A Pilot Trial to Prevent Hospital Readmission of Patients With Diabetes
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: Temple University

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1) Abstract of the study  
 
Post-discharge hospital utilization, i.e., readmissions within 30 days of 
discharge (30d readmissions) and emergency department (ED) visits, are a high-
priority quality measure and target for cost reduction. Patients with diabetes are 
disproportionately over-represented in 30d readmissions, especially among racial 
minorities and urban populations. We have developed and validated a tool, the 
Diabetes Early Readmission Risk Indicator (DERRI), to predict 30d readmission 
risk among diabetes patients, which is a critical prerequisite for targeting limited 
resources for reducing readmission risk to those most in need. Currently, there 
are no proven interventions to reduce the risk of 30d readmission specifically 
among patients with diabetes. This proposal will assess the feasibility and 
acceptability of a novel, multifactorial intervention, the Diabetes Transition of 
Hospital Care Program (DiaTOHC or “My Temple Extra Care Service”), designed 
to reduce post-discharge hospital utilization rates in a pilot randomized controlled 
trial. The intervention will include inpatient diabetes and discharge education, 
comprehensive discharge planning and coordination of care, A1c-based 
adjustment of diabetes therapy, and post-discharge support.  Hospitalized 
patients with diabetes identified as high risk for readmission based on the DERRI 
will be randomized to the intervention or the control group, which will receive 
usual care. Such work is highly relevant in the current era of soaring health care 
costs and national health care reform.  
 
2) Protocol Title 
A Pilot Trial to Prevent Hospital Readmission of Patients with 
Diabetes (NCT03243383) 
3) Investigator 
Daniel Rubin, MD, MSc 
4) Objectives 
We have retrospectively developed and validated a tool to predict the 
risk of all-cause 30d readmission among patients with diabetes called the 
Diabetes Early Readmission Risk Indicator (DERRI).[1] Based on easily obtained 
clinical and sociodemographic information available prior to the time of 
discharge, the DERRI accurately stratifies patients by risk of 30d readmission.  
The proposed study will use the DERRI to identify diabetic patients at 
high-risk of readmission who will be provided with a novel intervention designed 
to reduce hospital utilization rates within 30 days of discharge. This multifactorial 
intervention builds on techniques effectively used in other inpatient populations, 
specifically, patient-centered discharge education, peri-discharge coordination of 
care, and post-discharge support by nurses and community health workers 
(CHWs), and adapts them to patients with diabetes.[2-8] In addition, the 
intervention includes adjustment of diabetes therapy upon discharge based on 
the admission A1c, which improves post-discharge glycemic control and is 
associated with a lower risk of 30d readmission.[9, 10] 

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We propose a pilot randomized controlled trial to address the following 
aims:   
  
Aim 1: To explore the feasibility, acceptability, and efficacy of a novel 
multifactorial intervention designed to reduce all-cause readmission or ED visit 
rates within 30 days of discharge among hospitalized patients with diabetes who 
are identified as high risk based on the DERRI 
 
Aim 2: To prospectively validate the readmission risk predictions generated by 
the DERRI 
 
The usual care control group will provide the baseline risk of 30d post-discharge 
hospital utilization in the patient population predicted to be at high risk by the 
DERRI. Furthermore, we will prospectively follow patients who are predicted to 
be at lower risk to validate the DERRI in this population. 
 
5) Background  
 
Significance 
Post-discharge hospital utilization, i.e., readmissions and ED visits, 
represent a costly failure of medical care, especially among diabetic 
patients.[11-13] Patients with diabetes represent about 9% of the US 
population,[14]  but they account for 23% of hospitalizations (over 8 million per 
year).[15, 16] The number and proportion of hospitalized patients with diabetes 
has increased steadily over the past two decades,[15, 17, 16] mirroring the 
increasing incidence and prevalence of diabetes in the general population.[18, 
19, 14] While the overall 30d readmission rate is 8.5-13.5%,[20, 21] the 30d 
readmission rate of diabetic patients is 14.4-21.0%.[22-25] In 2012, costs 
associated with the hospitalization of diabetic patients in the US were $124 billion 
of which an estimated $25 billion was attributable to 30d readmissions.[26, 27, 
15] ED visits of patients with diabetes also impose significant costs to health 
systems.[28] Reducing 30d readmissions among diabetic patients has the 
potential to greatly reduce healthcare costs. A modest 5% reduction in the 30d 
readmission rate would result in 82,754 fewer admissions per year, 
translating into an estimated annual cost savings of $1.2 billion.[26, 16] 
Starting October 1, 2012, the Centers for Medicare and Medicaid Services 
decreased payments to hospitals that have greater-than-expected 30d 
readmission rates, reflecting an effort to improve  care while reducing costs.[29] 
These data and the widespread interest in healthcare reform have prompted 
recent calls for more research on how to prevent 30d readmissions in this 
important group of patients.[30-32]  
 
Identifying and intervening in the highest risk diabetic patients to reduce 
readmission rates may have a large impact. Such an approach, colloquially 
known as “medical hot-spotting,” has been successfully applied in a 
socioeconomically disadvantaged population to reduce hospital utilization in 

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Camden, NJ.[33]  Identifying high risk patients, i.e., the “hot spots”, is the first 
step. However, there had been no published, validated tools to predict the risk of 
30d readmission among patients with diabetes.  Most prediction models among 
hospitalized patients have relatively poor discriminative ability (C-statistic 
<0.7).[34] Furthermore, most studies of readmission risk factors in diabetic 
patients are limited by the use of administrative rather than clinical data, lack of 
clinical utility at the point of care, and/or a narrow focus on a primary discharge 
diagnosis of diabetes.[35-37, 22, 38, 23] Identifying high-risk diabetic patients 
will enable targeting of interventions to those at greatest need, which may 
optimize the cost-benefit ratio for the health care system.  
 
To date, preventive interventions targeting 30d readmissions have included 
multiple components but have not focused on diabetic patients.  Several 
trials have shown significant relative risk reductions in 30d readmissions ranging 
from 30% to 75%.[2-8] Of the successful studies, all except one tested multi-
component discharge bundles, suggesting that bundled interventions may realize 
an additive effect beyond that seen with a single intervention. Common 
components of these interventions were patient-centered discharge education, 
peri-discharge coordination of care, and post-discharge support. The majority of 
trials that targeted higher risk patients showed a benefit in reducing 
readmissions.[3, 5, 6, 4] In contrast, trials that failed to reduce readmission risk 
did not focus on higher risk patients.[2, 39] This suggests that targeting higher 
risk patients is an important component of an effective intervention, and efforts to 
reduce readmissions may be more effective in a high risk population.  A major 
limitation of these studies, however, is that they did not report data stratified by 
diabetes status or address diabetes management. Our proposal will address 
important knowledge gaps concerning readmission risk prediction and 
prevention strategies in patients with diabetes.  
 
Innovation 
This research proposal consists of important innovations. There are no 
proven strategies specifically developed for patients with diabetes to reduce the 
risk of 30d readmission. This proposal combines elements of successful 
readmission risk reduction interventions designed for other populations to create 
a novel multi-component intervention for a high-risk diabetic population. 
Furthermore, the DERRI will be used to select patients at the highest risk of 30d 
readmission to receive the intervention, which has a higher likelihood of success 
than testing the intervention without regard for predicted readmission risk. 
Readmission interventions in other populations that focused on higher risk 
patients have been successful;[3, 5, 6, 4] however, none of these used a 
validated model specifically developed to predict 30d readmission risk. This 
approach could serve as a model to test and target interventions in other 
populations at high risk of readmission.  Lastly, although the DERRI has been 
internally validated in a retrospective sample, the proposed study will test the 
model prospectively in a new population. External prospective validation is 
important for demonstrating generalizability.[40, 41] Achieving these aims 

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would represent a major advance in the peri-discharge care of hospitalized 
diabetes patients, reducing 30d readmissions, socioeconomic disparities, 
and healthcare costs. 
 
Preliminary studies 
Qualitative assessment of readmission risk factors and causes 
We conducted semi-structured interviews of 20 adult inpatients with 
diabetes readmitted to TUH within 30 days of discharge and performed thematic 
analysis.[42] In 76% of cases, reasons for the index admission and the 
readmission were similar.  While 65% of patients felt they needed help after 
discharge, only 47% reported getting the help they needed. Only 29% of patients 
were aware of the A1c test.  Despite 65% of discharge instructions listing a 
scheduled follow-up visit, only 41% of patients recalled having a scheduled 
follow-up visit. Most patients said they followed the discharge instructions but did 
not accurately answer questions about them. Few could list their medications or 
the reasons for taking them. Discharge instructions rarely addressed diabetes 
care other than medications, even for patients with a diabetes-related primary 
discharge diagnosis.  
We concluded that recurring reasons for admission of patients with 
diabetes are not being sufficiently addressed to prevent 30d readmission, and 
many patients do not get adequate discharge support. Furthermore, readmitted 
patients lack important knowledge about their diabetes and medications. The 
discharge process does not successfully communicate instructions to patients, 
and instructions often fail to address diabetes. These findings inform the planned 
intervention, and a similar qualitative method will be used to assess the 
intervention.  
  
6) Setting of the Human Research 
Potential subjects will be recruited at Temple University Hospital. All research 
procedures will be performed on the Temple Health Science Center Campus. 
 
7) Resources Available to Conduct the Human Research 
We estimate that in order to meet the desired final sample size, up to 
300 subjects will need to be enrolled. Approximately 27,500 patients with 
diabetes are hospitalized at TUH annually. Assuming 25% of them will not 
meet eligibility criteria, there will be 20,600 potential subjects remaining 
over 1 year. We will therefore need to recruit 1.14% of potential subjects. 
This work is being funded by an NIH K23, which covers 75% of the PI’s 
total effort through February of 2019. A majority of the PI’s research effort 
will be devoted to this project. One full-time Research Specialist 
(Shaneisha Allen) will support the study, including screening, consenting, 
and enrolling patients, entering data, and managing regulatory 
requirements. Our base of operation is at the General Clinical Research 
Center (GCRC), located at Rock Pavilion, room 422. Shaneisha Allen will 

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supervise the following research assistants for screening, consenting, and 
enrolling patients, and entering data (Samantha Watts, Felicia Dillard, 
Madeline Amberge, Dominic Recco, and Samuel Tanner). Dr. Cherie Vaz, 
one of the PI’s colleagues in the Section of Endocrinology, will serve as a 
co-investigator to help with the clinical management of patients in the 
study. 
In addition to the research specialist, a Nurse Navigator in the TUH 
Care Transitions Program (Jeff Slocum) will deliver parts of the 
intervention, including diabetes education, coordination of care, and post-
discharge follow-up.  
All persons on the team administering the trial will be fully trained on 
the protocol and their study-related duties and functions. The Nurse 
Navigators have participated in protocol development. 
 
8) Study Design 
a) Recruitment Methods 
We will recruit study subjects as follows: 
1. We will review a daily computer-generated admission log of patients 
admitted to medical-surgical units at TUH who have been ordered for 
routine glucose testing. This captures most patients with recognized 
diabetes. 
2. We will review the medical chart of patients on the admission log to 
determine potential eligibility. We request a waiver of consent and 
HIPAA to identify candidates. We will access only the minimum data 
needed to obtain this information.  
3. We will request permission to approach the potential subject about the 
study from a physician on the primary team providing hospital care. 
4. Study participants will be provided $50 after 30 days of follow-up has 
been completed and outcomes have been assessed. Subjects who 
also provide an in-depth interview after the follow-up period will be 
given another $50. 
 
b) Inclusion and Exclusion Criteria 
Screening for eligibility will be performed by chart review and brief 
history of the potential subject. 
Inclusion criteria 
1. Diabetes, defined by pre-admission use of a diabetes-specific medication 
and/or documentation of the diagnosis in the medical record. 
2. Age 18 years or older at the time of admission 
3. Admission to a non-critical care unit 
 
Exclusion Criteria:  
1. Female subjects who are pregnant and/or admitted to an obstetric service 

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2. Binge drinking (5 or more alcoholic drinks for males or 4 or more alcoholic 
drinks for females on the same day) or drug abuse within 3 months before 
admission 
3. Receiving palliative care during the hospitalization 
4. Participation in another readmission risk reduction program 
5. Inpatient death 
6. Planned or actual transfer to another hospital or subacute facility 
7. Discharge to hospice or a long-term care facility 
8. Discharge by signing out against medical advice 
9. Discharge expected within 12 hours or admission to a short-stay unit  
10. Lack of access to a phone 
11. Living more than 30 miles away from TUH 
12. Mental condition rendering the subject unable to understand the nature, 
scope, and possible consequences of the study 
13. A1c <5.7% 
14. Inability to speak English 
 
c) Local Number of Subjects 
Up to 300 subjects will be enrolled locally across the following study 
groups: 60 subjects in the intervention group, 60 in the high-risk 
control group, and 180 in the low-risk control group. 
We estimate that 25% of screened patients will not meet eligibility 
criteria, which means that at least 300 patients will be screened. 
 
d) Study Timelines 
Subjects will be enrolled during their hospital stay and will 
participate in the study for 3 months following hospital discharge. 
The intervention will be delivered during the 4 weeks following 
discharge. Final assessment for outcomes will be performed at 3 
months after discharge. We anticipate enrollment will occur 
between July and December of 2019. We estimate that primary 
analyses will be completed by June of 2020.  
 
e) Study Endpoints  
The primary outcome will be the number of initial hospital 
readmissions within 30 days of discharge. Secondary outcomes will 
also be assessed at 30 days of discharge unless otherwise 
specified. Secondary outcomes will include: 
1. time to first readmission  
2. number of emergency department (ED) visits 
3. a composite of 30d readmissions and ED visits 

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4. number of primary care and specialist provider follow-up 
visits scheduled and attended 
5. incidence of medication review or reconciliation post-
discharge 
6. cost of post-discharge care as a sum of ED visits, 
readmission, home health services, and outpatient provider 
visits 
7. cost of the intervention  
8. subject experience assessed by a brief questionnaire 
9. self-monitored blood glucose levels and frequency of testing 
10. change in well-being from baseline to 5 weeks after 
discharge as measured by the World Health Organization 
Well-Being Index (WHO-5).[43] 
11. change in diabetes-related distress at 5 weeks after 
discharge as measured by the Problem Areas in Diabetes 
(PAID) scale.[44] 
12. change in perceived social support at 5 weeks after 
discharge as measured by the Multidimensional Scale of 
Perceived Social Support (MSPSS).[45] 
13. change in perceived stress at 5 weeks after discharge as 
measured by the perceived stress scale (PSS).[46] 
14. change in diabetes knowledge at 5 weeks after discharge as 
measured by the Diabetes Knowledge Test (DKT2).[47]  
15. change in A1c level from baseline to 3 months after the 
index discharge 
f) Procedures Involved in the Human Research  
After enrollment, subjects will be sorted into 2 groups based on the predicted risk 
of readmission by the DERRI: high risk and low risk (Figure 1).  

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Figure 1. Allocation of study participants 
 
Low-risk group: 
The low-risk group will be followed in a prospective, observational arm of the 
study. About 5 weeks after hospital discharge, the Temple medical record will be 
reviewed for the presence of any hospital or ED visits within 30 days after 
discharge. If no post-discharge acute visits are found, then the subject will be 
contacted to determine if any hospital or ED visits occurred at another institution.  
 The following data will be collected at baseline: sociodemographics, 
medical history, including HIV, substance abuse, and mental health status, 
which are likely risk factors for admission, relevant laboratory results, 
admission diagnoses, well-being (WHO-5), diabetes-related distress 
(PAID scale), perceived social support (MSPSS), perceived stress (PSS), 
diabetes knowledge (DKT2), depression screening by the 2-item Patient 
Health Questionnaire (PHQ-2),[48] and health literacy by the Brief Health 
Literacy Scale (BHLS).[49, 50] Subjects who score 3 or more on the PHQ-
2 will complete the PHQ-9.[51] Subjects with a PHQ-9 score of 5 or more 
will be referred to their primary care physician (PCP) for evaluation and 
management of possible depression.[52] For subjects without a PCP, a 
study physician will begin medical therapy for depression as needed. For 
subjects newly discovered to be suicidal, psychiatry will be consulted in 
the hospital. 
 The following data will be collected during follow-up: A1c, discharge 
diagnoses, hospital readmission (date, primary diagnosis), ED visits (date, 
primary diagnosis) and patient experience according to a brief 
questionnaire (Appendix Item 3a). 
 
High-risk group: 

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For the high-risk group, there are two phases in the protocol. Phase A is the 
pilot RCT to explore the feasibility, acceptability, and efficacy of the intervention. 
Phase B consists of in-depth interviews with intervention participants and 
research staff to further explore acceptability and effects of the intervention and 
to refine the protocol for future study. Subjects in the high-risk group will be 
randomly assigned with a computer-generated randomization scheme 1:1 in 
randomly permuted blocks of 2, 4, or 6 to receive either the intervention, the 
Diabetes Transition of Hospital Care (DiaTOHC) Program (“My Temple Extra 
Care Service”) or usual care (control). 
Phase A: RCT of readmission risk reduction intervention 
Intervention protocol: The multifactorial intervention is based on strategies that 
reduced 30d readmissions in other populations, Temple’s successful readmission 
reduction program for heart failure patients (Temple Advantage), and the PI’s 
own preliminary studies. There are four components of the intervention: 1) 
patient-centered discharge education, 2) peri-discharge coordination of care, 3) 
A1c-based adjustment of diabetes therapy upon discharge, and 4) post-
discharge support. 
 
1) Patient-centered discharge education: 
1a)  Standardized diabetes discharge instructions and education: A 
Navigator will review instructions containing basic diet, activity, and diabetes-
specific self-care guidance, as well as education on how to recognize and treat 
hypoglycemia and hyperglycemia (Appendix Item 1). These instructions are 
based on the model published by one of the PI’s mentors, Dr. Mary Korytkowski, 
and others.[53] They also include a table that allows a provider to specify how 
and when insulin should be taken and discussion of the subject’s A1c level, of 
which many patients are not aware according to Preliminary studies. Lastly,  
patients who have not completed a formal diabetes education program in the 
past year will be referred to a Certified Diabetes Educator at the Temple 
Diabetes Center, an American Diabetes Association-certified outpatient diabetes 
education center. 
 
1b)  Comprehensive discharge plan review:  Prior to discharge or soon 
after discharge, a Navigator will review the discharge plan with participants, 
including medications, reasons for and importance of follow-up appointments and 
testing, and how to reach post-hospital providers.  
 
2) Peri-discharge coordination of care: Soon after discharge, a Navigator will 
assess and address barriers to following the discharge plan, including obtaining 
medications. A Navigator will confirm the scheduling of follow-up appointments 
and testing (including a visit with the primary care provider), help organize post-
discharge services, assess barriers to keeping appointments, and confirm plans 
to attend follow-up appointments including transportation. In addition, a Navigator 
will assist subject with obtaining medications if needed. See Appendix Item 2 for 
script. 

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3) A1c-based adjustment of diabetes therapy: Upon hospital discharge, diabetes 
therapy will be determined by the PI or co-Investigator (Endocrinologists) based 
on an algorithm tested in patients with type 2 diabetes,[9] and the American 
Diabetes Association Standards of Medical Care guidelines as follows [54]: 
a) For A1c <7%, resume the pre-admission treatment regimen. 
b) For A1c 7-7.9%  
 Patients who did not take insulin before admission, discharge on 
optimized pre-admission treatment regimen (see definition below) or 
add a non-insulin agent if the prior regimen was already optimal.  
 Patients who took basal insulin but not prandial insulin before 
admission, increase the home daily dose of basal insulin by 10-15% in 
addition to any non-insulin pre-admission treatments. Non-insulin pre-
admission treatments should be optimized. 
 Patients who took multiple daily insulin injections (MDI) before 
admission, increase the home total daily dose of insulin by 10-15% in 
addition to any non-insulin pre-admission treatments. Non-insulin pre-
admission treatments should be optimized. 
b) For A1c 8-9%  
 Patients who did not take insulin before admission, discharge on 50% 
of the last inpatient insulin glargine daily dose or 0.2 units/kg in 
addition to the pre-admission treatment regimen, which should be 
optimized.   
 Patients who took basal insulin but not prandial insulin before 
admission, discharge on 50-80% of the last inpatient insulin glargine 
daily dose or increase the home daily dose of basal insulin by 10-15% 
and/or add rapid-acting insulin before the largest meal at 50-80% of 
the last inpatient dose or 0.1 units/kg in addition to any non-insulin pre-
admission treatments. Non-insulin pre-admission treatments should be 
optimized. 
 Patients who took multiple daily insulin injections (MDI) before 
admission, discharge on 50-80% of the last inpatient total daily insulin 
dose or increase the home total daily dose of insulin by 10-15% in 
addition to any non-insulin pre-admission treatments. Non-insulin pre-
admission treatments should be optimized. 
c) For A1c >9% 
 Patients who did not take insulin before admission, discharge on 80-
100% of the last inpatient insulin glargine daily dose or 0.3 units/kg in 

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addition to the pre-admission treatment regimen, which should be 
optimized.  
 Patients who took basal insulin but not prandial insulin before 
admission, discharge on 80-100% of the last inpatient insulin glargine 
daily dose or increase the home daily dose of basal insulin by 20-30% 
and/or add rapid-acting insulin before the largest meal at 80-100% of 
the last inpatient dose or 0.1 units/kg in addition to any non-insulin pre-
admission treatments. Non-insulin pre-admission treatments should be 
optimized. 
 Patients who took multiple daily insulin injections (MDI) before 
admission, discharge on 80-100% of the last inpatient total daily insulin 
dose or increase the home total daily dose of insulin by 20-30% in 
addition to any non-insulin pre-admission treatments. Non-insulin pre-
admission treatments should be optimized. 
Optimization of non-insulin diabetes therapy is defined as using the next higher 
dose up to the maximum tolerated dose. The maximum dose specified below will 
be used unless the subject must use a lower dose to avoid side effects or there is 
a contraindication. 
 DPP4-inhibitors (i.e., linagliptin, saxagliptin, sitagliptin): FDA-approved 
maximum daily dose 
 GLP1-analogues (i.e., albiglutide, exenatide, dulaglutide, liraglutide): FDA-
approved maximum daily dose 
 Metformin: 2000 mg per day 
 Pioglitazone: 30 mg per day 
 Secretagogues (i.e., sulfonylureas, repaglinide, nateglinide): Half the FDA-
approved daily maximum dose. Pre-admission daily dose will be reduced by 
50% in patients starting prandial insulin or those at risk for hypoglycemia. 
Secretagogues will be discontinued in patients with inpatient hypoglycemia 
(BG <70 mg/dL) within 48 hours of discharge.  
 SGLT2-inhibitors (i.e., canagliflozin, dapagliflozin, empaglizflozin): FDA-
approved maximum daily dose 
Patients who cannot use insulin glargine as outpatients will have the equivalent 
dose substituted with another basal insulin. Only FDA-approved diabetes 
therapies will be used in the study. Pre-admission diabetes medications may 
be adjusted to optimize patient safety and benefit. Deviations from the above 
protocol will be allowed on a case-by-case basis if the PI or co-Investigator 
deems it necessary for patient safety. 

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4) Post-discharge support: At 24 to 48 hours post-discharge, a nurse Navigator 
will call the patient to assess the patient’s status, confirm receipt of and 
compliance with medications, verify the follow-up appointment schedule, assess 
for barriers to following the discharge plan, determine the need for a community 
health worker (CHW) referral, and review blood glucose control (patients who are 
discharged on non-insulin regimens will be expected to test their blood glucoses 
at least once a day, and patients who are discharged on an insulin regimen will 
be expected to test their blood glucoses at least twice a day). Similar phone calls 
will be made weekly for four weeks following discharge by a Navigator. If a 
patient reports significant high or low blood glucose levels, then the PI or a co-
Investigator (Endocrinologists) will call the patient to adjust diabetes therapy (See 
Tables 1a and 1b for insulin dose adjustment protocols). Eligible patients will 
receive a referral for a nursing visit from a local home care agency to assess 
medical needs for support at home and medication reconciliation. Referral to a 
CHW may be made if subjects are found to have non-medical needs and/or 
obstacles to maintaining self-care and attending follow-up appointments. Such 
non-medical support might include transportation to and from medical 
appointments, food, housing, or legal assistance, relief from utility bills, 
verification of insurance, support groups and delivery of durable medical 
equipment.  
Table 1a. Outpatient basal insulin dose adjustment: 
Basal Insulin 
If mean FBG > 180 mg/dL for the last 2 consecutive days 
and no episodes of hypoglycemia 
Increase daily basal dose by 
4 IU 
If mean FBG > 140 mg/dL for the last 2 consecutive days 
and no episodes of hypoglycemia  
Increase daily basal dose by 
2 IU 
If mean FBG between 100 to 140 mg/dL for the last 
2 consecutive days and no episodes of hypoglycemia 
No Change 
If any FBG between 70 – 99 mg/dl 
Decrease by 4 IU or 10% of 
total daily basal dose 
If any FBG < 70 mg/dl 
Decrease by 8 IU or 20% of 
total daily basal dose 
If any FBG < 40 mg/dl 
Decrease total daily basal 
dose by 30% 
FBG=Fasting blood glucose; Hypoglycemia=typical symptoms (e.g., sweating, tremor, acute 
hunger, anxiety) and/or blood glucose <70 mg/dL 
 
Table 1b. Outpatient prandial/pre-meal insulin dose adjustment based on 
subsequent mealtime/HS BG values:  
Pre-meal Rapid Insulin 
Pre-meal Dose, U  
BG 70 – 100 mg/dl*  
BG 141-180 mg/dl**  
≤ 10 U  
Decrease by 1 U  
Increase by 1 U  
>11- 19 U  
Decrease by 2 U  
Increase by 2 U  
≥ 20 U  
Decrease by 3 U  
Increase by 3 U  
Pre-meal Dose, U  
BG 40-70 mg/dl x 1 
BG 180-240 mg/dl x 1 

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≤ 10 U  
Decrease by 2 U  
Increase by 2 U  
>11- 19 U  
Decrease by 3 U  
Increase by 3 U  
≥ 20 U  
Decrease by 4 U  
Increase by 4 U  
Pre-meal Dose, U  
BG < 40 mg/dl x 1***  
BG > 240 mg/dl x 1 
≤ 10 U  
Decrease by 4 U  
Increase by 3 U  
>11- 19 U  
Decrease by 6 U  
Increase by 4 U  
≥ 20 U  
Decrease by 8 U  
Increase by 5 U  
Pre-meal insulin dose adjustment is based on the subsequent BG value, e.g., pre-breakfast 
insulin dose is based on the pre-lunch BG. 
* If > ½ of the mealtime/HS BG values for the week were below target. 
**If > ½ of the mealtime/HS BG values for the week were above target. 
*** Decrease by 30-40% in the event of severe hypoglycemia (mealtime/HS BG < 40 mg/dl). 
BG=blood glucose; Mealtime/HS=pre-lunch, pre-dinner, or bedtime 
 
The above algorithm provides recommended insulin doses and may be modified 
based on clinical judgment of the investigator or co-investigator.  
 
Usual care: Most aspects of 
the intervention go above-and-
beyond usual care.  Patients in 
the usual care group will 
receive the standard discharge 
instructions and medication 
reconciliation process. Those 
who are new to diabetes 
receive training by a floor 
nurse on using a glucometer 
as well as a stock set of 
printed educational materials. 
The floor nurses also train 
patients who are new to insulin 
injections as needed. Patients 
with diabetes are referred to 
outpatient diabetes education 
at Temple on a case-by-case 
basis as determined by the 
primary hospital provider team. 
Diabetes therapy upon 
discharge is decided on a 
case-by-case basis by the 
primary team. Discharge 
instructions are routinely sent 
to the primary care physician 
either by fax or EPIC. Most 
TUH patients receive a phone 
call 2 to 4 days after discharge from a CHW that includes checking on the status 
Table 2. Timeline for assessments of subjects 
  
  
Visit # 
1 
2 
3 
4 
5 
6 
7 
8 
Time (weeks) 
0 
2 days 
1 
2 
3 
4 
5 
13 
Intervention group 
 
 
 
 
 
 
 
 
Phone call/clinic visit 
 
 
 
 
 
 
X 
 
Psychometric assessments 
X 
 
 
 
 
 
X 
 
Diabetes knowledge 
X 
 
 
 
 
 
X 
 
30d endpoints 
 
 
 
 
 
 
X 
 
Interview 
 
 
 
 
 
 
X 
 
A1C 
X 
 
 
 
 
 
 
X 
Navigator call 
 
X 
X 
X 
X 
X 
 
 
Blood glucose 
 
X 
X 
X 
X 
X 
X 
 
Adverse events 
 
X 
X 
X 
X 
X 
X 
 
Usual care group 
 
 
 
 
 
 
 
 
Phone call 
 
 
 
 
 
 
X 
 
Psychometric assessments 
X 
 
 
 
 
 
X 
 
Diabetes knowledge 
X 
 
 
 
 
 
X 
 
30d endpoints 
 
 
 
 
 
 
X 
 
A1C 
X 
 
 
 
 
 
 
X 
Blood glucose 
 
 
 
 
 
 
X 
 
Adverse events 
 
 
 
 
 
 
X 
 
Low-risk group 
 
 
 
 
 
 
 
 
Chart review/phone call 
 
 
 
 
 
 
X 
 
Psychometric assessments 
X 
 
 
 
 
 
X 
 
Diabetes knowledge 
X 
 
 
 
 
 
X 
 
A1C 
X 
 
 
 
 
 
 
X 
30d endpoints 
 
 
 
 
 
 
X 
 

Readmission Pilot Trial 
 
 
 
Page 14 of 24 
Revised on October 22, 2019 
  
of follow-up appointments, confirming access to medications, and answering 
questions.  
Data collection: The following data will be collected at baseline: A1c, 
sociodemographics, medical history, including HIV, substance abuse, and mental 
health status, which are likely risk factors for admission, relevant laboratory 
results, admission diagnoses, self-reported goals for health and diabetes, well-
being (WHO-5), diabetes-related distress (PAID scale), perceived social support 
(MSPSS), perceived stress (PSS), diabetes knowledge (DKT2), depression 
screening by the PHQ-2/9, and health literacy by the BHLS (Table 2). 
The following data will be collected during follow-up: A1c, discharge diagnoses, 
hospital readmission (date, primary diagnosis), ED visits (date, primary 
diagnosis), physician follow-up appointments scheduled and/or attended, post-
discharge medication reconciliation (yes/no), cost of post-discharge care, self-
monitored blood glucose levels, Nurse Navigator time to deliver the intervention 
(minutes), well-being (WHO-5), diabetes-related distress (PAID scale), perceived 
social support (MSPSS), perceived stress (PSS), diabetes knowledge (DKT2), 
depression (PHQ), and patient experience according to a brief questionnaire 
(Appendix Item 3a [usual care] or 3b [intervention]). These follow-up data will 
be collected during a phone call about 5 weeks after the index discharge. 
Baseline and 3-month post-discharge A1c levels will be obtained as part of 
standard-of-care. A letter reminding patients to do the 3-month blood draw for the 
A1c test will be sent by mail. 
Data will be collected by phone interviews with subjects and review of the 
electronic medical record (EMR). The Research Specialist will be primarily 
responsible for screening and recruiting subjects, data collection and data entry. 
 
Phase B: Qualitative evaluation of intervention 
In Phase B, in-depth individual interviews with intervention-group 
participants and the Navigators from Phase A will be conducted in-person to 
develop a better understanding of the intervention’s acceptability, feasibility and 
effects. The interviews will be conducted between one and two months after the 
index discharge. These findings will provide critical information about the 
intervention to guide a future proposal for a definitive RCT. In addition to this 
formal qualitative work, the research team’s experience with implementing the 
study will help refine the manual of procedures for the trial. 
 
Study sample: Approximately 20 (maximum of 25) intervention-group 
participants in the Phase A pilot trial will be interviewed. The final sample size will 
be determined by achieving saturation of themes, the point at which no new 
information is being collected. This will be based on continual assessment by the 
investigators as the interviews are analyzed.[55] In the PI’s prior study with a 
similar design (see Preliminary studies), 20 patients were included.[42] 

Readmission Pilot Trial 
 
 
 
Page 15 of 24 
Revised on October 22, 2019 
  
Data collection and analysis: The PI will use an in-depth guide for semi-
structured participant interviews that addresses the following topics: 1) the 
participants’ experience in the intervention; 2) the acceptability of written 
materials; 3) barriers and facilitators to working with the Navigators and CHWs; 
and 4) suggestions for improving the intervention (Appendix Item 4). In a semi-
structured interview, the interviewer uses the guide to address topics of interest 
and is encouraged to pursue relevant lines of questioning as they arise during 
the interview. Interviews will be conducted by the PI or research staff. Each 
interview will take about 30 to 45 minutes and will be recorded with a portable 
digital recorder. Hand-written observations and impressions during the interviews 
will complement the transcribed audio data. Thematic analysis will be used to 
identify common themes that reflect the underlying attitudes, values, and 
contextual constraints of participants in the intervention.[56, 55] Each interview 
will be coded by the interviewer then reviewed by the PI and research staff 
together to assure accuracy and consistency of coding. Initial codes will be 
standardized then organized into themes.  
g) Data and Specimen Banking  
All data collected by the research team will be considered part of the 
participant’s confidential record. Data collected on paper from research 
participants will be placed in a locked file cabinet in the GCRC within 24 
hours. The destruction date of paper files will be at least 7 years from the 
termination of the study and will be authorized by the PI. Access to 
research and confidential records will be limited to clinical investigators 
and research coordinators. 
 
h) Data Management  
Statistical analysis: Distributions of the data will be assessed by descriptive 
statistical and graphical methods. To assess the randomization procedure, 
baseline values of all variables will be compared between the intervention and 
usual care group. Between-group differences for continuous variables will be 
compared using the Wilcoxon test. Proportions will be compared between groups 
using the chi-square test or exact tests when expected cell counts are less than 
5. The primary outcome of 30d readmission rate will be compared between 
intervention and control groups with the chi-square test. Point estimates of 30d 
readmission rates will be obtained and presented with 95% confidence intervals. 
Time to readmission will be estimated by Kaplan-Meier curve and compared 
between groups by log-rank test. The composite of 30d readmission and ED 
visits will be compared by Cox regression model. Continuous secondary 
outcomes will be compared using Wilcoxon test. Categorical secondary 
outcomes will be compared using chi-square test. The primary analyses for all 
outcomes will be performed in the intention-to-treat (ITT) population. Secondary 
analyses for all outcomes will be performed in a per-protocol population restricted 
to subjects who complete at least one follow-up phone call. In addition, outcomes 
will be assessed for differences by the number of follow-up phone calls 

Readmission Pilot Trial 
 
 
 
Page 16 of 24 
Revised on October 22, 2019 
  
completed (dose-response analysis). Lastly, all outcomes will be assessed in the 
ITT subgroup of subjects with a baseline A1c >7%. Statistical significance will be 
claimed at an alpha level of 0.05. 
Power analysis: The sample size for Phase 2A was based on an expected drop-
out and post-enrollment exclusion rate of 25% as well as the capacity of the 
research team. Because this is a pilot feasibility trial, the study is not powered to 
detect a difference in outcomes. 
 
Data Entry Requirements: All data will be coded by the research 
assistant prior to entry. The research assistants will maintain a log of any 
reviewed data issues so that future occurrences of problems will be 
handled in the same manner. The data entry system (REDCap) will 
require a login identification and password to gain access to the data. 
When appropriate, validation and range rules will be applied to the actual 
entry fields. Only the research assistants will be able to view the data in its 
raw state. All other authorized personnel (i.e. the PI, statistician and Data 
Safety Officer) will view data via forms and reports created by the 
research assistants. 
Audit/Verification of Entered Data: 
Primary Outcome Data: Data designated as primary outcome date (i.e., presence 
or absence of 30d readmission) will be subject to a 100% cross-reference check 
with original hard copies. This audit must have an error rate less than 0.5%. If the 
verification fails the audit, all data will be re-entered, the original computer files 
discarded, and the newly re-entered data audited. This process will continue until 
the audit no longer exceeds the maximum allowable error rate. All audits will be 
supervised and documented by the study’s research assistant. 
 
All Other Information: All other entered information will be subject to a 20% 
sample that will be cross-referenced with the original paper copy. This audit must 
have an error rate less than 0.5%. If the sample fails the audit, all data will be 
verified against the paper originals. If the error rate of the complete audit is 
greater than 0.5%, all data will be re-entered, the original computer files 
discarded, and the newly re-entered data audited. This process will continue until 
the audit no longer exceeds the maximum allowable error rate. At the discretion 
of the PI, the full audit may be omitted in favor of a complete re-entry of the 
original paper data. All audits will be supervised and documented by the research 
assistant. 
 
Storage of Data: Data collected on paper from research participants will be 
placed in a locked file cabinet in the locked GCRC office. The destruction date of 
paper files will be at least 7 years from the termination of the study and will be 
authorized only by the PI. Electronic data will not include personal identifiers 
other than the unique study ID. Audio files for the in-depth interviews will be 
stored on the Research Specialist’s password-protected computer and erased 
from the digital recorder after storage. All data will remain confidential. Access to 

Readmission Pilot Trial 
 
 
 
Page 17 of 24 
Revised on October 22, 2019 
  
research and confidential records will be limited to trained clinical investigators 
and research coordinators. 
 
Access to Cleaned Computer Data: Once the study is complete and data have 
been collected, entered, and passed the audit process, the Research Specialist 
will make the data available to the PI and anyone he designates. Only the PI can 
give permission for the release of aggregated study data. No confidential 
information may be released without the expressed written consent of the study 
participants. Only copies of the finalized, aggregated data will be released so that 
original data can remain confidential. 
 
i) Confidentiality  
Only trained research staff will have access to individually identifiable information 
under supervision of the PI. Staff will be trained to collect data for the study and 
maintain participants’ confidentiality. Printed materials with identifiable participant 
information will be stored in a locked filing cabinet in the GCRC. The destruction 
date of paper files will be at least 7 years from the termination of the study and 
will be authorized only by the PI. Electronic data will be entered into REDCap, 
which requires a login identification and password to gain access. Electronic data 
will not include personal identifiers other than the unique study ID. Audio files for 
the in-depth interviews will be stored on the Research Specialist’s password-
protected computer and erased from the digital recorder after storage.  
Presentation of the study results at regional or scientific meetings or in 
publications will not identify the subjects. 
j) Provisions to Monitor the Data to Ensure the Safety of 
subjects 
All participants will be given unique study identifiers. Data with personally 
identifiable information will be stored securely on HIPAA-compliant TUH servers. 
Data exported for statistical analysis will be stripped of personal identifiers. 
Participants will be free to withdraw from the study at any time. 
 
Phase A: To minimize the risk of hypoglycemia, only patients with uncontrolled 
diabetes according to an elevated A1c will have their diabetes therapy adjusted. 
Patients will be followed closely for 30 days after discharge with weekly phone 
calls, and glycemic control will be monitored. Patients discovered to have 
hypoglycemia or hyperglycemia will be referred for adjustment of their diabetes 
therapy by the PI, an Endocrinologist.  
 
A Data Safety Officer (DSO) not otherwise directly involved with the 
research, a senior diabetologist and clinical investigator with inpatient diabetes 
research experience, Dr. Boris Draznin at the University of Colorado Denver, will 
review de-identified data every 3 months. Adverse events will be reported to the 
Temple Institutional Review Board and the NIH according to standard policy. 
 

Readmission Pilot Trial 
 
 
 
Page 18 of 24 
Revised on October 22, 2019 
  
Phase B: Every effort will be made to ensure that all qualitative data are kept 
confidential. The digital audio files produced will be used only for the purpose of 
this study. They will be downloaded from the recording device and stored on a 
secure computer in the research assistant’s private GCRC office. The audio files 
will be transcribed. In the transcript, each subject will be assigned an anonymous 
study identification number. The data file linking personal identifiers and study 
identification numbers will be stored separately from the transcript data. The files 
with the transcribed data will have no personal identifiers and will contain no 
information linking an individual participant with their study code. The DSO will 
not monitor Phase B because there is minimal risk involved with this phase. 
 
The following procedures will be implemented to ensure data safety and 
adequate monitoring: 
• 
The PI will monitor study progress on an on-going basis and ensure the 
protection of human subjects, including the safe and secure collection and 
storage of data. An annual review will include assessment of accrual, 
adverse events, and data management practices.  
• 
All data linking subjects to de-identified information will be maintained in a 
password-protected, encrypted computer with access limited to only those 
research personnel with a reasonable need to have such information. 
 
• 
Reporting Adverse Events 
o Definitions: 
 Adverse Event: Any medical problem that manifests during 
the course of the study, as a result of an assessment or an 
aspect of the study intervention. 
 Serious Adverse Event: An adverse event that is fatal or life-
threatening, results in significant or persistent disability, or 
requires hospitalization. 
 Unexpected Serious Adverse Event: Any event that has not 
been described in the protocol or informed consent 
document.  
o Reporting Mechanisms 
 All adverse events will be discussed at weekly operations 
meetings and reported to the PI and IRB according to 
standard operating procedure. 
 Serious adverse events (expected and unexpected) will be 
reported to the PI immediately and to the IRB in writing 
within 1 business day.  
 The NIH procedure for Reporting Clinical Study Serious 
Adverse Events will be followed for the reporting of expected 
and unexpected serious adverse events to the study 
sponsor. 
• 
The DSO will review the protocol and study procedures every 3 months to 
ensure that proper regulatory processes are followed during study 
execution. In this role, he will: 

Readmission Pilot Trial 
 
 
 
Page 19 of 24 
Revised on October 22, 2019 
  
o Review all adverse events or complications related to the study and 
make recommendations for protocol changes if indicated. 
o Assure scientific integrity of the study by providing regulatory 
oversight. 
o Assure participants’ confidentiality and informed consent by 
reviewing study procedures. 
o Provide advice, as requested, on quality assurance measures. 
k) Withdrawal of Subjects 
Subjects may withdraw at will at any time. Subjects may be withdrawn from the 
trial at the discretion of the PI due to a safety concern, if judged non-compliant 
with trial procedures, or pregnancy during the primary follow-up period (30 days 
after discharge). For subjects in the intervention group, we will obtain permission 
to continue to collect data from the electronic medical record. 
 
9) Risks to Subjects 
The study involves low risk from interviews and the intervention, which entails 
education, coordination of care, and post-discharge support. A1c-based 
adjustment of diabetes therapy poses the usual risk of hypoglycemia associated 
with diabetes therapy. However, only patients with uncontrolled diabetes 
according to an elevated A1c will have their diabetes therapy adjusted. Patients 
will be followed closely for 30 days after discharge and glycemic control will be 
monitored. Because the study will only be using FDA-approved medicines and 
checking routine A1C blood tests, it is unlikely that costs will be more than if a 
doctor was managing the subject outside the study. 
10) 
Potential Benefits to Subjects 
Participants in the intervention may have a lower risk of readmission and 
improved glycemic control with 30 days of discharge. 
11) 
Privacy and Confidentiality 
The study will use PHI and a HIPAA Authorization has been submitted. Paper 
data collection records with personal identifiers will be stored in locked file 
cabinets.  Electronic data will not include personal identifiers other than the 
unique study ID. Audio files for the in-depth interviews will be stored on the 
research assistant’s password-protected computer and erased from the digital 
recorder after storage. Access to research and confidential records will be limited 
to clinical investigators and research coordinators. All data linking subjects to de-
identified information will be maintained in a password-protected, encrypted 
computer with access limited to only those research personnel with a reasonable 
need to have such information. Staff will be trained to collect data for the study 
and maintain participants’ confidentiality. Interviews with subjects will be 
conducted in private. Presentation of the study results at regional or scientific 
meetings or in publications will not identify subjects.   
 
12) 
Compensation for Research-Related Injury 

Readmission Pilot Trial 
 
 
 
Page 20 of 24 
Revised on October 22, 2019 
  
If study volunteers sustain injury as a result of their participation in this study, 
they will be advised to seek immediate medical attention.  However, there is no 
commitment by Temple University, Temple University Health System or its 
subsidiaries to provide monetary compensation or free medical care in the event 
of a study-related injury. The study volunteers have not waived any of their legal 
rights which they would otherwise have as a participant in an investigational 
study. 
 
13) 
Economic Burden to Subjects 
No additional cost to subjects or the institution will be incurred for research 
purposes. 
 
14) 
Consent Process 
We will follow INVESTIGATOR GUIDANCE: Informed Consent (HRP-802). 
15) 
Process to Document Consent in Writing 
We will follow INVESTIGATOR GUIDANCE: Documentation of Informed Consent 
(HRP-803). 
 
 
16) 
Drugs or Devices 
Most subjects will obtain their diabetes medications through insurance. 
For high-risk subjects in the intervention group who cannot afford their 
diabetes medication, the TUH research pharmacy will provide medication 
for the duration of the study. 
 
17) 
Sharing of Results with Subjects 
Data obtained beyond standard of care will not be shared. 
 
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