Expanded MedStar Diabetes Pathway Ongoing Chart Review Protocol
Conditions: Type2 Diabetes Mellitus
Sponsor: Medstar Health Research Institute

MEDSTAR HEALTH RESEARCH AND DIABETES INSTITUTES 
MedStar Diabetes 
Pathway Ongoing Chart 
Review Protocol 
Michelle Magee, MD Principal Investigator 
Sub-Investigators 
Alex Montero MD, MPH 
Debra Thayer, CRNP, CDE 
Maranda Jackson-Parkin, PhD, CRNP 
Mihriye Mete, PhD 
 
Gretchen Youssef, MS,RD, CDE and Carine Nassar, MS,RD, CDE 
Program Managers 
 
      
June 1.2016 
 
 
 
 
 

MedStar Diabetes Pathway Ongoing Chart Reviews 
I- Background. 
The MedStar Diabetes Pathway (MDP) early pilot program has generated evidence that an 
innovative technology-enabled “Boot Camp” approach to the delivery of diabetes survival skills 
education and medication management has a significant impact on glycemic control and 
healthcare utilization measures. The MDP is a 12 week Diabetes “Boot Camp” technology-
enabled intervention which will offer learner-centered survival skills self-management education 
(DSSE) and algorithm-driven diabetes medications (DM) titration by Endocrinologist-supervised 
Certified Diabetes Educators (CDE), NPs and PharmDs.  The program has been offered at 5 
MedStar Medical Group (MMG) Primary Care Practices in FY 15-16 to high risk adults with 
uncontrolled type 2 diabetes who have a hemoglobin A1C (A1C) level -a marker of average 
blood glucose (BG) levels in the 2-3 months prior to the time the test is done- which is at or 
above 9% - considered to be poor control, and 1 or more additional risk factors for poor health 
outcomes. The program has been well received by MedStar Primary Care Providers and their 
diabetes patients. 
Patients who consent to join the program attend two 1:1 visits with a CDE followed by “virtual” 
visits via telephone/texting. DSSE is tailored to baseline DM knowledge and medication 
adherence deficits. An FDA cleared cellular-enabled blood glucose (BG) monitoring system 
(Telcare BGM®) auto- transmits BGs to a provider dashboard in near-real-time.  The CDE 
reviews BGs and contacts patients at minimum weekly to discuss and make adjustments to DM 
medications and/or lifestyle, until BG targets are reached.  The patient then returns to his/her 
Primary Care Provider (PCP) with any further ongoing DM management recommendations.  
Ninety-eight (98) patients with uncontrolled type 2 diabetes have completed the MedStar 
Diabetes Pathway Boot Camp.  A1C, a measure of average blood glucose control over the 2-3 
months prior to the test being done, was  checked at baseline and then after 3 months follow-
up.  Admissions and resource utilizations were measured for the period 6 months before 
baseline and then recorded between baseline and 3 months and between 3 months and 6 
months.  For comparison of A1C improvement, patients were matched to controls at a 1:3 ratio 
on age, sex, race/ethnicity, insurance group, and baseline A1C.  The difference in 
improvements of A1c between a case and its matched control was tested.   Utilization has not 
yet been captured for controls.  
Clinical and Health Resources Utilization Outcomes. 
• 
A1C Performance.   
Blood glucose control improvement, as measured by change in A1C results is shown below. 
 
 
 

Table 1: Change in A1C 
 
Boot Camp Cases 
Control Cases 
P value 
Baseline A1C (%) 
11.35 (1.86) 
11.41 (1.71) 
0.439 
3 month A1C (%) 
8.31 (1.52) 
9.77 (1.98) 
<0.001 
Change in A1C (%) 
-3.08 (2.01) 
-1.64 (1.97) 
<0.001 
Percent A1C lowering 
27% 
14% 
 
 
The 3.08 %  lowering of A1C among Boot Camp patients is highly clinically important.  In 
comparison, most drug trials where A1C lowering is measured, there is typically reduction in 
A1C of 0.5-1.5% depending upon the drug or drugs being tested1. Furthermore, a 1% absolute 
reduction in A1C can be correlated with an approximately 15% reduction in risk for myocardial 
infarction2. The fact that lowering in A1C was also seen among control cases is not completely 
unanticipated.  Per current standard care, when a patient presents with a markedly elevated 
A1C the physician caring for him/her would implement measures to help improve control which 
explains the concurrent fall in A1C over time. These results show that the Boot Camp 
intervention effectively doubled A1C lowering when compared to controls.   
• 
Health Resource Utilizations. 
Utilization for urgent care visits, urgent PCP visits, hospitalizations, and Emergency Department 
(ED) visits due to diabetes, taken in the 6 months before the listed time is shown in Table 2.  
Table 2.  Health Resource Utilizations  
 
Baseline (n) 
3 months 
6 months 
 
P value 
 
Number 
Number 
% Reduction 
Number 
% Reduction 
Urgent Care Visits 
3 
0 
 
0 
 
0.109 
Urgent PCP Visits 
13 
1 
91% 
1 
92% 
0.002 
Hospitalizations 
9 
1 
88% 
3 
66% 
0.207 
ED Visits 
18 
1 
94% 
2 
88% 
<0.001 
 
There is an association between time and urgent PCP visits and ED visits.  This means that for 
those patients enrolled in the program there appears to be a reduction over time in urgent PCP 
visits and ER visits following program completion. The number of hospitalizations was low 
overall and does show a trend for reduction over time. 
Summary of Findings. 
This pilot evidence demonstrates a significant impact on glycemic control and healthcare 
utilization measures as the result of a concise, focused DM education and medication 
management intervention.  
Phase 2.0 MedStar Diabetes Pathway Expanded Pilot 
Building on the success of the MDP Phase 1.0 pilot, the next steps in expanding the program 
will be as follows: 

➢ Transition of the Pathway from early feasibility pilot to the next phase as an expanded 
pilot program integrated within the MedStar Health System care delivery network and 
built upon a sustainable infrastructure (brick and mortar –plus- virtual components) 
across early adopter MMG practice sites. 
➢ Expand recruitment to include high risk patients with uncontrolled type 2 diabetes, 
including those with a new diagnosis and A1C >9%,  who have MedStar Emergency 
Department and/or Inpatient encounters 
➢ Spread to additional targeted MedStar Medical Group (A&B) Primary Care Practices 
and/or to MedStar Managed Care Plan participants (MedStar Family Choice, MedStar 
Select) 
 
As the MDP is transitioning into a clinical program offered at various MedStar sites, the MDP 
clinical team is reviewing the data collected during the pilot to improve the program and adapt it 
to various clinical settings in order to better serve the target patient population. It will be 
imperative to continue reviewing patient clinical outcomes as the program expands in order to 
insure continuous quality improvement of the program. This will be achieved through chart 
reviews of patients receiving diabetes care via the MDP. 
III- Chart Review and Data Collection 
MDP patients’ chart review: 
MDP target population: 
Inclusion Criteria 
• Active and established patient  of a MedStar Medical Group Ambulatory Primary Care 
practice provider:  
• Diagnosis of type 2 diabetes on EMR problem list for >1 year 
• New diagnosis of type 2 diabetes with A1C>9 
• Active practice patient as evidenced by one or more visits to PCP in the past 12 months 
• Age > 21 to < 75 years 
• A1C > 9.0% at their last visit to MedStar Medical Home, ED or hospital admission. 
• Primary Care Provider willing to have patient enter the program 
• Patient is able and willing to participate in the program  
• Proficient in English    
 
     -AND-  one or more of the following high risk characteristics:  
• Acute care encounter(s) including) ED visit(s) or hospital admission(s) in the past year 
with uncontrolled diabetes (BG> 200mg/dL or A1C >9%; severe hypoglycemia = BG 
<40mg/dL requiring assistance to treat)  
• Evidence of low medication adherence as evidenced by no refills since one or more 
prescribed DM RXs “ran out” (based on last Rx for each DM med and time period was 
prescribed for on EMR/SureScripts medications list); or any other circumstance that has 

been identified by the health care team which indicates  poor adherence to prescribed 
medication. 
• Does not meet HEDIS diabetes measures for two or more of: no MA/Cr, no DM retinal 
exam, no lipid profile  
• SBP  >140 mmHg  
• LDL>100 mg/dL  
• Depression diagnosis on problem list (or depression medication on med list)  
• BMI >32  
 
Exclusion Criteria 
• Known history of DKA 
• No MedStar PCP visit within past 12 months 
• Endocrine or Diabetes Education consult referral order in the past 6 months which 
resulted in Endo visit(s) or DSME visit(s) documented in chart or self-reported by patient 
during initial screen 
• Active additional medical issues which in the opinion of the care team would preclude 
concentrating on BG control and/or would predispose to ED visits and/or hospital 
admits independent of glycemic control, e.g.: severe CHF, severe COPD; severe mental 
illness. 
• Resident of skilled nursing facility, nursing home or receiving home health care services. 
• Active cancer in the preceding 3 years excluding nonmalignant basal cell cancer 
• Supraphysiologic doses of glucocorticoids (hydrocortisone > 30mg/day; prednisone > 5-
6mg daily; dexamethasone > 2mg daily). 
• Pregnant or anticipates attempting conception in the following year 
• Patient and/or custodial caregiver unwilling and/or unable to participate in program-
related activities 
 
The following data will be collected retrospectively from the charts of patients that complete the 
MDP. 
- 
Demographics  
- 
A1C baseline, at 3 month  after baseline visit to assess impact of the pathway. 
- 
Hypoglycemic events (BG<70 and <40) during the 6 months of enrollment in MDP 
- 
Diabetes 2 go Knowledge test  
- 
ED and hospital visits in 30 days and 90 days prior to and after the boot camp 
- 
Referring MedStar Provider satisfaction with intervention 
- 
Patient satisfaction with the MDP 
 
 
In addition, the clinical team will also compare the clinical and utilization outcomes of patients 
enrolled in the MDP with those of a randomly selected control group consisting of MedStar 

patients with elevated A1C levels. This will be done to allow a better assessment of the impact 
and effectiveness of the MDP. 
Once the data is obtained, it will be de-identified prior to data analysis and reporting. 
Demographics will be reported as a group, i.e. percentage of patients within a certain age group 
or geographic area or with a certain type of insurance to insure equal access to the MDP, and 
help recruit underrepresented groups so they can also benefit from the program.  
Data Management    
The MedStar Health Research Institute will provide data management services for all aspects of 
the chart review process, including preparation of the program REDCap database, quality 
checks of data and developing processes for bringing data into REDCap from available data 
sources held by system partners which will be leveraged for the program.  All data will be de-
identified prior to presentation to the Biostatician for analysis.  
Data Analysis and Reporting Plan 
Data analysis will be performed by the MHRI Biostatistician.  All data will be de-identified prior to 
submission to the biostatistician for analysis.  Results will be reviewed for quality improvement 
purposes and will also be presented at national meetings.  Additionally, one or more 
manuscripts will be prepared for submission to peer-reviewed journals. 
References 
1- Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach 
Position Statement of the American Diabetes Association (ADA) and the European Association 
for the Study of Diabetes (EASD). Silvio E. Inzucchi, MD,
1 Richard M. Bergenstal, MD,2 John 
B. Buse, MD, PHD,3 Michaela Diamant, MD, PHD,4 Ele Ferrannini, MD,5 Michael Nauck, MD,6 
Anne L. Peters, MD,7 Apostolos Tsapas, MD, PHD,8 Richard Wender, MD,9 and David R. 
Matthews. Diabetes Care. 2012 Jun; 35(6): 1364–1379.  
 
2- Turnbull FM, Abraira C, Anderson RJ, Byington RP, Chalmers JP, Duckworth WC, et al. 
Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 
2009;52:2288–2298.