Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Patient Discharge, Blood Glucose, Low, Blood Glucose, High
Sponsor: Ohio State University

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
Effectiveness of a diabetes focused discharge orderset among poorly controlled hospitalized patients 
transitioning to glargine U300 insulin. 
 
Principal Investigator: Kathleen Dungan, MD, MPH 
Sub-Investigators: David Bradley, MD, Elizabeth Buschur, MD, Vijay Dugirala, MD, Michael Pennell, PhD, 
Kwame Osei MD 
 
Introduction:   
Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with 
diabetes are understudied.1  In particular, patients who are initiating or intensifying insulin therapy have the 
most to benefit in terms of glycemic control.2,3  However, these patients are also particularly vulnerable to poor 
transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, 
differences in patient and provider expectations, and insufficient resources. 4,5,6  Disruption of insulin therapy 
following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and 
medical costs.7  In a recent Society of Hospital Medicine Survey, only one fourth of hospitals were supported 
with written protocols to standardize medication, education, equipment, and follow-up instructions.8  However, 
discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide 
insulin use at hospital discharge.9,10,11,12,13 This study will assess whether a nurse supported diabetes focused 
inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with 
poorly controlled insulin-requiring diabetes.     
Primary Aim:  Evaluate the efficacy of a diabetes focused inpatient discharge order set (DOS) on reducing 
HbA1c at 24 weeks  compared to enhanced standard care (ESC) among hospitalized basal insulin requiring 
patients with uncontrolled diabetes.  
Secondary Aims: 
 
Evaluate the efficacy of a diabetes focused DOS on reducing HbA1c at 12 weeks compared to ESC among 
hospitalized basal insulin requiring patients with uncontrolled diabetes. 
 
Evaluate the efficacy of a diabetes focused inpatient discharge order set (DOS) on change in fasting 
plasma glucose from baseline to 12 and 24 weeks. 
 
Evaluate the efficacy of a diabetes focused inpatient discharge order set (DOS) on % of subjects reaching 
HbA1c <7.0% or <6.5% at 12 and 24 weeks. 
 
Determine whether the DOS in conjunction with nurse supported self-titration of basal insulin glargine U300 
is associated with improved persistence with insulin therapy, adequate dose titration, and use of self-
monitored blood glucose. 
 
Determine whether the DOS is associated with improved discharge instructions and processes of care for 
insulin-requiring patients. This will be measured in terms of clarity of instructions, adequacy and 
completeness of prescriptions for insulin and diabetes supplies, and follow-up plan.   
Study Design: In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 
diabetes and poor glycemic control (HbA1c >8.5%) will receive glargine U300 plus additional background 
therapy (non-insulin and prandial insulin therapies) with or without a diabetes focused discharge order set and 
follow-up communication to facilitate insulin titration and outpatient follow-up.  Patients in the control group will 
receive traditional standard of care with the support of a patient care resource manager.   
Study Population:  Hospitalized patients with type 2 diabetes (HbA1c >8.5%) who are receiving basal insulin 
at least 10 unit per day and are able to provide informed consent will be approached.  Patients must have 
access to some form of communication (phone, electronic patient messaging) post discharge and be willing to 
obtain HbA1c at follow-up. Patients will be identified through daily screening of the inpatient medical and 
surgical services throughout the institution. 
Intervention:  For the DOS group the primary team will be contacted to review the discharge order set, which 
will be pre-populated into the electronic discharge navigator.  Patients in both groups will receive survival skills 
education by a dedicated nurse and study drug throughout the study.  The study nurse will contact the patient 
at 2 weeks and 6 weeks to confirm titration and hospital follow-up in the DOS group, and study coordinator will 
contact patients to obtain data at similar time points in the ESC group. At 12 and 24 weeks, HbA1c is 
measured and the staff will assess outpatient follow-up, hospital readmission or emergency department visit, 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
adherence to insulin and glucose monitoring, hyperglycemic and hypoglycemic events, and perform the DES-
SF in person at CarePoint East or McCampbell Hall.   
Study Drug:  Patients will be provided standard of care insulin therapy including FDA-approved basal insulin  
(TOUJEO® U300, insulin glargine)  plus additional background therapy (non-insulin and prandial insulin 
therapies) based upon discharge team preference.  The starting dose will be determined during hospitalization 
from the dose of glargine/detemir U100 in a 1:1 dose conversion.  Upon discharge, standard titration 
instructions (every 4 days) will be implemented in the DOS group but will be left to the discretion of the 
discharge team in the ESC group. Endpoints: 
Primary:  Change in HbA1c from baseline to 24 weeks (+/-2 weeks) post-discharge 
Secondary: 
 
Change in HbA1c from baseline to 12 weeks (+/-2 weeks) post-discharge 
 
Change in fasting plasma glucose (FPG) from baseline in DOS vs ESC 
 
% of patients achieving HbA1C 7% in DOS vs ESC  
 
% of patients achieving HbA1C 6.5% in DOS vs ESC 
 
% of patients achieving individualized HbA1c target in DOS vs. ESC: HEDIS HbA1c target (<8% if age 
≥ 65 years or known history of ischemic vascular disease, heart failure, advanced kidney disease 
[eGFR <30], dementia, proliferative retinopathy/blindness, advanced neuropathy [history of ulcer or 
amputation] or history of severe hypoglycemia; otherwise goal is <7%)  
 
Proportion of patients with accurate and complete discharge orders for insulin and related supplies. 
 
Adherence to glargine U300 (>80% of doses) at 2, and 24 weeks 
 
Proportion of patients who remain on glargine U300 at 24 weeks 
 
Mean dose of glargine U300 at 2 and 24 weeks 
 
Proportion of patients who follow up with their primary care provider within 2, 6 weeks of discharge 
 
Incidence of documented symptomatic (BG <54 mg/dl) hypoglycemia 
 
Analysis:  Outcomes will be further analyzed by type of diabetes, pre-admission therapy, and bolus insulin 
requirements. 
 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
B. Background 
Long-term glycemic control reduces the frequency of microvascular complications in patients with diabetes,14,15 
but is frequently difficult to achieve.16  Diabetes is associated with intense resource utilization; medical costs 
are estimated at 2.3 times that of a patient without diabetes, and the largest expenditure is inpatient care.17,18 A 
large proportion of hospital costs are accumulated by a small percentage of patients, particularly those with 
chronic medical conditions,19,20 largely due to repeated hospitalizations.21 Prevention of unplanned hospital 
readmission has received attention as a way of reducing hospital costs.22,23,24  Diabetes is present in 25% of 
hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. 25   
Transitions of care among hospitalized insulin requiring subjects  
A report from the Health Care Utilization Project of the Agency for Health Care Research and Quality highlights 
the need for careful monitoring of recently hospitalized patients with diabetes and suggests enhanced 
interventions for vulnerable populations with diabetes.26  While inpatient glycemic control has improved over 
time,27 there is little indication that this translates automatically to better outcomes following discharge. In a 
recent Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols 
to standardize medication, education, equipment, and follow-up instructions.28   
Traditional efforts to improve transitions of care have focused on the primary reasons for hospital admission.29  
Unfortunately, most studies do not target diabetes specifically.   Failure to acknowledge diabetes at discharge 
is associated with increased 30 day readmissions. 30  Although the current recommendation for discontinuation 
of pre-admission diabetes therapies (other than insulin) is sound in principle, 31 it can add to confusion and 
lapses in care of diabetes at discharge.   
Few published data exist for interventions targeting improved discharge care in patients with diabetes. Several 
strategies have demonstrated potential but require larger, more scientifically rigorous studies.32 There is some 
evidence supporting individualized discharge planning for decreasing readmissions in undifferentiated 
hospitalized patients. Successful programs utilize multiple approaches (e.g., a nurse discharge advocate, pre-
arranged follow-up appointments, medication reconciliation, patient education, and primary care provider 
communication).29 A Cochrane Review suggested that nurse or pharmacist follow-up calls alone had favorable 
effects for some outcomes, but did not decrease readmissions.30 However, conclusions were limited due to low 
methodological quality and heterogeneity of studies. In addition, these studies did not target diabetes 
specifically.  
In particular, patients who are initiating or intensifying insulin therapy at discharge have the most to benefit in 
terms of glycemic control.2,3 However, these patients are also particularly vulnerable to poor transitions of care 
for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in 
patient and provider expectations, and insufficient resources.6,33,34  Disruption of insulin therapy following 
hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical 
costs.35   
Role of the Electronic Medical Record (EMR) 
The implementation of comprehensive electronic medical records (EMR) has led to improvement in achieving 
recommended standards of glycemic control and intermediate outcomes in the ambulatory setting. 36,37  In the 
hospital, the EMR has added many benefits including computerized decision support, medication 
reconciliation, and facilitation of communication between providers.  Studies in undifferentiated populations 
have reported that while medication reconciliation using the EMR can reduce medication errors at discharge, 38 
a multifactorial approach that includes the patient, primary care provider and the inpatient team is desirable.39  
In a non-randomized study of 283 patients before and after implementation of a pharmacist and nurse driven 
electronic discharge system featuring systematic medication reconciliation, patients had greater understanding 
of their medications and were more likely to adhere to them following the intervention. 40 
However, diabetes specific discharge order sets have largely been limited to the inpatient setting and have not 
been utilized to guide insulin use at hospital discharge.41,42,43,44,45 EMR systems inadequately support 
complexities in certain prescriptions including insulin therapy, and fail to assure accurate, and reasonable 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
medication reconciliation.46 Insulin, in particular, is not easily ordered using the electronic fields provided for 
other medications, incentivizing prescribers to resort to copying and pasting medical jargon or typing in free 
text, both of which reduce accuracy and clarity, or providing instructions outside of the EMR.  47   
This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can 
improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.   
Insulin Titration in the era of Longer-acting Basal insulins 
Previous studies indicate that patients beginning either basal or prandial insulin achieve the greatest benefit 
from inpatient education following hospital discharge.2,3  These patients often undergo optimization of the 
insulin dose prior to discharge.  Most previous inpatient studies have utilized daily titration algorithms. 48,49  
Insulin stacking has not been a significant concern, since higher treatment targets are generally implemented 
and only small adjustments (10-20%) in the total daily dose are made.  In contrast, daily titration may not be 
appropriate for newer longer-acting insulins, even at higher treatment targets.  For example, glargine U300 
(Toujeo) is a concentrated formulation of glargine with a longer duration of action than glargine U100 (Lantus).  
Therefore, titration is not recommended more frequently than every 3-4 days.  In addition, patients receiving 
glargine U100 in the hospital who are transitioned to glargine U300 at discharge will require approximately 11 -
17.5% more insulin to maintain equivalent glycemic control.50  This is further complicated by changing insulin 
requirements in the setting of resolution of illness and glucotoxicity as well as changes in diet and activity 
following discharge.  As a result, additional titration will be necessary following discharge for many patients.  
Finally, while numerous studies support patient self-titration of insulin, these studies are generally conducted 
among highly motivated ambulatory patients.  It is unclear whether patient self-titration is feasible in recently 
hospitalized patients.   
Glargine U300 (300 units/mL) is 3-fold more concentrated than traditional insulin glargine U100.  It has a 
smaller depot surface area, thereby reducing the rate of absorption.51,52 As a result, glargine U300 provides 
flatter and more prolonged pharmacokinetic and pharmacodynamic profiles compared to standard insulin 
glargine. Its duration of action is ≤36 hours, and its half-life is approximately 23 hours. 
In major clinical trials (EDITION 1, 2 and 3), the efficacy and safety of glargine U300 was compared to insulin 
glargine.53,54,55 These studies included patients not adequately controlled with basal and mealtime insulin, 
patients who had previously received basal insulin in combination with oral antidiabetic drugs, and insulin-
naïve patients. A meta-analysis that pooled data from all 3 studies reported comparable glycemic control with 
both glargine formulations, as well as similar rates of adverse events.56  However, glargine U300 was 
associated with a significantly lower overall risk of hypoglycemia (-14%) over 6 months of treatment, and a 
31% lower rate of nocturnal hypoglycemia. 
C. Approach  
C.1. Investigative Team  
Dr. Dungan and colleagues have been successfully conducting inpatient diabetes research studies for the past 
8 years through collaboration with clinical and research staff at multiple levels, including administration, quality 
improvement, nursing, physician, physician extender, and pharmacy interactions.  
 
C.2. Preliminary Studies 
   
C.2.a. Study 1:  Predictors of Readmission in Patients 
with Poorly Controlled Diabetes  
Among hospitalized patients with an HbA1c >9%, fewer 
patients who were readmitted at 30 days had a diabetes 
education consultation than those with no readmission (32 
vs. 44%, p<0.0001, Table 1).57  This relationship persisted 
(OR 0.68, 95% CI 0.52-0.89, p=0.006) after adjusting for 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
demographics, income, marital status, physician consultation, insurance, length of stay, need for critical care, 
HbA1c, and year of admission. While attenuated, the relationship persisted for 180 day readmissions.  
Readmissions were more common than previously reported (30% at one year vs. 32% at 6 months in this 
study).27 Thus, we have identified a higher risk population than previously recognized.   
 
C.2.b. Study 2:  Hospital Discharge Program for Patients with Poorly Controlled Diabetes  
This pilot program incorporated 
individualized education with phone follow-up 
at one week following discharge and then 
monthly.2 Patient characteristics are 
summarized in Table 2.  HbA1c was reduced 
1.5% overall (p=0.04). Patients with type 1 
diabetes had no change in HbA1c (0%, p= 
0.96), while patients with type 2 diabetes 
experienced a 2.8% mean reduction in 
HbA1c (p<0.0001 within type 2 diabetes, p= 
0.0001 between type 1 and 2 diabetes 
groups). Both patients who were newly 
diagnosed (−4.5 ± 3.8%, p =0.02, n = 7) and 
patients with established diabetes (−1.5 ± 
2.1, P =0.0002, n = 34), had a significant 
HbA1c reduction (p =0.08, between groups). 
In multivariable analysis, independent 
predictors of reduction in HbA1c included 
older age, higher body mass index, shorter 
duration of diabetes, higher baseline HbA1c, 
insulin naïve at admission, and education 
prior to the day of hospital discharge (Table 
3, 4).  In this sample, patients who were 
discharged new to insulin, new to basal 
insulin, or new to bolus insulin had significant 
HbA1c reductions.    
Of this sample, functional health literacy was 
limited (median score 4/5, IQR 3-5), but 
Diabetes Empowerment Scores (DES) were 
relatively high (median 36, IQR 34-38). The 
literacy score predicted patients who were 
ultimately discharged with flexible mealtime 
insulin dosing using carbohydrate counting 
(median literacy score 5 [4-5] vs. 3 [1-4], p 
=0.001) and thus may be an effective screening tool for targeting patients for appropriate modalities and 
intensity of therapy.8   Hospital follow-up was associated with higher income as well as higher DES. In addition, 
earlier education was associated with better HbA1c reduction and patient-follow-up.   
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 3.  Univariable Predictors of Change in HbA1c 
Estimate 
SE 
P value 
Age 
–0.09 
0.03 
0.009 
Male 
-0.19 
0.42 
0.65 
AA 
0.32 
0.46 
0.49 
BMI (kg/m
2) 
–0.093 
0.037 
0.02 
T2DM 
–1.39 
0.43 
0.003 
Duration of DM 
0.10 
0.047 
0.046 
Any insurance 
–0.86 
0.47 
0.07 
Admit severe hyperglycemia 
0.26 
0.44 
0.56 
Phone follow-up 
–0.07 
0.47 
0.89 
Readmission 1 month 
0.91 
0.79 
0.26 
HbA1c baseline 
–0.64 
0.22 
0.006 
Any goal adherence 
0.49 
0.43 
0.26 
DES score 
–0.16 
0.35 
0.65 
Literacy 
–1.46 
0.71 
0.06 
Outpatient diabetes follow-up at 
30 days 
0.25 
0.43 
0.57 
First education day of discharge 
1.04 
0.40 
0.01 
Any Insulin on admission 
0.95 
0.40 
0.02 
Any insulin on discharge 
0.23 
0.56 
0.69 
Discharge basal insulin 
–1.22 
0.61 
0.05 
Discharge bolus insulin 
0.27 
0.56 
0.63 
New to insulin 
–1.51 
0.45 
0.002 
New to bolus insulin 
–0.99 
0.43 
0.03 
Abbreviations: AA, African American; BMI, body mass index; DES, 
Diabetes Empowerment Scale; DM, diabetes mellitus; T2DM, type 2 
DM 
Table 4.  Multivariable Predictors of Change in 
HbA1c 
Model 1 
 Estimate 
SE 
P value 
Original Model 
 
 
 
 
Intercept 
 
25.3 
5.4 
<0.0001 
Age 
 
–0.086 0.028 
0.004 
T2DM 
 
–0.43 
0.35 
0.23 
Log(HbA1c baseline) 
 
–9.82 
2.00 
<0.0001 
New to basal insulin 
 
–1.17 
0.32 
0.0008 
Final Model 
 
 
 
 
Intercept 
 
24.7 
5.3 
<0.0001 
Age 
 
–0.087 0.026 
0.002 
Log(HbA1c baseline) 
 
–9.61 
2.00 
<0.0001 
New to basal insulin 
 
–1.10 
0.32 
0.002 
Model 2 
 Estimate 
SE 
P value 
Final Model 
 
 
 
 
Intercept 
 
22.5 
5.19 
0.0001 
Age 
 
–0.081 0.025 
0.003 
First education day of 
discharge 
 
0.59 
0.29 
0.047 
Log(HbA1c baseline) 
 
–8.86 
1.95 
<.0001 
New to basal insulin 
 
1.03 
0.31 
0.002 
Abbreviations: HbA1c, glycated hemoglobin; T2DM, 
type 2 diabetes mellitus 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
C.2.c. Study 3:  Clarity and effectiveness of EMR based discharge procedures in patients with stress 
hyperglycemia:  role of the diabetes consult service 
 
Patients without prior diagnosis of diabetes 
(HbA1c <6.5% without pre-admission glucose 
lowering therapy) who were discharged on 
any anti-diabetic medication following cardiac 
surgery were identified and individual chart 
reviews were performed.47  Outcomes of 
interest included discharge and follow-up 
medications as well as clarity of discharge 
instructions, stratified by electronic medical 
record (EMR) and diabetes consult service 
(DCS) status.   
 
A total of 125 patients were identified (Table 
5).  Patients had a baseline HbA1c of 5.8 +/- 
0.41% and admission (random) glucose of 
7.6+/-2.3 mmol/L. At discharge, 76, 31, and 
33% of patients received oral agents, bolus 
insulin, or basal insulin respectively.  EMR 
discharge instructions were clear in 67% of 
patients overall, including 83, 54, and 20% of 
patients receiving oral agents, basal insulin 
and bolus insulin respectively. At the 6 week 
post-operative follow-up visit, 44, 9 and 6% 
still had these respective therapies listed.  
DCS involvement was less frequent following 
conversion to an inpatient EMR but was 
associated with better glucose control (similar 
admission glucose but lower peak and a 
trend for higher trough glucose levels).  
Patients with diabetes consults were more 
frequently discharged on oral agents as 
opposed to insulin, and had greater 
frequency of clear discharge instructions 
(Table 5).The most common reason for 
unclear discharge instructions was medical 
jargon prior to the EMR, while it was 
conflicting instructions (either with the consult 
notes or within the prescription itself, typically 
because insulin regimens require “free text” 
rather than direct entry of dosing fields, Figure 1). 
 
Conclusion: The need for glucose lowering therapies at 
discharge may represent prediabetes or unrecognized type 
2 diabetes, but requirements generally decline over time.  
The data illustrate the extent of unclear EMR based 
discharge instructions, particularly for patients requiring 
insulin. A systematic, multidisciplinary team approach may 
improve processes of care at discharge. 
Table 5. Baseline and Hospital Information Stratified by Diabetes Consult 
Service Involvement 
 
Overall 
No 
Diabetes 
Consult 
(N=19) 
Diabetes 
Consult 
(N=106) 
p-Value 
Age (Year)  
61+/-13 
67+/-14 
60+/-12 
0.07 
Male  
93 (74%) 
9 (47%) 
84 (79%) 
0.008 
Race 
   Caucasian 
   African American 
   Other  
 
113 (90%) 
10 (8.0%) 
2 (2%) 
15 (13%) 
3 (30%) 
1 (100%) 
98 (87%) 
7 (70%) 
1 (100%) 
0.07
1 
Chronic kidney disease  
6 (4.8%) 
2 (10.5%) 
4 (3.8%) 
0.23 
Type of Procedure 
   CABG 
   Valve surgery 
   Aortic root/AA Repair 
   Other  
 
69 (55%) 
51 (41%) 
14 (11%) 
19 (15%) 
9 (47%) 
8 (42%) 
3 (16%) 
3 (16%) 
60 (57%) 
43 (41%) 
11 (11%) 
16 (15%) 
0.47 
>0.99 
0.45 
>0.99 
Body Mass Index 
32 +/-9.8 
26+/-6.8 
35+/-9.7 
0.002 
Hemoglobin A1c (%)  
5.8 +/-0.41 
5.7+/-0.56 
5.8+/-0.38 
0.52 
Glucose (mmol/) 
 
 
 
 
   At admission 
7.6+/-2.3 
7.3+/-3.2 
7.6+/-2.2 
0.69 
   Peak 
12.4+/-2.7 
13.9+/-3.2 
12.2+/-2.4 
0.03 
   Trough 
1.6+/-2.8 
4.1+/-0.7 
4.4+/-0.7 
0.06 
   Peak difference 
6.3+/-1.0 
9.9+/-4.4 
7.8+/-2.6 
0.01 
   Discharge morning  
6.3+/-1.0 
6.3+/-0.7 
6.3+/-1.1 
0.60 
Estimated glomerular 
filtration rate
2 
46+/-10 
45+/-15 
48+/-7.0 
0.80 
Length of stay (day)  
10 (8-14) 
14 (11-25) 
9 (7-13) 
0.0002 
Total daily insulin 24 hour 
prior to discharge
3  
 
10 (0-25) 
12.5 (4.5-
23) 
1 (0-26.5) 
0.13 
Discharge to Facility  
37 (30%) 
15 (79%) 
22 (21%) 
<0.0001 
Post-EMR conversion 
37 (30%) 
12 (63%) 
25 (24%) 
0.002 
Post-operative Follow-up 
109 (88%) 
13 (72%) 
96 (91%) 
0.04 
Discharge Instructions 
Clear   
84 (67%) 
7 (37%) 
77 (73%) 
0.004 
Discharge medication 
 
 
 
 
Oral
  
95 (76%) 
6 (32%) 
89 (84%) 
<0.0001 
Any insulin 
62 (50%) 
13 (68%) 
49 (46%) 
0.09 
Bolus insulin  
39 (31%) 
13 (68%) 
26 (25%) 
0.0003 
Basal insulin 
41 (33%) 
1 (5%) 
40 (38%) 
0.006 
Follow-up medication 
 
 
 
 
Oral
  
44 (44%) 
3 (21%) 
41(43%) 
0.15 
Any insulin 
15 (23%) 
5 (36%) 
11 (11%) 
0.03 
Bolus insulin  
10 (9%) 
5 (36%) 
5 (5%) 
0.003 
Basal insulin 
7 (6%) 
0 (0%) 
7 (7%) 
0.59 
Data are reported as mean +/- SD or median (IQR) for continuous variables and 
number (%) for dichotomous variables. 
1Fisher’s exact test used due to 20% of cells 
with expected count less than 5.  
2 Modification of Diet in Renal Disease
 equation. 
 
3Insulin doses were only available following electronic medical record upgrade, N=37. 
EMR=electronic medical record. 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
C.2.d. Application to proposed study: The retrospective data (Study 1) as well as the pilot program (Study 
2) used an intensive yet individualized education approach within an ADA accredited program; however, in 
both cases discharge support was often provided to providers through reminders of the scope of prescriptions 
and supplies needed, direct entry of discharge orders, and facilitation of hospital follow-up. Study 3 illustrates 
how implementation of an EMR does not guarantee better outcomes and in fact may introduce new problems 
that were not previously anticipated.  In particular, the ease of carrying forward prescriptions through the 
medication reconciliation process may actually facilitate suboptimal use of insulin or unclear instructions.  The 
current proposal will address these discharge problems through implementation of an insulin-specific orderset 
within the most commonly utilized EMR nationwide, Epic.   
D. Research Design & Methods 
D.1 Aims 
D.1.a Primary Aim:  Evaluate the efficacy of a diabetes focused inpatient discharge order set (DOS) on 
reducing HbA1c at 24 weeks compared to enhanced standard care (ESC) among hospitalized basal insulin 
requiring patients with uncontrolled diabetes.  
D.1.b.  Secondary Aims: 
 
Evaluate the efficacy of a diabetes focused inpatient discharge order set (DOS) on reducing HbA1c at 12 
24 weeks compared to enhanced standard care (ESC) among hospitalized basal insulin requiring patients 
with uncontrolled diabetes. 
 
Determine whether the DOS in conjunction with nurse supported self-titration of basal insulin glargine U300 
is associated with improved persistence with insulin therapy, adequate dose titration, and use of self-
monitored blood glucose. 
 
Determine whether the DOS is associated with improved discharge instructions and processes of care for 
insulin-requiring patients. This will be measured in terms of clarity of instructions, adequacy and 
completeness of prescriptions for insulin and diabetes supplies, and follow-up plan.   
 
D.2. Research Design 
D.2.a Study Design: In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with 
type 2 diabetes and poor glycemic control (HbA1c >8.5%) will receive standard of care insulin therapy 
including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial 
insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to 
facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 
D.2.b Study Population:  222 
patients (type 2 diabetes) will be 
recruited. Inclusion/exclusion criteria 
appear in Table 6. Hospitalized 
patients with type 2 diabetes 
(HbA1c >8.5%) who are receiving 
basal insulin at least 10 unit per day 
and are able to provide informed 
consent will be approached.  
Patients must have access to some 
form of communication (phone, electronic patient messaging) post discharge and be willing to obtain HbA1c at 
follow-up. Patients will be identified through daily screening of the inpatient medical and surgical services 
throughout the institution. 
D.2.c. Recruitment 
Participants will be identified from the diabetes consult, medicine and surgery ward services at the main OSU 
Hospital System and OSU East hospital. OSU East is a community hospital with a high percentage of indigent 
and minority patients. An efficient system is already in place for screening patients for inpatient diabetes 
studies. Each morning, the research assistant screens services through the electronic medical record, initially 
Table 6: Inclusion and Exclusion Criteria 
Inclusion Criteria 
Exclusion Criteria 
Diagnosis of diabetes, type 2 3 
months duration 
HbA1c >8.5%  
Ages 25-75 years 
Phone or electronic media 
availability 
Receiving basal insulin >10 
unit/day 
Sensitive admissions: Prisoners 
Pregnancy 
Unable to consent or follow  study directions in English 
Expected nursing facility stay longer than 2 w eeks 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
filtering by insulin use and then HbA1c. Permission will be obtained from the attending physician of the 
admitting inpatient service to contact the patient. Current annual inpatient diabetes physician and educator 
consults at OSU main and OSU East are roughly 3000 per year, but there are approximately 13,000 
admissions with a diagnosis code for diabetes each year. Approximately 1000 admissions per year have an 
HbA1c >9%. Diabetes nurse practitioners and certified diabetes educators are available weekdays at both 
sites.  
 
 
D.2.d. Enrollment and Randomization 
Enrollment is expected at a rate of approximately 3 patients per week with the last patient enrolled within 18 
months to allow completion and analysis of all data within 3 years. The study and all study-related documents 
will be approved by the OSU IRB. Written informed consent will be obtained.  Patients will be stratified by pre-
admission insulin therapy (yes/no) and randomized using a random number generator program. 
 
D.2.e. Initial Assessment: Trained interviewers will perform initial data collection.  
 
Contact information, including email address, best times to reach the patient, contact information for 2 
additional individuals, and PCP.  
 
Type of diabetes, duration, complications, reason for hospital admission  
 
Age, gender, race and ethnicity, education level, marital status, work status, home ownership, insurance 
coverage, medical history, concomitant medications, weight, height, BMI, standard of care lab results 
 
Social support is an environmental factor that is associated with readmissions 58, determines behavior in 
SCT and influences self-efficacy.59 It will be measured using the Multidimensional Scale of Perceived 
Social Support (PSSS).60  
 
Health literacy is a determinant of hospital readmissions61 and will be assessed using the Newest Vital 
Sign.62  
 
Diabetes Empowerment Scale Short-Form (DES-SF) measures perceived self-efficacy and predicts 
adherence to a therapeutic plan. The DES-SF63 is has been shown to have acceptable reliability (α=0.84). 
 
Comorbidity is key determinant of readmission; it is measured with the Charlson comorbidity index. 64 
 
It is anticipated that nearly all patients who are hospitalized with an HbA1c >8.5% will go home on insu lin 
therapy. The complexity of the discharge regimen will be assessed as number of injections per day, total 
units per day, and number of glucose checks per day.  
 
D.2.f. Retention 
Staffing will be funded by the study to reach patients after hours. Incentives will be provided for completing the 
follow-up HbA1c at the 12 and 24 week visits. Patients will be contacted at pre-arranged times, with up to 3 
attempts during the week of the encounter. In the event of failure to contact, a letter/email will be sent and staff 
will then reach out to the patient designated secondary contacts. The medical records will be monitored at 
OSU and queries to the patient’s designated primary care physician will be made up to 24 weeks following 
enrollment.  
D.2.g. Program Completion 
Participants will receive an order to complete the HbA1c at 12 and 24 weeks at any OSU lab. A reminder letter 
will be sent 1 week prior to the date and a phone call reminder will occur 2 days before the visit. Study team 
will complete the 12 week and 24 week call and search the electronic medical record and primary provider’s 
chart for HbA1c and healthcare utilization at 12 and 24 weeks. 
E. Study Drug:  Patients in both groups will be provided standard of care insulin therapy throughout the study, 
includinginsulin glargine (TOUJEO® U300) plus additional background therapy (non-insulin and prandial insulin 
therapies), based upon discharge team preference.  The starting dose will be determined during hospitalization 
from the dose of glargine/detemir U100 in a 1:1 dose conversion.  Upon discharge, standard titration 
instructions (every 4 days) will be implemented in the DOS group but will be left to the discretion of the 
discharge team in the ESC group. 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
Table 7.  Intervention procedures 
 
Enhanced Standard Care 
Discharge Order Set 
Diabetes Education 
Basic survival skills 
Basic survival skills 
Discharge orders 
Per primary team:  medication 
reconciliation, prescriptions and 
instructions, follow-up appointments 
Discharge order set in addition to 
primary team 
Patient Care Resource Manager 
Yes 
Yes 
U300 glargine at discharge 
Yes  
Yes 
U300 glargine titration 
Per primary team 
Yes 
Follow-up 
Coordinator call to assess adherence, 
outcomes 
Nurse call to confirm titration 
 
F. Intervention 
F.1 Enhanced Standard Care 
F.1.a. Discharge  
In the enhanced standard care arm, the discharge regimen will be determined by the primary team with input 
from the diabetes service if requested. All patients will receive standard discharge instructions using the 
electronic medical record as per usual practice. Hospital discharge is coordinated by the primary team and 
existing patient care resource manager who arranges follow-up prior to discharge. A discharge summary is 
sent to the primary provider per routine practice.  Patients are instructed to maintain a glucose and insulin 
diary.  Patients will receive survival skills education by a dedicated nurse.  
F.1.b. Follow-up Encounters 
Study staff will conduct phone calls or email communications at 2 and 6 weeks to confirm contact information 
and inquire about discharge follow-up. Patients will be given an appointment day and time prior to discharge 
for the first phone contact at 2 weeks. Any specific medical concerns reported during any call will be forwarded 
to the primary provider.  At 12 and 24 weeks, HbA1c is measured and the staff will assess outpatient follow-up, 
hospital readmission or emergency department visit, adherence to insulin and glucose monitoring, 
hyperglycemic and hypoglycemic events, and perform the DES-SF.   
F.2 Discharge Order Set group 
F.2.a  Discharge 
As with the ESC group, the discharge regimen will be determined by the primary team with assistance from the 
diabetes service if requested.  Hospital discharge is also coordinated by the primary team and existing patient 
care resource manager who arranges follow-up prior to discharge. A discharge summary is sent to the primary 
provider per routine practice. Patients are instructed to maintain a glucose and insulin diary.  Patients will 
receive survival skills education by a dedicated nurse. 
In addition to these elements, for the DOS group the primary team will be contacted to complete the Diabetes 
Discharge order set, which will be pre-populated into the electronic discharge navigator.  The discharge order 
set contains a variety of elements that are intended to ensure a clear/complete communication to the patient 
and outpatient provider (summarized in Table 8, detailed mock-up provided in Appendix 1).  In particular, the 
instructions facilitate identifying an appropriate diet, establishing timely and effective follow-up and ordering 
clear and complete prescriptions.  The standardized instructions provide guidance to the patient for monitoring 
and interpreting glucose levels as well as a basic summary of survival skills. 
 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
Table 8. Diabetes Order Set Summary 
Standard Elements 
Code Status 
Activity 
Wound/Drain//Tube/Catheter Care 
DME Orders 
Diabetes-specific 
elements 
Detail 
Prescriber Guidance 
Diet 
Choice of consistent (defaults to 45 or 60 gram/meal) or flexible 
carbohydrate  
Selection criteria for flexible carb diet. 
Follow -up and 
referrals 
Choice of primary care or endocrinology (call for appointment for 
*** w eeks, appointment has been made for ***) 
Diabetes education (general education or survival skills) 
Only local patients should be referred 
to OSU. 
Patient instructions 
Call provider for hypoglycemia 
Call provider for hyperglycemia 
Bring glucose log to appointment 
Glucose targets 
Home diabetes management attachment 
Identification of glucose targets 
Insulin prescriptions 
Each insulin is presented as a panel, linked to pen needle or 
syringe as appropriate 
Each insulin Rx defaults to 3 pen or 1 vial w ith 1 refill 
Insulins categorized by basal, prandial set meal dose w ith 
correction, or prandial flexible meal dose w ith correction 
Number of units per pen or vial 
Syringe size 
Titration options for basal insulin 
Selection criteria for flexible meal 
dosing 
Correction dosing from pick list of low , 
standard, or high doses 
Glucose Monitoring 
supplies 
Panels categorized by frequency of monitoring 
Each panel contains glucometer, test strips, lancets, alcohol 
w ipes 
Prescriptions default to dispense appropriate number of supplies 
w ith 1 refill 
Guidance on monitoring frequency  
Other DM supplies 
Ketone strips 
Glucagon 
Selection criteria provided for each 
 
F.2.b.  Basal insulin titration 
The patient will receive instructions via the discharge order set and nurse to adjust the U300 basal insulin dose 
2 unit Q4 days for glucose >130 mg/dl, provided no values <80 mg/dl.   
 
F.2.c. Follow-up Encounters 
The study nurse will contact the patient at 2 weeks and 6 weeks to confirm titration and hospital follow-up.  
Patients will be given an appointment day and time prior to discharge for the first phone contact at 2 week. Any 
specific medical concerns reported during any call will be forwarded to the primary provider. At 12 and 24 
weeks, HbA1c is measured and the staff will assess outpatient follow-up, hospital readmission or emergency 
department visit, adherence to insulin and glucose monitoring, hyperglycemic and hypoglycemic events, and 
perform the DES-SF.  Patients are instructed to maintain a glucose and insulin diary. 
G. Procedures  
Major study procedures and visits are summarized in Table 8. 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
H. Data Management and Analysis Plan 
H.1. Data Management  
The database used for this study is 
REDCap, which is a secure web-based 
application for building and managing data. 
It is designed specifically for clinical 
research and administered by the OSU 
Center for Clinical and Translational 
Research. Permission for data access or 
entry will be granted or revoked at a level 
that is appropriate for each individual 
involved in the study. Following verification, 
data will be locked. Data and data labels 
can be downloaded selectively (for interim 
progress reports) or in entirety (end of 
study) directly from REDCap in SAS or 
Excel format. The study team will record 
information from the 2, 6, 12, and 24 
weeks visits (Table 9).  
H.1.a. Missing Data  
All data analyses will be completed as 
intention to treat analyses (i.e., individuals 
analyzed by group according to original 
random assignment, without regard to 
adherence to the intervention). 
Longitudinal outcomes (e.g., HbA1c) will 
be analyzed using mixed models utilizing all available measurements from individuals randomized.  Missing 
binary outcomes (e.g., accurate and complete discharge orders, adherence) and missing covariate data will be 
imputed, using multiple imputation in SAS v9.3 PROC MI. 
 
H.2. Overview of Analytic Plan  
Statistical analyses of these data must not only demonstrate the efficacy of the discharge order set, but also 
estimate effect sizes, examine intervention group differences and identify subgroup differences. Analysis will 
begin with characterization of the sample with descriptive statistics that identify differences between 
intervention and control groups (1) evident at baseline, despite randomization, and (2) between groups due to 
differential attrition. Data will be screened for normality, outliers, and homogeneity. Descriptive statistics will 
summarize the sample characteristics and distribution of each variable. We will test hypotheses for each aim.       
H.2.a. Statistical Power and Sample Size 
The sample size for our study was based on a comparison of change in HbA1c over three months adjusting for 
baseline covariates related to change in HbA1c:  age, whether or not patient is new to insulin, and dose of 
insulin; the first two were selected based on our preliminary data and the latter was selected based on an 
expected relationship.  The following expression, adapted from Oakes and Feldman, 65 was used to calculate 
the number of individuals per group: 
 
𝑛/𝑔𝑟𝑜𝑢𝑝=
4𝜎2(1 −𝜌)(1 −𝑅2)(𝑍1−𝛼/2 + 𝑍1−𝛽)2
∆2
 
Table 9.  Study Procedures and Visits 
 
Visit number 
0 
1 
2 
3 
4 
Time of Visit 
Screen/cons
ent 
2 week 
6 week 12 week 
24 
week 
Type of visit 
In-person 
Phone 
Phone In-person 
In-
person 
Informed consent/contact team 
x 
 
 
 
 
Randomization 
x 
 
 
 
 
Load DOS into EMR and inform 
discharge team 
x 
 
 
 
 
Provide study drug and glucose 
monitoring instructions 
x 
 
 
 
 
Demographics/Socioeconomic 
status 
x 
 
 
 
 
Diabetes history 
x 
 
 
 
 
Hospitalization history 
x 
 
 
 
 
PSS scale 
x 
 
 
 
 
DES-SF 
x 
 
 
x 
x 
Newest Vital Sign 
x 
 
 
 
 
Glucose/insulin diary 
x 
 
 
 
 
Review DOS  
 
x 
 
 
 
Ascertain health care utilization 
 
x 
x 
x 
x 
Review glucose/insulin diary 
 
x 
x 
x 
x 
Hypoglycemia/Hyperglycemia 
 
x 
x 
x 
x 
Review insulin adherence, 
persistence 
 
x 
x 
x 
x 
Nurse counsellor (DOS group only) 
 
x 
x 
x 
x 
HbA1c 
x 
 
 
x 
x 
Fasting blood glucose 
X 
 
 
X 
X 
DOS=discharge order set, EMR=electronic medical record, PSS=Perceived Social Support 
scale, DES-SF=Diabetes empowerment scale-short form, In-Person clinic visits will be 
conducted at either CarPoint East or McCampbell Hall 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
 
where is the standard deviation of HbA1c, is the correlation between baseline and 24 week HbA1c levels, 
R2 is the proportion of variability in change in HbA1c explained by the baseline covariates,  is the difference 
in change in HbA1c between treatment groups, and Z1- and Z1-are standard normal quantiles calculated at 
the two-sided type-I error rate () and power (1-).  Using parameter values based on our preliminary data 
(= 2.2%, = 0.25, R2 = 0. 5) and based on the effect observed by Wexler3 ( = 0.8%), we will need 89 
individuals per treatment group with 24 week follow-up to achieve 80% power at  = 0.05.  Since we expect 
20% attrition, we will recruit 111 individuals per group into our study.  The study is powered to detect a 
difference in the primary endpoint only.  However, additional secondary endpoints of strong interest are pre-
specified and included in the analysis.   
H.2.b. Endpoints 
Primary:  Difference in the change in HbA1c from baseline to 24 weeks (+/-2 weeks) post-discharge (%, 
mmol/l) 
Secondary: 
 
Difference in the change in HbA1c from baseline to 12 weeks (+/-2 weeks) post-discharge (%, mmol/l) 
 
Difference in the change in HbA1c from baseline to 12 and 24 weeks (+/-2 weeks) post-discharge (%, 
mmol/l) 
 
Difference in the change in fasting plasma glucose (FPG) from baseline to 12 and 24 weeks in DOS vs 
ESC (mg/dl) 
 
Difference in the % of patients achieving HbA1C 7% in DOS vs ESC (12, 24 weeks) 
 
Difference in the % of patients achieving HbA1C 6.5% in DOS vs ESC (12, 24 weeks) 
 
Difference in the % of patients achieving individualized HbA1C target in DOS vs ESC (12, 24 weeks) 
 
Difference in the proportion of patients with accurate and complete discharge orders for basal insulin 
and related supplies. (%) 
o Assessed as complete dose, quantity dispensed, adequate refills (separate for basal and prandial 
insulin), and correct prescription for pen needles (presence, quantity, adequate refills), no jargon 
 
Difference in the proportion of patients with accurate and complete discharge orders for prandial insulin 
and related supplies. (%) 
o Assessed as complete dose, clear dosing instructions, quantity dispensed, adequate refills, and 
correct prescription for pen needles (presence, quantity, adequate refills), no jargon 
 
Difference in the proportion of patients with a discharge prescription for glucose monitoring supplies (%) 
 
Difference in adherence to glargine U300 (% taking >80% of doses) at 2, and 24 weeks  
 
Difference in the proportion of patients who remain on glargine U300 at 24 weeks (%) 
 
Difference in the mean dose of glargine U300 at 2 and 24 weeks (units) 
 
Difference in the frequency of glucose monitoring at 2 and 24 weeks (times per day) 
 
Difference in the proportion of patients who follow up with their primary care provider or endocrinologist 
within 2, 6 weeks of discharge (%) 
 
Difference in the incidence of documented symptomatic (BG <54 mg/dl) hypoglycemia (%) 66 
 
H.2.c  Primary Aim:  To determine whether a Discharge order set with nursing support (DOS) is 
associated with lower HbA1c at 24 weeks post-program than enhanced standard care (ESC) alone. We 
will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed 
model for the longitudinal HbA1c measurements.  Our model will contain a random subject-specific effect and 
fixed effects of time (baseline vs. 24 weeks), treatment, a treatment-by-time interaction, and baseline 
covariates related to change, which we expect to include age, whether or not patient is new to insulin, and 
dose of insulin based on our preliminary data.  We will adjust for changes in prandial insulin dose by including 
dose as a time-varying covariate in our mixed models. The inclusion of covariates is not to account for 
differences in these factors across treatment groups (which we don’t expect due to randomization) but to 
increase the precision of our treatment effect estimate.  A Wald test of the treatment-by-time interaction will be 
used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac. 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
H.2.d. Secondary Aims:   
 
Determine whether DOS is associated with lower HbA1c at 12 months compared to ESC.  
 
Determine whether the DOS in conjunction with nurse supported self-titration of basal insulin glargine U300 
is associated with improved persistence with insulin therapy, adequate dose titration, and use of self-
monitored blood glucose. 
 
Determine whether the DOS is associated with improved discharge instructions and processes of care for 
insulin-requiring patients. This will be measured in terms of clarity of instructions, adequacy and 
completeness of prescriptions for insulin and diabetes supplies, and follow-up plan.   
Each of these secondary outcomes will be binary (e.g., adequate vs. inadequate dose titration).  Missing 
values of the outcomes will be imputed using treatment group and baseline covariates.  The difference in 
proportions between treatment groups will be computed for each data set and the results will be combined 
using Rubin’s rules67 to obtain a final two-sample test of proportions.   
I. Potential Limitations & Proposed Solutions 
Limitations of the study relate to the potential loss to follow-up. From our preliminary data, we have determined 
that even the addition of a single specially trained student improved successful telephone contacts 
substantially. Therefore, within the context of a specifically dedicated study staff and the other enhancements, 
it is anticipated that further improvement in successful telephone contacts can be achieved. Furthermore, a 
large percentage of individuals in the pilot studies are followed in the OSU health system, simplifying the 
access to follow-up data at 24 weeks.  Finally, there may be some difficulty discerning whether the discharge 
instruction or the nursing support were the primary determinants of success.  We already know that education 
alone is of limited value for in the management of chronic illness. The purpose of the study is really to serve as 
a model of a comprehensive discharge program with the intent to maximize potential benefits of its individual 
elements.   
J. Work Plan and Timeline 
The overall project is anticipated to last 3 years (Table 10). The first 3 months will involve project start-up 
activities, including development of the REDCap database, regulatory submission, and training study staff.  
Study recruitment and enrollment will commence during the second quarter of the first study year and is 
anticipated to last 18 months to achieve a final enrolled sample of 222 participants. The final visit is expected 
at 6 months post-enrollment. Data gathering activities are scheduled to take 3 additional months. Data 
processing activities will commence at the start of data gathering and continue through the 33 months. The last 
quarter of Study Year 3 will be spent preparing reports and manuscripts.  It is anticipated that at least 2 posters 
and 2 manuscripts will be generated from this work, including the first manuscript demonstrating improved 
processes of care at discharge and the second manuscript demonstrating change in glycemic control, titration 
and persistence of insulin.  
Table 10.  Study Timeline 
Activities 
Year 1 
Year 2 
Year 3 
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 
Start-up procedures 
X 
 
 
 
 
 
 
 
 
 
 
 
Recruit & enroll sample 
  
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Follow-up visits 
  
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
X 
X 
 
Prepare reports & manuscripts 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
 
 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
Summary and Future Directions 
For the hospitalized patient, multiple factors collude to impede successful transitions in care in the current 
fragmented health system. Diabetes provides a suitable framework for chronic disease management in general 
due to its complexity regarding therapies, self-care, and multiple comorbidities. This proposal seeks to redefine 
the role of diabetes management throughout the continuum of care. Future applications would include multi-
center studies and studies to determine the efficacy of the individual components. 
 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
Appendix:  Diabetes Discharge Orderset 
 Drop-down Choices 
Diet—Note:  Most patients will require consistent carbohydrate diet 
 Consistent carbohydrate diet Note: appropriate for 
most patients, including those discharging to skilled 
nursing   
 45 grams per meal 
 60 grams per meal 
 Flexible carbohydrate diet Note: carbohydrate 
counting method, only if patient using prior to 
hospitalization or has demonstrated competency 
 
Follow-up 
 Primary Care Provider  
[see below] 
 Endocrinologist  Note: If patient does not live near 
Columbus, please locate an Endocrinologist nearest 
to their home. The phone number for OSU 
Endocrinology is 614-685-3333 
 Call for an appointment.  You should be seen within 
2 weeks of discharge from the hospital, your 
diabetes medications may need adjustment 
 Call for an appointment.  You should be seen within 
*** weeks 
 You have a follow-up appointment with *** on [date] 
 Diabetes Education  Note: If patient does not live near 
Columbus, please locate a diabetes educator  nearest 
to their home. The phone number for OSU 
Endocrinology is 614-685-3333 
 Survival skills 
 General diabetes education 
 Bring a blood sugar log (record of your glucose 
readings), medications and glucose meter with you. 
 
Notify Physician 
 
 Call your healthcare provider if you are having 
recurrent low sugars (less than 70 mg/dl) more than 2 
days in a row or if you have any severe low sugars 
requiring the assistance of someone else to treat.  
 
 Call your healthcare provider if you have recurrent 
high (above 250 mg/dl) blood sugars for more than 3 
days in a row, or if you have glucose readings over 
250 mg/dl with new symptoms such as nausea, 
vomiting, or dizziness. 
 
Patient Instructions 
 Your target glucose is *** mg/dl fasting and under *** 
mg/dl nonfasting  
<Note: Typical blood sugar goals for many people are 80-
130 mg/dl in the mornings (fasting) and less than 180 
mg/dl throughout the rest of the day> 
 
 Instructions for Managing Your Diabetes at Home 
[Attachment] 
Diabetes Medication and Supply:  Note: U100 Insulin vials contain 1000 units, U100 pens contain 300 unit/pen, 
glargine U300 contains 450 unit/pen, degludec U200 contains 600 unit/pen, lispro U200 contains 600 unit/pen. 
[each prescription option is paired with U100 0.3 or 0.5 ML syringe or pen needles as appropriate] 
 Basal Insulin  
 Glargine U100 Solostar pen and pen needles 
 Glargine U300 Solostar pen and pen needles 
 Detemir U100 Flextouch pen and pen needles 
 Degludec U100 Flextouch pen and pen needles 
 Degludec U200 Flextouch pen and pen needles 
 Glargine U100 vial and syringes  
[Example Drop-down Menu:]  
 Insulin Glargine 300 unit/ml pen 
*** units every day. 
 Increase *** unit every 4 days until AM (fasting) 
glucose is under *** mg/dl, provided that you 
have no glucoses under 80 mg/dl, do not go 
above  *** unit per day. 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
 Detemir U100 vial and syringes 
 NPH U100 vial and syringes 
 [Cardiac surgery patients]: Reduce dose by 2 
unit every day that you wake up with a glucose 
less than 100 mg/dl or if you have any glucose 
levels under 80 mg/dl. 
 No titration 
Dispense: 3 prefilled pens;  Refills: 1 
 Pen needle 31 G x 4 mm 
For use with insulin once daily 
Dispense: 50;  Refills: 1 
 Set Meal Insulin Dose:  appropriate for most patients 
using prandial insulin in addition to consistent 
carbohydrate diet 
 Aspart U100 Flextouch pen and pen needles 
 Glulisine U100 Solostar pen and pen needles 
 Lispro U100 Kwikpen and pen needles 
 Lispro U200 Kwikpen and pen needles 
 Aspart U100 vial and syringes 
 Lispro U100 vial and syringes 
  
[Example Drop-down Menu:] 
 Insulin Glulisine  100 Unit/ML Pen-injector  
*** units SQ QAC. 
 High dose correction 
 Standard correction 
If your glucose 
is this 
Add this much insulin to 
your mealtime dose 
150-199 
200-249 
250-299 
300-349 
350-400 
Over 400 
1 
2 
3 
4 
5 
6 
 Low dose correction 
Dispense: 3 prefilled pens;  Refills: 1 
 Pen needle 31 G x 4 mm 
For use with insulin 4 times daily 
Dispense: 150;  Refills: 1 
 Flexible Meal Insulin Dose:  appropriate ONLY if 
patient using prior to hospitalization, discharging to 
Dodd Hall or demonstrates competency, in addition to 
flexible carb diet 
 Aspart U100 Flextouch pen and pen needles 
 Glulisine U100 Solostar pen and pen needles 
 Lispro U100 Kwikpen and pen needles 
 Lispro U200 Kwikpen and pen needles 
 Aspart U100 vial and syringes 
 Lispro U100 vial and syringes 
 
[Example Drop-down Menu:] 
 Insulin Glulisine  100 Unit/ML Pen-injector  
1 unit for every *** grams of carbohydrate SQ QAC. 
 High dose correction 
 Standard correction 
If your glucose 
is this 
Add this much insulin to 
your mealtime dose 
150-199 
200-249 
250-299 
300-349 
350-400 
Over 400 
1 
2 
3 
4 
5 
6 
 Low dose correction 
Dispense: 3 prefilled pens;  Refills: 1 
 Pen needle 31 G x 4 mm 
For use with insulin 4 times daily 
Dispense: 150;  Refills: 1 
Glucose Monitoring 
 Once per day (non-insulin requiring patients) 
 4 times per day before meals and at bedtime 
 6 times per day (before and 2 hours after meals) 
[Example Drop-down Menu:] 
 Glucose monitor (if patient does not have one at 
home) 
Dispense: 1;  Refills: 0 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
 Glucose test strips 
Testing 4 times per day, ICD-10:  *** 
Dispense 150;  Refills: 1 
 Lancets 
Testing 4 times per day, ICD-10:  *** 
Dispense 150;  Refills: 1 
 Alcohol wipes 
Testing 4 times per day, ICD-10:  *** 
Dispense 150;  Refills: 1 
 Ketostix strips (for Type 1 DM or history of DKA) 
Test urine prn glucose >400 mg/dl or >250 mg/dl with 
nausea, vomiting or other symptoms of DKA 
Dispense 50;  Refills: 0 
 
 Glucagon emergency kit (for Type 1 DM or history of 
severe hypoglycemia or hypoglycemia unawareness) 
1 mg SQ prn severe hypoglycemia 
Dispense 1;  Refills: 0 
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
HUMAN SUBJECTS 
A. Protection of Human Subjects 
A.1  Risk to human subjects 
A.1.a  Human Subjects involvement, characteristics, and design 
This is a randomized controlled trial of the use of a discharge order set (DOS) with post-discharge nursing 
support in hospitalized patients with poorly controlled diabetes. The outcomes include glycemic control 
(HbA1c), persistence of insulin use and adequate dose titration, and discharge processes of care, measured in 
terms of clarity of instructions, adequacy and completeness of prescriptions for insulin and diabetes supplies, 
and follow-up plan. Patients in the standard group will receive basal insulin and otherwise enhanced standard 
care. Patients in the intervention group will undergo utilize a diabetes focused discharge order set and 
instructions for specific dose titration with nurse follow-up contacts at 2 and 6 weeks following discharge. 
Records will be obtained from primary physicians if needed.  Specific medical concerns will be forwarded to the 
primary provider, who will receive a packet at discharge that will assist with transition of the patient’s care to 
the community and updates at 3 months. HbA1c and diabetes empowerment, is checked at baseline and 12 
and 24 weeks for both groups. Outcomes are assessed at 2, 6, 12 and 24 weeks.  
The sample is obtained from two hospitals from a single academic medical center. The main campus hospital 
consists of University hospital, Ross Heart Hospital, James Cancer Hospital, and Brain and Spine hospitals 
and has a referral base from central and southern Ohio as well as a diverse array of medical and surgical 
patients. OSU East is a community hospital that serves a large percentage of local, often indigent patients. A 
total of 222 participants are planned, approximately 80% from the main hospital. Data will be entered into 
REDCap from both sites via an online secure database tool. Completed informed consent and questionnaires 
will be scanned into this system as well. The OSU electronic medical record has the capability of designating 
the patient is enrolled in a research study in order to improve communication between providers and patients.  
Based upon preliminary data, we found that approximately 30% were of African American race. We are 
enrolling a wide age range, 25-75, in order to achieve optimal external validity, but have excluded the younger 
and older participants due to insufficient numbers in those ranges and possibly different educational needs, 
that may involve people (family) other than the patient. Participants are anticipated to be sick and have other 
comorbidities (in our pilot data, 70% were admitted for a problem that was not directly related to diabetes). 
However, all participants will be free-living in the community and have a phone. Due to bias introduced by 
additional support staff at institutions such as nursing homes and rehabilitation centers, these participants will 
be excluded. Participants who are unable to provide consent in English will be excluded as this number is very 
small and will hinder motivational interviewing (MI) process. Other vulnerable populations, such as prisoners 
will be excluded. Pregnant individuals will be excluded since the HbA1c is not as reliable and because such 
individuals have different motivations and follow-up already in place. 
Permission will be obtained from the attending physician of the admitting inpatient service prior to approaching 
participants for enrollment. Randomization will be conducted using a computerized random number generator 
program that is weighted and will be stratified by race.  The frequency of telephone follow-up is felt to be 
adequate to establish reasonable endpoints for reinforcement of behavior and capture a realistic window for 
readmission.  
A.1.b. Sources of Materials 
 
Blood work will be collected for HbA1c at baseline and follow-up.  

IRB Protocol Number: 
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IRB Approval date:  12/02/2017 
Version:  
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 
Data that will be collected for both groups include:  
o Contact information, including email address and best times to reach the patient, contact 
information for two emergency contacts, and contact information of the patient’s primary care 
provider 
o Type of diabetes, complications, duration 
o Education level, marital status, work status, home ownership, medical coverage, and 
demographics 
o Social support, measured using the Multidimensional Scale of Perceived Social Support.  
o Reason for hospital admission, medical history, concomitant medications, weight, height, BMI, 
standard of care lab results 
o Functional health literacy assessment.  
o Diabetes Empowerment Scale Short-Form (DES-SF):  The DES-SF will be obtained at baseline 
and follow-up 
o Charlson comorbidity index 
o Blood Sugar Log 
o Outcomes including readmission or other acute care services, outpatient physician follow-up, 
medication adherence. Records will be requested from outpatient providers as needed. 
 
A.1.c. Potential Risks 
There are no physical risks that would not otherwise be anticipated, as the blood draw for HbA1c is considered 
standard of care. No specific prescriptive regimen for medications is planned and therefore this also represents 
standard of care. Furthermore, we already know that this is a high-risk population. Psychological harm may be 
a possibility if participants neglect other aspects of self-care in favor of diabetes. However, this seems unlikely 
and will be averted with frequent contact and anticipated increased outpatient follow-up. No financial or legal 
consequences are anticipated. Breach of confidentiality is a possibility but with standard procedures for 
immediate entry of paper data into the secure online database, use of a study identification code on all d ata 
gathering instruments, and the use of electronic health records, this should be limited. 
Other forms of contact, such as internet, could be considered but this would not be a viable forum for all 
patients. Therefore, email (in secure mail format) will be reserved for follow-up of specific problems or in the 
event of failure to contact the patient.  
A.2 Adequacy of Protection Against Risks 
A.2.a  Recruitment and Informed Consent 
Potential participants will be identified during their hospitalization through screening inpatient medicine and 
surgery wards. A partial HIPAA waiver will be obtained for this purpose. Permission will be obtained from the 
admitting team’s attending physician or appropriate designee. The patient will be approached in private. 
Personnel (coordinator) will describe the purpose of the study in the same words that are used on the 
consent form, which states lack of participation will not otherwise influence patient care. Participants are 
expected to read the consent form (or have it read to them) in full and be able to explain the study purpose, 
risks, and procedures to the investigator before consent will be considered complete and informed. 
Participants will be encouraged to ask questions and have any questions answered to their satisfaction. 
Participants that seem unsure or want to consider it further will be re-approached with their permission, after 
several hours or the following day or otherwise per the participant’s request. The samples and study-related 
information will not be used if the participant subsequently declines enrollment.  

IRB Protocol Number: 
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IRB Approval date:  12/02/2017 
Version:  
1.0 
 
A.2.b.  Protections against risk 
Participants will be assigned a study number that will be the primary means of identifying patient data. A key 
will be kept on the secure endocrine network drive but this will only be for internal investigator use.  Any 
personal information acquired will be entered into the secure online database (REDCap), which is password 
protected, and allows limited access to varying degrees.  Only immediate study staff (PI, nurse, research 
assistants) will have access to REDCap.  Other personal information (such as signed consent forms) will be 
kept in the office of the PI or the study coordinator and locked when not in use. Personal data that is otherwise 
not recorded into the database will be destroyed immediately through appropriate confidential shredding bins. 
After the program is complete and the data has been analyzed, identifiable/coded(linked) data will be retained 
and stored confidentially for the minimum required amount of time.  Personally identifiable past medical history 
and study data (glucose, laboratory assessments) will be obtained from EPIC/IHIS, REDCap and the chart 
reviews. No highly sensitive information (mental illness, HIV status, social security number) will be collected 
and vulnerable populations such as prisoners will not be enrolled.  
During phone call follow-ups, diabetes-specific events will be referred to the participant’s primary provider with 
use of the study nurse or PI as back-up for urgent matters only. Study-related adverse events will be recorded 
and severe adverse events will be reported to the study PI and the institutional review board. Any severe 
adverse events felt to be related to the study will be reported immediately to the PI and IRB. Participants may 
leave the study for any reason and are assured that this will not otherwise affect their care. Thus, informed 
consent is treated as a continual process.  
A.3. Potential Benefits of the Proposed Research to Human Subjects and Others 
Participants may benefit from more intensive interaction with study staff, through improved glycemic control as 
well as close follow-up and anticipatory guidance. Benefits to society include improved glycemic control and 
hospital readmission, which may result in reduced medical costs, particularly among uninsured individuals. The 
risks are primarily related to breach of confidentiality and are limited, though still possible. Given the 
safeguards that are put in place, the potential benefits should outweigh the risks. 
A.4.  Importance of the Knowledge to be Gained 
The importance of the knowledge is in the understanding of the role of diabetes, in particular diabetes 
education and PN, on the discharge process. Currently, diabetes is overlooked in the hospital and at 
discharge, despite its importance for the overall well-being of the patient. The current protocol provides an 
easily adaptable hierarchical process for inpatient to outpatient transitions in care for a population of 
complicated medical patients. Currently, few randomized studies have examined whether telephone follow-up 
or post-discharge support is effective in this population. The rising epidemic of diabetes will continue to 
contribute significantly to the morbidity of these patients, frequently necessitating hospital care. Providing 
solutions to this problem is of considerable urgency.  Therefore, the potential benefits outweigh the given the 
aforementioned risks.  
A.5.  Data and Safety Monitoring Plan  
The Data and Safety Monitoring Plan is written to ensure the safety of the participants and to verify th e validity 
and integrity of the data. 
1. Study risk assessment:  

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
 Exempt  (protocols exempt from IRB review are not required to submit a DSMP) 
 Level I risk (identify all applicable study procedures) 
 Anthropometric evaluations 
 DEXA scans 
 Electrocardiograms (ECG) 
 Exercise testing 
 Intravenous glucose tolerance tests 
(IVGTT) 
 Intravenous catheter insertion 
 Computerized Axial Tomography (CAT) 
or Magnetic Resonance Imaging (MRI)  
 Observational/Behavioral studies 
 Oral glucose tolerance tests (OGTT) 
 Pathology slide review 
 Special or prescribed diets/Nutritional 
studies  
 Venipuncture 
 Other low risk non-therapeutic tests or studies (list):       
 
 Level II risk (identify all applicable study procedures) 
 Child population  
 Normal volunteers using well-described research 
procedures 
 Endoscopy 
 Vulnerable population(s), e.g.  minorities, indigent, MRDD, 
prisoners, military personnel, individuals with diminished 
capacity for decision-making and/or limited literacy skills 
(e.g. <8th grade reading level) 
 Elderly population 
 Pharmaceutical agent(s) under study/Phase IV (post-
marketing) studies 
 Insulin clamp  
 Pregnant population 
 Muscle biopsy 
 Psych. or neuro. impaired population 
 Research-associated procedures (please specify):       
Other moderate risk non-therapeutic tests or studies (please specify):       
The risks for the actual study procedures are considered low as the intervention is limited to behavioral 
strategy with a blood draw that is otherwise considered to be standard of care. Study-related adverse events, 
enrollment compliance, proper informed consent, data analysis, confidentiality will be reviewed annually by the 
study PI and independent safety advocate (Carson Reider, PhD). 
2. Plan for reporting adverse events and unanticipated problems:  
Adverse event and unanticipated problem reporting will comply with University, as well as Federal guidelines, 
as appropriate. All adverse events and unanticipated problems will be reported to the IRB, and to the funding 
agency as well as other entities, as required. Such events or problems requiring reporting include those that 
may involve physical, psychological, social, legal and/or economic harms to the participants. Adverse events 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
will include severe hypoglycemia rates (defined as hypoglycemia associated with seizure or hemodynamic 
compromise in need of outside assistance), pregnancy, overdose, and breach of confidentiality.   In addition 
the following definitions apply: 
DEFINITIONS 
Serious adverse event (SAE): any untoward medical occurrence that at any dose:  
 
Results in death, 
 
Is life threatening, (Note: the term “life-threatening” refers to an event/reaction in which the patient was 
at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically 
might have caused death if it were more severe), 
 
Requires inpatient hospitalization or results in prolongation of existing hospitalization, 
 
Results in persistent or significant disability/incapacity, 
 
Is a congenital anomaly/birth defect, or 
 
Is a medically important event or reaction. Medical and scientific judgment should be exercised in 
deciding whether other situations should be considered serious, such as important medical events that 
might not be immediately life-threatening or result in death or hospitalization, but might jeopardize the 
patient or might require intervention to prevent one of the other outcomes listed in the definition above.  
 
Related Adverse Event, i.e. Adverse Drug Reaction (ADR): There is a reasonable possibility according to the 
investigator that the product may have caused the event. 
 
Unexpected Adverse Event, i.e. Adverse Drug Reaction (ADR): An adverse reaction, the nature or severity of 
which is not consistent with the applicable product information (package insert/summary of product 
characteristics for an approved product). An expected ADR with a fatal outcome should be considered 
unexpected. 
 
New safety finding: Any safety issue that may require expedited reporting because providing information that 
may lead to a change in the known risk-benefit balance for the  product and as mentioned, but not limited to, in 
the following regulatory texts: US: FDA: 21 CFR Parts 312 Investigational New Drug Application- Section 312.32, 
(c) (1) IND safety reports. 
 
REPORTING ADVERSE EVENTS 
 
The study will be performed in compliance with all applicable local and international laws and regulations, 
including without limitation ICH E6 guidelines for Good Clinical Practices.  
 
The investigator shall be responsible for ensuring submission of required expedited and periodic reports 
to the appropriate Regulatory Authority (RA), the Ethics Committee and investigators.  
 
Periodic reports (e.g. Development Safety Update Report (DSUR)), submitted to Regulatory Authority 
will be first transmitted to Sanofi for review and comment. 
 
The study reports will contain a section describing safety review and conclusion and must be reviewed 
by Sanofi before finalization. 
 
New Safety Findings in a study pertaining to safety of product must be transmitted within 1 business day. 
The investigator must provide to Sanofi upon request results of any relevant complementary exams 
performed to obtain the final diagnosis of any SAE (e.g., hospital discharge summary, autopsy, 
consultation). 
 
The Institution must report the following information in English to the Sanofi group entity 
Pharmacovigilance contact: 
 
Routine transmission of all Serious Adverse Events (SAEs) including pregnancy, overdose. These 
events must be transmitted within 1 business day of the Institution’s awareness or identification of the 
event. 
 
Routine transmission of SAEs related to the use of the Sanofi product must be transmitted within 1 
business day of the Institution’s awareness or identification of the event. The reference safety 

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IRB Approval date:  12/02/2017 
Version:  
1.0 
 
information to be used by the Institution for evaluation of expectedness of adverse events shall be 
the current approved product label available in the country. 
 
Any Periodic reports (e.g. Development Safety Update Report (DSUR)), submitted to Regulatory 
Authority must be transmitted to Sanofi at the time of submission. 
 
New Safety Findings in a study pertaining to safety of product must be transmitted within 1 business 
day. (e.g., Data Safety Monitoring Board recommendations) 
 
Defining and reporting of adverse events and/or unanticipated problems will otherwise follow the 
recommended guidelines and algorithm of the Office of Human Research Protection and comply with 
applicable University Human Research Protection Program Policies 
[http://orrp.osu.edu/irb/osupolicies/HRPPPolicies.cfm]. 
All serious adverse events and/or unanticipated problems (e.g. protocol deviations or violations), including any 
unexpected adverse event that occurs during the course of the investigation, will be promptly reported to the 
appropriate institutions and offices, e.g. OSU Institutional Review Board. The investigator will continue to follow 
or obtain documentation of the resolution course of such events.  
These events and/or problems will be brought to the attention of the University’s Institutional Review Board as 
soon as possible but at least within 10 days of the investigator or research team learning of the event. Any 
events that result in a temporary suspension or interruption of study activities in order to avoid potential harm 
to subjects should be reported within 48 hours, or as soon as feasibly possible. Where appropriate or as 
requested, a final report will be submitted. 
Each submitted report will be in compliance with the appropriate HIPAA guidelines [i.e., not contain any 
personal identifiers of the study participant(s) for reports which will be disclosed, but will possess confidential 
patient identifiers (e.g., participant study identification number) that can be used by the investigator and study 
personnel to identify the patient(s)]. Expected adverse events, excluding those deemed to be serious, will only 
be summarily reported to the IRB at the designated intervals of continuing review. 
Subjects who prematurely withdraw from the study due to an adverse event will be followed as is feasibly 
possible (e.g. telephone contact, and/or follow-up visits, etc.), until resolution of the event.  
Data collection and safety monitoring activities for this study will continue until all subjects have completed their 
participation and all subjects are beyond the time point at which study-related adverse events and/or 
unanticipated problems would likely present. 
 
3. Plan for assuring data accuracy and protocol compliance: 
The clinical research coordinator and/or investigator will be responsible for collecting and recording all relevant 
data for the protocol. As these results are collected, all toxicities and adverse events will be identified, 
recorded, and reported to the principal investigator. Adverse events and unanticipated problems will be 
reported as described above. The principal investigator will determine the relationship of the adverse event(s) 
to the intervention(s), procedure(s), and/or agent(s) of the protocol and decide the appropriate course of action 
for the study participant(s). 
Compliance will be achieved via IRB Continuing Review, and conscientious conduct by members of the study 
team, adhering to relevant regulations and the principles of the ethical conduct of human subject research.  
 

IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
4. Periodic Reports: 
In accordance with Federal and institutional guidelines, an annual summary of all serious and unexpected 
adverse events, as well as of any unanticipated problems will be submitted to the OSU Biomedical IRB. The 
purpose is to review the entire study, determine that the risks and benefits are reflected in the actual 
experience of subjects and that the measures implemented to minimize risk continue and are deemed to be 
adequate. New data that would be expected to alter the risk/benefit profile will also be reviewed annually by the 
PI and IRB. The sponsor will be informed of any action taken by the OSU IRB or study monitor committee. 
Note: Nothing in the DSMP replaces a researcher’s responsibility for prompt and appropriate reporting of 
serious adverse events, protocol amendments, data collection procedures, etc. to the OSU ORRP-IRB, 
sponsor(s), or other responsible parties. Any reporting required by the DSMP is in addition to these core 
compliance responsibilities. 
 
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IRB Approval date:  12/02/2017 
Version:  
1.0 
 
                                                                                                                                                                                                                                  
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IRB Approval date:  12/02/2017 
Version:  
1.0 
 
                                                                                                                                                                                                                                  
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IRB Protocol Number: 
2017H0354 
IRB Approval date:  12/02/2017 
Version:  
1.0 
 
                                                                                                                                                                                                                                  
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