range of 58% (based on 
current rates in our facility) with a standard deviation of 20% 
2. Anticipated mean CGM % time in range of 70% (based on CGM 
interpretation guidelines) 
3. 80% power, 5% alpha 
 
c. Inclusion Criteria:  
i. Patients age 18-89 
ii. Past medical history of any diabetes mellitus OR patients with at least 
1 measured BG of 180 being treated with insulin (subcutaneous or 
infusion) 
1. Enrollment will occur within 72 hours after being admitted to 
an ICU if history of diabetes 
2. Enrollment will occur within 72 hours after developing 
hyperglycemia in ICU if no diabetes 
 
d. Exclusion Criteria:  
i. Pregnant patients 
1. Female patients who report no known current pregnancy, will 
be considered to not have potential to be pregnant with one 
of the following:  

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a. History of surgical sterilization (methods include 
hysterectomy, bilateral tubal ligation, bilateral 
salpingectomy or bilateral oophorectomy) 
b. Postmenopausal (defined as age greater than 62 years, 
or age 62 years or less than with amenorrhea for at 
least 12 consecutive months) 
c. No sexual partners within previous 9 months who can 
father children (those who cannot father children 
include female partners; and male partners who are 
incapable of fathering children because of congenital 
anomalies, surgery, or medical treatment) 
d. Reported consistent use of hormonal (oral 
contraceptives, implant, injection, patch, vaginal ring) 
or intrauterine device (IUD) contraception.   
ii. Diagnosis of diabetic ketoacidosis (DKA) 
iii. Diagnosis of hyperosmolar hyperglycemic state (HHS) 
iv. Anticipated to require prone positioning while on insulin therapy 
v. Any contraindications to CGMs based on manufacturer labeling 
vi. BG above maximum reading for CGM (e.g. greater than 400 mg/dL) 
vii. Receiving medication that could interfere with CGM readings (based 
on manufacturer specifications) 
1. Receiving any dose of hydroxyurea as this could falsely elevate 
the sensor readings (if applicable for specific CGM)  
2. Receiving greater than 1,000mg acetaminophen every 6 hours 
in any form as this could falsely elevate the sensor readings (if 
applicable for specific CGM) 
 
e. Recruitment:  
i. Patients who meet eligibility criteria for this study may be referred to 
the study team by a clinical staff member of the ICU team responsible 
for the clinical care of the patient. Study team members are ICU 
clinicians and may also be part of the team providing clinical care. 
Patients (or their authorized decision maker) will first be asked if they 
wish to learn about the study. If the patient is interested in 
participating in the study, the research team will contact the patient 
and provide details of study participation and informed consent. 
ii. Patients will be provided information on standards of care. As a 
participant in this study, all care including medical procedures, 
diagnostic tests, monitoring, medications, treatments, and other care 
will be the same for all patients as those who do not participate in the 
study, with the exception of the method of glucose monitoring. 
 
 
f. Randomization:  

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i. Study participants will be randomly assigned to one of the study 
groups after being found eligible for inclusion and giving consent to 
participate 
ii. A randomization process, such as a computerized algorithm or 
random number generator will be used to assign patients a group 
upon inclusion 
iii. Patients will be allocated 1:1 to the monitoring groups based on this 
randomization 
 
g. Study Groups:  
i. Group 1: POC group (Blinded to CGM)  
1. All patients will have Dexcom G6 Pro CGM sensor/transmitter 
placed per device instructions 
2. Nurses and all members of the medical treatment team will be 
BLINDED to the CGM blood glucose readings during the study 
period 
3. Glycemic management will be based on POC glucose values.  
ii. Group 2: CGM group (Unblinded to CGM) 
1. All patients will have Dexcom G6 CGM sensor/transmitter 
placed per device instructions 
2. Nurses and all members of the medical treatment team will be 
UNBLINDED to the CGM blood glucose readings during the 
study period 
3. Glycemic management will be based on CGM values.  
 
h. Study Outcomes 
i. Primary Outcome 
1. Percentage of time in target range (BG 70-180mg/dL) 
[Appendix E] 
a. Comparison of CGM readings between both types of 
monitoring/treatment groups  
ii. Secondary Outcomes 
1. Percentage of time in each range (Appendix E) [Comparison of 
CGM readings between both types of monitoring/treatment 
groups] 
a. Clinically significant hypoglycemic range (BG < 54 
mg/dL) 
b. Hypoglycemic range (BG 54-69 mg/dL) 
c. Hyperglycemic range (BG 181-250 mg/dL) 
d. Clinically relevant hyperglycemic range (BG >250 
mg/dL) 
2. ICU length of stay 
3. ICU mortality 
4. 30-day mortality 

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5. Costs associated with monitoring 
6. Mean BG 
7. Glucose variability for each group 
a. % coefficient of variation = SD/mean BG*100% 
8. Patient satisfaction  
 
iii. Safety 
1. Proportion of patients with a new infection 
2. Proportion of patients with new AKI (AKIN guidelines) 
3. Proportion of patients with CAM-ICU positive delirium 
4. Proportion of patients with agitation (RASS > 2) 
5. Proportion of patients with a positive pain score (CPOT vs 
DVPRS) 
a. Correlate pain score with timing of BG check for POC 
and at time of placement of CGM 
 
i. Inpatient Hyperglycemia Management:  
i. Hyperglycemia management will be directed by the ICU team per 
standard of care 
ii. Standard nutritional guidelines are recommended. Nutritional care 
will be managed at the discretion of the providers 
iii. IV insulin infusion targeting BG 140-180 mg/dL is preferred treatment, 
especially if NPO, on an inconsistent nutritional regimen, 
hemodynamically unstable, or in setting of organ dysfunction 
1. Will use validated protocol with computerized decision 
support tool (Appendix D) 
2. Converting from IV insulin infusion to SC insulin managed as 
described in Appendix D 
iv. SC insulin regimen may be used based on the discretion of the 
treating ICU team, with dosing/agents recommended in Appendices 
A, B, and C 
1. Only recommended for patients on consistent nutritional 
regimen who are hemodynamically stable 
2. Daily insulin dose adjustments to the SC insulin regimen will 
be managed at the discretion of the treating ICU team, 
considering use of correctional insulin and concomitant 
factors (e.g. use of medications which increase blood glucose) 
 
j. Hypoglycemia Management: 
i. Managed per protocol in both groups. 
1. If able to eat/swallow, 15 grams of carbohydrates (glucose 
tablets/glucose gel) PRN 
2. If unable to eat/swallow or developed severe hypoglycemia, ½ 
ampule vs 1 ampule intravenous D50W PRN 

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3. If no intravenous access is available, 1mg glucagon 
subcutaneous PRN 
ii. Additional treatment may be given after 15 minutes if the patient has 
an inadequate response to the glucose correction. 
 
k. CGM Devices:  
i. Two CGM devices will be used in this study, Dexcom G6 and Dexcom 
G6 Pro. Both devices are placed similarly onto patients. Both devices 
can be worn for same timeframe (10 days). Both devices can interact 
with same applications, smartphone, and manufacturer software 
(Dexcom Clarity). Both devices carry same manufacturer instructions 
for placement and use with specific medications and diagnostic 
procedures. Dexcom G6 can only be used in an Unblinded mode 
where CGM values are visible to the patient and clinical care team. 
Dexcom G6 Pro allows for a Blinded mode where CGM values are not 
visible to patients or the clinical care team.  
ii. Dexcom G6 
1. Will be used in the CGM group 
2. Used only in Unblinded mode 
3. Sensor and transmitter are separate components  
iii. Dexcom G6 Pro 
1. Will be used in the POC group  
2. Will be used in Blinded mode  
3. Sensor and transmitter are combination device 
 
l. Blood Glucose Correlation:  
i. CGMs will be calibrated if necessary, per manufacturer instructions 
with POC or venipuncture BG sample 
ii. CGM and POC tests will be correlated with routine venipuncture 
monitoring on at recommended daily interval unless clinical suspicion 
of an inaccurate reading 
 
m. POC Group Procedures: 
i. CGMs will be placed on the abdomen (or other site) per manufacturer 
recommendations and can be at the discretion of placing provider. 
a. Placement at least 3 inches from insulin pump infusion 
or injection site 
b. Placement away from waistband, scarring, tattoos, 
irritation, and bones 
c. Placement in a location unlikely to be bumped, 
pushed, or laid on while sleeping 
d. CGMs will be removed prior to any surgery, computed 
tomography (CT) scan, or magnetic resonance imaging 

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(MRI), or other procedure as necessary per 
manufacturer instructions  
ii. Patients, nurses, and other treatment team will be blinded to the 
CGM readings 
1. All treatment decisions for this group will be based on POC 
readings and venipuncture  
iii. POC BG will be checked per protocol based on treatment received 
1. Every 1-2 hours per protocol if receiving an insulin infusion  
2. At least 3 times per day if receiving a basal:bolus insulin 
regimen 
 
n. CGM Group Procedures: 
i. CGMs will be placed on the abdomen (or other site) per manufacturer 
recommendations and can be at the discretion of placing provider. 
a. Placement at least 3 inches from insulin pump infusion 
or injection site 
b. Placement away from waistband, scarring, tattoos, 
irritation, and bones 
c. Placement in a location unlikely to be bumped, 
pushed, or laid on while sleeping 
2. Remote monitoring software will be set up for nursing staff 
3. All staff will be educated on using the monitoring software 
4. CGMs will be removed prior to any surgery, computed 
tomography (CT) scan, or magnetic resonance imaging (MRI), 
or other procedure as necessary per manufacturer 
instructions  
ii. Nurses and treatment team will NOT be blinded to the CGM readings 
1. All treatment decisions for this group will be based on CGM 
readings, confirmatory POC readings (as necessary), and 
venipuncture  
iii. Nursing staff will obtain a confirmatory POC for hypoglycemia alarms 
and administer appropriate therapy per protocol 
1. If a different reading is recorded, a venipuncture will be 
obtained 
iv. CGMs will record the BG and transmit to a remote device 
1. The duration of CGM use for the study will be limited to 10 
days (or the maximum duration allowable for use as 
recommended by the manufacturer)  
v. CGMs are pre-set with the following alerts: 
1. Low-glucose alerts set to 70 mg/dL 
2. Urgent low alerts set to 55 mg/dL, with urgent low soon alerts 
set if BG is expected to be 55 mg/dL within 20 minutes 
3. High alerts set to 250 mg/dL 

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vi. BG readings less than 40 mg/dL are read on the CGMs as “LOW”. 
While the exact reading will be unable to be determined, the amount 
of time spent in the “LOW” reading will be recorded 
1. When this occurs, a confirmatory POC reading will be 
obtained. If these numbers differ, a venipuncture will be 
collected 
 
o. Data Collection 
i. CGM Sensor Data 
1. Clinical CGM data will be transmitted and evaluated using 
manufacturer software.  
ii. The following will be obtained from the Computerized Patient 
Records System (CPRS): 
1. Demographic Data: age, sex, race, weight, height, 
comorbidities 
2. Admission Data: length of stay, diagnoses, mortality 
3. Clinical Data: vital signs, complete metabolic panel (BMP) and 
other serum electrolytes (magnesium/phosphate), complete 
blood counts, liver function tests, infection/microbiology 
results (gram stains/cultures/sensitivities/PCR or other 
microbiology identification), blood gases, other laboratory 
data need to assess treatment/diagnoses/severity of illness, 
blood glucose levels, antidiabetic treatments (including type 
of insulin and doses administered), other medications 
(including presence of additional medications [e.g. steroids, 
vasopressors, or any other medications that may affect blood 
glucose or the CGMs sensors]), sedation/agitation (e.g. 
Richmond Agitation Sedation Scale) scores, delirium (e.g. 
CAM-ICU) scores, pain (e.g. CPOT, DVPRS) scores, 
diet/nutritional regimen 
iii. Satisfaction survey data: patient satisfaction survey 
iv. Cost Analysis: a comparison will be conducted based on the costs of 
equipment, staff time, and other relevant costs related to glucose 
monitoring in each group  
 
p. Privacy, Security, and Confidentiality:  
i. Investigators will be responsible for maintaining patient privacy and 
confidentiality 
ii. The principal investigator has the responsibility for security of the 
study 
iii. Study data will be entered, managed, and stored securely using VA 
Research Electronic Data Capture (REDCap).  
iv. Study data will be coded then de-identified for data analysis.   
 

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6. Analysis Methods: 
Descriptive statistics and inferential statistical methods will be used as 
appropriate to report findings of this study.  
 
To minimize risk of bias, data collection and analysis will be by performed by 
study team members not involved in the clinical care of the study participants, as 
possible. 
 
7. Possible Discomforts and Risks: 
• Inaccurate measurement of BG which could lead to hypo- and 
hyperglycemia 
• CGMs are minimally invasive but could cause some patients mild physical 
pain or discomfort 
• Apart from the type of monitoring utilized, no further changes to patient 
care will be made. Investigators will not alter medication prescribing to 
deviate from standard of care. As such, no additional discomfort or risk to 
the patient caused by this study is expected.  
 
8. Possible Benefits: 
• Reduction of serious hypoglycemia or other adverse events is the most 
relevant potential benefit of using CGM 
• Decreased point-of-care finger sticks compared to standard care. This 
may lead to benefits such as increased patient comfort and reduced 
costs. 
• Possible benefit of improved glycemic control with the ability to monitor 
glucose levels more carefully and adjust treatment as appropriate; this 
could lead to improved patient outcomes. We hypothesize the use of 
CGM will yield less cases of hypoglycemia and more glucose values at 
goal.  
 
9. Anticipated Costs: 
GGM devices and other necessary equipment will be provided through a 
manufacturer sponsored grant. Administrative and regulatory expenses will be 
covered by a manufacturer sponsored grant. No other costs beyond investigator salary 
and those for routine clinical care are anticipated.    
 
10. Conflicts of Interest: 
None of the investigators hold a patent or license for any material, object, or 
process involved with this research.  None of the investigators own stock in or 
serve as consultants to any company involved in this research. The researchers 
will not receive payment or other financial incentive for conducting this study.  
 
The PI or any of the Sub-investigators have no real or potential conflict of 
interest with regards to this research project. 

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11. References: 
1. Galindo RJ, Rushakoff RJ, et al. Continuous Glucose Monitors and Automated 
Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci 
Technol. 2020 Nov; 14(6):1035-1064. 
2. Spanakis EK. Diabetes and Technology in the Covid-19 Pandemic Crisis. J 
Diabetes Sci Technol. 2021 Mar; 15(2):377-378. 
3. Spanakis EK, Levitt DL, et al. 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. 
4. Fact Sheet for Healthcare Providers: Use of Dexcom Continuous Glucose 
Monitoring Systems During the COVID-19 Pandemic. Dexcom, Inc. 2020 Apr 
1. Accessed 2021 Mar 23. Available from: 
https://www.dexcom.com/hospitalfacts.  
5. Dexcom, Inc. (2020 Dec). Dexcom G6 System User Guide. San Diego, CA. 
Accessed 2021 Mar 22. Available from: https://s3-uswest- 
2.amazonaws.com/dexcompdf/G6-CGM-Users-Guide.  
6. Singh LG, Satyarengga M, et al. Reducing Inpatient Hypoglycemia in the 
General Wards Using Real-time Continuous Glucose Monitoring: The Glucose 
Telemetry System, a Randomized Clinical Trial. Diabetes Care. 2020 Nov; 
43(11):2736-2743. 
7. Jacobi J, Bircher N, et al. Guidelines for the use of an insulin infusion for the 
management of hyperglycemia in critically ill patients. Crit Care Med. 2012 
Dec; 40(12):3251-3276. 
8. Galindo RJ, Migdal AL, et al. Comparison of the Freestyle Libre Pro Flash 
Continuous Glucose Monitoring (CGM) System and Point-of-Care Capillary 
Glucose Testing in Hospitalized Patients with Type 2 Diabetes Treated with 
Basal-Bolus Insulin Regimen. Diabetes Care. 2020 Nov; 43(11):2730-2735. 
9. Boom DT, Sechterberger MK, et al. Insulin treatment guided by subcutaneous 
continuous glucose monitoring compared to frequent point-of-care 
measurement in critically ill patients: a randomized controlled trial. Crit Care. 
2014 Aug 20; 18(4):453. 
10. Leelarathna L, English SW, et al. Feasibility of fully automated closed-loop 
glucose control using continuous subcutaneous glucose measurements in 
critical illness: a randomized controlled trial. Crit Care. 2013 Jul 24; 
17(4):R159. 
11. Holzinger U, Warszawska J, et al. Real-time continuous glucose monitoring in 
critically ill patients: a prospective randomized trial. Diabetes Care. 2010 
Mar; 33(3):467-472. 
12. De Block CEM, Gios J, et al. Randomized evaluation of glycemic control in the 
medical intensive care unit using real-time continuous glucose monitoring 
(REGIMEN Trial). Diabetes Technol Ther. 2015 Dec; 17(12):889-898. 

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13. Kopecky P, Mraz M, et al. The use of continuous glucose monitoring 
combined with computer-based eMPC algorithm for tight glucose control in 
cardiosurgical ICU. Biomed Res Int. 2013 Feb; 2013:186439. 
 
 
 
 
 

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Appendix A. Weight-Based SC Insulin Dosing – PO diet eating full meals 
 
• Age > 70 years, eGFR <60mL/min, underweight, risk for hypoglycemia 
o Total Daily Insulin Dose = 0.2 units/kg 
▪ 0.1 unit/kg/day basal glargine 
▪ 0.03-0.05 units/kg/meal nutritional aspart 
▪ Correctional Aspart AC = Low (1 unit:50 mg/dL BG >150 mg/dL) 
• Normal Body Weight (BMI 18.5-25) 
o Total Daily Insulin Dose = 0.4 units/kg 
▪ 0.2 unit/kg/day basal glargine 
▪ 0.07 units/kg/meal nutritional aspart 
▪ Correctional Aspart AC = Low (1 unit:50 mg/dL BG >150 mg/dL) 
• Overweight or Obese (BMI >25) 
o Total Daily Insulin Dose = 0.5 units/kg 
▪ 0.25 unit/kg/day basal glargine 
▪ 0.08 units/kg/meal nutritional aspart 
▪ Correctional Aspart AC = Medium (2 units:50 mg/dL BG >150 mg/dL) 
 
Additional Considerations:  
• Aspart dose should be given immediately prior to meal. If it is unknown if patient 
will eat, hold aspart prior to meal and give after meal if patient consumes at 
least 50%. Give aspart dose within 15 minutes of first bite.  
• If patient is expected not to eat or consumes less than 50% of meal: nurse to 
notify physician, hold scheduled nutritional aspart dose, continue basal glargine, 
and give aspart correctional sliding scale. 
• Correctional aspart to be given in addition to nutritional aspart dose.  
• If blood glucose is less than 100 mg/dl, nurse to hold nutritional/correctional 
insulin and notify physician. Basal insulin should be continued as prescribed 
unless instructed otherwise by physician orders.  
• If patient has abrupt change in diet (e.g. made NPO for urgent procedure), nurse 
to notify physician. It is recommended to start dextrose containing IV fluids and 
continue basal insulin glargine to prevent rebound hyperglycemia. Insulin 
regimen should be re-evaluated by provider as warranted.  
• Pre-meal blood glucose goal is 100-150 mg/dl. 
 
 
 
 
 

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Appendix B. Weight-Based SC Insulin Dosing –NPO, Liquid Diet Only, or Minimal Diet Intake 
 
• Age > 70 years, eGFR <60mL/min, underweight, risk for hypoglycemia 
o Total Daily Insulin Dose = 0.1 units/kg (100% Basal Glargine) 
▪ Correctional Regular insulin (every 6 hours) or aspart (every 4 hours) = 
Low (1 unit:50 mg/dL BG >150 mg/dL) 
• Normal Body Weight (BMI 18.5-25) 
o Total Daily Insulin Dose = 0.2 units/kg (100% Basal Glargine) 
▪ Correctional Regular insulin (every 6 hours) or aspart (every 4 hours) = 
Low (1 unit:50 mg/dL BG >150 mg/dL) 
• Overweight (BMI 25-30) 
o Total Daily Insulin Dose = 0.25 units/kg (100% Basal Glargine) 
▪ Correctional Regular insulin (every 6 hours) or aspart (every 4 hours) = 
Medium (2 units:50 mg/dL BG >150 mg/dL) 
• Obese (BMI >30) 
o Total Daily Insulin Dose = 0.3 units/kg (100% Basal Glargine) 
▪ Correctional Regular insulin (every 6 hours) or aspart (every 4 hours) = 
Medium (2 units:50 mg/dL BG >150 mg/dL) 
 
Additional Considerations:  
• Dextrose containing maintenance IV fluids are recommended for patients with 
prolonged NPO status receiving scheduled insulin. 
• If blood glucose is less than 100 mg/dl, nurse to hold basal insulin and notify 
physician.  
 
 
 
 
 

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Appendix C. Management of SC Insulin Dosing –Continuous tube feedings or PN 
 
• Age > 70 years, eGFR <60mL/min, underweight, risk for hypoglycemia 
o Total Daily Insulin Dose = 0.2 units/kg 
▪ 0.1 units/kg/day basal glargine 
▪ 0.025 units/kg every 6 hours nutritional regular insulin 
▪ Correctional Regular insulin every 6 hours = Low (1 unit:50 mg/dL BG 
>150 mg/dL) 
• Normal Body Weight (BMI 18.5-25) 
o Total Daily Insulin Dose = 0.4 units/kg 
▪ 0.2 units/kg/day basal glargine 
▪ 0.05 units/kg every 6 hours nutritional regular insulin 
▪ Correctional Regular insulin every 6 hours = Low (1 unit:50 mg/dL BG 
>150 mg/dL) 
• Overweight or Obese (BMI >25) 
o Total Daily Insulin Dose = 0.5 units/kg 
▪ 0.25 units/kg/day basal glargine 
▪ 0.06 units/kg every 6 hours nutritional regular insulin 
▪ Correctional Regular insulin every 6 hours = Medium (2 units:50 mg/dL 
BG >150 mg/dL) 
 
Additional Considerations:  
• If patient is receiving bolus enteral tube feedings, daily nutritional insulin dose 
should be evenly divided and given prior to each feeding. 
• For cyclic enteral tube feeding or parenteral nutrition (e.g. nocturnal only), 
insulin dosing must be individualized and coincide with nutritional regimen.   
• Correctional regular insulin is given in addition to nutritional regular insulin dose.  
• If blood glucose is less than 100 mg/dl, nurse to hold nutritional/basal insulin and 
notify physician.   
• If nutrition is interrupted: nurse to notify physician, start dextrose 5%/0.45% 
NaCl infusion at twice the rate of nutrition order, hold scheduled regular insulin, 
give glargine and correctional regular insulin.   
 
 
 
 
 

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Appendix D. Management of Intravenous Insulin Infusion 
 
Excel tool (pictured below) developed using the algorithm of the paper-based IIP developed by the 
University of Pittsburgh Medical Center (UPMC).  
• Initial IV insulin infusion rate based on initial BG level  
• Adjusted IV insulin infusion rate based on current BG, change in BG from previous, and 
current IV insulin infusion rate 
• Instructions for converting from IV insulin infusion to SC insulin are provided, based on 
the average hourly rate of IV insulin  
 

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IV Insulin Infusion Titration  
 
BG (mg/dL) 
Current rate 0.1-3.9 units/hour 
Current rate 4-6.9 units/hour 
Current rate 7-10 units/hour 
Current rate >10 units/hour* 
<70 
(1) D/C insulin. Give 50mL (1 amp) D50 IV. Recheck BG in 15 min. Repeat as necessary. (Do not restart insulin until at least 1 hr after D50.) Notify MD. If no 
continuous glucose, start IV fluid as per page 1. Restart insulin at 50% (half) previous rate when BG >140 AND it is at least 1 hr after D50. Recheck BG in 1 hr. 
70-99 
(2) D/C insulin. Recheck BG in 1 hr and then hourly. When BG >140, restart insulin but decrease rate by 50% (half) and recheck BG in 1 hr. 
100-139 
(3.1) If BG drop >25 mg/dl from last 
check, D/C insulin. Recheck BG in 1 
hr and then hourly. When BG 
>140, restart insulin but decrease 
rate by 50% (half) and recheck BG in 
1 hr. 
(3.2) Otherwise, decrease by 0.5 
units/hr (if current rate <0.5 units/hr, 
then D/C) and recheck BG in 1 hr. 
(4.1) If BG drop >25 mg/dl from last check, 
D/C insulin. Recheck BG in 1 hr and then 
hourly. When BG >140, restart insulin but 
decrease rate by 2 units/hr and recheck BG 
in 1 hr. 
(4.2) Otherwise, decrease rate by 1 unit 
and recheck BG in 1 hr. 
(5.1) If BG drop >25 mg/dl from last check, 
D/C insulin. Recheck BG in 1 hr and then 
hourly. When BG >140, restart insulin but 
decrease rate by 3 units/hr and recheck BG 
in 1 hr. 
(5.2) Otherwise, decrease rate by 1.5 units 
and recheck BG in 1 hr. 
(6.1) If BG drop >25 mg/dl from last 
check, D/C insulin.   Recheck BG in 
1 hr and then hourly. When BG >140, 
restart insulin but decrease rate by 4 
units/hr and recheck BG in 1 hr. 
(6.2) Otherwise, decrease rate by 2 
units and recheck BG in 1 hr. 
140-180 
(7.1) If BG drop >50 mg/dl from last 
check, D/C insulin. Recheck BG in 1 
hr and then hourly. Restart insulin 
(as long as BG>140), but decrease 
rate by 50% (half) and recheck BG in 
1 hr. 
(7.2) If BG drop 25-50 mg/dl from last 
check, decrease rate by 50% (half) 
and recheck BG in 1 hr. 
(7.3) Otherwise, make no changes. 
If BGs 140-180 for 2 consecutive 
hours, recheck q2h. 
(8.1) If BG drop >50 mg/dl from last check, 
D/C insulin. Recheck BG in 1 hr and then 
hourly. Restart insulin (as long as BG>140), 
but decrease rate by 2 units/hr and recheck 
BG in 1 hr. 
(8.2) If BG drop 25-50 mg/dl from last 
check, decrease by 2 units/hr and recheck 
BG in 1 hr 
(8.3) Otherwise, make no changes. If BGs 
140-180 for 2 consecutive hours, recheck 
q2h. 
(9.1) If BG drop >50 mg/dl from last check, 
D/C insulin. Recheck BG in 1 hr and then 
hourly. Restart insulin (as long as BG>140), 
but decrease rate by 3 units/hr and recheck 
BG in 1 hr. 
(9.2) If BG drop 25-50 mg/dl from last 
check, decrease by 3 units/hr and recheck 
BG in 1 hr 
(9.3) Otherwise, make no changes. If BGs 
140-180 for 2 consecutive hours, recheck 
q2h. 
(10.1) If BG drop >50 mg/dl from last 
check, D/C insulin. Recheck BG in 1 
hr and then hourly. Restart insulin (as 
long as BG>140), but decrease rate 
by 4 units/hr and recheck BG in 1 hr. 
(10.2) If BG drop 25-50 mg/dl from 
last check, decrease by 4 units/hr 
and recheck BG in 1 hr 
(10.3) Otherwise, make no changes. 
If BGs 140-180 for 2 consecutive 
hours, recheck q2h. 
181-250 
(11.1) If BG drop >50 mg/dl, 
decrease rate by 50% (half) and 
recheck BG in 1 hr. 
(11.2) If BG drop 25-50 mg/dl from 
last check, make no change and 
recheck BG in 1 hr 
(11.3) Otherwise, increase rate by 1 
unit/hr and recheck BG in 1 hr. 
(12.1) If BG drop >50 mg/dl, decrease rate 
by 2 units/hr and recheck BG in 1 hr 
(12.2) If BG drop 25-50 mg/dl from last 
check, make no change and recheck BG in 
1 hr 
(12.3) Otherwise, increase rate by 1.5 
units/hr and recheck BG in 1 hr. 
(13.1) If BG drop >50 mg/dl, decrease rate 
by 3 units/hr and recheck BG in 1 hr 
(13.2) If BG drop 25-50 mg/dl from last 
check, make no change and recheck BG in 
1 hr 
(13.3) Otherwise, increase rate by 2 
units/hr and recheck BG in 1 hr. 
(14.1) If BG drop >50 mg/dl, 
decrease rate by 4 units/hr and 
recheck BG in 1 hr 
(14.2) If BG drop 25-50 mg/dl from 
last check, make no change and 
recheck BG in 1 hr 
(14.3) Otherwise, increase rate by 3 
units/hr and recheck BG in 1 hr. 
>250 
(15.1) If BG drop >25 mg/dl from last 
check, make no change and recheck 
BG in 1 hr 
(15.2) Otherwise, give 2 units insulin 
IV push AND increase rate by 1 
unit/hr. Recheck BG in 1 hr.* 
(16.1) If BG drop >25 mg/dl from last check, 
make no change and recheck BG in 1 hr 
(16.2) Otherwise, give 2 units insulin IV 
push AND increase rate by 1.5 units/hr. 
Recheck BG in 1 hr.* 
(17.1) If BG drop >25 mg/dl from last check, 
make no change and recheck BG in 1 hr 
(17.2) Otherwise, give 2 units insulin IV 
push AND increase rate by 2 units/hr. 
Recheck BG in 1 hr.* 
(18.1) If BG drop >25 mg/dl from last 
check, make no change and recheck 
BG in 1 hr 
(18.2) Otherwise, give 2 units insulin 
IV push AND increase rate by 3 
units/hr. Recheck BG in 1 hr.* 
*Notify MD when insulin infusion rate exceeds 10 units/hr or if 4 consecutive BGs are >250 mg/dL. 
 
Reference:  
• 
University of Pittsburgh Medical Center. Regular Insulin IV Infusion Protocol: Goal Blood Glucose 140–180 
mg/dL. (Updated: Nov 30, 2009.) 2009. http://inpatient.aace.com/sites/all/files/UPMC_140-
180_IV_Insulin_Protocol.pdf. 
 
 

Protocol 
Page 18 of 18 
IRB version 03.09.04 
PI version 10/0/2022 
Appendix E. CGM Blood Glucose Target Ranges, defined in CGM interpretation guidelines: 
 
• DM type 1/type 2 
o Time in Range (TIR) 
▪ BG 70-180 mg/dL 
• >70% of readings; >16 h, 48 min per day 
o Time Below Range (TBR) 
▪ BG <70 mg/dL 
• <4% of readings; <1 h per day 
▪ BG <54 mg/dL 
• <1% of readings; <15 min per day 
o Time Above Range (TAR) 
▪ BG >180 mg/dL 
• <25% of readings; <6 h per day 
▪ BG >250 mg/dL 
• <5% of readings; <1 h, 12 min per day 
 
• Older/high-risk DM type 1/type 2 
o Time in Range (TIR)  
▪ BG 70-180 mg/dL 
• >50% of readings; >12 h per day 
o Time Below Range (TBR)  
▪ BG <70 mg/dL 
• <1% of readings; <15 min per day 
o Time Above Range (TAR)  
▪ BG >250 mg/dL 
• <10% of readings; < 2h, 24 min per day