Clinical trial NCT03511521
Conditions: Hyperglycemia Steroid-induced Insulin Resistance, Diabetes
Keywords: steroid prednisone methylprednisolone hyperglycemia insulin hypoglycemia
Sponsor: Northwestern University
Start date: 2018-03-27; Completion date: 2019-08-15
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glucocorticoids are known to cause an increase in insulin resistance, leading to hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and outpatient setting, steroids are used for their anti-inflammatory property to treat a variety of conditions. There is a paucity of information regarding the best way to treat steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin, an intermediate-acting insulin, given at the time of steroid administration to the patient's standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen which will consist primarily increasing the prandial doses at lunch and supper in order to determine which regimen is superior for glycemic control.

Detailed description:
Inpatients who will receive single daily doses of prednisone or methylprednisolone for treatment of their underlying condition and who become hyperglycemic will be eligible. Subjects will be randomized in a 1:1 fashion to one of two arms: (1) to their standard basal bolus insulin the addition of NPH insulin given at the time of the steroid adminstration, adjusting the dose based on the dose of steroid; (2) an increase in the basal and prandial bolus insulin doses based on the dose of steroid. Glycemic control and the incidence of hypoglycemia will be assessed over the first 3 days after initiating these insulin regimens.

Arms: arm 1: NPH will be given at the time of steroid administration to the patient in addition to standard basal/bolus insulin the patient may be receiving in the following doses:

Prednisone Dose (mg/day) - NPH dose (U=Units): 10-20 mg/day - 1.2U (units)/mg; 21-40 mg/day - 0.6U/mg; 41-60 mg/day - 0.45U/mg; 61-80 mg/day - 0.3U/mg; \>80 mg/day - no additional NPH. Note that the amounts of NPH are added to each other for the various prednisone doses. For example, a dose of 75 mg/day of prednisone would come out to be (1.2U x 20mg = 24U) + (0.6U x 20mg = 12U) + (0.45U x 20mg = 9U) + 0.3U x 15 mg = 4.5U) for a total of 24 + 12 + 9 + 4.5 = 49.5U of NPH for 75 mg of prednisone. arm 2: Basal insulin (glargine) and Bolus insulin (insulin aspart) will be increased (doses given in U \[units\]/kg) according to the Prednisone dose (mg/day) as follows:

Prednisone Dose (mg/day) - doses of insulin (U/kg): Prednisone 0 mg - Glargine 0.25U/kg, Bkfst Aspart 0.08U/kg, Lunch Aspart 0.08U/kg, Dinner Aspart - 0.08U/kg; Prednisone 10-20 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.15U/kg, Dinner Aspart - 0.2U/kg; Prednisone 21-40 mg - Glargine 0.25U/kg, Bkfst Aspart 0.1U/kg, Lunch Aspart 0.2U/kg, Dinner Aspart - 0.25U/kg; Prednisone 41-60 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.25U/kg, Dinner Aspart - 0.30U/kg; Prednisone 61-80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.30U/kg, Dinner Aspart - 0.35U/kg; Prednisone \>80 mg - Glargine 0.30U/kg, Bkfst Aspart 0.15U/kg, Lunch Aspart 0.35U/kg, Dinner Aspart - 0.40U/kg.
Interventions: intervention 1: NPH Insulin intervention 2: glargine intervention 3: Insulin Aspart
Intervention descriptions: intervention 1: Intermediate acting insulin intervention 2: basal insulin intervention 3: prandial insulin

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL TITLE:  Use of NPH versus Basal Bolus Insulin for Steroid Induced Hyperglycemia 
 
PRINCIPAL INVESTIGATOR: 
Mark E. Molitch, M.D. 
Division of Endocrinology, Metabolism and Molecular Medicine 
Department of Medicine 
Northwestern University Feinberg School of Medicine 
645 N. Michigan Ave, Suite 530 
Chicago, IL 60611 
(312) 503-4130 
molitch@northwestern.edu 
 
VERSION NUMBER: 
Version Number 1 
VERSION DATE: 
2/19/2018 
 
Co-Principal Investigator 
Amisha Wallia, M.D., Division of Endocrinology, Metabolism and Molecular Medicine 
Fellow Investigator 
Smita Kumar, M.D., Division of Endocrinology, Metabolism and Molecular Medicine 
Co-Investigators: 
Kathleen Schmidt, MSN, APRN,  Glucose Management Service 
Tiffany Grant,  APRN, Glucose Management Service 
Study Site: 
Northwestern Memorial Hospital 
Study identifiers:   
STU00207079, NCT03511521 


OBJECTIVES:   
1.) To determine which insulin regimen, NPH in addition to basal/bolus insulin or just basal/bolus 
insulin, provides better glycemic control in patients on once daily dosing of steroids 
2.) Determine which dosing regimen leads to less adverse events, specifically hypoglycemia 
 
BACKGROUND: 
Glucocorticoids are known to cause an increase in insulin resistance, leading to hyperglycemia, in both 
diabetic and non-diabetic patients. In both the inpatient and outpatient setting, steroids are used for 
their anti-inflammatory property to treat a variety of conditions.  There is a paucity of information 
regarding the best way to treat steroid-induced hyperglycemia.   Generally insulin is administered in the 
hospital using a basal/bolus approach, i.e. giving a long-acting insulin such as glargine to control hepatic 
glucose production overnight and between meals and giving a short-acting insulin as a bolus before 
meals to control the postprandial rise in glucose.  Approaches that have been used to adjust for the 
additional hyperglycemia induced by high dose steroids, which are usually administered once daily in 
the morning, include the addition or substitution of NPH insulin for glargine insulin vs. adjusting the 
basal/bolus regimen. 
In 2008, Bevier et al investigated increasing doses of total daily insulin needed in Type I diabetic patients 
on an insulin pump who were administered a fixed dose of steroids for three days.  The study noted an 
increase in basal rates and insulin boluses required after six hours following the first dose of prednisone 
due to rising insulin resistance.  The study concluded that insulin doses should be increased by at least 
30% when the corticosteroid therapy is started but may need to be increased by up to 70% or more to 
normalize blood glucose levels4.  While it is known that steroids cause an increase in insulin resistance 
and an increased total daily dose of insulin requirements; the best way to administer this insulin is still 
unknown.   
While some studies have looked at using NPH versus glargine as basal insulin for steroid-induced 
hyperglycemia1,2,3, few studies have looked at the addition of NPH to a basal bolus regimen for treating 
steroid-induced hyperglycemia.   
A pilot study done at the University of Colorado looked into the use of NPH plus basal bolus insulin 
versus just basal bolus insulin doses to treat steroid induced hyperglycemia, specifically in cystic fibrosis 
related diabetes patients receiving methylprednisolone.5 Similar to Beiver et al4, they concluded that 
with the addition of steroids, there was an overall increase of total daily doses of insulin by 40%; half of 
the arm received this increase in the form of NPH in addition to glargine and lispro while half of them 
received this in the form of an increase in the glargine and lispro doses. The study showed that 
methylprednisolone raised prelunch and predinner glucose levels in patients treated with glargine/lispro 
alone; however, the addition of NPH with methylprednisolone significantly decreased the rise in 
postprandial glucose at lunch and dinner compared to the glargine/lispro group but still did not return 
the glucose levels to acceptable levels.5   
Our study aims to further study the use of NPH in addition to glargine and lispro in the setting of steroid 
use to achieve improved glycemic control in the inpatient setting.  
 
References: 


 
1. Dhital SM, SHenker Y, Meredith M, Davis DB. A retrospective study comparing neutral 
protamine Hagedorn insulin with glargine as basal therapy in prednisone-associated diabetes 
mellitus in hospitalized patients. Endocrine Pract 2012;18: 712–719. 
 
2. Ruiz de Adana MS, Colomo N, Maldonado-Araque C,et al. Randomized clinical trial of the 
efficacy and safety of insulin glargine vs. NPH insulin as basal insulin for the treatment of 
glucocorticoid induced hyperglycemia using continuous glucose monitoring in hospitalized 
patients with type 2 diabetes and respiratory disease. Diabetes Res Clin Pract. 2015;110:158–
165. 
3. Radhakutty A, Stranks JL, Mangelsdorf BL, et al. Treatment of prednisolone-induced 
hyperglycaemia in hospitalized patients: Insights from a randomized, controlled study. Diabetes, 
Obes Metab 2017;19:571-578. 
4. Bevier WC, Zisser HC, Jovanovic L et al.  Use of continuous glucose monitoring to estimate 
insulin requirements in patients with type 1 diabetes mellitus during a short course of 
prednisone. J Diab Sci Technol 2008;2: 578–583.  
5. Seggelke SA, Gibbs J, Draznin B.  Pilot study of using neutral protamine Hagedorn insulin to 
counteract the effect of methylprednisolone in hospitalized patients with diabetes. J. Hosp. 
Med., 2017;6:175–176.  
 
 
INCLUSION AND EXCLUSION CRITERIA: 
Inclusion Criteria: 
 
Patient’s receiving once daily dosing of methylprednisolone in a dose of 10 mg/day or  
greater or prednisone in a dose of  12 mg/day or greater 
 
Hyperglycemic (Glucose > 126 mg/dL) diabetic and non-diabetic patients 
 
Age Range: > age 18 
 
Expected duration of hospital stay and time on steroids > 3 days 
 
Patient or appropriate caregiver able to give Informed Consent 
 
Exclusion Criteria:   
 
Patient’s with two or more doses of methylprednisolone/prednisone per day or other 
steroids, such as hydrocortisone or dexamethasone 
 
Pregnancy 
 
eGFR < 45 ml/min/1.73m2 
 
 
 


STUDY TIMELINES: 
Once a participant is recruited for the study, participants will be followed for three days with the 
intervention on the inpatient service.  Anticipated duration of enrollment will be 2 years.   
STUDY ENDPOINTS: 
Primary endpoint:  Determine which of these regimens is superior with respect to glycemic control in 
these two groups.   
Secondary Endpoints:  A secondary outcome will be to determine which of these regimens will result in 
less hypoglycemia.   
 
PROCEDURES INVOLVED: 
Subjects 
Our study aims to recruit 25 inpatients at Northwestern Memorial Hospital to each study arm. Eligible 
patients will be those who are receiving once daily dosing of prednisone or methylprednisolone for any 
medical condition.  Examples include patients being treated with steroids for respiratory issues, stem 
cell transplant patients, and cystic fibrosis related diabetes patients.  This will be a prospective, 
randomized control study in which each patient will be randomized to one of two arms.  Consent will be 
obtained at the initial day of an Endocrine or Glucose Management Service (GMS) inpatient consult, and 
then subsequently randomized.   
Study Intervention 
One group will receive NPH in addition to their current glargine lispro basal/bolus regimen at the time of 
the prednisone administration.  Another group will continue to receive glargine and lispro; however, 
their basal and bolus regimens will be increased (see attached tables for details).    
 
DATA AND SPECIMEN BANKING: 
Data will be stored both in a locked cabinet and password protected computer and deidentified data will 
be stored on endocrine FSM research server (R Drive) where only study personnel will have access. 
Only the investigators in the study will have access to the data. 
Data will be stored until final analyses and all publications have been completed and will then be 
destroyed by erasing any stored files on the computer and any printed out data. 
There will be no specimen banking. 
 
DATA AND SPECIMEN MANAGEMENT: 
An analysis of the routine finger stick capillary blood glucose levels will be done (see below).  No extra 
fingersticks will be carried out just for the study.  Glycemic control will be assessed by measuring the 
mean of the 4 glucose levels (premeal and bedtime) for the first 3 days of treatment and comparing 
these means between the groups.    A secondary analysis will be to compare the proportions of values in 


the therapeutic targets of 80 – 140 mg/dL and 80 – 180 mg/dL.  An additional analysis will compare the 
proportion of values < 70 mg/dL, the threshold value for hypoglycemia. 
In the study by Seggelke et al (5), the 3 day means of 3 daily premeal glucose levels for the two groups 
(basal/bolus alone vs. basal/bolus + NPH) were 241 and 176 mg/dL (a difference of 65 mg/dL) with 
standard deviations of 36 and 28 mg/dL for the two groups.   If we assume that our modified basal/bolus 
regimen gives improved glycemic results comparable to theirs, we have assumed the following for our 
statistical power calculations:  a standard deviation of 30 mg/dL and assume half the difference in the 
means of about 30 mg/dL, which can be considered to be clinically significant, then a sample size of 20 
in each group would have statistical (two-tailed) power of 0.869 to demonstrate this difference between 
the groups of 30 mg/dL using an alpha=0.05.  We plan to recruit 25 in each group to allow for drop-outs, 
because some patients may not stay on methylprednisolone/prednisone for 3 days. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS: 
There is always a risk of both hyperglycemia and hypoglycemia when managing hyperglycemic patients 
with insulin and it is not known which of our two approaches will be better with respect to reducing 
hyperglycemia and hypoglycemia.   Each patient will have a routine consultation by the Endocrinology 
Consult Service (ECS) or the Glucose Management Service (GMS) and will have blood glucose levels 
monitored at least daily by those services.  If glucose levels are outside the target range of 80 – 180 
mg/dL, insulin doses will be adjusted accordingly by those services.  Cumulative data, including the 
frequency of hypoglycemia, will be reviewed by the Principal, Co-Principal and Fellow Investigators after 
the first 3 patients are entered into each group and then after every 5 patients in each group to 
determine if the basic algorithms (see Table) need to be adjusted.   
WITHDRAWAL OF PARTICIPANTS: 
Participants with be withdrawn from the study if their steroid regimen changes or stops from once a day 
dosing of methylprednisolone or prednisone.   
RISKS TO PARTICIPANTS: 
Risks: A confidentiality breach is a risk associated with data review research.   As noted above, both 
hyperglycemia and hypoglycemia are inherent risks with inpatient glycemic management with insulin.  
Every effort will be made to reduce these by at least daily review of blood glucose levels on every 
participant with adjustments of insulin doses as needed.   
There are no dangers to an embryo/fetus from insulin but we plan to exclude women known to be 
pregnant.  Because there are no known dangers from insulin, we do not plan to do pregnancy tests, 
however. 
POTENTIAL BENEFITS TO PARTICIPANTS: 
Benefits: The participants are not likely to receive any benefit from the proposed research; however, 
society and investigators will benefit from the knowledge gained.   As with all patients seen by the ECS 
and the GMS, patients will benefit from having their glucose levels monitored closely with frequent 
insulin adjustments made as needed. 


 
VULNERABLE POPULATIONS: 
No vulnerable populations will be included in this study 
COMMUNITY-BASED PARTICIPATORY RESEARCH: 
N/A 
SHARING OF RESULTS WITH PARTICIPANTS: 
Results of the study will not be directly shared with the participants. 
 
SETTING: 
All of the research including recruitment of patients and analyzing the data will take place at 
Northwestern Memorial Hospital  
 
RESOURCES AVAILABLE: 
The PI, Co-PI, ECS and GMS have extensive experience in managing blood glucose levels in 
inpatients at NMH and have published extensively on our experience. 
 
Based on our previous experience, we anticipate that 2 –4 patients per week seen routinely by 
the ECS and GMS would be appropriate for this study and expect that at least 50% of patients 
will agree to participate.   
 
The PI and Co-PI plan to devote about 5% of our time to supervising this research and the Fellow 
Investigator plans to devote 50% of her time to carrying out this research. 
 
All patients will be seen at Northwestern Memorial Hospital.  No special facilities are needed.  
Data analysis will be carried out using the computers and software available to the PI and Co-PI. 
 
All participants will be followed individually by the Endocrinology Consult Service and Glucose 
Management Service and often will be seen by the hospital Diabetes Educator.  These will 
provide additional medical and psychological support in addition to the Investigators in this 
study. 
 
All members of the ECS and GMS will be informed about the nature of the study and instructed 
in how the study will be carried out.  The Fellow-Investigator will liason directly with them each 
day on all participants in the study.  
 
PRIOR APPROVALS: 
N/A 
 
 
 


RECRUITMENT METHODS: 
 
We will use patients primarily seen on the Endocrine Consult Service as well as the Glucose 
Management Service (GMS) who are on once daily dosing of prednisone or 
methylprednisone 
 
Consent will be obtained at the initial day of Endocrine or GMS inpatient consult, and then 
subsequently randomized.   
 
One group will receive NPH in addition to their current glargine lispro basal/bolus regimen 
with the addition of steroids.  (See Table) 
 
Another group will continue to receive glargine and lispro; however, their basal and bolus 
regimens will be increased. (see Table)   
NUMBER OF LOCAL PARTICIPANTS: 
Proposed sample size : Our study aims to recruit 25 inpatients at Northwestern Memorial Hospital to 
each study arm for a total of 50 patients in the study. 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS: 
All glucose and demographic information will be stored on anonymized confidential files stored in 
firewalled FSM computers.  A separate file will be kept with a patient number and any identifiable 
information and stored in the firewalled FSM computers. 
Participants will be followed daily by the ECS or the GMS as well as the Fellow Investigator who will be 
able to address all questions and concerns, 
The Research Staff will create a dataset in the Enterprise Data Warehouse so as to obtain access to any 
stored data on participants. 
 
COMPENSATION FOR RESEARCH-RELATED INJURY: 
N/A 
 
ECONOMIC BURDEN TO PARTICIPANTS: 
NONE 
 
CONSENT PROCESS: 
Consent will be obtained at the initial consult while the patient in inpatient at Northwestern Memorial 
Hospital.  Consent with be obtain by the team members of the GMS or Endocrine Fellows on the ECS. 
Adults Unable to Consent/ Cognitively Impaired Adults 
Because the goal here is to improve glycemic control with less hyperglycemia and less hypoglycemia 
than standard methods, it seems reasonable to include adults who are cognitively impaired or who are 
unable to consent and who have appropriate individuals who can give appropriate assent.  Such 


appropriate individuals, in order of priority, would be those with durable power of attorney for health 
care, court appointed guardian for health care decisions, spouse, and adult child.  Such assent will be 
documented on the Consent Form. 
 
PROCESS TO DOCUMENT CONSENT IN WRITING: 
Participants will be consented at the initial day of consult.  A written document will be provided for 
signature.  (see attached) 
 
 
 
 
 
 
 
 
 


Table 1.  Continue Standard Basal/Bolus Insulin* and add NPH in units adjusted for Prednisone doses 
according to the following table: 
 
Prednisone Added 
(mg/day) 
NPH Dose (U/mg 
Prednisone/day 
Amount of total NPH 
added at top of range 
Added total NPH 
Insulin (U/kg) for 70 kg 
person 
> 80 
No additional NPH 
51 
0.73 
61 – 80 
0.3 
51 
0.73 
41-60 
0.45 
45 
0.64 
21-40 
0.6 
36 
0.51 
10-20 
1.2 
24 
0.34 
 
*Standard Basal/Bolus Insulin will be considered either a weight based dose (total daily dose of insulin 
0.5 U/kg) or patient’s home doses of insulin without adjustment 
 
 
Table 2.  Basal/Bolus Insulin adjusted for Prednisone doses according to the following table: 
 
Prednisone 
Added 
(mg/day) 
Glargine Dose 
(U/kg) 
Breakfast 
Novolog Dose 
(U/kg) 
Lunch  
Novolog Dose 
(U/kg) 
Dinner 
Novolog Dose 
(U/kg) 
>80 
0.30 
0.15 
0.35 
0.40 
61-80 
0.30 
0.15 
0.3 
0.35 
41-60 
0.30 
0.15 
0.25 
0.30 
21-40 
0.25 
0.1 
0.2 
0.25 
10-20 
0.25 
0.1 
0.15 
0.2 
0* 
0.25 
0.08 
0.08 
0.08 
*standard weight based dose of  0.5 U/kg divided 50/50 into basal (glargine) and prandial insulin divided 
into 3 premeal doses 
 
Note:  Prednisone and IV methylprednisolone will be judged to be equivalent with respect to addition of 
insulin doses according to above tables. 
 

ICF_001.pdf: 
IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
Version 1 3/6/2018 
Page 1 of 8 
HRP-592 / v122017 
Title of Research Study: Use of NPH versus Basal Bolus Insulin for Steroid 
Induced Hyperglycemia 
Investigator:  
Mark E. Molitch, M.D. 
Division of Endocrinology, Metabolism and Molecular Medicine 
Supported By: This research is supported by Northwestern University 
Why am I being asked to take part in this research study? 
We are asking you to take part in this research study because you are currently receiving 
steroids as a part of your care here at the hospital.  We would like to investigate the best way to 
control your blood sugar while on these steroids.  
Key Information:  
The first few pages of this document include a summary of this study to help you 
decide whether or not to participate. Detailed information is provided after the 
summary. 
  
What should I know about a research study? 
• 
Someone will explain this research study to you. 
• 
Whether or not you take part is up to you. 
• 
You can choose not to take part. 
• 
You can agree to take part and later change your mind. 
• 
Your decision will not be held against you. 
• 
You can ask all the questions you want before you decide. 
Why is this research being done?   
The goal of the study is to see which method of giving insulin will provide the best control of your 
blood sugar while you are receiving steroids for other medical conditions.  There is no standard 
way to control blood sugars while on steroids, and we would like to find out if any method 
provides better control.   
How long will the research last and what will I need to do? 
We expect that you will be followed in this research study for three days during your hospital 
stay.  However, we will continue to collect and analyze data over a two year time period. 
There is nothing that you need to do during this time.  The nurses will continue to give you the 
insulin and measure your blood sugar during your hospital stay. 


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
Version 1 3/6/2018 
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HRP-592 / v122017 
More detailed information about the study procedures can be found under the section What 
happens if I say “Yes, I want to be in this research”? 
Is there any way being in this study could be bad for me? 
There is always a risk of both hyperglycemia (high blood sugar levels) and hypoglycemia (low 
blood sugar levels) when managing hyperglycemia patients with insulin.  However, we monitor 
your blood sugars very closely while in the hospital and will adjust the insulin as needed on a 
daily basis to minimize any risk. 
More detailed information about the risks of this study can be found under “Is there any way 
being in this study could be bad for me? (Detailed Risks)” 
Will being in this study help me any way? 
You will benefit from having your glucose levels monitored closely with frequent insulin 
adjustments made as needed by our Endocrine Consult Service or our Glucose Management 
Service. 
What happens if I do not want to be in this research? 
Participation in research is completely voluntary. You decide whether or not to participate. If you 
choose to not participate, there will be no penalty to you or loss of benefit to which you are 
entitled.   
Your alternative to participating in this research study is to not participate. 
Detailed Information: 
The rest of this document includes detailed information about this study (in addition to the 
information listed above). 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to Dr.  
Mark Molitch at  
Northwestern University Feinberg School of Medicine 
Division of Endocrinology, Metabolism, and Molecular Medicine 
645 N Michigan Ave 
Suite 530 
Chicago, IL, 60611 
312-695-7970 


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
Version 1 3/6/2018 
Page 3 of 8 
HRP-592 / v122017 
This research has been reviewed and approved by an Institutional Review Board (IRB). You 
may talk to them at (312) 503-9338 or irb@northwestern.edu if: 
• 
Your questions, concerns, or complaints are not being answered by the research 
team.  
You cannot reach the research team. 
• 
You want to talk to someone besides the research team. 
• 
You have questions about your rights as a research participant. 
• 
You want to get information or provide input about this research. 
How many people will be studied? 
We expect about 50 people will be in this research study. 
What happens if I say “Yes, I want to be in this research”? 
You will be randomized to one of two research arms.  You either may receive a type of insulin 
known as NPH along with your dose of steroids in addition to the standard Lantus and Lispro 
insulins you usually get or you will receive insulin in the form of Lantus and Lispro in increased 
doses to help control your blood sugars.  Your sugars will be tested 4 times a day, which is 
routine regardless of whether you are in the study or not.  You will be followed by the Endocrine 
Consult Service or Glucose Management Service who will adjust your insulin doses according 
to your blood sugars.  We will collect data from the chart for three days while you are in the 
hospital and receiving steroids. All of the research will take place while you are here at 
Northwestern Memorial Hospital.  You will interact with the members of our team including 
nurse practitioners, the attending physician, and the endocrine fellows. 
The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study 
doctor will choose what treatment you get. You will have an equal chance of being given either 
treatment. 
What are my responsibilities if I take part in this research? 
If you take part in this research, you do not have any responsibilities.  We will manage your 
sugars and check your blood sugars as we normally would while you are in the hospital 
What happens if I say “Yes”, but I change my mind later? 
You can leave the research at any time; it will not be held against you. 
Choosing not to be in this study or to stop being in this study will not result in any penalty to you 
or loss of benefit to which you are entitled.  Specifically, your choice not to be in this study will 
not negatively affect your right to any present or future medical treatment. 
You will be asked whether the investigator can collect data from your routine medical care.  
If you agree, this data will be handled the same as research data. 
Is there any way being in this study could be bad for me? 
Both hyperglycemia and hypoglycemia are inherent risks with inpatient blood glucose 
management with insulin.  Every effort will be made to reduce these by at least daily review of 


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
Version 1 3/6/2018 
Page 4 of 8 
HRP-592 / v122017 
blood glucose levels on every participant with adjustments of insulin doses as needed.  These 
risks would be there regardless of being in the study as you would be on insulin already as a 
part of your routine care.  
This study involves the use of your identifiable, personal information and there is a chance that 
a loss of confidentiality could occur. The researchers have procedures in place to lessen the 
possibility of this happening.  See the section below titled: “What happens to the information 
collected for the research?”.  
Will it cost me anything to participate in this research study? 
Taking part in this research study will not lead to any costs to you.  
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. 
However, as with all patients seen by our consult services, you will benefit from having your 
glucose levels monitored closely with frequent insulin adjustments made as needed. 
Society and investigators will benefit from the knowledge gained. 
What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including 
research study and medical records, to people who have a need to review this information. We 
cannot promise complete secrecy. Organizations that may inspect and copy your information 
include the IRB and other representatives of this institution.  
An exception to our promise of confidentiality is when we in good faith are permitted by law or 
policy to report evidence of child [or elder] abuse or neglect. 
All glucose and demographic information will be stored on anonymized confidential files stored 
in firewalled Northwestern University computers.  A separate file will be kept with a patient 
number and any identifiable information and stored in these firewalled computers. 
Data Sharing  
De-identified data from this study may be shared with the research community at large to 
advance science and health. We will remove or code any personal information that could 
identify you before files are shared with other researchers to ensure that, by current scientific 
standards and known methods, no one will be able to identify you from the information we 
share. Despite these measures, we cannot guarantee anonymity of your personal data. 
Can I be removed from the research without my OK?   
The person in charge of the research study or the sponsor can remove you from the research 
study without your approval. Possible reasons for removal: If your primary treatment team 
changes your steroid regimen that does not fit within the inclusion criteria for our study, you can 
be removed from the research.   


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
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What else do I need to know? 
If you become ill or get injured as a result of this study (medications, devices or procedures), 
you should seek medical treatment through your doctor or treatment center of choice. You 
should promptly tell the study doctor about any illness or injury.   
The hospital [university, researchers] will not pay for medical care required because of a bad 
outcome resulting from your participation in this research study. This does not keep you from 
seeking to be paid back for care required because of a bad outcome. 
HIPAA Authorization 
We are committed to respect your privacy and to keep your personal information confidential.  
When choosing to take part in this study, you are giving us the permission to use your personal 
health information that includes health information in your medical records and information that 
can identify you. For example, personal health information may include your name, address, 
phone number or social security number. Your health information we may collect and use for 
this research includes:  
• 
All information in a medical record  
• 
Results of physical examinations 
• 
Medical history 
• 
Lab tests, or certain health information indicating or relating to a particular condition 
as well diaries and questionnaires 
• 
Records about study medication or drugs 
• 
Records about study devices 
• 
Billing information 
During this study, you may be coming to a Northwestern Memorial Healthcare Corporation entity 
(for example, Northwestern Memorial Hospital, Prentice Women’s Hospital) for research 
appointments or to get clinical services, such as lab tests, needed for the study.  When that 
happens, you will be scheduled for these services through the NMHC computer system.  When 
a clinical exam or lab is done by NMHC or one of its employees for the purpose of this research 
study, that information will be kept in both NMHC’s clinical records and in the study records. 
The following clinical providers may give the researchers information about you:  all current and 
previous health care providers, including but not limited to the Shirley Ryan AbilityLab 
(SRALAB), Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), and 
Northwestern Lake Forest Hospital (NLFH). 
Once we have the health information listed above, we may share some of this information with 
the following offices or entities outside of Northwestern University and its clinical partners (or 
affiliates):  the Northwestern University Institutional Review Board Office and Office for 
Research Integrity; the US Office of Research Integrity; the US Office for Human Research 
Protections; the US Food and Drug Administration.   
Any research information shared with outside entities will not contain your name, address, 
telephone or social security number or any other personal identifier unless disclosure of the 
identifier is necessary for review by such parties or is required by law or University policy 


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
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[except that such information may be viewed by the Study sponsor and its partners or 
contractors at the Principal Investigator’s office]. 
• 
Authorized members of the Northwestern University  workforce, who may need to 
see your information, such as administrative staff members from the Office for 
Research, Office for Research Integrity and members of the Institutional Review 
Board. 
• 
Clinical affiliates, including but not limited to the Shirley Ryan AbilityLab (SRALAB), 
Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH),  
Northwestern Lake Forest Hospital (NLFH), and the Ann & Robert H. Lurie 
Children’s Hospital of Chicago (Lurie Children’s).  Your participation in this clinical 
trial may be tracked in an electronic database and may be seen by investigators 
running other trials that you are enrolled in and by your healthcare providers.  
• 
Clinical affiliates, including but not limited to Northwestern Medical Group (NMG), 
Northwestern Memorial Hospital (NMH), and Northwestern Lake Forest Hospital 
(NLFH), for purposes including, but not limited to, the affiliate’s provision of care to 
you and/or the affiliate’s scheduling of appointments and/or billing activities. 
• 
Other University research centers and University contractors who are also working 
on the study, 
• 
Study monitors and auditors who make sure that the study is being done properly,  
• 
Government agencies and public health authorities, such as the Food and Drug 
Administration (FDA) and the Department of Health and Human Services (DHHS). 
• 
Registries or other research-related databases: The following registries: Enterprise 
Data Warehouse 
Those persons who get your health information may not be required by Federal privacy laws 
(such as the Privacy Rule) to protect it. Some of those persons may be able to share your 
information with others without your separate permission. 
However, Illinois law does not allow the re-release of HIV/AIDS, genetic testing, mental health 
and developmental disabilities information by the recievers of the information except in precise 
situations allowed by law.  
Also, Federal Confidentiality Rules, 42 CFR Part 2, prohibit making any further disclosure of 
substance use disorder information unless further disclosure of this information is expressly 
permitted by written consent of the person to whom it pertains or as otherwise permitted by 42 
CFR Part 2.  
The results of this study may also be used for teaching, publications, or for presentation at 
scientific meetings.   
Unless you revoke your consent, it will expire at the end of the research study. 
Although you may revoke consent to participation in this research at any time and in any format, 
you must revoke authorization for use or disclosure of your health information in writing. To 
revoke your authorization, write to: 
Mark E. Molitch, M.D. 


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
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Division of Endocrinology, Metabolism and Molecular Medicine 
Department of Medicine 
Northwestern University Feinberg School of Medicine 
645 N. Michigan Ave, Suite 530 
Chicago, IL 60611 
(312) 503-4130 
You do not have to authorize the use or disclosure of your health information; however, you will 
not be allowed to take part in this research study. If you do not authorize the use or disclosure of 
your health information, it will not affect your treatment by health care providers, or the payment 
or enrollment in any health plans, or affect your eligibility for benefits. 
A copy of this signed consent document, information about this study, and the results of any test 
or procedure done may be included in your medical records and may be seen by your insurance 
company. 
Your signature documents your permission to take part in this research.  You will be provided a 
copy of this signed document. 
_______________________________________________      __________________ 
Signature of Participant                                                               Date 
_______________________________________________ 
Printed Name of Participant 
____________________________________________            __________________ 
Signature of Person Obtaining Consent                                     Date 
______________________________________________________ 
Printed Name of Person Obtaining Consent 
For Adult Unable to Consent: 
Your signature documents your permission for the named participant to take part in this 
research. 
_____________________________________________ 
Printed Name of Participant 
_____________________________________________ 
___________________
Signature of Legally Authorized Representative 
Date 
_____________________________________________ 
___________________
Printed Name of Legally Authorized Representative 
Date 
_____________________________________________ 
___________________


IRB #: STU00207079 Approved by NU IRB for use on or after 3/27/2018 through 3/21/2019. 
Permission to Take Part in a Human Research Study 
Do not sign this consent if today’s date is later than the stated expiration date above. 
Version 1 3/6/2018 
Page 8 of 8 
HRP-592 / v122017 
Signature of Person Obtaining Consent 
Date 
_____________________________________________ 
___________________
Printed Name of Person Obtaining Consent 
Date