Practice Guidelines

2007-05-01

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American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Diabetes and pregnancy

American Association of Clinical Endocrinologists - Medical Specialty Society
American College of Endocrinology - Medical Specialty Society

Released: 2000 Jan (revised 2007)

MAJOR RECOMMENDATIONS:

The levels of evidence (1–4) and the recommendation grades (A–D) are defined at the end of the "Major Recommendations" field.

Diabetes and Pregnancy

Provide Prepregnancy Counseling

  • Identify the possibility of pregnancy annually by directly questioning all fertile women of childbearing age with diabetes mellitus; provide contraceptive advice when appropriate (grade A).
  • Offer prepregnancy counseling to all women with diabetes mellitus who are considering pregnancy (grade A); counseling should address:
    • Information and skills relevant to the management of pregnancy in a woman with diabetes mellitus (grade B)
    • The need for optimal control of the HbA1c level (<6%), if safely achievable, (grade A) and blood glucose concentration between 60 mg/dL (fasting) and 120 mg/dL (1 hour after a meal) (grade A)
    • The need for optimal blood pressure control (<130/80 mm Hg) (grade A)
    • The importance of a healthy lifestyle, including advice on nutrition, exercise, smoking cessation, and alcohol use (grade B)
  • Discontinue oral glucose-lowering drugs and start insulin if needed (grade A).
  • Discontinue angiotensin-converting enzyme inhibitors and angiotensin receptor blockers; use methyldopa, hydralazine, nifedipine extended release, or labetalol (grade A).
  • Discontinue statins and fibrates (grade A).
  • Assess the patient for retinopathy, nephropathy, and thyroid function (grade A).
  • Initiate folic acid supplementation to reduce the risk of neural tube defects (grade A).

Screen for Undiagnosed or New (Gestational) Diabetes During Pregnancy

  • In all pregnant women, measure fasting glucose at the first prenatal visit (no later than week 20). Perform a 75-g oral glucose tolerance test if the fasting glucose concentration is greater than 85 mg/dL (grade A).
    • Initiate medical nutritional therapy immediately if the diagnosis of gestational diabetes is established (grade B).
    • Initiate insulin therapy if the patient is following an optimal diet but the self-monitored glucose levels reveal fasting glucose concentrations greater than 90 mg/dL and/or if postprandial glucose concentrations are greater than 120 mg/dL 1 hour after the first bite of food at each meal (grade A).

Diabetes Management Throughout Pregnancy

  • Frequently assess the status of diabetes control, risk for and presence of diabetic complications, and the presence of other medical conditions (including weight gain) (grade B).
    • Strive for a HbA1c level less than 6%; blood glucose concentrations should remain between 60 to 90 mg/dL (fasting) and less than 120 mg/dL (1 hour after the first bite of food at each meal) (grade A).
    • Monitor weight gain and blood pressure and advise and treat the patient accordingly; blood pressure should be maintained at less than 130/80 mm Hg, avoid using renin-angiotensin system blocking drugs (grade A).
  • Persistently monitor and adjust insulin therapy to achieve all glucose targets (grade A).
    • Initiate a basal-bolus insulin regimen if a patient cannot maintain glucose targets with diet alone; this regimen may include either neutral protamine Hagedorn (NPH) insulin (basal) and rapid-acting insulin at meals or subcutaneous insulin infusion with an insulin pump (grade B).
    • Patients should intensively monitor blood glucose levels (grade A):
      • Diet only&#8212;instruct patients to assess blood glucose concentration 4 times daily, prebreakfast and 1 hour after the first bite of food at each meal (grade A)
      • Insulin therapy&#8212;instruct patients to assess blood glucose concentrations 6 times daily, before each meal to determine insulin dosage correction and 1 hour after the first bite of food at each meal (grade A)
    • Accurate timing of glucose testing at meals is critical to accurately assess glucose control (grade B).
    • Expect insulin requirements to rise as pregnancy progresses; insulin requirements may be decreased by hyperemesis; steroid therapy increases insulin requirements (grade B).
  • Offer medical nutrition therapy and education; if the patient is overweight, advise a diet suitable for someone of optimal weight and encourage moderate exercise such as armchair exercises (grade A).
    • Management by a health care team is needed to assess and reinforce patient understanding of diabetes management including dietary needs and considerations, knowledge of glucose targets, current pharmacologic therapy, and use of self-monitoring of blood glucose (timing and interpretation of test results and appropriate response) (grade B).

Labor and Delivery

  • Maternal hyperglycemia is the main cause of neonatal hypoglycemia; therefore, intrapartum maintenance of maternal euglycemia is essential (grade B).
  • Insulin is still required before active labor and can be given subcutaneously or by intravenous infusion with a goal of maintaining blood glucose concentrations between 70 to 90 mg/dL (grade B).
  • As the mother enters active labor, insulin resistance rapidly decreases because of the energy expenditure of labor as a form of strenuous exercise; as a result, insulin requirements drop to zero (see Table 9.1 and 9.2 below) present protocols for adjusting intrapartum intravenous solutions and insulin administration during labor and the postpartum period in women with insulin-requiring diabetes mellitus (Table 9.3 below lists sample glucose infusion rates in active labor) (grade B).
  • To prevent hypoglycemia:
    • Infuse glucose at a rate of 2.5 mg/kg per min (grade C).
    • Measure the capillary blood glucose concentration hourly (grade C).
    • Double the glucose infusion for the next hour if the blood glucose value is less than 60 mg/dL (grade C).
    • Glucose values greater or equal to 120 mg/dL require the administration of regular insulin subcutaneously or intravenously until the blood glucose value falls to 70 to 90 mg/dL; now, the insulin dose is titrated to maintain normoglycemia while glucose is infused at a rate of 2.5 mg/kg per min (grade C).
    • Do not give bolus doses of glucose because they can raise maternal blood glucose concentrations and increase the risk of neonatal hypoglycemia, fetal hypoxia, and fetal or neonatal acidosis (grade A).
    • Anticipate changed insulin requirements, and thus the need for more frequent glucose monitoring, if the patient is continuing insulin therapy postpartum and during lactation (grade C).
  • Provide appropriate care and facilities for the newborn (grade B).
  • At 45 to 60 days after delivery, screen for diabetes in women who developed new diabetes in pregnancy; if there is no evidence of diabetes, advise the patient of the high risk of future diabetes and educate the patient about preventative lifestyle measures; advise the patient to be examined for diabetes annually because women with gestational diabetes mellitus (GDM) have a 50% risk of developing type 2 diabetes mellitus (T2DM) within 5 years (10% conversion per year) (grade A)

Table 9.1: Protocol for Adjusting Intrapartum Intravenous Solutions and Insulin Administration During Labor and the Postpartum Period in Women With Insulin-Requiring Diabetes Mellitus Treated With Insulin Pump Therapya

Blood Glucose Concentration, mg/dL Adjustment
<70 D10 normal salineb, 100 mL/h for 10 to 15 min
71-100 D5 normal salinec, 100 mL/h
101-120 Normal saline, 100 mL/h
>121 Normal saline plus regular insulin intravenously or bolus analog subcutaneously as percent of TDIR
121-140 Normal saline, 100 mL/h plus 3% of TDIR
>141 Normal saline, 100 mL/h plus 6% of TDIR

Abbreviation: TDIR, total daily insulin requirement.

aBasal insulin infusion rate to be reduced in half. At term, the insulin requirement is 1.0 units/kg/d; thus, 3% of this dose would be 3 units in a woman weighing 100 kg at term.

bD10 normal saline is 10% dextrose in normal (isotonic saline).

cD5 normal saline is 5% dextrose in normal (isotonic) saline.

Table 9.2: Protocol for Adjusting Intrapartum Intravenous Solutions and Insulin Administration in Women With Insulin-Requiring Diabetes Mellitus Based on Hourly Blood Glucose Measurementa

Blood Glucose Concentration, mg/dL Adjustment
<60 Twice the target rateb
61-100 Target rateb or D5 normal salinec
101-120 Normal saline, 100 mL/h
121-140 Normal saline, 100 mL/h plus 3% of TDIR
>141 Normal saline, 100 mL/h plus 6% of TDIR

Abbreviation: TDIR, total daily insulin requirement.

aDiscontinue neutral protamine Hagedorn (NPH) insulin administration.

bGlucose infusion rate is 2.55 mg/kg of pregnant weight/min.

cD5 normal saline is 5% dextrose in normal (isotonic) saline.

Table 9.3: Sample Glucose Infusion Rates for Women With Insulin-Requiring Diabetes Mellitus in Active Labora

Weight, kg Glucose, mg/min D5 normal salineb, mL/min
50 127.5 2.55
60 153.0 3.06
70 178.5 3.56
80 204.0 4.08
90 229.5 4.58
100 255.0 5.10
110 280.5 5.60
120 306.0 6.12

aThe rate of infusion is equal to dextrose 2.55 mg/kg/min.

bD5 normal saline is 5% dextrose in normal (isotonic) saline.

Definitions:

Levels of Substantiation in Evidence-Based Medicinea

Level-of-Evidence Categoryb Study Design or Information Type Comments
1 Randomized controlled trials

Multicenter trials

Large meta-analyses with quality ratings
Well-conducted, well-controlled trials at 1 or more medical centers

Data derived from a substantial number of trials with adequate power; substantial number of subjects and outcome data

Consistent pattern of findings in the population for which the recommendation is made &#8211; generalizable results

Compelling nonexperimental, clinically obvious evidence (e.g., use of insulin in diabetic ketoacidosis); "all or none" evidence
2 Randomized controlled trials

Prospective cohort studies

Meta-analyses of cohort studies

Case-control studies
Limited number of trials, small number of subjects

Well-conducted studies

Inconsistent findings or results not representative for the target population
3 Methodologically flawed randomized controlled trials

Nonrandomized controlled trials

Observational studies

Case series or case reports
Trials with 1 or more major or 3 or more minor methodologic flaws

Uncontrolled or poorly controlled trials

Retrospective or observational data

Conflicting data with weight of evidence unable to support a final recommendation
4 Expert consensus

Expert opinion based on experience

Theory-driven conclusions

Unproven claims

Experience-based information
Inadequate data for inclusion in level-of-evidence categories 1, 2, or 3; data necessitates an expert panel's synthesis of the literature and a consensus

aAdapted from the American Association of Clinical Endocrinologists Protocol for the Standardized Production of Clinical Practice Guidelines.

bLevel-of-evidence categories 1 through 3 indicate scientific substantiation or proof; level-of-evidence category 4 indicates unproven claims.

Recommendation Grades in Evidence-Based Medicinea

Grade Description
A Homogeneous evidence from multiple well-designed randomized controlled trials with sufficient statistical power

Homogeneous evidence from multiple well-designed cohort controlled trials with sufficient statistical power

>1 conclusive level of evidence category 1 publications demonstrating benefit >> outweighs risk
B Evidence from at least one large well-designed clinical trial, cohort or case-controlled analytic study, or meta-analysis

No conclusive level of evidence category 1 publication; >1 conclusive level of evidence category 2 publications demonstrating benefit >> risk
C Evidence based on clinical experience, descriptive studies, or expert consensus opinion

No conclusive level 1 or 2 publication; >1 conclusive level of evidence category 3 publications demonstrating benefit >> risk

No conclusive risk at all and no conclusive benefit demonstrated by evidence
D Not rated

No conclusive level of evidence category 1, 2, or 3 publication demonstrating benefit >> risk

Conclusive level of evidence category 1, 2, or 3 publication demonstrating risk >> benefit

aAdapted from the American Association of Clinical Endocrinologists Protocol for the Standardized Production of Clinical Practice Guidelines.





SOURCE(S):

AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Diabetes and pregnancy. Endocr Pract 2007 May-Jun;13(Suppl 1):55-9. [19 references]

COPYRIGHT STATEMENT:

All rights reserved. No part of these materials may be reproduced or retransmitted in any manner without the prior written permission of American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE).

ADDITIONAL INFORMATION

This recommendation is taken from the National Guideline Clearinghouse, and is subject to copyright as indicated in the COPYRIGHT STATEMENT. The full guideline is available from the NGC website (www.guidelines.gov).