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Complete Summary

GUIDELINE TITLE

Basic guidelines for diabetes care.

BIBLIOGRAPHIC SOURCE(S)

  • Diabetes Coalition of California, California Diabetes Program. Basic guidelines for diabetes care. Sacramento (CA): Diabetes Coalition of California, California Diabetes Program; 2008.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Diabetes Coalition of California, California Diabetes Program. Basic guidelines for diabetes care. Sacramento (CA): Diabetes Coalition of California, California Diabetes Program; 2005. 16 p.

The Basic Guidelines Packet is updated regularly and may be downloaded at www.caldiabetes.org.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s)/intervention(s) for which important revised regulatory and/or warning information has been released.

  • July 31, 2008, Erythropoiesis Stimulating Agents (ESAs): Amgen and the U.S. Food and Drug Administration (FDA) informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
  • April 10, 2008, Exubera (insulin inhalation): Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera. This warning relates to a small number of primary lung malignancies that have been discovered in users of Exubera in clinical trials and post-marketing reports.

COMPLETE SUMMARY CONTENT

 ** REGULATORY ALERT **
 SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • Gestational diabetes

GUIDELINE CATEGORY

Counseling
Evaluation
Management
Screening

CLINICAL SPECIALTY

Endocrinology
Family Practice
Internal Medicine
Obstetrics and Gynecology
Pediatrics

INTENDED USERS

Advanced Practice Nurses
Allied Health Personnel
Nurses
Physician Assistants
Physicians

GUIDELINE OBJECTIVE(S)

  • To present basic guidelines for diabetes care programs aimed at reducing the personal and societal impact of diabetes
  • To update the 2005 version of these basic guidelines

TARGET POPULATION

Adults, children, and adolescents with type 1 and type 2 diabetes mellitus

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Physical and emotional assessment, including blood pressure, weight, height and body mass index (BMI) (for adults and children), foot exam (for adults), dilated eye exams (by trained expert), screening for depression, dental exam
  2. Laboratory examination, including hemoglobin A1C (HbA1c) measurement (for adults and children), microalbuminuria (albumin/creatinine ratio) assessment; glomerular filtration rate, blood lipids measurement (for adults)
  3. Self-management training, including management principles and complications, self-glucose monitoring, medical nutrition therapy (physical activity, weight management)
  4. Interventions, including preconception, pregnancy, and postpartum counseling and management, aspirin therapy, smoking cessation, immunizations (influenza, pneumococcal)

MAJOR OUTCOMES CONSIDERED

  • Morbidity and mortality
  • Incidence of complications of diabetes
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METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Pertinent articles for review were identified from the current American Diabetes Association (ADA) Clinical Practice Recommendations, Medline searches and the reference list from the previous year's Basic Guidelines for Diabetes Care.

The article list for each was then reviewed for completeness. Articles from older or lower-rated studies were removed from the list if a more current, higher quality study on the list contributed the same or new information.

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Experts in diabetes care reviewed and rated the body of evidence using a system adopted from the American Diabetes Association (ADA) grading system for clinical practice recommendations. The system rates practice recommendations based on the level of evidence for the recommendation and the likelihood of clinical benefit. A is the highest rating and "expert consensus" is the lowest.

  1. Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered, including:
    • Evidence from a well-conducted multi-center trial
    • Evidence from a meta-analysis that incorporated quality ratings in the analysis
    • Compelling non-experimental evidence ( i.e. "all or none" rule developed by the Center for Evidence Based Medicine at Oxford)

    Supportive evidence from well-conducted randomized controlled trials that are adequately powered including:

    • Evidence from a well-conducted trial at one or more institutions
    • Evidence from a meta-analysis that incorporated quality ratings in the analysis
  1. Supportive evidence from well-conducted prospective cohort studies, including:
    • Evidence from a well-conducted prospective study or registry
    • Evidence from a well-conducted meta-analysis of cohort studies

    Supportive evidence from a well-conducted case control study

  1. Supportive evidence from poorly controlled or uncontrolled studies
    • Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results
    • Evidence from observational studies with high potential for bias (such as case series with comparison with historical controls)
    • Evidence for case series or case report
    • Conflicting evidence with the weight of evidence supporting the recommendation
  1. Expert consensus or clinical experience

Diabetes Care, Vol 29, (Supplement 1):S-5, January 2006

METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses
Systematic Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Experts in the respective fields reviewed and analyzed the evidence.

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Experts in the respective fields formulated recommendations that were then discussed with the Guidelines Committee. Expert consensus was reached prior to inclusion.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

COST ANALYSIS

The guideline developers reviewed published cost analyses.

METHOD OF GUIDELINE VALIDATION

Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

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RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Basic Guidelines for Diabetes Care

Physical and Emotional Assessment *Blood Pressure, Weight/ Body Mass Index (BMI) - Every visit. For Adults: Blood pressure target goal <130/80 mm Hg; BMI (body mass index) < 25 kg/m2.

For children: Blood pressure target goal <90th percentile adjusted for age, height, and gender; BMI-for-age <85th percentile.

Foot Exam (for adults) - Thorough visual inspection every diabetes care visit; pedal pulses, neurological exam yearly.

Dilated Eye Exam (by trained expert) - Type 1: Five years post diagnosis, then every year.

Type 2: Shortly after diagnosis, then every year. Note: Internal quality assurance data may be used to support less frequent testing.

*Depression - Probe for emotional/physical factors linked to depression yearly; treat aggressively with counseling, medication, and/or referral.

*Dental - Exam at least twice yearly; Assess oral symptoms that require an urgent referral.
Lab Exam *A1C (HbA1c) - Quarterly, if treatment changes or if not meeting goals; One-two times/year if stable. Target goal <7.0% or <1% above lab norms. For children: Modify as necessary to prevent significant hypoglycemia.

*Microalbuminuria (Albumin/Creatinine Ratio) - Type 1: Begin with puberty once the duration of diabetes is more than five years unless proteinuria has been documented. Type 2: Begin at diagnosis, then every year unless proteinuria has been documented.

*Glomerular Filtration Rate (GFR): Estimate whenever chemistries are checked.

*Blood Lipids (for adults) - On initial visit, then yearly for adults. Target goals (mg/dL): cholesterol, LDL<100 (<70 for high CVD risk); triglycerides <150; HDL>40 for men; HDL>50 for women.
Self Management Training Management Principles and Prevention of Complications - Initially and ongoing: Focus on helping the patient achieve the American Association of Diabetes Educators (AADE) 7 self-care behaviors: healthy eating, being active, monitoring, taking medications, problem solving, healthy coping, and reducing risks. Screen for problems with and barriers to self-care; assist patient to identify achievable self-care goals.
For children: As appropriate for developmental stage.

Self-Glucose Monitoring - Type 1: Typically test four times a day. Type 2 and others: As needed to meet treatment goals.

Medical Nutrition Therapy (by trained expert) - Initially: Assess needs/condition, assist patient in setting nutrition goals. Ongoing: Assess progress toward goals, identify problem areas.

Physical Activity - Initially and ongoing: Assess and prescribe physical activity based on patient's needs/condition (goal of at least 150 min/week of moderate intensity exercise [50-70% of max. heart rate]).

Weight Management - Initially and ongoing: Must be individualized for patient.
Interventions *Preconception, Pregnancy, and Postpartum Counseling and Management - Consult with high-risk, multidisciplinary perinatal/neonatal programs, and providers where available (e.g., California Diabetes and Pregnancy Program "Sweet Success"). For adolescents: Age appropriate counseling advisable, beginning with puberty.

Aspirin Therapy (for adults) – 75-162 mg/day as primary and secondary prevention of cardiovascular disease unless contraindicated.

Smoking Cessation - Ask every patient if they use tobacco, Advise them to quit, Refer them to the California Smokers' Helpline at 1-800-NO-BUTTS (1-800-662-8887).

Immunizations - Influenza and pneumococcal, per the Centers for Disease Control (CDC) recommendations

*See Explanatory Notes in the original guideline document.

It is assumed that the following are routinely occurring in the medical setting:

  • A history and physical appropriate for a person with diabetes are performed. Visits are sufficiently frequent to meet the patient's needs and treatment goals.
  • Abnormal physical or laboratory findings result in appropriate and individualized interventions.
  • Expert multi-disciplinary health professionals provide self-management training. For children/adolescents and their families, training from a diabetes team or team member with experience in child and adolescent diabetes is strongly recommended to begin at diagnosis.
  • Physicians should consult current references for normal values and for appropriate treatment goal values, both for children and adults.
  • Specialists should be consulted when patients are unable to achieve treatment goals in a reasonable time frame, when complications arise, or whenever the primary care physician deems it appropriate. Under similar circumstances, children/adolescents should be referred to specialists who have expertise in managing children and adolescents with diabetes.

Additional comments on specific items included in these Guidelines:

  • Blood Pressure/BMI – For children, to determine blood pressure percentile adjusted for age, height, and gender use http://www.cdc.gov/nccdphp/dnpa/growthcharts/training/modules/module3/text/bloodpressure.htm. To calculate and determine BMI percentile use http://www.cdc.gov/nccdphp/dnpa/bmi/childrens_BMI/about_childrens_BMI.htm.
  • Psychosocial Assessment – Assess barriers to self-care: common environmental obstacles, cultural issues, beliefs and feelings about diabetes, disorders of eating and mood, life stresses, and substance use. Consider using PHQ9 as a depression monitoring tool (http://www.phqscreeners.com).
  • A1C (HbA1c) / Self-Glucose Monitoring – Certification by the National Glycohemoglobin Standardization Program as traceable to the Diabetes Control and Complications Trial (DCCT) reference ensures portability of A1C results. Verify that the laboratory is certified in this method. A1C target goals should be achieved gradually over time. Target goals should be less stringent for children, the elderly, and other fragile patients. Clinicians have found that making the patient aware of his/her A1C values and their significance helps motivate the patient toward improved glycemic control. This principle also applies to self-glucose monitoring. Target goals should be individualized for each patient.
  • Microalbuminuria – Screening is not needed if proteinuria has been documented. See Screening and Initial Management of Diabetic Microalbuminuria and Nephropathy algorithm.
  • Glomerular Filtration Rate (GFR) – See Screening and Initial Management of Diabetic Microalbuminuria and Nephropathy algorithm and explanatory notes for purpose and calculation of GFR.
  • Blood Lipids – Abnormal blood lipids are often under-treated. An active, progressive treatment and monitoring plan should be instituted. High risk cardiovascular disease (CVD) patients are defined as patients with overt CVD (i.e., patients with acute coronary syndromes or previous cardiovascular events) or patients without overt CVD but are >40 years of age and have 1 or more CVD risk factor.
  • Dental – Refer all patients with diabetes for a dental examination, as a component of the comprehensive diabetes evaluation, regardless of oral findings or complaints.
  • Children / Adolescents – For specific diabetes care recommendations, see references.

A list of general and specific references is included in the Basic Guidelines for Diabetes Care Packet.

CLINICAL ALGORITHM(S)

The original guideline document contains clinical algorithms for:

  • Therapy for Glycemic Control of Type 2 Diabetes Mellitus in Adults*
  • Screening and Initial Management of Diabetic Microalbuminuria and Nephropathy*
  • Foot Care for People with Diabetes
  • Oral Health Care for People with Diabetes
  • Gestational Diabetes (GDM) Screening, Diagnosis, and Management**
  • Lipid Management in People with Diabetes

* These algorithms are adapted from the American Diabetes Association (ADA) Clinical Practice Recommendations, 2008.

** This algorithm is adapted from the American Diabetes Association (ADA) Clinical Practice Recommendations, 2003.

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EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

An annotated bibliography, categorizing the references used to support the inclusion of specific items, is provided in the original guideline document. Each reference is rated according to the scheme listed above (see "Rating Scheme for the Strength of the Evidence"). In general, items in the guidelines are included based on one or more of the following criteria:

  • Published evidence demonstrated either the efficacy or the effectiveness of the item.
  • Published studies on cost-identification, cost-effectiveness, or cost-benefit analysis of the item demonstrated favorable economic results.
  • A preponderance of expert opinion held that the item is considered to be essential to the care of persons with diabetes.
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BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Prevention or delay of diabetic morbidity and mortality

POTENTIAL HARMS

Not stated

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QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

  • These Guidelines are intended for use by primary care professionals, optimally in a team care setting.
  • These Guidelines are meant to be basic guidelines, not accountability standards.
  • Internal quality assurance data may be used to support less frequent testing.
  • These guidelines, developed by local and national diabetes experts, are consistent with American Diabetes Association's Clinical Practice Recommendations.
  • The Guidelines and supporting materials are products of the Diabetes Coalition of California and the California Diabetes Program. The Diabetes Coalition of California is an independent, not-for-profit organization working to improve the lives of people with diabetes. The California Diabetes Program is part of the California Department of Public Health and works to prevent diabetes and its complications in California's diverse communities.
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IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms
Clinical Algorithm
Foreign Language Translations
Patient Resources
Slide Presentation

For 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 CATEGORIES

IOM CARE NEED

Living with Illness
Staying Healthy

IOM DOMAIN

Effectiveness
Patient-centeredness

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IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Diabetes Coalition of California, California Diabetes Program. Basic guidelines for diabetes care. Sacramento (CA): Diabetes Coalition of California, California Diabetes Program; 2008.

ADAPTATION

Some of the algorithms that accompany the "Basic Guidelines for Diabetes Care" were adapted by the American Diabetes Association Clinical Practice Recommendations, 2008.

DATE RELEASED

1999 Jan (revised 2008 Aug)

GUIDELINE DEVELOPER(S)

California Diabetes Program - Private Nonprofit Organization
Diabetes Coalition of California - Private Nonprofit Organization

GUIDELINE DEVELOPER COMMENT

The Basic Guidelines serve as a framework for developing diabetes care programs aimed at reducing the personal and societal impact of diabetes. For over 15 years health plans and medical groups throughout California have adopted them to assure improved outcomes for their patients with diabetes. References are individually rated by experts.

SOURCE(S) OF FUNDING

California Diabetes Program and Diabetes Coalition of California

GUIDELINE COMMITTEE

Diabetes Coalition of California Guidelines Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

ENDORSER(S)

American Diabetes Association - Professional Association
Blue Cross of California State Sponsored Program - Managed Care Organization
California Cooperative Healthcare Reporting Initiative - Professional Association
Conference of Local Health Offices (California) - Independent Expert Panel
Health Resource Services Administration Health Disparities Collaborative - Federal Government Agency [U.S.]
Hill Physicians Group - Professional Association
Lumetra - Professional Association
Medical Board of California - State/Local Government Agency [U.S.]
Pacific Business Group on Health - Private For Profit Organization

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Diabetes Coalition of California, California Diabetes Program. Basic guidelines for diabetes care. Sacramento (CA): Diabetes Coalition of California, California Diabetes Program; 2005. 16 p.

The Basic Guidelines Packet is updated regularly and may be downloaded at www.caldiabetes.org.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the California Diabetes Program Web site.

Print copies: Available from the California Department of Health Services, Diabetes Prevention and Control Program, 1616 Capitol Avenue, MS 7211, PO Box 997377, Sacramento, CA 95899-7377; Phone: (916) 552-9888; Fax: (916) 552-9988; Web site: www.caldiabetes.org.

AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

Print copies: Available from the California Department of Health Services, Diabetes Prevention and Control Program, 1616 Capitol Avenue, MS 7211, PO Box 997377, Sacramento, CA 95899-7377; Phone: (916) 552-9888; Fax: (916) 552-9988; Web site: www.caldiabetes.org.

Assessment checklists for a foot exam, a diabetes eye exam, and a diabetes flow sheet are included in the original guideline document.

PATIENT RESOURCES

The following are available

Print copies: Available from the California Department of Health Services, Diabetes Prevention and Control Program, 1616 Capitol Avenue, MS 7211, PO Box 997377, Sacramento, CA 95899-7377; Phone: (916) 552-9888; Fax: (916) 552-9988; Web site: www.caldiabetes.org.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

This summary was completed by ECRI on January 10, 2000. The information was verified by the guideline developer as of January 31, 2000. This summary was updated July 9, 2001. This summary was updated again on October 23, 2002, and verified by the guideline developer on December 5, 2002. This summary was updated again on May 4, 2004. The updated information was verified by the guideline developer on July 20, 2004. This summary was updated on December 9, 2005. The updated information was verified by the guideline developer on January 10, 2006. This summary was updated by ECRI Institute on March 25, 2009. The updated information was verified by the guideline developer on April 16, 2009.

COPYRIGHT STATEMENT

These guidelines may be reproduced with the citation: Developed by the Diabetes Coalition of California and the California Diabetes Prevention and Control Program.

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DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.
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