guidelines for diabetes mellitus guidelines

8/3/2019 Guidelines for Diabetes Mellitus Guidelines

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l Measurement of the albumin -to-creatinine ratio in a random, spot collection. This is easiest to perform,generally accurate and therefore is the preferred screening method.l 24 -hour collection with creatinine, allowing for simultaneous measurement of creatinine clearancel Timed (four -hour or overnight) collection

Some factors can artificially increase the levels of albumin in the urine and should be avoided at the time of theurine collection; these factors include blood in the urine, prolonged heavy exercise, fever, congestive heart failure,uncontrolled diabetes, severe hypertension, urinary tract infection, and vaginal fluid contamination of specimen.

If the dipstick or urine analysis test is negative for protein, then a more sensitive early screening test is indicated.A qualitative urinary microalbumin screen can be used to detect urinary microalbumin. If the qualitative test is

positive, a quantitative test must be performed.A microalbumin screening test should be done each year on patients with type 2 diabetes. If positive (exceeds 30mg/g), it should be repeated twice in the next 3 months.

If 2 out of 3 of these screening microalbuminuria tests are positive, the individual has microalbuminuria andinterventions should be considered. A negative finding should be followed yearly; a positive finding should befollowed periodically, for example annually, to see if the interventions are effective in diminishing the albuminuria[R] .

See Appendix A, "Treatment of Diabetic Nephropathy," in the original guideline document.

Comprehensive Foot Exam w ith Risk A ssessment

Patients with one or more risk factors for foot complications should be educated about their risk factors andappropriate measures taken to avoid complications. Measures may include self-management education, moreintensive follow-up, and/or referral to appropriate specialist [R] .

A foot exam should include assessment for the following risk factors for complications:l Loss of protective sensation. Protective sensation can be assessed using either a 5.07 Semmes -Weinsteinmonofilament for light touch or by testing vibration using a 128-Hz tuning fork at the dorsum of theinterphalangeal joint of the great toe, or both. Patients with reduced or absent sensation with either of thesetests should be educated about their risk and the need for proper foot care to prevent foot complications. (SeeAppendix B, "Using a Semmes-Weinstein Monofilament to Screen the Diabetic Foot for Peripheral SensoryNeuropathy" and Appendix C, "Using a Tuning Fork to Screen the Diabetic Foot for Peripheral Neuropathy" in theoriginal guideline document)l Peripheral vascular disease (absent pedal pulse, history of claudication, or ischemic skin changes)l Structural deformities (bunion, hammertoes, Charcot deformity, limited joint mobility, or prior amputation)l Skin disorders (nail deformity, callus, fissure, tinea, or ulceration)l Footwear (excessively worn, ill fitting, or inappropriate shoes)

Cardiovascular and Cerebrovascular Complication Assessment l History of cardiovascular symptoms such as chest pain, vascular claudication, transient ischemic attack (TIA)l Cardiac and carotid exams

l Evaluate cardiovascular status before advising increased intensity of exercise [R] Special Considerations

l Influenza vaccine every yearl Pneumococcal vaccine - consider repeating the immunization for those at risk of losing immunity after fiveyears including:

l Nephrotic syndromel Chronic renal diseasel Other immunocompromised states

l There is evidence that ACE inhibitors and ARBs are beneficial in reducing cardiovascular morbidity andmortality in acute myocardial infarction, congestive heart failure, and type 2 diabetes patients at high risk forcardiovascular disease; they are also beneficial in improving renal outcomes in diabetes. Results of the HOPE(Heart Outcomes Prevention Evaluation) study strongly support the use of ACE inhibitors for patients withdiabetes who are at high risk for cardiovascular disease. In the Second Australian National Blood Pressure Study(ANblood pressure2), the use of ACE inhibitors in older patients was associated with better cardiovascular

outcomes, despite similar reductions in blood pressure from diuretics. Confirming studies would be helpful tostrengthen this recommendation or to generalize recommendations to all patients with diabetes [A] .l Vitamin E has no apparent effect on cardiovascular outcomes [A] .l Osteoporosis: Type 2 diabetes does not appear to be a risk factor for decreased bone mineral density;nonetheless, some studies have found an increased fracture risk for people with type 2 diabetes [B] .Hypoglycemic episodes, decreased visual acuity secondary to retinopathy, and altered balance and posturalcontrol secondary to peripheral and autonomic neuropathy can all increase the risk of falls and fracture.In the absence of diabetes specific osteoporosis screening guidelines, it is reasonable to follow generalosteoporosis screening recommendations for people with diabetes. See the NGC summary of the ICSI guidelineDiagnosis and Treatment of Osteoporosis for more information.

Evaluate for Depression

There is a substantial increase in the prevalence of depression among people with diabetes as compared to theeneral adult o ulation M . Self-administered or rofessionall administered instruments such as the PH -9 are
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useful adjuncts to the clinical interview in the identification of depression. Depression impacts the ability of aperson with diabetes to achieve blood glucose control, which in turn impacts the rate of development of diabetescomplications [M] , [R] .

36. Treatment and Referral for Complications

Nephropathy

In type 2 diabetes, albuminuria may be present at the time of diagnosis in about 10% of patients, and another10% later develop it. Progression to renal failure is less certain in type 2 patients than in type 1 patients, andappears to be modulated by genetic and other factors.

Patients with clinical nephropathy almost always have retinopathy and coronary artery disease.

Numerous interventions are appropriate at different stages of renal function in order to prevent or slow theprogression of renal disease and associated cardiovascular disease and include [R] :

l Glucose Control - Improved glucose control at any stage of renal function reduces renal disease progression.See the Glycemic Control algorithm annotations.l For patients with type 2 diabetes mellitus, ACE Inhibitors and ARBs can reduce progression of micro - andmacrovascular complications. [Conclusion Grade I: See Conclusion Grading Worksheet E Annotations #28, 36(Treatment with ACE Inhibitors or ARBs) in the original guideline document] [A] . These agents appear effectiveeven in normotensive microalbuminuric individuals. This class of drugs must not be used in pregnancy. Within oneweek of initiation, check for elevations in potassium and creatinine levels.l Hypertension Control - Although ACE inhibitors and ARBs seem to have special renal protective propertiesbeyond their antihypertensive effect, any effort to optimize blood pressure will preserve renal function. Whensignificant microalbumin or overt nephropathy is present, there may be a tendency to retain sodium. In this case,a loop diuretic added to the antihypertensive regimen is often helpful to decrease blood pressure. A goal bloodpressure of 140/85 mm Hg is recommended [R] . See the Blood Pressure Control algorithm annotations.l Cardiovascular Risk Factor Intervention - Dyslipidemia is often present with microalbuminuria and should be

treated aggressively. Dyslipidemia may be an independent risk factor for progression of renal disease. Smoking isassociated with the onset and progression of microalbuminuria.l Restriction of dietary protein has been shown to slow progression of overt nephropathy (macroalbuminuria),and there may be some benefit in dietary protein reduction in microalbuminuric patients. In these circumstances,protein intake should be reduced to the adult recommended daily allowance of 0.8 to 1.0 g/kg body weight perday with microalbuminuria present, and 0.8 g/kg body weight per day with macroalbuminuria present [R] .Treatment for microalbuminuria includes aggressive blood pressure control, glycemic control, ACE inhibitor or ARBuse, and aggressive cardiovascular risk factor screening and management. Strongly consider referral to nephrologyany patients with a creatinine greater than 1.5 mg or nephrotic range proteinuria (greater than 3 g/24 hr).Nephrology interventions often include early patient education as renal disease progresses, review andreinforcement of the medical regimen, and preservation of arm veins for future vascular access. Patients with acreatinine clearance of less than 30 mL/min should be referred to nephrology for discussions of future options andto enhance the ability to receive a future transplant. These patients also have significant enough renalimpairment that they also benefit from more intensive nutritional interventions and proper management of anemia and bone disease [A] , [B] , [R] .

Neuropathy - Peripheral neuropathy is difficult to prevent and treat. Most patients with type 2 diabetes andperipheral neuropathy have few symptoms but are found on examination to have diminished reflexes and sensation.Sometimes neuropathy can be very painful, especially at night, with "pins-and-needles" numbness and tingling in astocking-and-glove distribution. Absence of reflexes or decreased thermal, vibratory, proprioceptive or painsensation may be noted on examination and confirm the diagnosis. Good glycemic control should be the first controlto symptomatic neuropathy. Treatment with amitriptyline, nortriptyline, or trazodone in doses beginning at 25 mgat night and increasing to 75 mg may help some patients. Topical treatment with capsaicin, 0.025% cream three tofour times per day, has also shown benefit. Carbamazepine, duloxetine, and gabapentin may also improveneuropathic pain. These medications may provide symptomatic relief, but they do not improve the neuropathy [R] .

Retinopathy - Prevalence of retinopathy is related to the duration of diabetes mellitus. After 20 years of diabetesmellitus more than 60% of patients have some degree of retinopathy [R] . Diabetic retinopathy is estimated to bethe most frequent cause of new cases of blindness among adults ages 20 to 74 years.

Up to 21% of patients with type 2 diabetes mellitus are found to have retinopathy at the time of diagnosis of diabetes mellitus [R] . Generally retinopathy progresses from mild background abnormalities to preproliferativeretinopathy to proliferative retinopathy.

Poor glucose control is associated with progression of retinopathy. High blood pressure is a risk factor for thedevelopment of macular edema and is associated with the development of proliferative retinopathy [R] .

Screening for diabetic retinopathy saves vision at a relatively low cost. In fact, screening costs may be less thanthe costs of disability payments for those that go blind. Laser photocoagulation surgery is effective in preventingvisual loss in diabetic retinopathy.

Studies have shown that retinal examinations by physicians who are not eye care specialists are not reliable indetecting retinopathy [A] , [C] , [R] .

Treatment includes glycemic and blood pressure control. Periodic screening and dilated eye exams by an eyespecialist and early treatment of diabetic retinopathy prevents visual loss [R] . See the Glycemic Control and BloodPressure Control algorithms.

Cardiovascular and cerebrovascular disease - Treatment includes control of cardiovascular risk factors(hypertension, hyperlipidemia, and smoking cessation) and aspirin use. Consider referring patients with knowncoronary artery disease to cardiology and patients with known carotid disease to surgery.

Heart failure is also common in patients with diabetes. Caution should be used when prescribing spironolactone andeplerenone to people with diabetes, especially in combination with ACE inhibitors.


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Close monitoring of potassium and renal function is necessary. Thiazolidinediones must also be used with cautionin patients with Class I and II congestive heart failure or patients at high risk for congestive heart failure. Closemonitoring for fluid retention and signs of congestive heart failure is needed. Thiazolidinediones should not be usedin Class III and IV congestive heart failure.

For patients with type 2 diabetes mellitus, thiazide diuretics in the treatment of hypertension can reducecardiovascular events, particularly heart failure. [Conclusion Grade I: See Conclusion Grading Worksheet F --Annotations #28, 36 (Thiazide Diuretics) in the original guideline document] [A] .

Patients with type 2 diabetes have twice the average risk of suffering a stroke [R] . It is unclear whether goodglycemic control reduces this risk. However, treatment of hypertension, smoking, and dyslipidemia reduces the riskof stroke in most persons. See Annotation #14, "Treatment Goals for Patients with Cardiovascular Disease" and the

Blood Pressure Control algorithm annotations.Peripheral vascular disease - Peripheral arterial disease is commonly associated with diabetes [R] . As many as36% of patients with diabetes have lower-extremity peripheral arterial disease based on lower-extremity bloodpressure readings. However, a typical history of intermittent claudication or an absent peripheral pulse is lesscommonly noted.

Peripheral vascular disease in combination with peripheral neuropathy places patients with diabetes at increasedrisk for non-traumatic amputations of the lower extremity. Peripheral vascular disease may be slowed by smokingcessation and treatment of hypertension and dyslipidemia. (See Annotation #14 "Treatment Goals for Patients withCardiovascular Disease" and the Blood Pressure Control algorithm annotations).

Aggressive daily foot care, inspection of the feet at every office visit for diabetes mellitus, early treatment of footinfections, treatment of callus, use of moisturizing lotion, and proper footwear may forestall problems, includingamputation. Vascular surgery may also prevent amputation in some patients with established severe peripheralvascular disease [R] .

Proper high-risk foot management is necessary to prevent ulceration and amputation. Consider referral of patientswith claudication and/or absent pedal pulses to surgery. See the Glycemic Control and Blood Pressure Controlalgorithms.

Definitions :

Key conclusions (as determined by the work group) are supported by a conclusion grading worksheet that summarizesthe important studies pertaining to the conclusion. Individual studies are classed according to the system presentedbelow, and are designated as positive, negative, or neutral to reflect the study quality.

Conclusion Grades :

Grade I : The evidence consists of results from studies of strong design for answering the question addressed. Theresults are both clinically important and consistent with minor exceptions at most. The results are free of anysignificant doubts about generalizability, bias, and flaws in research design. Studies with negative results havesufficiently large samples to have adequate statistical power.

Grade II : The evidence consists of results from studies of strong design for answering the question addressed, butthere is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies orbecause of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively,the evidence consists solely of results from weaker designs for the question addressed, but the results have beenconfirmed in separate studies and are consistent with minor exceptions at most.

Grade III : The evidence consists of results from studies of strong design for answering the question addressed, butthere is substantial uncertainty attached to the conclusion because of inconsistencies among the results of differentstudies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size.Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering thequestion addressed.

Grade Not Assignable : There is no evidence available that directly supports or refutes the conclusion.

Study Quality Designations

The quality of the primary research reports and systematic reviews are designated in the following ways on theconclusion grading worksheets:

Positive : indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generalizability,and data collection and analysis.

Negative : indicates that these issues (inclusion/exclusion, bias, generalizability, and data collection and analysis)have not been adequately addressed.

Neutral : indicates that the report or review is neither exceptionally strong nor exceptionally weak.

Not Applicable : indicates that the report is not a primary reference or a systematic review and therefore the qualityhas not been assessed.

Quality of individual research reports is assessed using a hierarchical rating system.

Classes of Research Reports :

A. Primary Reports of New Data Collection:

Class A:l Randomized, controlled trial

Class B:l Cohort study

Class C:


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l Nonrandomized trial with concurrent or historical controlsl Case -control studyl Study of sensitivity and specificity of a diagnostic testl Population -based descriptive study

Class D:l Cross -sectional studyl Case seriesl Case report

B. Reports that Synthesize or Reflect upon Collections of Primary Reports:

Class M:l Meta -analysisl Systematic reviewl Decision analysisl Cost -effectiveness analysis

Class R:l Consensus statementl Consensus reportl Narrative review

Class X:l Medical opinion

Clinical Algorithm(s)

Four detailed and annotated clinical algorithms are provided in the original guideline document for:l Diagnosis and Management of Type 2 Diabetes Mellitus in Adultsl Glycemic Controll Blood Pressure Controll Ongoing Management

Additionally, an algorithm for Treatment of Diabetic Nephropathy is provided in Appendix A of the original guidelinedocument.

Evidence Supporting the RecommendationsType of Evidence Supporting the Recommendations

The type of supporting evidence is classified for selected recommendations (see "Major Recommendations").

In addition, key conclusions contained in the Work Group's algorithms are supported by a grading worksheet thatsummarizes the important studies pertaining to the conclusion. The type and quality of the evidence supporting thesekey recommendations (i.e., goal for glycemic control; goal for low-density lipoprotein [LDL] level; goals for bloodpressure, aspirin use, and treatment with angiotensin converting enzyme [ACE] inhibitors or angiotensin II receptorblockers [ARBs]) is graded for each study.

Benefits/Harms of Implementing the Guideline RecommendationsPotential Benefits

Effective medical management of prediabetes and type 2 diabetes mellitus through a comprehensive approach thatincludes nutrition therapy, physical activity recommendations, pharmacologic therapy, self-management, as well asprevention and diagnosis of diabetes-associated complications and risk factors

Potential Harmsl The action of insulin preparations is highly variable among individuals, with values varying depending on the siteand depth of injection, skin temperature, and exercise.l Oral agents do not have U.S. Food and Drug Administration (FDA) approval for use in pregnancy.l Hypoglycemia is a risk in individuals who participate in physical activity and are taking insulin, sulfonylureasand/or meglitinides. Depending on the level of physical activity, the medication dosage or the amount of carbohydrate ingested, hypoglycemia can occur. For patients on these drug classes and pre-exercise glucose monitorresults less than 100 mg/dL, additional carbohydrate should be ingested for prevention of hypoglycemia.

Refer to the "Safety" sections of the "Major Recommendations" for safety information on specific non-insulin agents.
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4. High-Risk P opulation Measures : The purpose of this aim is to decrease the percentage of adult patients, ages18 to 75 with type 2 diabetes mellitus, with poorly controlled glucose and cardiovascular risk factors (clinicalstrategies that target high-risk populations may be more viable with limited resources).

Possible measures for accomplishing this aim:

a. Percentage of patients with type 2 diabetes mellitus with A1c test in the last year greater than 9%.

b. Percentage of patients with type 2 diabetes mellitus with low -density lipoprotein test in the last yeargreater than 130 mm/dL and not on a statin.

c. Percentage of patients with type 2 diabetes mellitus with blood pressure greater than 150/90 mm Hg.

d. Percentage of patients with type 2 diabetes mellitus with A1c greater than 9% or low -density lipoproteingreater than 130 mg/dL or blood pressure greater than 150/90 mm Hg (high-risk comprehensive measures).

At this point in development for this guideline, there are no specifications written for possible measures listed above.Institute for Clinical Systems Improvement (ICSI) will seek input from the medical groups on what measures are of most use as they implement the guideline. In a future revision of the guideline, measurement specifications may beincluded.

Refer to the original guideline document for more information.

Key I mplementation Recommendations

The implementation of type 2 diabetes mellitus clinical guidelines at medical groups and clinics is a complex andchallenging task. However, a number of key processes have been shown to accelerate effective clinical guidelineimplementation and care improvement. These overlapping care elements can be categorized at the medical group andprovider levels:

l Essential Elements at the Medical Group Level:l Leadership . Medical group leaders must communicate the need for change in clinical practice patterns andconsistently identify improvement priorities.l Resources . Resources adequate to the task at hand will be needed to assure the success of a change effort.Resources may include staff time, money and provision of tools (such as electronic medical records) to support careimprovement.l Select Specific Improvement Goals and Measures . For most chronic diseases, including diabetes, the mostefficient improvement strategy is to focus on a limited number of specific improvement goals. These may be basedon observed gaps in care, potential clinical impact, cost considerations or other criteria. In type 2 diabetes,focusing on glycemic control, lipid control and blood pressure control is a strategy that has been shown to beeffective in preventing up to 53% of heart attacks and strokes, the leading drivers of excess mortality and costs inadults with diabetes.l Accountability . Accountability within the medical group is a management responsibility, but externalaccountability may also play an important enhancing role to motivate sustained efforts to implement guidelines andimprove care. Examples of external accountability include participation in shared learning activities (such asInstitute for Healthcare Improvement or ICSI and its action groups), or public reporting of results (such as in pay-for-performance or the Minnesota Community Measures Project).l Prepared P racticed Teams . The medical group may need to foster the development of prepared practice teamsthat are designed to meet the many challenges of delivering high-quality chronic disease care.

l Essential Elements at the Clinic Level:l Develop "Smart" Patient Registries . These are registries that are designed to identify, automatically monitor,and prioritize patients with diabetes based on their risk, current level of control, and possibly patient readiness-to-change.l Assure "Value -Added" Visits . These are office visits or other patient encounters (by phone, e-mail, etc.) thatinclude intensification of treatment if the patient has not yet reached his/her evidence-based clinical goals. Failureof providers and patients to intensify treatment when indicated (referred to as "clinical inertia") is a key obstacle tobetter diabetes care. Previsit planning and best practice prompts may help to increase the efficiency of patientvisits and remind providers of needed tests and care.l Develop "Active Outreach" . These are strategies to reach patients with chronic disease who have not returnedfor follow-up or for other selected elements of care. Outreach strategies that enhance the likeliness of a futureprovider encounter that addresses one of the barriers to patient activation (discussed below) may be moreeffective. Simple reporting of lab test results or care suggestions through the mail may be ineffective at addressingthese barriers.l Emphasize "Patient Activation" Strategies . These may include diabetes education and other actions designed

to sustain engagement of patients with their diabetes care. Many patients with diabetes either (a) do not reallybelieve they have diabetes, or (b) do not really believe that diabetes is a serious disease, or (c) lack motivation forbehavioral change, or (d) do not believe that recommended treatments will make a difference to their ownoutcomes. For care to be effective, these issues must be addressed for many patients.

Implementation ToolsChart Documentation/Checklists/Forms

Clinical Algorithm

Quality Measures

Quick Reference Guides/Physician GuidesFor information about availability, see the Availability of Companion Documents and Patient Resources fields below.


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Institute of Medicine (IOM) National Healthcare Quality Report CategoriesIOM Care Need

Living with Illness

Staying Healthy

IOM DomainEffectiveness

Patient-centeredness

Identifying Information and AvailabilityBibliographic Source(s)

Institute for Clinical Systems Improvement (ICSI). Diagnosis and management of type 2 diabetes mellitus in adults.Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2010 Jul. 112 p. [168 references]

Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released1996 Mar (revised 2010 Jul)

Guideline Developer(s)Institute for Clinical Systems Improvement - Nonprofit Organization

Guideline Developer Comment

Organizations participating in the Institute for Clinical Systems Improvement (ICSI): Affiliated Community MedicalCenters; Allina Medical Clinic; Aspen Medical Group; Brainerd Lakes Health; Brown Clinic; Center for DiagnosticImaging/Medical Scanning Consultants; CentraCare; Chippewa County Montevideo Hospital & Clinic; Fairview HealthServices; Family HealthServices Minnesota; Family Practice Medical Center; Fergus Falls Medical Clinic; GilletteChildren's Specialty Healthcare; Grand Itasca Clinic and Hospital; HealthEast Care System; HealthPartners CentralMinnesota Clinics; HealthPartners Medical Group & Regions Hospital; Hennepin County Medical Center; HennepinFaculty Associates; Hudson Physicians; Hutchinson Area Health Care; Hutchinson Medical Center; Innovis Health;Integrity Health Network; Lake Region Healthcare Corporation; Lakeview Clinic; Mankato Clinic; Marshfield Clinic; MayoClinic; Mercy Hospital and Health Care Center; Midwest Spine Institute; Minnesota Association of Community HealthCenters; Minnesota Gastroenterology; Multicare Associates; New Richmond Clinic; North Central Heart Institute; NorthClinic; North Memorial Health Care; Northwest Family Physicians; Obstetrics and Gynecology Specialists; OlmstedMedical Center; Park Nicollet Health Services; Paynesville Area Health Care System; Planned Parenthood Minnesota,North Dakota, South Dakota; Quello Clinic; Raiter Clinic; Rice Memorial Hospital; Ridgeview Medical Center; River FallsMedical Clinic; Riverwood Healthcare Center; Saint Mary's/Duluth Clinic Health System; Southside Community HealthServices; Stillwater Medical Group; SuperiorHealth Center; University of Minnesota Physicians; Winona Health

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814 -7060; fax, (952) 858-9675;

e-mail: [email protected] ; Web site: www.icsi.org .

Source(s) of Funding

The following Minnesota health plans provide direct financial support: Blue Cross and Blue Shield of Minnesota,HealthPartners, Medica, PreferredOne, Security Health Plan of Wisconsin, and UCare. In-kind support is provided by theInstitute for Clinical Systems Improvement's (ICSI) members.

Guideline Committee

Committee on Evidence-Based Practice

Composition of Group That Authored the Guideline

Work Group Members : Bruce Redmon, MD ( Work Group Leader ) (University of Minnesota) (Division of Endocrinology);JoAnn Sperl-Hillen, MD ( Work Group Leader ) (HealthPartners Medical Group) (Internal Medicine); Richard Bergenstal, MD(Park Nicollet) (Endocrinology); Sidney Jones, MD (Hennepin County Medical Center) (Endocrinology); Steve Smith, MD(Mayo Clinic) (Endocrinology); Patrick O'Connor, MD (HealthPartners Medical Group) (Family Medicine); Todd Wade, MD(Mayo Clinic) (Family Medicine); Julie Roberts, MS, RD, CDE (HealthPartners Medical Group) (Health Education); EugeneOllila, MD (Allina Medical Clinic) (Internal Medicine); Penny Louise Flavin, RN, CNP (Olmsted Medical Center) (Nursing);Carol Manchester, MSN, ACNS (Fairview Health Services) (Nursing); Mikaila Engel, PharmD (Olmsted Medical Center)(Pharmacy); Ryan Michels, PharmD, BCPS (HealthPartners Medical Group) (Pharmacy); Gail Hunt (Institute for ClinicalSystems Improvement) (Facilitator); Kari Retzer, RN (Institute for Clinical Systems Improvement) (Facilitator)

Financial Disclosures/ Conflicts of Interest

Institute for Clinical Systems Improvement (ICSI) has adopted a policy of transparency, disclosing potential conflictand competing interests of all individuals who participate in the development, revision and approval of ICSI documents(guidelines, order sets and protocols). This applies to all work groups (guidelines, order sets and protocols) andcommittees.
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Participants must disclose any potential conflict and competing interests they or their dependents (spouse, dependentchildren, or others claimed as dependents) may have with any organization with commercial, proprietary, or politicalinterests relevant to the topics covered by ICSI documents. Such disclosures will be shared with all individuals whoprepare, review and approve ICSI documents.

Richard Bergenstal, MD has stock in Merck through a family inheritance. Dr. Bergenstal participates in clinical researchand/or serves on a scientific advisory board for Amylin, Merck, Pfizer, ResMed, Valeritas, Eli Lilly, Novo Nordisk, Sanofi-Aventis, MannKind, Intuity, Roche, LifeScan, Abbott, Bayer and Medtronic. All compensation goes directly to the non-profit Park Nicollet Institute. Dr. Bergenstal is an officer within the American Diabetes Association.

Carol Manchester, MSN, ACNS received speakers' fees or honorarium from Sanofi-Aventis and Unomedical Inc.

Patrick O'Connor, MD receives research or grant funding from HealthPartners Research Foundation; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute for Health; National Heart, Lung, and Blood Institute;Robert Wood Johnson Foundation; Agency for Healthcare Research and Quality; Centers for Disease Control; MinnesotaDepartment of Health, University of Minnesota. Dr. O'Connor received speakers' fees or honorarium from Merck.

Sidney Jones, MD received honorarium from Merck, Sanofi-Aventis and Amylin. He has received payment for experttestimony in Dakota County Court.

Bruce Redmon, MD is contracted with Ingenix and receives research or grant funds from Mannkind Corp.

Steve Smith, MD is a member of the national board of directors for the American Diabetes Association.

JoAnn Sperl-Hillen, MD receives research support through HealthPartners Research Foundation from National Heart,Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; Merck; andGlaxoSmithKline.

No other work group members have potential conflicts of interest to disclose.

ICSI's conflict of interest policy and procedures are available for review on ICSI's website at www.icsi.org .

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Institute for Clinical Systems Improvement (ICSI). Diagnosis andmanagement of type 2 diabetes mellitus in adults. Bloomington (MN): Institute for Clinical Systems Improvement(ICSI); 2009 May. 114 p. [168 references]

Guideline Availability

Electronic copies: Available from the Institute for Clinical Systems Improvement (ICSI) Web site .

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-

7060; fax, (952) 858-9675; Web site: www.icsi.org ; e-mail: [email protected] .

Availability of Companion DocumentsThe following is available:

l Diagnosis and management of type 2 diabetes mellitus in adults. Executive summary. Bloomington (MN):Institute for Clinical Systems Improvement, 2010 Jul. 2 p. Electronic copies: Available from the Institute for Clinical

Systems Improvement (ICSI) Web site .

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425; telephone, (952) 814-

7060; fax, (952) 858-9675; Web site: www.icsi.org ; e-mail: [email protected] .

In addition, two forms on diabetic foot screening are available in the appendices of the original guideline document

.

Patient Resources

None available

NGC Status

This summary was completed by ECRI on June 30, 1999. The information was verified by the guideline developer onAugust 4, 1999. This summary was updated by ECRI on October 13, 2000 and May 7, 2002. The summary was mostrecently updated on March 14, 2003. The updated information was verified by the guideline developer on May 15, 2003.This summary was updated again by ECRI on July 8, 2004, January 25, 2005, December 30, 2005, and December 18,2009. This summary was updated by ECRI Institute on May 17, 2010 following the U.S. Food and Drug Administrationadvisory on Plavix (clopidogrel). This summary was updated by ECRI Institute on December 27, 2010. This summarywas updated by ECRI Institute on June 27, 2011 following the U.S. Food and Drug Administration advisory on Zocor(simvastatin).

Copyright Statement
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