STANDARDIZED PROTOCOL: TREATMENT OF DIABETES IN …...STANDARDIZED PROTOCOL: TREATMENT OF DIABETES...

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STANDARDIZED PROTOCOL: TREATMENT OF DIABETES IN ADOLESCENTS 1 Management of Type 2 Diabetes in American Indian Adolescents Ages 1319 Carissa Bergman RN, BSN, CHPN N895 San Francisco State University

Transcript of STANDARDIZED PROTOCOL: TREATMENT OF DIABETES IN …...STANDARDIZED PROTOCOL: TREATMENT OF DIABETES...

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Management of Type 2 Diabetes in American Indian Adolescents Ages 13­19

Carissa Bergman RN, BSN, CHPN

N895

San Francisco State University

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Carissa Bergman

San Francisco State University 2014

Abstract

American Indians are two to six times more likely to have diabetes compared to the overall United

States population. Over the last 20 years, within the American Indian community, the predominance of

type 2 diabetes has sharply risen in the adolescent age bracket. The purpose of this field study is to

evaluate the most current evidence­based research and use the acquired data to create a standardized

protocol to assist Nurse Practitioners in the management of American Indian adolescents, ages 13­19,

with type 2 diabetes.

I hereby certify that the Abstract is a correct representation of the content in this field study.

Dr Andrea Renwanz Boyle, PhD, ANP­BC Date Chair: Field Study

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Certificate of Approval

I certify that I have reviewed Management of Type 2 Diabetes in American Indian Adolescents ages

13­19 by Carissa Bergman RN, BSN, CHPN and that it meets the appropriate criteria for the field

study requirements for the degree of:

Master’s of Science in Nursing, emphasis in Family Nurse Practitioner from San Francisco State

University.

Andrea Boyle PhD, ANP­BC

Connie H.Carr MSN, FNP­BC

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Introduction

Type 2 diabetes mellitus (T2DM) is becoming a worldwide health concern among children and

adolescents. This disease, formally known as adult­onset diabetes, is being diagnosed with increasing

regularity in the young. According to a recent study, the projected burden of childhood diabetes in this

country will nearly quadruple by 2050, an increase of nearly 49% (Imperatore, 2012). This diabetic

crisis is already costing the United States $174 billion annually and is anticipated to rise (NDEP,

2011).The financial burden is even reflected amongst the diabetic youth with the expenditure for

diabetes being 6.2 times higher than with a healthy child (Imperatore, 2012).

Ethnic minorities are disproportionately impacted by type 2 diabetes and found in especially high

numbers within the juvenile American Indian population. One study, evaluating disease incidence among

different ethnic adolescents, found type 2 diabetes among non­hispanic whites to be 6% as compared to

American Indian youth with a prevalence of over 76% (1.74 cases per 1000 youths), rating higher than

any other racial group (Liese, 2006). Not only do American Indian children/adolescents have a higher

percentage rate of type 2 diabetes, but the increase in incidence of disease is considered alarming.

According to the American Diabetes Association, type 2 diabetes amongst American Indian youth ages

15­19 has increased 68% from 1994­2004 (ADA, 2013). Unlike other ethnicities where type 1

diabetes is dominant, American Indians (AI) are 95% more likely to have type 2 diabetes than type 1

diabetes (ADA, 2013).

At the present time very little integrated research on diabetes in American Indian adolescents

have been executed. It is imperative for Nurse Practitioners (NPs), practicing within the confines of the

American Indian community, to have proficiency and mastery of culturally specific diabetes in order to

provide medical care and education to this population. To better assist the Indian community, this

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project will review relevant research to create a medical protocol for the care of American Indian

adolescents, ages 13­19, with type 2 diabetes mellitus (T2DM). With the use of valid research, the

topic will be reviewed and cover the latest evidenced­based recommendations for: evaluation,

treatment, follow up, and educational needs for American Indian Adolescents, while observing special

care in the cultural differences within this population.

Significance and Definition of Type 2 Diabetes in American Indians

The prevalence of type 2 diabetes among American Indians is four times higher than the general

population in the United States and is considered the fourth leading cause of death within this culture

(O’Connell, 2010). Although type 2 diabetes is more prevalent in adulthood, there has been a significant

increase amidst children and adolescents. For those in this population under the age of 20, it is estimated

that 3,700 children/adolescents will be diagnosed with type 2 diabetes annually (Imperatore, 2012).

Type 2 diabetes is a metabolic, chronic condition, triggered by insulin resistance or decreased

insulin production. This in turn decreases an ability to metabolize sugar resulting in hyperglycemia

(ADA,2013). High levels of glucose in the bloodstream over long periods of time can cause damage to

both the micro and macrovascular systems resulting in other chronic illnesses which can cause potentially

life threatening complications.

The American Diabetic Association (ADA) recommends individuals diagnosed with type 2

diabetes be closely monitored and treated according to appropriate guidelines. It is possible to manage

diabetes in adolescents through proper monitoring, treatment, and education on interventions such as

blood glucose monitoring, medication, and/or appropriate lifestyle choices.

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Purpose of Standardized Protocol in Diabetic Adolescent

The purpose of this document is to evaluate current evidenced­based research in order to

create a protocol that focuses on the treatment and disease prevention of type 2 diabetes in

asymptomatic adolescent American Indians ages 13­19. This protocol has been developed to assist the

Nurse Practitioners (NP) in the treatment of type 2 diabetes in adolescents which includes the use of lab

monitoring, lifestyle modification therapy, (through diet and exercise regimens) and medication therapy.

It provides criteria for determining which adolescent requires further evaluation for diabetes when a

patient presents asymptomatically. The protocol recommends a detailed history be taken along with a

thorough physical examination focusing on the clinical presentation of diabetes and any potential vascular

complications. Laboratory tests should be done to establish initial diagnosis, using fasting blood sugar

(FBG) and the oral glucose tolerance test (OGTT), as well as hemoglobin A1c (HgbA1c) every three

months to monitor and titrate current treatment. Other tests should also be complete to evaluate for

complications of disease, these include lipid profile and renal levels.

The Nurse Practitioner should also design a culturally friendly, family­peer driven treatment plan

for AI adolescents addressing medication, diet, and exercise regimens. Education for this population is

imperative and should include blood glucose monitoring, nutrition, physical activity, emotional support,

stress management, and other supportive therapy.

By developing this youth centered protocol, nurse practitioners will understand how to direct

and manage care of adolescents ages 13­19 with type 2 diabetes. This protocol utilizes the latest in

evidence­based literature providing a comprehensive guideline for nurse practitioners to follow when

addressing management of AI youths with type 2 diabetes.

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Literature Review

To locate recent evidence­based studies from 2009­2014, the bibliographic database of

CINAHL (Cumulative Index to Nursing and Health Literature), PubMed, American Diabetic

Association (ADA) Diabetes Pro were chosen as well as the utilization of Google Scholar as the search

engine. A combination of search terms: ‘American Indian’, ‘youth’, ‘type 2 diabetes’, ‘treatment’,

‘education’, ‘13­19 years of age’, and ‘adolescent’ were used to collect relevant data. The studies

include a variety of randomized controlled trials, prospective cohort studies, case control studies,

descriptive studies, as well as one seminal study from 2002. A compilation of multiple peer reviewed

publications were integrated to formulate the best method of care for the treatment and prevention of

diabetes type 2 in American Indians (AI) adolescents. After analyzing the content of the research, it was

determined that the best strategy to organize this literature review was a topical approach. Seventy

journals were explored however, only twenty three journals were used to create this protocol.

The relevance and appropriateness of the research content was reviewed and determined

whether it used primary or secondary information, compared/contrasted data, and/or searched for the

strengths and weaknesses within each of these studies. The intention was to point out major themes in

the literature and acknowledge the gaps that may exist in order to create a protocol to use in any

medical practice.

Prevalence of Type 2 Diabetes amongst American Indians

Previous research suggests a strong correlation between type 2 diabetes and American Indians.

In a 2012 prospective cohort study, Imperatore, et al. observed the future projection of diabetic

increase incidence among the under 20 year old population. The purpose of this study was to project

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what the future of diabetes in children would be in 2050 if current health trends progressed incrementally

as they are today. In order to create a relevant study, the researchers used a large sample size of

154,000 diabetic children from both the U.S. census and the SEARCH study data pool. The study was

strengthened by utilizing modern models (ie poisson regression and dynamic transmission model) to

most accurately estimate the advancement of type 2 diabetes in children and adolescents through the

year 2050. The analysis was also bolstered by the consistently used inclusion criteria of age, sex and

racial ethnicity to collect data. While the study had its strengths, it was also limited by not factoring in the

research of current and future diabetic interventions across the country that have shown a decrease in

the presence of type 2 diabetes. The study concluded that a four fold increase in type 2 diabetes

amongst the youth of the US is expected by 2050.

Another study supporting the disparity of diabetes amongst American Indians is the 2010 study

by O’Connell, et al. This study concentrated its research on the potential morbidity of type 2 diabetes

amongst two specific populations­ the American Indians and the general United States population. The

study drew its data from a combination of both Indian Health Service (IHS) database (n=30,121) as

well as from the MarketScan Research Database (MSRD) (n= 1,500,002). The independent variables

of age, sex, and comorbidities were uniformly collected from both databases.The researchers used

ICD­9 codes to accurately identify comorbidities which further strengthen the variables. The Diagnostic

Cost Group (DCG) model was utilized to incorporate an overall relative risk score for each individual

based on comorbidities­ the higher the risk score the higher the morbidity. The study was strong with its

large sample size and its ability to capitalize on an established model like DCG. One weakness of this

study is the lack of data collected from individuals with no insurance, medi­cal, or medicare

recipients­data that may better represent the American Indian population. Another limitation is the

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study’s focus solely on adults ages 18­64. Even though the study does not target adolescents, the data

may shed some light on future complications of improperly managed diabetes amongst 13­19 year olds.

The data noted a mortality burden among American Indians with diabetes that exceeded insured US

adults by 50%, a statistically significant (P<0.05) finding. The data also suggested AI with type 2

diabetes were found to have higher rates of end stage renal disease, lower limb amputation, and heart

disease compared with the rest of the US.. Overall, this study was able to create a cause and effect

relationship between diabetes and a higher morbidity amongst the American Indian population.

Hemoglobin A1c directed treatment in American Indian Youth

Although the current American Diabetic Association (ADA) guidelines suggest use of the lab

value Hemoglobin A1C (HbA1c) for monitoring disease progression in youths (at or below 7%) with

type 2 diabetes, it is unclear in the studies whether HbA1c should be used to establish a diagnosis and a

treatment plan in this population as well.

A cohort study by Nowicka, et. al. (2011) attempts to address this concern by evaluating the

“sensitivity and specificity” of HbA1c and its potential use as a diagnostic tool with or in lieu of the

current gold standard oral glucose tolerance test (OGTT) for children/adolescents. The sample of 1,156

obese adolescents was recruited from the Yale pediatric clinic between 2005­2010. One strength of the

study was that the dependent variables of oral glucose tolerance test (OGTT) and HbA1c were

consistently evaluated throughout the study. Another strength is the subjects had strict inclusion criteria

(>95% BMI for age, sex and no diabetes) and exclusion criteria (known diagnosis of type 2 diabetes,

previous testing, and/or on medication to lower diabetes). Although the study did evaluate various

cultures (Caucasian 36%, African American 35%, Hispanic 29%), a major limitation was the lack of

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American Indian culture in the data set. In conclusion, HbA1c data was meaningful as a clinical tool

however, as a diagnostic measurement the level highly underestimates the actual lab values for

prediabetes, making HbA1c a poor choice to diagnose children/adolescents.

The Petitti, et. al. 2009, study was focused on what HbA1c lab value levels mean when

monitoring in youths (ages 20 and younger) with diabetes. The research itself was a cross­sectional

analysis from a six centered US study with a sample size of 3947 children with type 1 and 552 with type

2 diabetes. The research demonstrated that certain ethnicities, in particular the American Indian youth,

had worse glycemic control than non hispanic whites. The results also suggested a higher percentage of

youth fall above the recommended HbA1c target value, which if not controlled, could cause a lifetime of

poor health (ie. macro/micro vascular conditions, cardiac disease, or premature death). The strengths of

the study were the sample size, diversity, and coverage of both Type 1 and T2DM. Another strength

was the authors’ ability to acknowledge the limitations of the study and the need for further research.

One limitation was the researchers did not distinguish between type 1 and 2 diabetes in the data

interpretation. Another weakness was the use of a single variable, HbA1c, without consideration of

length of patients diabetes, current treatment regimen, underlying disease process, or

“sociodemographic factors”( ie. living environment, parental involvement, education level as possible

other causes for poor control).

Although neither study was able to establish HbA1c was useful in the diagnosis of diabetes, the

literature suggested that use of Hemoglobin A1c is an appropriate tool in the continued monitoring of

children/adolescent with an established diagnosis of type 2 diabetes. In conclusion, the use of the ADA

recommendation HbA1c level (at or below 7.0%) should continue to dictate treatment but should not

be used to diagnose a child/adolescent with diabetes.

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Use of Medications in Asymptomatic American Indian Diabetic Adolescents

Due to safety and efficacy issues, the FDA has yet to conduct trials on the use of medications

on diabetic youths. Since limited research on medication use have been completed, most practitioners

remain guarded in practice and chose to prescribe only Metformin, the one medication considered safe

for administration in children/adolescents.

The Jones, et. al. clinical trial from 2002 is the most well referenced research as pertaining to

youth, diabetes type 2, and medication administration. This seminal work was referenced to in several,

well established organizations research including the American Academy of Pediatrics, ISPAD 2009,

American Diabetes Association, as well as cited over 300 times on Google Scholar. The purpose of this

research was to establish the safety and efficiency of using Metformin in children with type 2 diabetes.

This research, although small, was strong due to its use of randomized double blind control trial. The

study used children ranging in age from 10­16 and was completed at 44 various sites in 5 countries

using stringent, uniform protocols. Each subject had very strict inclusion/exclusion criteria in order to

participate including a fasting plasma glucose (FPG) level of > or = 7.0, HbA1c of > or = 7.0 %,

stimulating C­peptide of > or = 0.5 nmol/l, and a BMI > 50th percentile for age which strengthen the

study. The 82 individuals who met the criteria were randomly assigned to either Metformin (titrating to

1000 mg BID) or the placebo group. The study does have its limitations including the sample size being

small (N=82) and the length of study being short (16 weeks). However, overall the results showed to

have statistical significance (P < 0.001) in meeting the target FPG and HbA1c level in the Metformin

group at 85% (with no adverse reactions) compared with the children that received the placebo (22%).

In 2012, the TODAY study (2004­2009), by Zeitler, et al., investigated three separate

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treatment options: Metformin (1000 mg BID) alone, Metformin (1000 mg BID) combined with

Rosiglitazone (4 mg BID), or Metformin along with lifestyle modification program. The study, funded by

the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), consisted of 699

participants ranging in age from 10­17 years of age and assigned randomly via computer generated

selection into one of the three groups. Criteria of eligibility consisted of a diagnosis of type 2 diabetes

within last 2 years, a body mass index (BMI) > or = 85% for sex and age, a negative diabetic related

autoantibody test, a fast C­peptide level of 0.6 ng per ml, and availability of caregiver willing to support

the child through study. Once assigned to a group, children participated in the study from July

2004­February 2009 and continued with a minimum of 2 years follow up after the study. The study

used HbA1c as the variable, testing every 2 months the first year and then four times a year thereafter.

The study was strong in its equal representation of races (blacks­32.5%, hispanics 39.7%, white 20%),

length of study (average of 3.86 years of participation), and its randomization. A limitation to this study

was adherence to the medication regimen dropped from 84% at 8 months to 57% at month 60 with no

major differences across comparison groups. Although these results appear to have a significant

downfall, the adherence did not seem to impact the rate of glycemic control between participants who

did and did not have treatment failure.

Serious adverse effects noted in 19.2% of participants (18.1% Metformin group, 14.6%

Metformin + Rosiglitazone, and 24.8% in Metformin with lifestyle group) however, 87% of the

reactions were not considered related to the study and were due predominantly to hypoglycemic events.

On the one hand, the results found clinically significant improvement in glycemic control with Metformin

and Rosiglitazone group (with a P value of of 0.006) on the other hand, one major consideration is this

cohort had an increase in weight gain (similar to another study conducted on Rosiglitazone.)

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Monotherapy with Metformin captured glycemic control in only half the children, while Metformin with

lifestyle change showed no clinical significant differences. Not to decrease the importance of lifestyle

changes in this population, the researchers did find this group to have a decrease in the percentage of

overweight children..

At the time this study was conducted, Rosiglitazone was restricted due to potential

complications of heart attacks. However since November 2013, the ban has since been lifted and

medication is back on the US market. Besides cardiac complications, there is also another potential

complication with the decrease of bone density in the use of rosiglitazone which is a major concern in

the long term use in children. Due to the potential serious complications, in October of 2013, the FDA

denied the drug manufacturers petition to include Rosiglitazone as an optional treatment for children.

Although Rosiglitazone/Metformin showed significant glycemic control compared to the other

two groups, potential weight gain, decrease in bone density, and cardiac complications are of major

concern. In conclusion, the use of Rosiglitazone for diabetic therapy is too risky for use in children and

adolescents, metformin is the only safe option for therapy.

The use of physical activity and dietary changes to decrease incidence of diabetes in

American Indian children and adolescents

Diet and exercise modifications have been the most effective therapy over the years for type 2

diabetes management in all age groups. Research has proven that through exercise and proper dietary

intake, weight loss occurs, and therefore, decreases the likelihood of type 2 diabetes. This is especially

important amongst children/adolescents with type 2 diabetes who are already deemed overweight and

obese.

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In 2009, Fretts et al. initially focused their study on cardiovascular disease and its risk factors

on American Indians but chose to expand their research further when statistical significance between

diabetes and exercise was found. The focus of the study then shifted from cardiac risk factors to

physical activity and incidence of diabetes amongst American Indians. This longitudinal study

(1989­1999) followed 1,651 subjects and encompassed 13 various American Indian tribes across four

states. The authors addressed physical activity limitations and the increase risk of diabetes by excluding

participants with other comorbidities. A baseline physical examination, smoking history, family history of

DM2, BMI, BP, and blood levels (HbA1C, oral glucose tolerance test, fasting glucose) were acquired.

A physical activity questionnaire was given during the study which measured the amount of hours per

week, type of leisure activities, and the perceived intensity of the exercise (moderate­severe). Some of

the strengths for this study include the use of a large sample size of 1,651, its longitudinal nature (10

yrs), and the use of Cox model (sensitive instrument) to observe the association between diabetic

incidences and physical activity. Although the study was strong, there were also weaknesses which

included the use of self reporting of physical activity to define intensity, as well as the lack of numerical

value to perceived activity using “moderate to high ”. Another limitation is that the research only

evaluated thirteen tribes in four states and focused solely on adults. Overall, the data was found to be

statistically significant (at 95% confidence interval) between those with no activity and the incidence of

diabetes. At the completion of the study, it was determined that those American Indians that were

physically inactive were at higher risk of diabetes than the general population.

As for dietary considerations, a meta­analysis by Malik, et.al. from 2010 evaluated eleven

prospective cohort studies on the topic of sugar sweetened beverages (sodas, fruit, energy, vitamin

water drinks) and the connection to metabolic syndrome and type 2 diabetes. The purpose of this study

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was to connect amount of daily sugar sweetened beverages intake to rate of type 2 diabetes. The meta

analysis data included a large sample size of 310,819 participants and the use of independent

meta­regressions to adjust for total energy which both strengthen the study. Another strength was the

study’s evaluation for potential bias (using Begg and Eggers test) and use of longitudinal studies ranging

from 4­20 yrs in length. There are weaknesses that exist within this meta analysis including a few studies

that did not define their serving size (even though it is assumed to be 12 ounces) which may over or

underestimate the sugar sweetened beverage intake levels, and therefore, skew the results. Overall, the

meta analysis study was clinically significant in the data for connecting sugar sweetened beverages and

diabetes had a (95% CI) p value of 0.003. The results concluded individuals consuming 1­2 servings of

sugar sweetened beverages daily have a 26% greater risk of developing type 2 diabetes compared to

those who consume <1 serving a month.

Another meta analysis in 2011 by Waters, et.al. aimed to determine the most efficient

interventions for weight loss in obese children. The majority of the thirty seven studies were in the school

setting (for less than 12 months) and evaluated close to 28,000 children. The researchers chose studies

with the same objective measurement tools in order to create legitimacy; these inclusion criteria included:

BMI, percentage of body fat, and waist circumference. Although many of the studies used these

measurement tools, others did not, taking away some validity to the data. Another limitation is the

majority of studies were not randomized, which the authors believed could have possibly led to bias.

Most of the studies evaluated were able to state their own limitations (ie missing data or not having

100% participation all the time). Overall, the research did determine several interventions to be efficient

in multiple studies including integration of diet and exercise programs into school led curriculum. Other

successful interventions included more exercise during the school week, better quality food available to

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students, encouragement by teachers to promote health improvements, involvement of parents to carry

over school based education into the home, and the ability for children to decrease screen time.

In conclusion, diet and exercise still play an important role in the management of type 2

diabetes. Integration of specific scientifically proven interventions can be instrumental in decreasing

obesity, therefore, limiting diabetes in children/adolescents.

Specific Diet and Exercise Considerations for the American Indian Youth

Just as important as diet and exercise regiments are important in the general diabetic population,

so are culturally specific considerations of American Indians and diabetes. Many studies suggest in

order to maintain a set diet and exercise regimen one must have the means to do so. Many American

Indian youth are plagued by limited resources and culturally specific diet options (ie far grocery stores).

Although the following studies are restricted, it is still important to incorporate ethnic considerations in

the overall protocol for the patients practical adherence.

The article by Gittelsohn, et. al. 2011 investigated three separate peer reviewed case studies,

completed within various American Indian tribes, that focused on the implementation of lifestyle changes

(ie diet, exercise, access to healthy foods) as a means to combat chronic illnesses. The three case

studies consisted of the Pathways trial, the Apache Healthy Stores programs, and the Zhiwaapenewin

Akino’maagewin trial. All three studies were peer reviewed and sponsored by well established

organizations: the National Heart, Lung, and Blood Institute, the US Dept of Agriculture, and the

American Diabetes Association. The focus for all studies were to implement environmental changes for

children as a means to combating chronic disease epidemic in different geographical settings. All were

longitudinal studies (2­8 years in length) and took place at various American Indian reservations around

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the country. Many limitations were present including the small sample size and the presumptive result

from the qualitative studies. The interventions included eating more meals in the home versus fast food,

incorporating spirituality into plan, and use of community and intergenerational support to push health

based programs.The results of the study interventions were considered only moderately successful due

to limited access to grocery stores within the region (with no means for transportation to supermarkets

or farmers markets) and lacking adequate support in the home setting. Overall, the interventions

appeared to have more of a success rate when functioning with community lead interventions versus

individual programs. The use of school based programs appeared to have the largest influence on

American Indian children/ adolescents more than interventions in the home setting.

Another study addressing cultural considerations is Bachar’s 2009 research which evaluated the

efficiency of the CDC sponsored REACH program (Racial and Ethnic Approaches to Community

Health 2010) within the Eastern Cherokee Indians community. The interventions incorporated three

separate subsections of the community: elementary school education, work instituted interventions for

adults, and church driven health promotion for the community. The funding allowed multiples levels of

interventions including reaching out into the community with the use of television advertising and

broadcasting a documentary series on diabetes. The research was limited by the majority of the 800

participants being children, as well as there being no inclusion/exclusion criteria identifiable within the

study.The research used a nonlinear, multilevel community based approach which appears to be key in

executing and sustaining lifestyle changes for diabetics in the American Indian community. The subjective

data, although not generalizable, is helpful in determining potentially useful culturally based interventions.

The results did appear to be clinically significant with a high level of participation (>94% amongst

community members) and high number of participants achieving set individual goals which suggests a

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greater understanding of healthy lifestyle choices of diet and exercise.

In conclusion, American Indian adolescents are at a higher risk of developing type 2 diabetes

than the general population. For adolescents with type 2 diabetes, it is imperative to provide a safe and

adequate treatment plan in order to prevent further progression and complications from the disease.

According to the most recent evidence based research, the use of HbA1c should be used to

titrate the recommended therapies of medications (Metformin), diet alterations, and increase in exercise.

Current guidelines suggest family and community involvement in diet and exercises plans play an

important role in improving the health of children and adolescents. Through these twelve peer reviewed

research studies on diabetes, a standardized protocol has been created to assist Nurse Practitioners in

the care of adolescent American Indians.

Description of Standardized Protocol

For Nurse Practitioners to perform medical duties and treat patients accordingly, a standardized

protocol is required by the California Board of Nursing’s Nurse Practice Act (BRN, 2014). The

development of the standardized protocol for the treatment American Indian adolescents with

asymptomatic type 2 diabetes was executed collaboratively and approved by the Interdisciplinary

Practice Committee (IDPC) whose members consist of nurse practitioners (NP), registered nurses

(RN), physicians (MD), and administrators all conforming to all 11 steps of the standardized procedure

as specified in Title 16, Section 1474 (BRN, 2014). The type 2 diabetes treatment protocol is to be

stored in a manual, including the signed approval sheets, and should be reviewed annually to ensure

protocol is updated based on changes made by the IDPC.

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Criteria for Screening

Initially the practitioner should decipher whether an adolescent meets certain criteria that may

predispose him/her to type 2 diabetes. Evaluation of commonly seen criteria is crucial in determining

whether or not an asymptomatic American Indian adolescent needs to be screened for type 2 diabetes.

The most significant indicator of type 2 diabetes in an adolescent is being overweight or obese. Over the

last 30 years, obesity has tripled among youth ages 6­19 years old and has proven to be more

prominent amongst minorities compared to non hispanic whites (Liu, 2010). An overweight individual is

defined as having a weight between the 85th­95th percentile for age and sex and an individual that is

above the 95th percentile is considered obese (ADA,2013). The strong correlations between obesity

and type 2 diabetes should not be overlooked. A recent cohort study echoed this when it concluded

children/adolescents between the ages of 3­19 years old previously diagnosed with type 2 diabetes,

10.4% were overweight and 79.4% were obesity (Lui, 2010). These statistics display the importance

weight plays in the consideration of a diabetes diagnosis in the youth.

According to the ADA consensus statement, the criteria for when to consider testing in an

asymptomatic adolescent includes being overweight/obese and two of the following risk factors: a

mother having gestational diabetes, a familial link (first or second degree relative with diabetes),

being of a certain ethnic background, and/or any symptoms of insulin resistance. In the case of

adolescents with type 2 diabetes in the US, greater than 75% of this population have at least one first or

second degree relative with diabetes (Rosenbloom, 2009). Ethnic considerations are also of concern

especially in high risk groups: American Indians, African Americans, Latinos, Asian Americans, Pacific

Islanders, all of which are more predisposed to having diabetes. Comparing prevalence rates within

these ethnicities, a recent study determined the American Indian population to have the highest diagnosis

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rate at 76% followed by Asian Americans at 40%, African Americans at 33%, 22% for Latinos, and

only 6% for non­Hispanic whites. (Liese, 2006). Insulin Resistance Syndrome, also known as metabolic

syndrome, is the final criteria to consider during a diabetic screening . Insulin resistance consists of signs

and symptoms that include one or all of the following: acanthosis nigricans, hypertension, dyslipidemia,

polycystic ovarian syndrome, and obesity (Copeland, 2013).

History

Nurse practitioners should take a comprehensive history, which includes family and social

history, when evaluating for diabetes amongst juveniles. According to ADA guidelines, the age of

assessment for diabetes should begin at age 10 or at onset of puberty (if occurs younger than 10) and

every three years after initial assessment (ADA, 2013). In a large demographic study, presentation of

type 2 diabetes mellitus peaks around the age of 14 (Imperatore, 2012). It is also important to

recognize that female American Indian adolescents have a higher likelihood of having diabetes

compared to males (Rosenbloom, 2009).

As previously mentioned, consideration of a family history is an important factor in the

recognition of diabetes. A connection between an adolescent whose mother had gestational diabetes

and/or a first degree relative with diabetes significantly increases the likelihood he/she will have the

disease as well. In addition to family history, a psychosocial assessment with special attention on

emotional state, eating disorders, and substance abuse should be complete. “Emotional and behavioral

disorders, particularly depression, have been associated with diabetes” (Gahagan, 2013). Assessment

of psychological needs should be assessed, and if needs are identified, a prompt referral to psychologist

or psychiatrist may be warranted.

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Comorbidities

It is important when making a diagnosis of type 2 diabetes that potential comorbidities also be

considered, evaluated, and treated to ensure the adolescents longevity. The health complications

associated with type 2 diabetes include hypertension, hyperlipidemia, sleep apnea, orthopedic

complications (fractures), hepatic steatosis, depression, heart disease, and/or stroke. Microvascular

complications such as renal disease, peripheral neuropathy, and retinopathy, all of which if left untreated

could potentially lead to kidney failure, amputations, and/or blindness (ADA,2013). Studies have shown

American Indians are genetically predisposed to having a higher rate of complications from diabetes,

more than any other single ethnic group. Higher rates of ESRD, lower limb amputation, and heart

disease have been documented among American Indians with type 2 diabetes (O’Connell, 2010).

Statistics have shown American Indians are more likely to have renal failure and ten times more likely to

have amputation than other adults (O’Connell, 2010). Mental disorders (depression and anxiety) are

also twice as prevalent in the American Indian versus the general US population (O’Connell, 2010)

The mortality burden among American Indians with type 2 diabetes exceeds the insured United

States population by an overwhelming 50% (O’Connell, 2010). Although the statistics are all regarding

adult American Indians, as a healthcare provider caring for an adolescent, it is important to predict

potential complications if the diabetes is not well managed at a young age. Heart disease and strokes are

2­4 times higher in those with diabetes and two out of three people with type 2 diabetes will die of one

of those illnesses (O’Connell, 2010). Early management of diabetes in the youth can “profoundly

affecting their productivity, quality of life, and life expectancy” (Imperatore,2012). It is imperative to

incorporate comorbidity monitoring and prevention into the management of the diabetic youth.

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Physical Examination

During the initial history and physical examination, the nurse practitioner should assess for the

presence of common primary and secondary symptoms that may be found in a patient with type 2

diabetes.

Although many documented cases of diabetes in adolescents present asymptomatically, it is

advantageous to be aware of classic symptoms of diabetes that may be present during the initial visit.

Typical symptoms for both type 1 and 2 diabetes include polyuria, polydipsia, blurred vision, recurrent

infections, or more critical symptoms when the patient presents with diabetic ketoacidosis (DKA) or

hyperglycemic hyperosmolar nonketotic (HHNK) symptoms (ADA, 2013). Depending on the extent of

symptoms, immediate medical care in an acute setting may be warranted. The severity of presentation

will determine course of action and may affect the choice in initial treatment. Symptoms like early onset

puberty, acanthosis nigricans, frequent infections (candida) may also be present in the juvenile with type

2 diabetes (Gahagan, 2013). For purposes of this protocol, the focus will only be on the presenting

adolescent whom have minimal or no symptomatology of type 2 diabetes.

During the physical exam for the diabetic adolescent, it is important for the nurse practitioner to

assess for any common micro or macrovascular complications that can ensue from diabetes.

Hypertension could occur with some adolescents and should be evaluated for every 3 months. If

hypertension is present and he/she is unable decrease blood pressure to <130/80 with lifestyle

modification, the use of ACE inhibitors or ARBs may be necessary (IHS,2012) Other common

problems that need to be evaluated are skin abnormalities, peripheral vascular circulation, kidney

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complications, vision changes, and gum problems (IHS, 2012).

The skin should be assessed annually for secondary symptoms that may be present in a diabetic

patient include acanthosis nigricans, hirsutism, tinea, and acne (Gahagan, 2013). Visual foot inspection

and pedal pulses should also be done every 3 months with a more in depth analysis annually of nail

inspection and a thorough neurologic examination to test sensation using a monofilament tool (See

Appendix C for detailed foot screening) (ADA, 2013).

Focused annual assessments for diabetic adolescents require not only physical examinations but

also annual lab evaluation and specialized referrals. Nephropathy is a large concern amongst long

standing unmanaged diabetics. Annual screening of microalbuminuria with a random spot urine should

be done to check the albumin/creatinine ratio to rule out kidney damage. (ADA, 2013). Referral to a

nephrologist would be important if nephropathy is present.

A fundoscopic eye exam should also be complete along with a dilated eye exam by an

ophthalmologist or optometrist at diagnosis, and then annually thereafter, to manage or rule out

retinopathy (IHS, 2012). Due to potential high glucose levels, another consideration is gum

complications which is also a common problem amongst diabetics, annual dental exams are

recommended (ADA, 2013).

Nurse practitioners need to have heightened awareness to both potential and actual

complications of type 2 diabetes amongst American Indian youth during initial physical examination as

well as during each consecutive visit.

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Diagnosis

According to all the major diabetic organizations: American Diabetic Association, International

Society of Pediatric/ Adolescent Diabetes, and American Academy of Pediatrics a diagnosis must meet

one of the following criteria: A fasting plasma glucose (FPG) is > or = 125 mg/dl (7.0 mmol/l), an oral

glucose tolerance test (OGTT) with a 2 hr postprandial plasma glucose > or = 200 mg/dl (11.1

mmol/L), or symptoms of diabetes AND a random plasma glucose > or = 200 mg/dl (11.1 mmol/L)

(ADA,2013).

Hemoglobin A1c (HgbA1c) is another powerful tool in the assessment of long term

management of glycemic levels and can be a good predictor of diabetic related complications. Although

HgbA1c is not a proficient diagnostic tool in the young, it is still an efficient way to monitor how

adolescents maintain their diabetic regimens. HgbA1c should be checked every three to four months

until a goal of < or = 7.0% is achieved (ADA, 2013). Along with HgbA1c, fasting blood glucose (FBG)

of < or = 126 mg/dl can also be used to adjust current therapy (Pettit,2009).

The American Diabetic Association also recommends other tests to monitor and prevent

diabetes related complications, including lipid and kidney lab evaluations. A fasting lipid profile with a

goal of less than 100 mg/dl is imperative to prevent dyslipidemia that could increase cardiovascular

disease risk factors in the adolescent. Microalbuminuria should also be checked using urine

albumin/creatinine ratio (UACR) through a random urine sample (normal <30 mg/g, micro 30­300

mg/g, macro >300 mg/g) to rule out kidney complications. These test should be performed at diagnosis

and then annually thereafter (See Appendix B for Comprehensive Care Chart).

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Treatment

Treatment may vary depending on the adolescent however, all diabetic regimens include lifestyle

modifications in the treatment plan. Diet and exercise improvements should be the first line treatment of

adolescents with type 2 diabetes (ADA, 2013).

Change in caloric intake and choice of food/beverage intake can significantly improve diabetes.

According to American Association of Pediatrics (AAP) because those younger than 20 are still

growing, restriction of calories should be no less than 1200 kcal (Copeland, 2013). Other dietary

changes should include an increase in the number of fruits and vegetables daily and a decrease in the

amount of high fatty food consumption (ADA, 2013). Over the last ten years, sugar sweetened

beverages have been on the rise in schools and home settings. A recent study suggests by decreasing

intake of sugar sweetened beverages there can be a marked difference in weight, therefore, creating a

reduction in diabetes prevalence (Malik, 2010). Although not always possible, promotion through

community programs that encourage good eating habits has proven to have a very positive response

especially in the American Indian community (Bachar, 2009).

Besides diet, evidence suggests that an increase in physical activity both in the home and school

setting decreases weight and prevalence of type 2 diabetes. According to AAP, moderate to vigorous

exercise for 60 minutes a day is recommended for adequate response for a diabetic adolescent

(Copeland, 2013). Studies suggest that the more exercise is introduced during school hours, the bigger

the positive impact is on the amount of exercise completed (Waters, 2011). Peer based activities

appear to enhance better adherence and encourage better weight loss results (Copeland, 2013).

A very important component of treatment that is often overlooked is the involvement of family.

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Parent encouragement and participation in exercise has proven to be much more successful than relying

on a child to have self motivation (Gittelsohn, 2011). Beyond the home setting, promotion of exercise

through community involved programs that advocate for exercise have been shown to be immensely

successful (Bachar, 2009). Besides encouragement of exercise it is also important, especially in the

electronic age today, to discourage overuse of screen time which includes television, phone, internet,

video games, etc. Decrease in screen time encourages more involvement in other more productive

activities (Waters, 2011).

Although diet and exercise are the ideal way to manage type 2 diabetes, sometimes adolescents

are not able to achieve FBG and HbA1c goals through lifestyle modification and should be placed on

medication to prevent long term health complications from type 2 diabetes.There is a heightened need

for further research supporting medication options in the child/adolescent populations. At this time, due

to safety and efficacy concerns, clinical trials on the issue are limited and warrant further evaluation in the

future. At this time, Metformin is the only medication to be safe and effective in the treatment of

adolescents with type 2 diabetes (Zeitler, 2012). Metformin should be started at 500 mg by mouth

every day, titrating up every 1­2 weeks (as necessary) for a max dose of 2000 mg daily (in divided

doses: 1000 mg twice a day).

Whatever treatment choice is made, education on what diabetes is and how it impacts him/her

needs to be incorporated into all treatment plans. Education needs to include blood glucose monitoring ,

nutrition, physical activity, emotional support, stress management, support needs, and family support.

Family appears to have a substantial role within the American Indian culture and disease

prevention. A provider should observe the resources within the home such as availability of healthy food

choices, parent literacy level, cultural beliefs about diabetes, and family understanding about the disease

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when considering the overall treatment plan (Gahagan, 2013). Inclusion of both diabetic adolescent

along with an involved family member will help drive successful management of diabetes.

In most cases, type 2 diabetes will be a life long ailment with life limiting consequences if not

managed properly. It is important to prepare adolescents as they transition into adulthood to

appropriately manage their own diabetes. Many adolescents have difficulty bridging into solo diabetic

management and tend to stop managing their own disease when they live independently of their support

system. If educational independence is not part of the overall treatment plan, many adolescents may be

lost to the health care system when they finally reach adulthood.

Follow up

Primary care providers should foresee actual and potential problems that may arise in a disease

process. When a diagnosis of a diabetes in an adolescent is made, it creates an important responsibility

for the nurse practitioner involved to appropriately manage care. The nurse practitioner should

collaborate with an MD and make referrals as deemed necessary. It is ideal with lifelong illnesses such

as diabetes to work in partnership with disciplines as needed including but not limited to collaborating

MDs, including diabetes educator, dietitian, social worker, psychologist/psychiatrist, endocrinologist,

nephrologist, optometrist/opthamologist, and/or dentist. Each plan should be individualized and

depending on the resources available. It is crucial to work with the patient, their family, and all

disciplines involved to develop a care plan that speaks to individual adolescents needs.

Conclusion

The ultimate goal of treatment for the type 2 diabetic adolescent is to maintain homeostasis of

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glucose levels and prevent life limiting complications. Through the use of commonly used assessment and

monitoring techniques, preventing progression of diabetic illness is plausible. It is imperative for the

Nurse Practitioner to follow steadfast assessment and diagnostic techniques to appropriately and

sufficiently monitor and treat type 2 diabetes in the American Indian adolescent. Use of this protocol will

ultimately contribute to the overall health of the young diabetic and help direct the Nurse Practitioner to

the best possible care for this population.

Appendix A

Protocol for Management of Type 2 Diabetes in American Indian Adolescents Ages 13­19

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I. Develop and Review

A. The development of the standardized protocol for the treatment American Indian

adolescents with asymptomatic type 2 diabetes was executed collaboratively and approved

by the Interdisciplinary Practice Committee (IDPC) whose members consist of nurse

practitioners (NP), registered nurses (RN), physicians (MD), and administrators conforming

to all 11 steps of the standardized procedure as specified in Title 16, Section 1474 (California

BRN, 2014).

B.The type 2 diabetes treatment protocol is to be stored in a manual and include the date and approval

sheets signed by the individuals protected by the standardized procedure.

C. The standardized procedure need to be reviewed annually and updated based on changes made by

IDPC

D. Any alterations to the diabetes protocol must be approved IDPC and include an approval sheet

II. Scope and Setting of Practice

A. Nurse Practitioners may implement the following duties within their speciality areas and consistent

with their credential and experiences: assessment, management, treatment of episodic illness, chronic

illness (ie diabetes), common health promotions, and general evaluation including but not limited to labs,

scans, recommended diets as well as possible referral to a diabetic clinic if indicated (California BRN,

2014)

B. Standardized procedures, such as medication regimens, are to be performed in local clinics by the

nurse practitioners where physicians are available for consult in person or by phone (California BRN,

2014).

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C Physician consultation should be obtainable in individual protocols and under the following cases:

1. Emergent condition requiring immediate medical interventions (after initial stabilization)

2. Acute decompensation of patient

3. Situation not resolved by intervention

4. History, physical examination, or labs not consistent with clinical depiction

5. Upon request of patient, RN, or supervising MD (California BRN, 2014).

III. Qualifications and Evaluations

A. Each nurse practitioner performing standardized procedures must possess a current RN license in the

state of practice, graduate from an accredited university nurse practitioner program, and hold a

certification for the California BRN

B. Evaluation of the Advance Practice Nurses’ competency will be evaluated as follows:

1. Initial: Evaluation by the nursing manager at 3, 6, and 12 months intervals by the

use of feedback from colleagues, MD’s, and chart reviews

2. Routine: Annually after initial evaluation continuing feedback and chart reviews

3. Follow­up: Areas where increased proficiency is required, nurse managers will

continue to evaluate until acceptable competency level is obtained.

IV. Protocol

A. History: A detailed history including evaluation of ethnicity, family history, and health history should be done to consider if further testing is needed. Psychosocial assessment should also part the history.

1. Frequency: a. Initial: Assessment for type 2 diabetes in children/adolescents should begin at the age of 10 or at the onset of puberty (if earlier) and every three years after initial assessment if no diabetes present.

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2. Risk Factors: Further testing should be considered if the adolescent is obese (>95th percentile for age and sex) and has two or more of the following risk factors:

Race/Ethnicity: American Indians, African Americans, Latinos, Asian Americans, Pacific

Islanders are considered high risk for early onset type 2 diabetes. Family history of first or second degree relative with type 2 diabetes Maternal history of gestational diabetes Low birth weight Signs/symptoms of insulin resistance Common conditions associated with insulin resistance including hypertension,

acanthosis nigricans, dyslipidemia, or polycystic ovarian syndrome

3. Psychosocial Assessment: a. Depression (unmanaged depression, suicidal ideations) b. Assess for substance abuse (alcohol, tobacco, drugs) c. Eating disorders (binge eating, bulimia)

B. Physical Examination: Documentation of initial physical examination should note the presences of

diabetes and monitor closely for any changes that may indicate further progression of disease

1. Blood pressure/pulse: to monitor for potential cardiac complications

2. Height/Weight/BMI: should be taken and calculated every visit

3. Any macro or microvascular changes: with eye exam such as of retinopathy, test extremity

sensation for diabetic neuropathy, observe for signs and symptoms of organ damage (especially

kidneys) are considered manifestations of diabetic complications and should be referred to

appropriate specialists

C. Laboratory:

1. Diagnosis: 2 hr OGTT with a plasma glucose of > or = to 200 mg/dl or a FBG > or =

126

2. Monitoring: Every 3 months recheck to achieve a goal FBG of < or = 126 mg/dl and

HbA1c of < or = 7.0%. Adjust current therapy regimen if goal not achieved

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D. Treatment

1. Lifestyle modifications: Diet and exercise improvements should be the first line treatment

of adolescents with type 2 diabetes

a. Diet: Change in caloric intake and choice of food/beverage intake can significantly

improve diabetes.

i. Restriction of calories to no less than 1200 kcal

ii. Increase of fruits and vegetables daily, decreasing high fatty food

consumption

iii. Decreasing intake of sugar sweetened beverages

iv. Promote community programs that encourage good eating habits

b. Exercise: Evidence suggests the increase in physical activity both in the home

and school setting decreases weight and prevalence of type 2 diabetes

i. Moderate to vigorous exercise for 60 minutes a day

ii. More exercise during school hours

iii. Decrease in screen time

iv. Parent encouragement and participation in exercise

v. Promote community programs advocate exercise

2. Medication: Adolescents that are not able to achieve FBG and HbA1c goals

through lifestyle modification should be placed on medication to prevent long term

health complications from type 2 diabetes

a. Metformin is the only medication to be safe and effective treatment in

adolescents.

i. Metformin 500 mg po q day, titrating up q 1­2 weeks (as necessary) for a

max dose of 2000 mg daily (in divided doses: 1000 mg BID)

E. Follow up: Once a diagnosis of type 2 diabetes has been made, the frequency of history/ physical

exam is every 3 months until metabolic control has been made then may decrease to every 6­12

months.

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F. Referrals: Depending on the complication of type 2 diabetes, potential referral include:

1. Collaboration with MD: In complex cases of adolescent type 2 diabetes

2. Endocrinologist: Inability to manage diabetes with standard guidelines

3. Diabetic Educator: Education for adolescents on management of diabetes

4. Ophthalmologist: Annually and with any visual changes

5. Psychiatrist: Possible depression (commonly seen in the adolescent diabetics)

V. Policy (Scope and setting of the practice)

A. Functions: To provide guidance in the treatment of asymptomatic type 2 diabetes

in American Indian adolescents

B. Circumstances for when protocol comes into practice

1. Setting: Outpatient clinic

2. Supervision required: Collaboration with consulting MD

3. Patient condition/diagnosis: Adolescents with asymptomatic type 2 diabetes

VI. Development and Approval of the Standardized Protocol

This protocol was derived from the collaborative work of nurse practitioner with physician or designee

and approved by the clinics governing body: Chief of Nursing Officer, Chief of Medicine, and Medical

Group Administrator.

VII. This Diabetic Protocol with be reviewed and potentially revised annually

Review Date: Revise Date:

Review Date: Revise Date:

Review Date: Revise Date:

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VIII. Signatures of Approval for Diabetic Protocol:

Chief of Nursing Officer: full name & date

(signature)

Chief of Medicine: full name & date

(signature)

Medical Group Administrator: full name & date

(signature)

Nurse Practitioners authorized to perform Diabetic Protocol:

Nurse Practitioner: Full name & date

(signature)

Nurse Practitioner: Full name & date

(signature)

Nurse Practitioner: Full name & date

(signature)

Appendix B

Comprehensive/Global Care of youth with Type 2 Diabetes

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(ADA, 2011)

Appendix C

Foot screening for youth with diabetes

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(Gahagan, 2013)

References

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American Diabetic Association. American Indian/Alaska Native Complications.(2013). Retrieved

on July 10th, 2013 from http://www.diabetes.org/living­with­diabetes/ treatment­and­care/

high­risk­populations/treatment­american­indians.html.

American Diabetic Association. Standards of medical care in diabetes­2013. (2013). Diabetes

Care 36: S11­ S44.

Bachar, J. (2009). Chapter 11: Cherokee Choices Diabetes Prevention Program. In L. Liburd

(Ed.).Diabetes and Health Disparities: Community based approaches for racial and

ethnic populations. (pp.275­293). New York, NY: Springer Publishing Company.

California Board of Registered Nursing (BRN).(2014). An explanation of standardized procedure

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