diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: Minneapolis Heart Institute Foundation

ENHANCED 798246 
 
PROTOCOL 
Title:  diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)  
IRB number:  798246 
Protocol Version: 1 
Version Date: 6/25/2016 
 
PI: Michael Miedema 
 
Staff on study: Gretchen Benson, Abbey Sidebottom, Arthur Sillah, Joy Hayes, Jeff VanWormer, Safa Gamam 
  
 

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1. Study Synopsis: 
This will be a randomized-controlled trial to examine the impact of a Registered Dietitian (RD) led telemedicine program on diabetes outcomes 
for adults with type 2 diabetes. Two groups will be compared over one year; an intervention group who receives the telemedicine program 
versus a control group who receives usual diabetes care.  Specifically, we will assess the ‘D5,’ which is a set of five treatment goals that when 
reached together, represent the gold standard for managing diabetes. D5 outcomes includes the proportion of participants in each group who 
achieve goal levels for blood glucose, blood pressure, tobacco use, statin use, and aspirin use.  
 
2. Background:  
Diabetes is a progressive, complex disease that requires frequent follow-up and ongoing care. Five key metrics—blood glucose, blood pressure, 
tobacco use, statin use, and aspirin use – commonly referred to as the “D5” are targeted in individuals with diabetes to reduce the risk of health 
complications1. A recent review found that some risk factors were generally improving in U.S. adults with diabetes (e.g. blood glucose, LDL 
cholesterol), but 30-50% still did not meet individualized targets for glycemic control, blood pressure, or lipid control, and more than 20% 
remained smokers2. 
 
Poor diabetes control is also evident at local levels, particularly where access to diabetes care and education is more limited. In Hutchinson, MN, 
a rural region about 60 miles west of the Minneapolis metropolitan area, diabetes care quality is below the state average.  The same is true for 
New Ulm Medical Center (NUMC). According to Minnesota Community Measurement, 30% of Hutchinson Health’s diabetes population is at goal 
on all D5 measures and 39% for NUMC. The breakdown of individual D5 measures for diabetes patients in Hutchinson and NUMC, respectively 
include:  
o Blood pressure <140/90 mmHg (81%, 87%) 
o Statin use (83%, 64%) 
o Glycated hemoglobin (A1C) <8% (46%, 68%) 
o Not using tobacco (86%, 88%) 
o Taking daily aspirin as appropriate (99%, 99%) 
 
Most diabetes care in the U.S. is delivered by primary care providers (PCPs), although it is well documented that PCPs face significant time 
constraints to address all health issues adequately. The National Standards for Diabetes Self-Management Education3 emphasize the importance 
of a multidisciplinary clinical care team, which includes a registered dietitian (RD), to reduce disease risks. The role of the RD is well established 
for nutrition, physical activity, and behavior change education with high risk patients, but the involvement of RDs in other aspects of diabetes 
care is more limited, particularly as it relates to medication management. The few studies in this area have found encouraging results. Robinson 
and colleagues demonstrated that RDs who followed a lipid-titration algorithm were able to double the number of patients meeting lipid goals4. 

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Worth and Davies found that RDs who recommended, monitored, and titrated lipid-lowering therapies were able to achieve significant 
improvements in both total cholesterol and triglycerides5. 
 
Innovative models are clearly needed to complement usual diabetes care. Achieving blood pressure, lipid, and glucose goals in adults with 
diabetes requires extensive lifestyle counseling, patient education, and pharmacological therapy, with frequent follow-ups to address challenges 
as they arise. This study will examine the impact of an RD-led, primary care integrated, telemedicine program on the D5 measures over one year 
as compared to a usual care group that will receive usual care only during this timeframe. 
 
 
 
 
3. Specific Aims 
The specific aims of this study are to: 
 
1. Compare individual and composite D5 optimal care measures between patients in the intervention group vs. those in the usual care group.  
 
2. Analyze changes in secondary outcomes including nutrition, physical activity, body mass index, medication adherence and gender.   
 
Methods 
4. Subjects and Setting:   
Sample.  We will seek to recruit 144 participants for this trial.  Patients will be recruited from Hutchinson Health in Hutchinson, MN and New 
Ulm Medical Center in New Ulm, MN in order to reach our recruitment goal.  Hutchinson Health is an independent hospital/clinic that contracts 
with Allina Health to use their EHR. New Ulm Medical Center is part of the Allina Health system. Eligible patients will be identified by Allina 
Health informatics personnel based on the most recent available information contained in the EHR. Only EHR data from the previous 2 years will 
be considered to determine eligibility. Data will be extracted from the EHR system to identify individuals who are seemingly eligible for this study 
based on the criteria listed below. Each individual’s most recent value for each measure from the previous 2 years will be considered. Values 
greater than 2 years old will be considered missing. Inclusion criteria will be: 
• 
Diagnosis of type 2 diabetes 
• 
Meeting 0-3 of the D5 measures 
• 
Individuals meeting 0 of the D5 measures and have no more than two missing measures 
• 
Individuals meeting 1 of the D5 measures and have no more than one missing measure 

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• 
Age 40-75 years 
• 
‘Homed’ in the Hutchinson Health clinic. This is defined as having at least one ambulatory care visit at the Hutchison Health clinic in the last 2 
years. 
• 
‘Homed’ at the New Ulm Medical Center. This is defined as having at least one ambulatory care visit at NUMC in the last 2 years. 
 
 
 
Exclusion criteria:   
• 
Individuals meeting ≥ 4 D5 measures 
• 
Individuals meeting ≥ 2 D5 measures with any missing measures 
• 
Type 1 diabetes  
• 
Chronic kidney disease (GFR <30) 
• 
HIV 
• 
Institutional residence 
• 
Major cognitive or language barrier (as determined by program enrollment staff) 
• 
Other active end-stage disease (e.g., late stage cancer or pulmonary disease) 
• 
Actively receiving cancer treatment 
• 
Pregnant 
 
 
 

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Study Recruitment 
 
Recruitment will be conducted over a four to six month timeframe beginning in late 2015 and will start with Hutchinson Health. Once 
recruitment efforts are exhausted in Hutchinson, the same process will occur at New Ulm Medical Center.  Contact information for study-eligible 
individuals will be extracted from the Hutchinson Health and New Ulm Medical Center/Allina Health EHR. A random sample of these 
enumerated individuals will be drawn and an initial letter will be mailed, signed by their PCP that contains a description of the study and an 
invitation to contact the study team by phone for eligibility screening. Up to three additional outreach attempts by phone will be made until a 
response is received. The screening phone call will confirm study eligibility and the baseline study (enrollment) visit will be scheduled with a 
study team member. Patients will be instructed to fast prior to their baseline visit in order to obtain accurate lab values. 
 
 
Baseline study visit  
 
• 
At the baseline visit, patients will be provided with study related information and have an opportunity to ask questions. Study personnel 
will verify inclusion/exclusion criteria to confirm eligibility. If subjects meet study criteria, they will be consented to participate in the 
study. The baseline visit will be completed in–person for all participants and will be led by a study coach with the assistance of lab 
personnel. They will last 30-45 minutes and include detailed study explanation and consent, completion of baseline lifestyle survey, 
measurement of anthropometrics, and a blood draw (described further below). In addition, a brief education session with a study coach 
will be conducted and focused on optimal diabetes measures and basic diabetes nutrition and physical activity recommendations. 
Individuals will also receive a diabetes basics booklet from the International Diabetes Center. Randomization will take place at the end of 
the visit using a 5 block envelope; an equal number of participants will be randomly assigned to the intervention and control groups. For 
those randomized to the intervention group, the first phone appointment will be scheduled upon completion of the baseline visit. 
 
Measures.  The primary outcomes will include changes in the D5 measures (A1C <8%, blood pressure <140/90 mmHg, not using tobacco, taking a 
statin and aspirin use as appropriate). These measures will be ascertained at baseline and 12 months after study enrollment. Interim D5 
measures and those unavailable at follow-up will be extracted from Hutchinson Health and NUMC’s EHR where possible. Secondary outcomes 
will include nutrition, physical activity, body mass index, medication adherence, confidence and satisfaction with diabetes management and 
gender. Specifically: 
- 
Height 
- 
Weight 
- 
Waist Circumference 
- 
Blood pressure 
- 
Labs: A1c, fasting glucose, lipids 
- 
Lifestyle questionnaire (see attachments) 

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Phone coaching 
Phone visits will occur monthly over the course of one year, with some variability as needed such as more frequent phone contacts when a 
medication is started. They will be conducted by study coaches and last approximately 30 minutes. Topics will include: 
• 
Brief lifestyle & medication assessment 
• 
Nutrition coaching regarding appropriate choices (e.g. carbohydrate choices at meals/snacks, healthy fats, portion control). 
• 
Physical activity recommendations 
• 
If needed, medication initiation/titration for blood pressure, cholesterol or blood glucose 
 
 
12-month/Final visit 
The study follow-up visit will be similar to the baseline visit and occur at the Hutchinson Health clinic about 12 months later. The study 
follow-up visit will occur at NUMC for those patients identified from New Ulm. This will again be in-person and conducted by study coaches 
and lab personnel. The same measures will be taken as at baseline.  
 
 
5. Study Procedures & intervention: 
At the baseline visit, study participants will be randomized into the intervention or control group by computer using block randomization (block 
size 5). 
 
Coaches in this study will be registered dietitian/certified diabetes educators trained to address the D5 optimal care measures. They will also be 
trained in the use of a medication protocol that permits initiation and titration of blood glucose, lipid, and/or blood pressure medications 
(attachment). All coaching aside from the baseline and final visits is done via telephone and participants will generally receive a minimum of one 
call per month. The intervention is designed to complement to usual clinic-based primary care, with coaches documenting lab, biometrics, and 
medication adjustments in the EHR, along with documenting phone encounters and communicating directly with patients’ PCPs as needed. 
 
Documentation in the EHR uses an order created specifically for the study indicating the patient’s research status; “opt-in” for those who choose 
to enroll.  
 
To answer outcome evaluation questions, all individuals with a diabetes research study order will be extracted from the EHR along with baseline 
and 12 month D5 measures collected during respective visits. For comparisons between the intervention and usual care patients, the analysis 

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will examine mean changes in biometric risk factors and the percentage of patients meeting recommended levels for the D5 measures at 
baseline and after the one year intervention period. Medication changes will also be examined and compared between the two groups. 
 
 
Study procedures will be approved in advance by the Allina Institutional Review Board. 
 
 
Analysis  
Analyses and power. A moderate effect size is expected of at least (Cohen’s w=0.25) in this trial. Over one year, this translates into about 30% of 
the intervention group experiencing improvement in ≥1 D5 measure vs. 10% of usual care participants. Under the assumptions of 85% power, an 
alpha-level of 0.05, and a one degree of freedom test, 144 total participants (72 in each group) will be needed for this study. Mixed regression 
models will be used to compare D5 outcomes between the two study groups over time. Similar analyses will be conducted on secondary 
outcomes as well. An intent-to-treat framework will be used that will include all randomized participants.   
 
 
6. Risk/ Safety information 
This study is minimal risk because the only risks associated with this study are: 1) Potential identification of individuals; 2) Individuals may be 
uncomfortable answering certain questions in the questionnaire; and 3) Potential risk associated with venipuncture at baseline and 12 month 
visit; 4) patient may experience adverse side effect from being started on a blood pressure, statin, or diabetes (blood glucose) medications. 
However, all of the medications on the protocol are currently used in diabetes care standards of practice (none are investigational).   
1. To mitigate this risk, the study personnel with access to this data already have access to similar types of data for their work and have 
procedures in place to limit access to this identifying information. Data is stored in a secure folder at Allina, and patient identifiers will be 
eliminated from data sets after appropriate analysis is done.  
2. Study participants can choose not to answer any questions in the questionnaire that may make them uncomfortable. 
3. Venipuncture: There are minor risks associated with drawing blood. Participants may feel brief pain, develop a bruise, become 
lightheaded, or faint. In rare cases, an infection may occur. 
4. Medication protocol: Any medications prescribed by the RD/Phone coach will require a co-signature by the patient’s primary care 
provider or medical director. This intervention poses no more risk than going to a primary care provider for diabetes care management. 
The protocol also has indications for assessment and action for those who experience side effects (see Diabetes Medication Protocol 
appendix). 
 
7. Monitoring / Reporting of AE/ SAE 

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We believe this study poses no more than minimal risk and as such do not expect any safety events. The main risk with this type of study is 
potential identification of individuals included in the study, risk associated with venipuncture or an adverse reaction to a medication. Only 
individuals on the study research team will see the individual level data in this study. If there is a breach of confidentiality, those people will 
work together to report it to the compliance office and IRB and follow the appropriate procedures. However, we will follow all standard 
procedures to ensure data privacy is maintained by storing data in a limited access folder that is on the Allina servers.  
 
8. Study Oversight 
We do not foresee any conditions under which this study would be prematurely terminated as the risks associated with participating in the 
diabetes research project are minimal and include no more risk than usual care. If the study is prematurely terminated, the study will be made 
available for monitoring, auditing, IRB review and regulatory inspection by providing direct access to study related source data. 
  
9. Data Management 
The diabetes research study database will be maintained by the MHIF team and a final research data set will be created which will be managed 
by team members from Allina Health who maintain this data as part of their routine job responsibilities. All analysis will be done in SPSS by 
members of the research team. Data will be maintained in a limited access folder on Allina Servers.  
 
10. IRB Review/ Ethics/ Informed Consent 
The protocol and relevant supporting information must be submitted to the IRB for review and must be approved before the study is initiated. In 
addition, any subject recruitment materials must be approved by the IRB prior to being used. This study will be conducted in accordance with the 
ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory 
requirements. The study must be conducted in accordance with applicable regulations, applicable laws and the IRB requirements. The Sponsor 
must submit any change to the protocol to the IRB for review and approval before implementation. 
 
 
11. Confidentiality 
Only 5 people will have access to identifying data through this study. Two are Allina employees who work with patient data for research 
purposes as part of their job and as such will follow standard procedures for protecting data privacy. The other three are employees of the 
Minneapolis Heart Institute Foundation who oversees the HBC program. Through a contractual agreement between Allina and MHIF, this person 

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has access to the Allina EHR and has access to patient data related to the HBC program. Data is stored in a secure folder at Allina with access 
limited to the people doing analysis and the health informatics person pulling data out of the EHR, and patient identifiers will be eliminated from 
data sets after data cleaning and analysis is done. All study records identifying the subjects will be kept confidential and will not be made publicly 
available or presented in any publications. 
The IRB could review records if determined necessary.  
12. Intended Use of the Data  
The data is intended to measure changes in D5 measures among study participants who receive a phone coaching intervention compared to a 
usual care group. A manuscript will be prepared based on the information obtained from the study.  
 
 
 
References 
 
 
1. The D5: Five Goals for Living Well with Diabetes. www.mnhealthscores.org. Accessed June 12, 2015.  
2. Mohammed KA, et al. Achievement of Goals in U.S. Diabetes Care, 1999–2010. NEJM. 2013; 368:1613-1624. 
3. Funnell, MM, et al. National Standards for Diabetes Self-Management Education. Diabetes Care. 2008; 31: S97-S104. 
4. Robinson, JG, Controy, C, Wickemeyer, WJ. A novel telephone-based system for management of secondary prevention to a low-density 
lipoprotein cholesterol < 100 mg/dl. Am J Cardiol. 2000;85:305-308. 
5. Worth, JM, Davies, RR, Durrington, PN. A dietitian-led lipid clinic is effective. Prac Diabet Int. 2006;23(5):221-228. 
 
 
 
 
 
 

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Primary and Secondary Outcome Measures of the ENHANCED Study 
Primary and Secondary Outcome Measures of the ENHANCED Study 
 
Measures 
Description 
Lifestyle  
(self-report survey) 
Tobacco use 
Self-reported; single item indicating current, former, or never 
used tobacco 
 
Secondhand 
smoke 
Self-reported; single item indicating weekly smoke exposure1  
 
Alcohol 
consumption 
Self-reported; modified version of screener developed for 
World Health Organization2; 2 items; frequency and  indicating 
‡ 15, 8–14, 1–7, or 0 drinks/wk; categorized as high ( > 14 
[men] or > 7 [women]), moderate (1–14 [men] or 1–7 
[women]), or none (0) per the EPIC-Norfolk study 
 
Physical activity 
Self-reported; screener developed for the Behavioral Risk 
Factor Surveillance System3; 2 items; moderate physical 
activity reported in days/week and minutes/day 
 
Breakfast 
Self-reported; single item; frequency4 
 
Fruit, vegetable 
and whole grain 
intake 
Self-reported; 3 items modified from AHA Simple 75; daily 
intake of fruits, vegetables  and whole grains  
 
Sodium intake 
Self-reported; 4 items modified from AHA Simple 75 (tracking, 
eating out, pre-packaged foods and added salt) 
 
Meal planning 
Self-reported; 4 items; frequency of carbohydrate counting 
and using portion control strategies 
 
Sugar-sweetened 
beverage intake 
Self-reported; single item modified from AHA Simple 75; 
weekly intake 
 
General health 
Self-reported; single item; rate poor to excellent7 
 
 
Intention to 
improve 
lifestyle 
Self-reported; single item indicating yes, maybe, or no 
intention to improve lifestyle habits over the next 
6 months 

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Confidence in 
managing 
diabetes 
Self-reported; single item modified from Kettering Health 
Network and Joslin Diabetes Center Diabetes Self-
Management Questionnaire6; degree of confidence   
 
Satisfaction with 
diabetes care 
Self-reported; single item; degree of satisfaction7 
 
Social and 
emotional support 
Self-reported; single item; frequency7 
General diabetes  
care 
(self-report survey 
Diabetes 
education 
Self-reported; 3 items; last diabetes class7, last visit with 
diabetes nurse educator8, and last visit with dietitian8 
 
 
Aspirin use 
Self-reported; single item indicating daily aspirin or every 
other day use9 
 
Medication 
adherence (statin, 
blood pressure, 
and diabetes) 
Self-reported; 15 items; The MMAS10 is a generic self-
reported, medication-taking behavior scale in which the 
specific health issue (high blood pressure, diabetes, 
elevated cholesterol, HIV, contraception, etc.) is inserted 
for the “health concern.” The MMAS consists of four items 
with a scoring scheme of “Yes” = 0 and “No” = 1. The items 
are summed to give a range of scores from 0 to 4. 
 
 
Blood glucose 
monitoring 
Self-reported; 2 items; frequency4,7 
 
Hypoglycemia 
Self-reported; single item; frequency11 
Anthropometrics 
(staff measured) 
Blood pressure 
Staff measured; participants sit for 5 min prior to 3 pressures 
taken 1 min apart using auto sphygmomanometers (mean of 
last 2 measures recorded)  
 
Body mass index 
Staff measured; calculated by dividing weight (measured with 
digital scale, in light street clothes and no shoes) in kg by 
height (measured using with a stadiometer and no shoes) in 
meters squared; categorized as obese ( ‡ 30.0), overweight 
(25.0–29.9), or not obese/overweight ( < 25.0) per national 
guidelines 
 
Waist 
circumference 
Staff measured; distance around the body at the superior 
border of the iliac crest; categorized as obese ( ‡ 30.0), 

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REFERENCE 
1. Prochaska JJ, Grossman W, 
Young-Wolff KC, Benowitz NL.   
Validity of self-reported adult 
secondhand smoke exposure. Tob 
Control. 2015 Jan; 24(1): 48–53.  
2. Saunders JB, Aasland OG, Babor 
TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO collaborative project on early 
detection of persons with harmful alcohol consumption-II. Addiction. 1993;88:791–804. 
3. Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, GA: US 
Department of Health and Human Services; 2009. 
4. Stanford Patient Education Research Center. Diabetes Questionnaire. Available from 
http://patienteducation.stanford.edu/research/breakfast.html. Accessed 26 October 2015. 
5. American Heart Association. My Life CheckTM Simple 7TM Assessment. Available from 
http://mylifecheck.heart.org/AssessmentTools2/main_en_US.html. Accessed 26 October 2015. 
6. Kettering Health Network and Joslin Diabetes Center. Diabetes Self-Management Questionnaire. Available from 
http://www.ketteringhealth.org/diabetes/pdf/questionnaireKett.pdf. Accessed 26 October 2015. 
7. Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, GA: US 
Department of Health and Human Services; 2014. 
8. Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey (NHANES). Atlanta, GA: US 
Department of Health and Human Services; 2014. 
9. Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, GA: US 
Department of Health and Human Services; 2013. 
10. 
Morisky DE, Green LW, Levine DM. Concurrent and Predictive Validity of a Self-Reported Measure of Medication Adherence and Long-Term Predictive Validity of Blood Pressure Control. Med Care 
1986; 24:67-74.  
11. University of Louisville Health Behavior Change Research Lab. Personal Diabetes Questionnaire. Available from 
http://louisville.edu/psychology/stetson/lab/personal-diabetes-questionnaire. Accessed 26 October 2015. 
 
 
overweight (25.0–29.9), or not obese/overweight ( < 25.0) per 
national guidelines 
Biometrics 
(laboratory) 
Total cholesterol 
Venipuncture following request of 12-hour fast; standard 
Hutchinson Health medical laboratory blood collection and 
processing procedures  
 
 
HDL cholesterol 
 
LDL cholesterol 
 
Triglycerides 
 
Blood glucose 
 
A1c