introduction to staged diabetes...

1 Introduction to StagedDiabetes Management

The underlying principle in managing diabeteshas undergone several important changes over thelast two decades. Diabetes was once believed tobe a disease with inevitable microvascular andmacrovascular complications. Current approachesto management, however, recognize the benefitof maintaining tight glycemic control and ad-dressing associated metabolic disorders. The focusin diabetes management has shifted to includethe importance of achieving blood pressure andlipid targets along with conventional blood glu-cose control. In fact, any improvement in thesephysiologic markers is seen as a means to pre-vent or slow the progression of microvascular andmacrovascular complications.1–4 Most individualswith diabetes and its associated disorders requirea variety of therapies to treat, delay, or preventcomplications. High-quality care is dependent onunderstanding which therapies are appropriate andwhen to use them.

The majority of individuals with diabetes havetheir first contact with a primary care provider(family practitioner, pediatrician, internist, nursepractitioner, physician assistant, or obstetrician).Only a small proportion (estimated, overall, atless than 10 per cent of all people with dia-betes) are initially seen and regularly followedby a specialist (either an endocrinologist in theUnited States or a diabetologist or endocrinolo-gist in other countries). Primary care providershave expressed the desire for guidelines to ensure

that they are conforming to current good prac-tices. Typically, primary care providers have hadan inconsistent approach to diabetes screening,diagnosis, treatment, and management of com-plications. This inconsistency may be traced tothe lack of ample, persuasive scientific evidenceavailable in the primary care setting showing thatimproved diabetes management through metaboliccontrol and intensive therapies are necessary toprevent the short- and long-term complications ofdiabetes. With the expansion of diabetes to en-compass attention to related metabolic disorders,including metabolic syndrome, the inconsistencyin treatment approaches has become more prob-lematic. In short, primary care providers needa carefully developed set of clinical guidelinesand algorithms that can be realistically imple-mented, tested, and shown to be efficacious andcost effective.5

Primary care is that care provided by physi-cians specifically trained for and skilledin comprehensive first contact and contin-uing care for persons with any undiagnosedsign, symptom, or health concern not limitedby problem origin, organ system, gender,or diagnosis. Primary care includes healthpromotion, disease prevention, health main-tenance, counseling, patient education, di-agnosis and treatment of acute and chronicillness in a variety of health care settings.Primary care is performed and managed by

Staged Diabetes Management: A Systematic Approach (Revised Second Edition) R.S. Mazze, E.S. Strock, G.D. Simonson and R.M. BergenstalCopyright 2006 Matrex

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4 INTRODUCTION TO STAGED DIABETES MANAGEMENT

a personal physician, utilizing other healthprofessionals, consultation and/or referral asappropriate. Primary care provides patientadvocacy in the health care system to ac-complish cost-effective care by coordinationof health care services.

– The American Academy of FamilyPhysicians

Staged Diabetes Management (SDM) is a sys-tematic approach to preventing, detecting, andtreating diabetes, metabolic syndrome, and associ-ated disorders using practice guidelines and clini-cal pathways (algorithms) that reflect the changingresponsibilities of the primary care provider andthe primary care team.

The purpose of SDM is to:

• provide a systematic, data-based approach forclinical decision making

• provide a consistent set of scientifically based

practice guidelines that can be adapted by acommunity according to its resources

• identify appropriate criteria for initiating andaltering therapies during three treatmentphases: Start, Adjust, and Maintain

• provide a common customized Master De-cisionPath for each type of diabetes andmetabolic syndrome that both patients andproviders can use to understand treatment op-tions, to enhance communication, and to op-timize therapies

• facilitate the detection and treatment of dia-betes, insulin resistance, and their complica-tions by primary care providers, in consulta-tion with specialists

• foster a patient centred team approach to themanagement of diabetes and associated com-plications

The development of Staged Diabetes Management

The idea for SDM stems from the need to pro-vide a systematic approach to disease preven-tion, detection, and treatment using methodolo-gies that are easily applicable to the primarycare setting. To accomplish this, a team of en-docrinologists, family physicians, clinical nursespecialists, dietitians, and community health spe-cialists joined together in 1988 to identify thetherapeutic principles that lie at the core of di-abetes management. Specialists joined the teamas needed, including perinatologists, epidemiolo-gists, and psychologists, among others. The teaminvestigated approaches to the treatment of type1 diabetes, type 2 diabetes, and diabetes in preg-nancy as well as their associated complicationsand co-morbidities. At biweekly conferences overa period of 5 months, each step in diagnosing andtreating each type of diabetes was carefully delin-eated.

Key decision points were placed on algorithmstermed “DecisionPaths.” These DecisionPathscontained the following:

• treatment modalities

• criteria for initiating treatment

• criteria for changing treatment

• key clinical decision points

• metabolic targets, including reasonable time-lines to achieve target

• recommended follow-up

Since its initiation in 1988, SDM has undergoneclinical trials and implementation studies in morethan 800 sites worldwide. The results have ledto changes in the original design of SDM andare reflected in this text. Nevertheless, the basic

THE DEVELOPMENT OF STAGED DIABETES MANAGEMENT 5

principles upon which SDM is founded remainintact.

To continue to refine this systematic approachto clinical decision-making, the records of ran-domly selected patients with diabetes or at riskfor developing diabetes are periodically evaluated.These are supplemented by research data fromSDM sites as well as a comprehensive review ofrelevant literature.

In type 1 diabetes, this review and update pro-cess focuses on:

• criteria for selecting an appropriate insulinregimen

• criteria for prescribing insulin analogues

• criteria for administering insulin pump ther-apy

• medical nutrition therapy (meal planning andexercise)

• patient education

• assessment of inhaled insulin and other newertherapies

For each of these subjects, where possible,metabolic markers such as sequential glycosylatedhemoglobin (HbA1c) and verified self-monitoredblood glucose data are obtained. Short- and long-term outcomes, such as metabolic control, com-plications surveillance, and microvascular andmacrovascular complications, are tracked. Re-cently, cost and patient satisfaction factors havebeen added to the analysis.

For type 2 diabetes, the focus has changed fromconcentration on criteria for initiation of medicalnutrition therapy, oral agent, combination, and in-sulin therapies to prevention, screening, early de-tection, and intensive multi-dimensional therapies.Treatment components such as patient education,nutritional interventions, and psychosocial coun-seling are also examined. Diabetes is examinedas part of the metabolic syndrome, with attentionto obesity, hypertension, dyslipidemia, and renaldisease.

In type 2 diabetes, data are organized to addressthe following:

• treatment modalities: medical nutritiontherapy, oral agent monotherapies (alpha- glu-cosidase inhibitors, biguanides, meglitinides,sulfonylureas, nateglinides, and thiazolidine-diones), oral agent combination therapies, in-sulin and oral agent combination therapies,insulin, and insulin analogues

• criteria for initiating treatment: factors to con-sider in selecting the first treatment modality

• criteria for changing treatment: factors toconsider for selecting subsequent treatmentmodalities

• information about establishing, monitoring,and evaluating therapies: details related to anyof the decisions, treatments, or actions. (Thisincludes information to be collected by eitherthe patient or the physician to evaluate howeffective the treatment is in meeting thera-peutic goals. It also encompasses monitoringassociated with the schedule of provider andpatient data collection, including the timingof laboratory tests and the frequency of self-monitoring of blood glucose.)

For gestational diabetes (GDM), the focus nowincludes an examination of the association be-tween GDM, insulin resistance, and type 2 dia-betes. Criteria for initiation of medical nutrition,glyburide, and insulin therapies are carefully eval-uated against the short- and long-term outcomes ofpregnancy (including neonatal size, childhood andadult obesity for the offspring, maternal metaboliccomplications, and the development of type 2 di-abetes, hypertension, and dyslipidemia).

Complications have been divided into thoseassociated with the metabolic syndrome (obe-sity, hypertension, and dyslipidemia) and thosemore closely associated with microvascular dis-ease (renal, retinal, and neurological disorders).For each complication general practice guide-lines, stipulating screening and diagnostic crite-ria, treatment options, targets, monitoring, and


follow-up, have been developed. Additionally,hospitalization for acute metabolic complicationsof diabetes and management of diabetes duringsurgery and other inter-current events are ad-dressed.

Developed for the primary care setting, thematerial on complications serves as a basis forclinical decision-making. As with all of SDM,referral to a specialist is advised whenever the

complexities of the disease exceed the resourcesavailable in the primary care setting. Each com-plication practice guideline is followed by De-cisionPaths, which outline screening, diagnosis,therapy selection, and follow-up procedures. Mostsections also include a table that addresses thechanges in treatment for diabetes in the presenceof the complication.

The structure of Staged Diabetes Management

Staged Diabetes Management is a systematic ap-proach to the prevention, detection, and treat-ment of diabetes and metabolic syndrome andtheir complications that organizes care in termsof stages and phases.6 Stages refer to type oftreatment, with the underlying concept that thereshould be a consistency in the use of treatmentmodalities: for example, the notion that med-ical nutrition therapy is a critical element inthe goal of managing blood glucose and bloodpressure. Thinking in terms of stages also helpsto understand the universal role, independent oftype of diabetes, that insulin plays in establish-ing and maintaining glycemic control. Most im-portant, however, is the concept that stages aredynamic, subject to initiation, adjustment, main-tenance, and abandonment. Care of a chronicillness such as diabetes or hypertension is, af-ter all, a continuum. It begins with diagnosisand/or initiation of a therapy (starting phase), andthen moves to the adjusting phase until the tar-gets are reached, at which point the current ther-apy is maintained. Therefore, we have chosento conceptualize care by way of the concepts ofstage, delineating therapy, and phase, delineatingprogress.

Stages of therapy for diabetes

Diabetes care is undergoing a revolution in termsof available therapies. During the past decademore than seven new classifications of medica-tions (both oral agents and insulin) have beenintroduced. We chose to call each therapy a

stage to enable us to demonstrate how they havean impact on diabetes management. The medi-cal nutrition and activity therapy stage, formerlyknown simply as diet and exercise, constituteswithin SDM the use of a food and activity planto help patients achieve their metabolic targets.Oral agents, both nonhypoglycemic and hypo-glycemic, constitute the oral agent stage. Finally,insulin (rapid, short, intermediate, and long act-ing) constitutes our insulin stages 1 through 4plus pump therapy. Within insulin therapies, stagenumbers refer to the number of insulin injec-tions administered per day. All insulin therapy isalso considered from the perspective of provid-ing basal (or background) and bolus (or pre-meal)requirements.

Phases of therapy

Approaching the treatment of any disease withouta structure in mind is akin to driving with a finaldestination in mind, but without a map to follow.To make certain that we have a map and thatwe know where we are on the map, we dividedcare into three phases: start phase, adjust phase,and maintain phase. This approach suggests thattreatment is dynamic. It reflects actual practice.At any point in treatment the individual is inone of these three phases. Knowing the phase isanalogous to knowing one’s place on the map. Itis possible to see instantaneously both where onehas been and where one is headed.

THE STRUCTURE OF STAGED DIABETES MANAGEMENT 7

Start phase

The start treatment phase refers to the collec-tion of data upon which to base diagnosis andinitiate treatment. Ideally, diabetes care and man-agement of complications begin with baseline datafrom which the practitioner can assess a patient’sclinical status. Each type of diabetes, associatedcomplication, or co-morbidity requires differentdata for diagnosis and clinical decision-making.In type 1 diabetes, for example, clinical symp-toms, blood glucose values, urine ketones, serumpH, age, and body weight serve as critical startingpoints. In type 2 diabetes, blood glucose values,HbA1c, body mass index, markers of insulin re-sistance, and co-morbidities are critical elementsin understanding the nature of this disease.

Adjust phase

During the adjust treatment phase, changes intherapy – whether in insulin dose or regimen,food plan, exercise/activity, or oral agent – aremade to optimize metabolic control. Lasting any-where from days to months, this phase is markedby substantial patient involvement in collectingdata upon which to decide on medication changesand to judge the effects of the alterations in ther-apy. The principles by which major alterations infood plan, exercise/activity, oral agent, or insulindose, mapped out in the Master DecisionPaths,are provided in greater detail in the Start andAdjust DecisionPaths for each stage (therapy) ofdiabetes management. For the purpose of routinediabetes management, a single standard or guide-line for glucose control is highly desirable. Theresults of the Diabetes Control and ComplicationsTrial1 in type 1 diabetes and the United KingdomDiabetes Prospective Study7 in type 2 diabeteshave demonstrated the desirability of one stan-dard of glucose control. It should be understoodthat the glycemic goals for type 2 diabetes un-complicated by pregnancy are the same as thosefor type 1 diabetes, specifically between 70 and140 mg/dL (3.9 and 7.8 mmol/L), pre-meal. How-ever, target blood glucose ranges should then bedetermined individually. For diabetes complicated

by pregnancy, blood glucose levels ranging from60 to 120 mg/dL (3.3 to 6.7 mmol/L) should serveas a guide. Glycosylated hemoglobin A1G (HbA1c)should be used to verify overall blood glucosecontrol. Therefore, as a general guide, HbA1c lev-els within one percentage point of the upper limitof normal should be the goal in type 1 and type 2diabetes. For diabetes in pregnancy, HbA1c valuesshould be within normal range. If this goal is notmet within a specified period of time, the ther-apy should be adjusted or changed. It is this lastpoint that underlines the need for thinking aboutdiabetes in terms of phases. The goal should beto move the patient from adjust to maintain asquickly and as safely as is reasonable. Patients inthe adjust phase are at higher risk for complica-tions. It is not until they reach the maintain phasethat the risk of complications is substantially low-ered.

Maintain phase

This phase begins when the patient has reachedand is involved in maintaining the target bloodglucose goals associated with the long-term pre-vention of complications. Patients are expectedto move in and out of this phase independentof the type of treatment, based on such factorsas changes in lifestyle, compliance with regimen,psychological and social adjustment to diabetes,willingness to achieve tighter control, and naturalprogression of diabetes. Thus, some changes intherapy are expected in this phase, but they are re-lated more to fine-tuning than to major alterationsin dose of medication.

Phases in the treatment of insulin resistanceand complications

As with the treatment of diabetes, managementof insulin resistance related disorders such ashypertension can be seen as divided into start,adjust, and maintain therapy. Naturally, for eachdisorder the object is to restore normal or near-normal status, when possible. In many cases, dueto pre-existing co-morbidities, the objective is toprevent further progression of the complication.


Practice guidelines

Staged Diabetes Management relies on practiceguidelines to lay the foundation for treatment andon DecisionPaths to provide the means. Thus,SDM consists of a set of practice guidelinesfor the three types of diabetes, for metabolicsyndrome, and for other complications. Practiceguidelines are structured to address prevention,screening and diagnosis, treatment options,metabolic targets, monitoring, and follow-up.Figure 1.1 shows the Type 2 Diabetes PracticeGuidelines.

For over a decade the Institute of Medicine(IOM) has been evaluating the characteristics ofpractice guidelines that contribute to successfulimplementation. Defined by the IOM, practiceguidelines are “systematically developed state-ments to assist practitioner and patient in decisionsabout appropriate health care for specific clinicalcircumstances.”8 Incorporating science and clini-cal judgment, practice guidelines are meant to im-prove the quality of care by ensuring consistencyin the delivery of health care services. Qualityof care has been directly associated with reducedvariation in medical practice. A common prac-tice guideline accepted by all health care providersremoves inconsistencies in the diagnosis and treat-ment of medical conditions and results in moreeffective use of health care resources, improvedoutcomes, cost savings, and reduced risk of legalliability for negligent care.

Scientific evidence and clinical judgment canbe systematically combined to produce clini-cally valid, operational recommendations forappropriate care that can and will be usedto persuade clinicians, patients and others tochange their practices in ways that lead tobetter health outcomes and lower health carecosts.

– Guidelines for Clinical Practice, TheInstitute of Medicine8

Valid practice guidelines facilitate consistent,effective, and efficient medical care and ultimately

lead to improved outcomes for patients. To ac-complish this, guidelines must contain sufficientdetail to have measurable clinical outcomes. Forbest results, practice guidelines should be specific,comprehensive, and accepted by the communityof physicians and all other medical team mem-bers. Guidelines need to be flexible enough foreveryday use in clinical practice and must reflectthe available community resources.

The first principle of practice guidelines isthat they are based on sound scientific findings.Staged Diabetes Management Practice Guidelinesare based on the recommendations of the Amer-ican Diabetes Association (ADA), the NationalDiabetes Data Group, the International DiabetesFederation (IDF), the World Health Organiza-tion (WHO), American Association of DiabetesEducators (AADE), and other diabetes organiza-tions representing several countries outside of theUnited States. These organizations have reviewedthe current scientific data and many have reachedconsensus on major elements of diabetes care:

• diagnostic criteria and classification

• treatment options

• therapeutic targets for blood glucose, HbA1c,blood pressure, and lipids

• frequency of blood glucose, urine ketones,and HbA1c monitoring

• complication surveillance (eye and foot ex-ams, screening for microalbuminuria)

• medical follow-up recommendations

• need to identify and treat complications ofdiabetes as early as possible

These organizations have also addressed insulinresistance and many have reached a working con-sensus that:

PRACTICE GUIDELINES 9

Screen all patients every 3 years starting at age 45; if risk factors present, start earlier and screen annually

• BMI � 25 kg/m2 (especially waist-to-hip ratio �1)• Family history of type 2 diabetes (especially first-degree relatives)• Age (risk increases with age)• Hypertension (�140/90 mm Hg)• Dyslipidemia (HDL � 35 mg/dL [0.90 mmol/L] and/or triglyceride �250 mg/dL [2.8 mmol/L])• Previous impaired fasting glucose (IFG) with fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L)• Previous impaired glucose tolerance (IGT) with oral glucose tolerance test (OGTT) 2 hour glucose value 140–199 mg/dL (7.8–11 mmol/L)• Previous gestational diabetes: macrosomic or large-for-gestational age infant• Polycystic ovary syndrome• Acanthosis Nigricans• American Indian or Alaska Native; African-American; Asian; Native Hawaiian or Other Pacific Islander; Hispanic

Screening

Risk Factors

Diagnosis

Casual � 200 mg/dL (11.1 mmol/L) plus symptoms, fasting �126 mg/dL (7.0 mmol/L), or 75 gram oralglucose tolerance test (OGTT) 2 hour glucose value � 200 mg/dL (11.1 mmol/L); if positive, confirmdiagnosis within 7 days unless evidence of metabolic decompensationOften noneCommon: blurred vision; urinary tract infection; yeast infection; dry, itchy skin; numbness or tingling inextremities; fatigueOccasional: increased urination, thirst, and appetite; nocturia; weight lossUsually negative

Plasma Glucose

Symptoms

Urine Ketones

Treatment Options Medical nutrition therapy; oral agent (a-glucosidase inhibitor, metformin, repaglinide, nateglinide, sulfonylurea,thiazolidinedione); combination therapy (oral agents, oral agent–exenatide, oral agent–insulin); Insulin Stage orInsulin–pramlintide

Targets

• More than 50% of SMBG values within target range• Pre-meal; 70–140 mg/dL (3.9–7.8 mmol/L)• Post-meal (2 hours after start of meal): �160 mg/dL (8.9 mmol/L)• Bedtime: 100–160 mg/dL (5.6–8.9 mmol/L)• No severe (assisted) or nocturnal hypoglycemia Adjust pre-meal target upwards if decreased life expectancy; frail elderly; cognitive disorders; or other

medical concerns (cardiac disease, stroke, hypoglycemia unawareness, end-stage renal disease)• Within 1.0 percentage point of upper limit of normal (e.g., normal 6.0%; target �7.0%)• Frequency: 3–4 times per year• Use HbA1c to verify SMBG data

Self-MonitoredBlood Glucose (SMBG)

Hemoglobin HbA1c

Monitoring

2–4 times per day (e.g., before meals, 2 hours after start of meal, bedtime); may be modified due to cost, technicalability, availability of meters; if on insulin, check 3 AM SMBG as needed

Meter with memory and log book

SMBG

Method

Office visit during adjust phase (weekly phone contact may be necessary)

Hypoglycemia; medications; weight or BMI; medical nutrition therapy; BP; SMBG data (download meter);HbA1c; eye screen; foot screen; diabetes/nutrition continuing education; smoking cessation counseling, aspirintherapy

In addition to the 3 month follow-up, complete the following: history and physical; fasting lipid profile;albuminuria screen; dilated eye examination; dental examination; neurologic assessment; complete footexamination (pulses, nerves, ankle-branchial index and inspection); immunizations

Monthly

Every 3 Months

Yearly

ComplicationsSurveillance

Cardiovascular, renal, retinal, neurological, foot, oral, and dermatologicalSee Chronic Complications MasterDecisionPath

Follow-up

Figure 1.1 Type 2 Diabetes Practice Guidelines

• relates insulin resistance to hyperglycemia,hypertension, dyslipidemia, central obesityand renal disease

• recognizes the need to intensively treat eachcondition

• recognizes the increased risk of developingone condition when another exists

• sets general targets

The second principle of practice guidelines isthat they contain sufficient specificity to allowfor their implementation. The SDM Master andSpecific DecisionPaths aid in implementing thepractice guidelines.


The third principle of practice guidelines is thatthey are adapted to the community, adopted bythe health care providers, and reflect the specificresources of the community. The key componentsof this process include:

• community needs assessment

• orientation to SDM

• adaptation and adoption of practice guidelinesby health care professionals

• implementation plan for SDM

• plan for short-term and long-term outcomeassessment:

Master DecisionPathsThe SDM Master DecisionPaths outline the ther-apeutic stages for each type of diabetes and showthe most effective route for attaining metaboliccontrol. Each stage represents a therapeutic regi-men. Stages include medical nutrition and activitytherapy, oral agent, combination therapy, and in-sulin.

The Master DecisionPaths guide the selectionof an initial treatment for diabetes based on thecurrent plasma glucose and/or HbA1c at diagnosis.They also help in setting the level of blood glucosecontrol and HbA1c targets with their patients. Ifa therapy fails, the Master DecisionPaths guidethe progression to other stages of therapy. TheType 2 Diabetes Master DecisionPath is shown inFigure 1.2 as an example.

Access to the Master DecisionPath takes placethrough the rounded rectangular shapes, whichcontain the entry criteria. Each rectangular shapedefines a particular therapeutic stage, the timelinewithin which to reach target, and guidelines for

moving to another stage of therapy if targets arenot met. All Master DecisionPaths follow thesame format.

The “shorthand” notations within the rectanglesrepresent the therapy and depict the four timesfor administering a pharmacologic agent: AM(fasting), Midday (before the Midday meal), PM(before the evening meal), and BT (bedtime, or atleast 2 to 3 hours after the evening meal). Lettersare written for each time period to indicate whichmedication is administered, or a “0” (zero) iswritten to indicate when no medication is given atthat time. Thus, Insulin Stage 2 is written as “R/N-0-R/N-0,” referring to the short-acting regularinsulin (R) mixed with N insulin injected beforebreakfast and again before the evening meal. Nomedication is taken at midday or at bedtime. Notethat rapid-acting (RA) Lispro or Aspart insulincan be substituted for regular insulin in mostinsulin regimens. For Insulin Stage 2, the resultingshorthand is “RA/N-0-RA/N-0.”

Specific DecisionPaths

The heart of the DecisionPath approach is theintersection of stage and phase (start, adjust, ormaintain). Staged Diabetes Management providesa DecisionPath for each such intersection, whichdescribes the action to be taken in terms of thespecific therapy and also indicates the general pathbeing followed and the progress being made.

There are two types of Specific DecisionPath:Start and Adjust/Maintain. Using Type 2 Diabetes

Insulin Stage 2 as an example (see Figure 1.3),note that the structure of the Start DecisionPathbegins with the entry criteria (blood glucose atdiagnosis or failure of a previous therapy). It thenmoves to the medical visit and the blood glucosetargets and is followed by notes related to startingthe treatment. After the “how to start” comes thefollow-up information. The same structure is usedfor all Start DecisionPaths.

SPECIFIC DECISIONPATHS 11

Figure 1.2 Type 2 Diabetes Master DecisionPath


At DiagnosisFasting plasma glucose �300 mg/dL (16.7

mmol/L) or casual plasma glucose�350 mg/dL (19.4 mmol/L)

Start insulin within 1 week; hospitalize ifoutpatient education not available

If acute illness, hospitalize and startinsulin immediately

From Oral Agent or Combination TherapyIf unable to achieve glycemic targets afterclinically effective dose of oral agent(s) for

3 months

History, physical exam, and laboratoryevaluation by clinican

See Medical Visit

Start Insulin Stage 2

OR

R/N � 0 � R/N � 0RA/N � 0 � RA/N � 0

At Diagnosis or from Oral Agent TherapyCalculate total dose at 0.3 U/kg based on currentweight

DistributionR/N or RA/N ratio

AM2/31:2

MIDDAY0�

PM1/31:1

BT0�

Pre-mixed insulin, 70/30, Mix 75/25, or Mix70/30 may be used for patients unable to drawinsulin correctly

Refer patient for nutrition and diabetes educationSee Nutrition Education and Diabetes Education

Daily phone contact for 3 days,then office visit within 2 weeks;24-hour emergency phonesupport neededWithin 24 hours, then officevisit in 2 weeks

Follow-upMedical:

Education:

Move to Insulin Stage 2/Adjust

SMBG Targets• More than 50% of values within target range• Pre-meal: 70–140 mg/dL (3.9–7.8 mmol/L)• Post-meal (2 hours after start of meal): � 160 mg/dL• (8.9 mmol/L) Bedtime: 100–160 mg/dL (5.6–8.9 mmol/L)• No severe (assisted) or nocturnal hypoglycemia

Adjust target upward if frail elderly, decreased life expectancy, cognitive disorders, or other medical concerns

HbA1c Target• Within 1.0 percentage point of upper limit of normal

SMBG Frequency• Test 2–4 times/day; before and 2 hours after start of meals and at bedtime

Rapid Acting (RA) Considerations• 1 unit of RA � 1 unit of regular insulin• Administer within 15 minutes before the meal due to rapid action• May need to increase basal insulin dose• Use both pre-meal and post-meal SMBG data to make RA dose adjustments• May have reduced need for snacks between meals

Figure 1.3 Type 2 Diabetes Insulin Stage 2 (Mixed)/Start DecisionPath

A second type of Specific DecisionPath relatesto adjusting and maintaining the current ther-apy. As shown in the Metformin/Adjust Decision-Path (Figure 1.4), the DecisionPath begins witha brief review of key data and a reminder ofthe target levels. These data (current medications,diabetes control, adherence, weight change, andhypo/hyperglycemic events) are common for allforms of diabetes. This is followed by a closerevaluation of current glycemic control.

When glycemic target levels are reached, thepatient enters the maintain phase. The Deci-sionPaths for adjusting therapy (i.e., Figure 1.4Metformin/Adjust) contain guidelines for routinefollow-up, which are consistent with the standardsof practice recommended by national diabetes or-ganizations. These include the frequency of visitsand the period of time between visits. If the tar-get blood glucose level has not been reached, thenext step is to determine why. Many practitioners

SPECIFIC DECISIONPATHS 13

Patient treated with Metformin

Interim History and Physical• Current medications• SMBG and HbA1c• Medical history (HTN, lipids, albuminuria)• Adherence to treatment plan• Intercurrent illness• Weight change• Hypoglycemia/hyperglycemia

Laboratory

• Lipid profile/albuminuria screening annually

See Medical Visit

If persistent gastro-intestinal discomfort, considerlowering dose or discontinuing Metformin andstarting thiazolidinedione

SMBG and/or HbA1c within target range?

Assess Monthly ImprovementHas average SMBG improved by 15–30 mg/dL

(0.8–1.7 mmol/L) and/or HbA1c by 0.5–1.0percentage points?

See Self Management Adherence, to assessday-to-day management

Patient on maximum dose ofMetformin for 2–4 weeks?

Consider alternative oral agent ormove to Combination TherapySelection or Insulin Therapy

Patient enters Metformin/Maintain

Continue current dose: use this DecisionPath forfollow-up

Follow-upMedical:Education:Nutrition:

See Medical Visit, Nutrition Education, andDiabetes Education

Every 3–4 monthsEvery 6–12 months (minimum)Every 6–12 months (minimum)

Patient remains in Metformin/Adjust

Continue current dose: use this DecisionPath forfollow-up

Follow-upMedical: Every 1–2 months

Metformin Dose Adjustments (in mg)

Metformin500 mg

Metformin850 mg

500

850

500/500

850/850

500/1000

–

1000/10001000/500/1000

– 850/850/850

May be increased weekly when using 500 mg tablets orbiweekly when using 850 mg tablets; note 1000 mg areavailable

Follow-upMedical:

NO

NO

YES

NO

YES

YES

STARTPM

NEXTAM/PM

NEXTAM/PM

NEXTAM/PM

MAXAM/MID/PM

• HbA1c every 3–4 months

monthly; use this DecisionPath for follow-up

Figure 1.4 Metformin/Adjust DecisionPath

blame a lack of patient adherence. When this is thecase, the Ancillary DecisionPaths entitled “Psy-chological and Social Assessment” and “DiabetesManagement Adherence Assessment” are usedto address issues related to adherence. However,an underlying principle of SDM is that thera-pies, not patients, fail. Thus, if adherence is notthe problem, the next step is to assess whether

any improvement has occurred. Over the periodof 1 month the average self-monitored bloodglucose (SMBG) should drop by 15–30 mg/dL(0.8–1.7 mmol/L), which corresponds to a dropin the HbA1c of 0.5–1 percentage point. If this isoccurring, the current treatment is continued with-out any adjustment. If these criteria are not met,further adjustment is necessary.


Diabetes education indicated

Obtain Referral Data••

••

•

Type of diabetes (diagnosis data)Diabetes treatment regimen (medications,medical nutrition therapy)Medical history (HTN, lipids, complications)HbA1c/ketones/SMBG dataSMBG/HbA1c targetsPrescription for BG testing, if needed

Establish Education Plan

Assesment•

•

••

•

•

•••

••

••

Height/weight (BMI)/BP/foot exam withmonofilamentRisk factors (family history, obesity, ethnicity,GDM)Diabetes knowledge/skillsPsychosocial issues (denial, anxiety,depression)Economic/cultural factorsReadiness to learn/barriers to learningLifestyle (work, school, food and exercisehabits)Tobacco/alcohol useSupport systemsHealth goals

GoalsSMBG/HbA1c in targetAchieve self-management knowledge/skills/behavior (SMBG, medications, nutrition,exercise)

PlanTeach initial education topicsEstablish 1 behavior change goal with patient(exercise, nutrition, medications, monitoring)

See Diabetes Education Topics and PsychosocialAssessment

Move to Diabetes Education/Follow-up

Document and communicate education deliveredand behavior change goals in writing to referralsource

Follow-upEducation: 2–4 weeks

Diabetes Complications and TreatmentCVD: antihypertensives, aspirin therapyDyslipidemia: lipid-lowering agentsRetinopathy: laser therapyNephropathy: nutritional interventions, ACEinhibitor or ARBNeuropathy: pharmacologic agentsFoot problems: ulcer treatment, foot care

Behavior Change Goals•

••

•

Goals must be specific, reasonable, andmeasurableEstablish a time frame and evaluation pointsDocument goals for the patient record and givecopy to patientEncourage rewards for progress

See Management Adherence Section

Figure 1.5 Diabetes Education/Initial DecisionPath

Each pharmacological agent has a maximumsafe and effective dose. For oral agents, SDMutilizes maximum dose criteria provided in thepackage insert, but also reports the clinically ef-fective dose, which sometimes is well below themaximum recommended dose. For example, the

clinically effective dose of sulfonylureas is ap-proximately two-thirds the maximum dose. Forinsulin, in general, between 1 and 1.5 U/kg(depending on the type of diabetes and the age ofthe patient) is considered the maximum safe dose.Exceeding this range requires a re-evaluation of

METABOLIC SYNDROME, COMPLICATIONS, AND HOSPITALIZATION DECISIONPATHS 15

the therapy. Staged Diabetes Management pro-vides similar criteria for each adjust phase, andalso provides reasons for moving from one stageto the next. For example, the choice of combi-nation or insulin therapy is based on whether thelack of improvement is due primarily to fasting

hyperglycemia or postprandial hyperglycemia. ForInsulin Stage 2 (Mixed) the criteria for movingto Insulin Stage 3 (Mixed) are persistent fastinghyperglycemia, nocturnal hypoglycemia, or insuf-ficient improvement in HbA1c.

Criteria for adjusting and changing therapy

The underlying principle in SDM is that there isa rational and consistent set of criteria that can beapplied when considering moving a patient fromone therapy (stage) to another. Part of the prin-ciple is that the decision be founded on (but notlimited to) verified SMBG data and HbA1c val-ues. The therapeutic goal is to achieve a changeof 0.5 to 1.0 percentage point in HbA1c eachmonth with a parallel improvement in averageblood glucose as measured by reduction in SMBGof 15–30 mg/dL (0.8–1.7 mmol/L). To achievethis therapeutic goal, current therapy must be re-considered frequently. Assessing the patient’s ad-herence to the treatment plan includes reviewingblood glucose monitoring technique and records,

food plan and activity record keeping, and consis-tency in following the pharmacologic regimen.

The first step to assess the current therapy is toensure that a sufficient number of SMBG tests areperformed. Generally, this requires a minimum offour tests each day at specified times, such as:before meals, 2 hours post-meal, bedtime, and3 AM as required. If patterns of SMBG dataconfirm blood glucose levels consistently greaterthan target, consider adjusting the therapy. If noimprovement is noted, consider changing to analternative therapy. The change to more complextherapies permits greater flexibility in reaching aparticular blood glucose target.

Diabetes Management Assessment DecisionPaths

Diabetes Management Assessment DecisionPathsprovide specific information for initial and follow-up medical visits, psychological and social evalu-ation, treatment and prevention of hypoglycemia,illness assessment and management, diabetes andnutrition education, exercise, and adherence as-sessment. For example, the Diabetes EducationDecisionPath shown in Figure 1.5 lists the datathe educator needs prior to seeing the patient as

well as the length of time each visit requires andthe topics to be covered. Nutrition and ExerciseDecisionPaths follow the same format. Adherenceassessment covers both metabolic parameters andbehavioural cues that may explain poor adherence.The therapeutic DecisionPaths refer as needed tothe Diabetes Management Assessment Decision-Paths.

Metabolic syndrome, complications, andhospitalization DecisionPaths

The DecisionPaths for vascular complications,nephropathy, retinopathy, neuropathy, and footdisease generally follow the same format as thosefor treatment of diabetes. They differ in terms

of their subject matter. They address prevention,screening, and diagnosis as well as starting andadjusting therapy (see Figure 1.6).


Patient with foot ulcer

Assess UlcerMeasure width and depth of ulcerTemperature; white blood countDeep space infection: abscess, osteomyelitis,gangrenePulses; ankle-brachial (ABI) indexIschemic symptoms

•••

•

Any of the following present:Ulcer � 2 cm diameter and/or � 0.5 cm deep;

cellulitis with 2 cm margin or ascendinginfection; temperature � 100.5°F (38° C);

with blood count � 12000; deep spaceinfection; pulses absent; or ABI� 0.8 with ischemic symptoms?

Classification: High-Risk Simple Ulcer(small superficial ulcer with no complications)

Weekly debridment; sterile dressing changes;limit weight bearing to foot

If exudate or limited cellulitis, start oral antibi-otic for staphylococcus and streptococcusArrange home care follow-up

•

•

•

Classification: High-Risk Complex Ulcer(active ulcer with extensive involvement)

Hospitalize patient for wide surgical debride-ment; culture for infection; sterile dressingchanges; no weight bearing on footConsider becaplermin gel for neuropathiculcers that have adequate blood suppleIf deep space infection, start parenteralantibiotic for staphylococcus and streptococcusComplete vascular evaluation if ischemiapresent

Follow-upMedical:

Education:

Daily until ulcer improves, then2 month complete examination:arrange home care follow-upIf improved reclassify to High-Risk Simple Ulcer

Daily foot inspection; report anyinjury or abnormaility; wearappropriate footwear; skin, nail,callus care; avoid foot soaks;tight glycemic control

If no improvement within 2 weeks for simpleulcer or 1 week for complex ulcer, refer to

specialist; consider amputation

•

•

•

•

Follow-upMedical:

Education:

Weekly until ulcer is resolved,then 2 month complete examina-tion; assess foot at every visit

Daily foot inspection; report anyinjury or abnormaility; wearappropriate footwear; skin, nail,callus care; avoid foot soaks;tight glycemic control

If no improvement within two weeks,reclassify to High-Risk Complex Ulcer;

consider hospitalization

Figure 1.6 Foot Ulcer Treatment DecisionPath

THE DIABETES CARE TEAM 17

The patient and Staged Diabetes Management

Because patient participation is an integral part ofSDM, they should be provided with a brief versionof the Master DecisionPath to familiarize themwith available therapeutic options. Along with theMaster DecisionPath, the patient should be awareof the tests that are generally performed (such asHbA1c). One approach is to provide patients withbooklets that provide places to record blood glu-cose and HbA1c targets along with actual values.

Additionally, SDM encourages the use of aprogress record, which is a tool that allows

patients and providers to track the course of treat-ment over time. The progress record provides thehistory of care at a glance, allowing both patientand provider to see where they have been andwhere they are going. This is a valuable aid inteaching and in maintaining adherence to com-plex therapies. The patient is kept informed andinvolved at every step. Figure 1.7 shows anexample of a progress record for type 2 diabetesand illustrates how it is used.

The diabetes care teamThe concept of a diabetes care team is not new.However, the role of the patient as a memberof the team is new. Because of the reliance onpatient collected data combined with the need forthe patient to cooperate, understand the therapies

and follow complex regimens, the patient mustbe considered at the centre of the care team. Inprimary care management, the team may includethe physician, nurse educator, nurse practitioner,physician’s assistant, pharmacist, and dietitian

Progress Record

Date YourHbA1c

HbA1cTarget

Stage ofTreatment

MedicationDose

Your Phase of Treatment

Start Adjust Maintain

6/1(office)

6/7(phone)

6/21(office)

7/5(phone)

7/19(office)

8/2(phone)

8/16(office)

9/7(phone)

9/21(office)

10/3(phone)

12/2(office)

233

225

205

210

207

200

180

188

100-160

90-155

70-140

70–140

70–140

70–140

70–140

70–140

70–140

70–140

70–140

70–140

70–140

70–140

9.5

Glipizide

Glipizide

Glipizide

Glipizide

Glipizide

Glipizide

InsulinStage 2

InsulinStage 2

8.5

6.9

less than7.0

10 mg AM

10 mg AM

15 mg AM

10 mg AM/PM

15 mg AM/PM

20 mg AM/PM

5/0-0-4/4-0

7/9-0-4/4-0less than7.0

less than7.0

Glipizide

InsulinStage 2

InsulinStage 2

5 mgAM

7/9-0-5/4-0

7/9-0-5/4-0

Your BloodGlucoseRange(mg/dL)

Pre-MealBlood

GlucoseTarget(mg/dL)

Figure 1.7 Patient Progress Record


with the psychologist/social worker or exercisephysiologist included where available. This teamapproach is especially needed in the absence of adiabetes specialist. If a specialist is available, theteam might include both the primary care physi-cian and a diabetes specialist. Under such circum-stances the DecisionPath to be followed wouldinclude the conditions for referral and would beshared by all involved in diabetes care. Deci-sionPaths specify the role of each professional.The nurse and dietitian have especially uniqueroles to play, roles that in many instances thephysician cannot assume without additional train-ing and time. The DecisionPaths and the narra-tives include specific information about nutritionalinterventions and education. The primary careprovider is specifically trained for, and skilled in,comprehensive first contact and continuing carefor persons with diabetes. Responsibilities includehealth promotion, disease prevention, health main-tenance, counseling, patient education, diagnosis,and treatment. The primary care provider coordi-nates the care of the individual with diabetes usingother health professionals, consultation, and/or re-ferrals as appropriate. The primary care providerserves as “patient advocate in the health caresystem to accomplish cost-effective care by co-ordination of health care services.” Is the primarycare physician to be considered the “diabetolo-gist?”

“Diabetologist” is a term that is often misunder-stood. In the United States, there is no such degreeor board examination. A diabetologist is oftenconsidered any health professional with expertisein diabetes. However, for both legal and ethicalconsiderations, the physician specialist in diabetesis generally referred to as a board-certified en-docrinologist. This is different from those physi-cians whose practice concentrates on diabetes.Currently, the National Committee for Quality As-surance (NCQA) recognizes individual providersor groups of providers as a “Recognized Physi-cian,” indicating that the physician (or group ofphysicians) has undergone a careful evaluation ofclinical practice and met specific criteria for thetreatment of diabetes. This focus on assessing ex-pertise by clinical outcomes in place of formal

education is in part recognition that extensiveclinical experience with beneficial outcomes is animportant factor in measuring clinical ability.

The team member known as the “diabetes ed-ucator” provides initial and ongoing educationrelated to self-management, survival skills, pre-vention and detection of complications, as wellas diabetes skills training. Generally nurses anddietitians (recently physicians and pharmacistshave taken on this role), educators have exten-sive knowledge of diabetes medical managementand ample experience in self-management edu-cation. Like the NCQA Physician Recognitionprogram, national organizations certify the exper-tise of the educator by making certain that theyhave provided at least 1000 hours of diabetes pa-tient education and passed a national examination.Upon completion the health care professional isawarded certification as a Certified Diabetes Edu-cator (CDE).

The registered dietitian is responsible for as-sessing the dietary needs of the individual andhelping develop a food plan consistent with thenutrient requirements for growth and developmentin children and sustained good health in adults.Often a CDE as well, the dietitian addresses eat-ing habits, suggests changes in behaviour, anddesigns a course of action to optimize the nutri-tional component of diabetes care. Dietitians willalso work with patients to establish an activityand/or exercise plan.

The psychologist/social worker assesses the in-dividual’s initial and ongoing emotional adjust-ment to diabetes as well as the family’s adjust-ment. Recently, as patients are more involved inclinical decisions and day-to-day therapy adjust-ments, the psychologist’s role as a force for em-powering patients to participate in their own carehas received renewed emphasis.

Other team members include the pharmacist,podiatrist, exercise physiologist, and such special-ists as cardiologists, neurologists, and nephrol-ogists. The underlying concept of team careis that all health care providers and the pa-tient agree in advance as to the course of treat-ment. This avoids both misunderstandings andcounterproductive treatment. More important, itsignificantly reduces error.

THE CHANGING PERSPECTIVE OF DIABETES CARE: DCCT AND UKPDS 19

The changing perspective of diabetes care: DCCTand UKPDSTwo long-term clinical trials between 1977 and1998 were designed to determine whether gly-cemic control was associated with the onset andprogression of complications of diabetes. The Di-abetes Control and Complications Trial (DCCT),conducted in the United States and Canada, andthe United Kingdom Prospective Diabetes Study(UKPDS), conducted in centers through the UnitedKingdom concluded that glycemic control was acritical factor in the development and progressionof microvascular complications and that treatmentshould be targeted to explicit metabolic markerssuch as blood glucose and blood pressure.1,7

The DCCT began in 1983 with a fundamen-tal question: does improvement in glycemic con-trol prevent the onset of and/or slow the pro-gression of microvascular complications in theindividual with newly detected type 1 diabetes?While the primary focus of the study was on reti-nal and renal complications, the research questionexpanded to include other microvascular compli-cations (neuropathies) as well as macrovascularcomplications (hypertension and cardiovasculardisease) and psychosocial disorders. The DCCTwas completed in June 1993. Over the period ofthe study, 1441 patients entered the study, and lessthan 1 per cent dropped out. Twenty-seven clini-cal centers and two satellites in the United Statesand Canada participated. Patients were randomlyassigned to conventional treatment, usually twoinjections of mixed (intermediate- and short- act-ing) insulin per day with the expectation of anHbA1c >8.5 per cent or to intensive treatment,usually three or more injections per day with thegoal of HbA1c <7 per cent. Patients in the in-tensively treated group were followed monthly,whereas those in the conventional group wereseen at three-month intervals. Eye examinations,renal function assessment, neurological evalua-tion, blood pressure measurement, and neurobe-havioral assessment along with metabolic mea-surements were completed on 95 per cent of the

patients throughout the study period. The resultsare summarized in Table 1.1.

Following completion of the DCCT several cen-ters agreed to follow the participants from boththe conventional and intensive control groups todetermine the long-term risk of developing com-plications as part of the Epidemiology of DiabetesInterventions and Complications (EDIC) study.10

The patients in the DCCT conventional therapygroup were offered intensive therapy and all pa-tients (including the intensive therapy group) wereplaced under the care of their physician and dia-betes team. The study is still ongoing; however,interim outcomes show that there continues tobe a close association between the developmentand progression of complications and level ofglycemic control throughout the DCCT study pe-riod. Patients from the intensive therapy groupcontinue to have significantly reduced risk ofretinopathy and nephropathy compared to patientsfrom the conventional therapy group several yearsafter the termination of the DCCT.11

The results of both the DCCT and EDIC re-quire a thoughtful process of integration into cur-rent practice in terms of the treatment of type 1diabetes. The intensively treated group did notsuffer adversely (except for a threefold risk ofhypoglycemia principally at the beginning of thestudy and marginal weight gain) when glycemiccontrol was tightened. At the onset of the study,the average HbA1c was approximately 9 per cent.More than 700 patients’ glycemic control hadto be rapidly reduced to an HbA1c of 7 percent or less for the duration of the study. While

Table 1.1 DCCT study results: complica-tions risk reduction for intensively treated group

Condition % RiskReduction

Retinopathy 76Neuropathy 60Nephropathy (macroalbuminuria) 54


hypoglycemia increased, once glycemic controlwas stabilized, these reactions were reduced inmost patients. Weighing the risk of hypoglycemiaagainst the benefit of improvement in control,study investigators concluded that, with appro-priate caution taken, all but a small minority oftype 1 patients would benefit from improved con-trol. It was further noted that any improvementin glycemic control would reduce the risk of mi-crovascular disease. An interesting finding in theintensified group was that the emphasis on morecomplex treatments and maintaining goals towardeuglycemia did not adversely affect the patients’psychosocial well-being. This was an importantfinding, since many have cited the possible neg-ative impact of intensified therapies on quality oflife and psychosocial well-being.

Not all patients in the experimental groupachieved tight control, and at least 20 per centof those in the conventionally treated group hadsignificantly improved HbA1c during the study.The two questions that remain are whether thestudy results can be duplicated under non-studyconditions and to what degree the findings remainconsistent over time. Since the end of the studyboth questions have been addressed.

Can the intensive treatment found in the DCCTbe duplicated in primary care practice? In 1993the International Diabetes Center published its al-gorithms that resulted in maintaining near- nor-mal glycemia in its cohort of DCCT patients. Itshowed that a systematic approach based on spe-cific glycemic criteria for alteration of therapysignificantly lowered and sustained blood glucoseto levels that matched the DCCT experimentalgroup. These protocols were used in numeroussites between 1993 and 2002 within primary carepractices within the United States, Japan, Poland,Mexico, Brazil, and France. In September 2000,health professionals from around the world re-sponsible for implementing SDM met to shareimplementation strategies and outcomes at an In-ternational Congress held in Puebla, Mexico.12

The findings are summarized in Table 1.2.Can the tight glycemic control achieved in the

DCCT be sustained? Follow-up of DCCT patientsfor 9 years confirmed that patients who are inten-sively treated and maintain near-normal glycemia

reduce their risk of complications. Called EDIC,the study showed that if patients are not treatedintensively, even those originally in the experi-mental group will have deterioration in HbA1c. Infact, over time, the significant difference that ex-isted at the end of the study in HbA1c levels allbut disappears if patients are not treated to specificmetabolic targets.

At the completion of the DCCT, and until thepublication of the results of the UKPDS, thefindings for type 1 diabetes served as the basisfor arguments supporting the need for intensi-fied treatment of type 2 diabetes. Ten times moreprevalent than type 1 diabetes, type 2 diabetesis also associated with micro- and macrovascu-lar complications. Within a short time after theresults of the DCCT were announced, many sci-entists and clinicians, as well as such nationalorganizations as the ADA, concluded that im-proved glycemic control in type 2 diabetes wasas beneficial as in type 1 diabetes.9 More recentlythis has been supported by several studies thathave been conducted in Denmark, Japan, and theUnited Kingdom involving individuals with type2 diabetes. The UKPDS is the largest study yetto be conducted in individuals with type 2 dia-betes. It was a prospective randomized controlledtrial, which enrolled more than 5000 individualswith newly diagnosed type 2 diabetes in 23 centersthroughout the United Kingdom between 1977and 1991.7,13 After a 3 month diet and exerciserun-in period, patients were randomized to re-ceive either “conventional” or “intensive” treat-ment using sulfonylurea (chlorpropamide, gliben-clamide, or glipizide), metformin, or insulin. Thegoal of conventional treatment was to main-tain fasting plasma glucose levels <270 mg/dL(15.0 mmol/L), while the goal of intensive treat-ment was to maintain fasting plasma glucose lev-els <108 mg/dL (6.0 mmol/L). By the completionof the trial the intensive therapy group and con-ventional therapy group had a difference in meanHbA1c of 0.9 per cent (7.0 versus 7.9 per cent).This difference in glycemic control was accom-plished in part due to the willingness to movefrom monotherapies to combination therapies andthe widespread introduction of insulin therapieswhen oral agents failed to maintain near-normal

THE CHANGING PERSPECTIVE OF DIABETES CARE: DCCT AND UKPDS 21

Table 1.2 International SDM outcomes

Country Outcome

France Improved metabolic and process outcomes versus control group. SDM Group (n = 30) versusStandard Care (n = 36)

• Mean decrease in HbA1c of 0.8 percentage points in SDM Group versus mean increaseof 0.45 percentage points in Standard Care Group, p = 0.001

• Microalbuminuria screening 77% in SDM Group versus 38% in Standard Care Group,p = 0.01

• 5.07 monofilament exam 80% in SDM Group versus 25% in Standard Care Group,p = 0.01

• HDL determination 53% in SDM Group versus 30% in Standard Care Group, p = 0.01

Germany Patients with diabetes (n = 196) receiving care by physicians following SDM hadsignificantly increased (p < 0.001) patient satisfaction and quality of life compared topatients receiving standard care (n = 174).

Japan Patients with diabetes (n = 76) treated by internists following SDM showed a 1.5 percentagepoint reduction in HbA1c from baseline while patients treated by usual care showed a0.5 percentage point increase in HbA1c.

Poland Women with gestational diabetes mellitus (GDM) managed by physicians following SDM(n = 205) had significantly improved outcomes shown by reduced rates of macrosomia andfetal hypoglycemia compared with women with GDM receiving standard care (n = 67).

glycemia. The study resulted in a 25 per centreduction in risk for microvascular complications(p < 0.01) and a 16 per cent reduction in risk formyocardial infarction (p = 0.052) when the inten-sively treated group was compared with controls.Moreover, the UKPDS provided no evidence foran increase in cardiovascular risk with either sul-fonylurea or insulin therapy.

Additional UKPDS findings:

• the incidence of hypoglycemia in intensivetherapies is minimal

• weight gain is not significant as patients moveto insulin therapies

• overall improvement in glycemic control re-quires attention to the natural history of thedisease

• improvement in indirect measures ofmacrovascular disease (hypertension and dys-lipidemia) occurs with improved glycemic

control, independent of the particular pharma-cological agent used

• control of blood pressure is a major contribu-tor to reduction in risk of cardiovascular andmicrovascular disease

Since the publication of the UKPDS numer-ous studies have supported the long-term benefitsand risk reduction associated with improved bloodglucose and blood pressure control. The currentconsensus is to treat the person with type 2 dia-betes with the same intensity and toward the samemetabolic goals as the person with type 1 diabetes.

While no such large-scale studies of diabetes inpregnancy exist, nevertheless these same princi-ples remain intact for gestational and pre- ges-tational diabetes. Achievement of near-normalblood glucose continues to afford the bestprotection from both adverse maternal and peri-natal morbidity and mortality. Increasingly, as thenumber of women with gestational diabetes andpre-gestational diabetes is becoming higher, theimportance of detecting and vigorously treating


hyperglycemia in pregnancy is becoming greater.Ample scientific evidence exists that untreatedhyperglycemia in pregnancy will not only have

short-term consequences for the mother andneonate, but can have long-term consequences forthe newborn as well.

Metabolic syndrome (insulin resistance syndrome)

In the early 1970s a constellation of commondisorders were recognized as occurring “coinci-dental” to type 2 diabetes. It was reported that 80per cent of those with type 2 diabetes were over-weight or obese at diagnosis; additionally, hyper-tension seemed present in most patients along withdyslipidemia. Many investigators found that theseindividuals also had hyperinsulinemia. These find-ings were initially presented by Gerald Reavenand associates, becoming known as Reaven’s syn-drome. Later it was called syndrome X, the deadlyquartet, metabolic syndrome, dysmetabolic syn-drome, and insulin resistance syndrome. For pur-poses of clarity, SDM uses the term metabolicsyndrome. Sometime during the evolution of thissyndrome, investigators found underlying renaldisease to be common as well in these patients.Currently its components are believed to be re-lated to both cellular and vascular insulin resis-tance. While the actual number is not certain, it

has been estimated that 50 million adults in theUnited States have metabolic syndrome.14

Several organizations have created criteria forthe clinical identification of metabolic syndrome.Useful criteria have been developed as part ofthe National Cholesterol Education Program AdultTreatment Panel III (NCEP-ATP III) guidelines.15

Current criteria from the NCEP-ATP III guidelinesrequire any three of the following risk factorsto make the diagnosis of metabolic syndrome(insulin resistance syndrome):

Risk Factor Defining Level

Abdominal obesity Waist circumference>40 in. (102 cm) men>35 in. (88 cm) women

Fasting glucose ≥110 mg/dL (6.1 mmol/L)Blood pressure ≥130/≥85 mmHgTriglycerides ≥150 mg/dL (1.7 mmol/L)High densitylipoprotein (HDL) <40 mg/dL men (1.0 mmol/L)

<50 mg/dL women (1.3 mmol/L)

Children and adolescents with type 2 diabetesand/or metabolic syndrome

The traditional view is that while type 1 dia-betes is a disease of childhood and adolescents,type 2 diabetes and concomitant metabolic syn-drome are diseases of adults. This view is corrob-orated by data that show the incidence of type1 diabetes reaches its peak during adolescenceand the number of new cases of type 2 diabetesrises with age. Additionally, more than 20 percent of those aged 65 years or older have type2 diabetes.16 It is only recently that type 2 di-abetes and metabolic syndrome are being diag-nosed in children and adolescents. This is most

probably due to recognition of the strong geneticcomponent in the etiology of diabetes. The iden-tification of type 2 diabetes in children clustersin Hispanic, African-American, Native American,and Pacific Island peoples. Among the Pima In-dians children as young as four years old havebeen diagnosed with type 2 diabetes. Hispanicchildren living near the Mexican border and inSan Antonio, Texas, have been found to have ahigh incidence of both insulin resistance and type2 diabetes. Along with a genetic predisposition,obesity in children and adolescents is associated

DIABETES MANAGEMENT IMPROVEMENT INITIATIVES 23

with the development of type 2 diabetes at a veryyoung age. High caloric intake from diets com-prised principally of fats and carbohydrate com-bined with reduced activity result in an imbalancebetween energy intake and energy output. This

results in increased obesity, further exacerbatinginsulin resistance. Because the identification andtreatment of these children require modificationfrom the approach to adults, a separate section isincluded in the text.

Common diagnostic criteria

In 1997 the American Diabetes Association(ADA) announced new fasting plasma glucose cri-teria for the diagnosis of diabetes to assure greateruniformity throughout the United States.17 Thenew criteria were developed in response to grow-ing evidence that the complications of diabetesbegin to emerge at much lower fasting plasmaglucose levels than previously thought. Thus, thefasting plasma glucose level required for diagno-sis was lowered from 140 mg/dL (7.8 mmol/L) to126 mg/dL (7.0 mmol/L). In addition, the lowerfasting plasma glucose diagnostic criteria wasmore aligned with the criteria for casual plasmaglucose – 200 mg/dL (11.1 mmol/L). Based onthese criteria, the Centers for Disease Control andPrevention (CDCP) made new estimates of the in-cidence and prevalence of diabetes and impairedglucose homeostasis (pre-diabetes) in the UnitedStates.16

• The prevalence of diabetes is 17 million(11.1 million diagnosed and 5.9 million undi-agnosed), representing approximately 6.2 percent of the population.

• The prevalence of diabetes in people 65 yearsor older is 7.0 million (20.1 per cent of thepopulation).

• The incidence of diabetes is 1.0 million newcases diagnosed in person aged 20 years orolder.

• 16 million adults 40–74 years of age haveimpaired glucose tolerance (2 hour oral glu-cose tolerance test values of 140–199 mg/dL[7.8–11 mmol/L]) and 10 million have im-paired fasting glucose (plasma glucose of100–125 mg/dL [5.6–6.9 mmol/L].

• The incidence of gestational diabetes mellitus(GDM) is 150000 cases/year.

• Projections to the year 2010 estimate as manyas 25 million individuals in the United Stateswill have diabetes.

The CDCP concluded that, based on these es-timates, more than 450000 people die each yearwith diabetes as a primary or contributing factor.

These figures highlight the significance of SDMfor primary care and for those who feel that accessto quality diabetes care should not be limited tothose whose geographical location or economicsituation allows treatment at an expert diabetescentre.

Diabetes management improvement initiatives

While many organizations have developed na-tional recommendations related to the diagnosisand treatment of diabetes and associated diseases,the American Diabetes Association is unique inhaving initiated a program to identify those physi-cians who consistently meet national standards.

Currently administered by the National Com-mittee for Quality Assurance (NCQA), the pro-gram is called the Diabetes Physician Recogni-tion Program (DPRP). DPRP establishes clinicalprocesses and outcomes as “benchmarks” thatconstitute quality care.18 Individual physicians or


Table 1.3 Diabetes Physician Recognition Pro-gram benchmarks of quality diabetes care

Required Measures AdultBenchmarks

HbA1c testing* ≥100%HbA1c < 7% ≥40%HbA1c > 9% ≤20%

Eye examination* ≥60%Foot examination* ≥80%Blood pressure measure* ≥100%

<140/90 mmHg ≥65%<130/80 mmHg ≥35%

Nephropathy assessment* ≥80%Lipid profile* ≥85%

LDL <130 mg/dL (3.4 mmol/L) ≥63%LDL <100 mg/dL (2.6 mmol/L) ≥36%

Optional Patient SurveyTobacco status and counseling ≥80%Self-management education ≥90%Medical nutrition therapy ≥90%Self-monitoring of blood glucose

Non-insulin-treated ≥50%Insulin treated ≥97%

Patient satisfaction**Diabetes care overall ≥58%Diabetes questions answered ≥56%Access during emergencies ≥46%Explanation of lab results ≥50%Personal manner of physician ≥77%

* At least once per year.** Rated as excellent, very good or good on a scale ofexcellent to poor.

groups of physicians may apply for recognitionby demonstrating that they have initiated a sys-temic quality improvement program. DPRP is de-termined by chart review through a formal appli-cation process. The number of charts reviewed isbased on the number of physicians in the prac-tice (see Table 1.3). A fee is charged for theapplication. The NCQA argues that its recognitionprovides the following benefits:

• establishment of a baseline of current diabetescare allowing comparison to benchmark data

• public recognition as a quality program

• differentiation of the practice from others inthe community

• designation by the NCQA as a referral site fordiabetes care

• improved position for third-party reimburse-ment.

References1. Diabetes Control and Complications Trial Re-

search Group. The effect of intensive treatment ofdiabetes on the development and progression oflong-term complications in insulin-dependent di-abetes mellitus. N Engl J Med 1993; 329: 977–986.

2. Ohkubo Y, Kishikawa H and Araki E. Intensiveinsulin therapy prevents the progression of diabeticmicrovascular complications in Japanese patientswith non-insulin-dependent diabetes mellitus: arandomized prospective 6-year study. Diabetes ResClin Pract 1995; 28: 103–117.

3. Meigs JB, Singer DE, Sullivan LM, et al. Meta-bolic control and prevalent cardiovascular dis-ease in non-insulin-dependent diabetes mellitus(NIDDM): the NIDDM patient outcomes researchteam. Am J Med 1997; 102: 38–47.

4. Turner RC, Millns H, Neil HA, et al. Risk factorsfor coronary artery disease in non-insulin depen-dent diabetes mellitus: United Kingdom Prospec-tive Diabetes Study (UKPDS:23). Br Med J 1998;316: 823–828.

5. Rith-Najarian S, Branchaud C, Beaulieu O, Go-hdes D, Simonson G and Mazze R. Reducing lowerextremity amputation due to diabetes: application

REFERENCES 25

of the Staged Diabetes Management approach ina primary care setting. J Fam Pract 1998; 47:127–132.

6. Mazze RS, Etzwiler DD, Strock ES, et al. StagedDiabetes Management: toward an integrated modelof diabetes care. Diabetes Care 1994; 17: 56–66.

7. United Kingdom Prospective Diabetes StudyGroup. Intensive blood-glucose control with sul-fonylureas or insulin compared with conventionaltreatment and risk of complications in patients withtype 2 diabetes (UKPDS 33). Lancet 1998; 352:837–853.

8. Institute of Medicine. Clinical Practice Guidelines.Field MJ and Lohr KN, eds. Washington, DC:National Academy Press, 1990.

9. Nathan DM. Inferences and implications: do re-sults from the Diabetes Control and Complica-tions Trial apply in NIDDM? Diabetes Care 1995;18(2): 251–257.

10. Epidemiology of Diabetes Interventions and Com-plications (EDIC) Research Group. Epidemiol-ogy of Diabetes Interventions and Complications(EDIC): design and implementation of a long-term follow-up of the Diabetes Control and Com-plications Trial cohort. Diabetes Care 1999; 22:99–111.

11. Epidemiology of Diabetes Interventions and Com-plications (EDIC) Research Group. Retinopathyand nephropathy in patients with type 1 dia-betes four years after a trial of intensive ther-apy. The Diabetes Control and ComplicationsTrial/Epidemiology of Diabetes Interventions andComplications Research Group. N Engl J Med2000; 342: 381–389.

12. Mazze RS and Simonson GS. Staged DiabetesManagement: a systematic evidence-basedapproach to the prevention and treatment of dia-betes and its co-morbidities. Proceedings of StagedDiabetes Management: Worldwide Outcomes2000. Pract Diabetes Int Suppl 2001; 7: S1–S16.

13. United Kingdom Prospective Diabetes StudyGroup. Effect of intensive blood-glucose controlwith metformin on complications in overweightpatients with type 2 diabetes (UKPDS 34). Lancet1998; 352: 854–865.

14. Ford ES, Giles WH and Dietz WH. Prevalence ofthe metabolic syndrome among US adults: find-ings from the third National Health and NutritionExamination Survey. JAMA 2002; 287: 356–359.

15. National Cholesterol Education Adult TreatmentPanel III, NIH Publication Number 01-3305, 2001.

16. Centers for Disease Control and Prevention. Na-tional diabetes fact sheet: general information andnational estimates on diabetes in the United States,2000. Atlanta, GA: US Departments of Health andHuman Services, Centers for Disease Control andPrevention, 2002.

17. The Expert Committee on the Diagnosis and Clas-sification of Diabetes Mellitus. Report of the Ex-pert Committee on the Diagnosis and Classifica-tion of Diabetes Mellitus. Diabetes Care 1997; 20:1183–1197.

18. National Committee for Quality Assurance(NCQA) Diabetes Physician Recognition Program.2004, www.ncqa.org/dprp.

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