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Evidence-Based Diabetes Management June 2018
CHAPTER 2. Clinical Nutrition Guideline for Overweight and Obese Adults With Type 2 Diabetes (T2D) or Prediabetes, or Those at High Risk for Developing T2D
Osama Hamdy, MD, PhD; Om P. Ganda, MD, Chair, Clinical Oversight Committee; Melinda Maryniuk, MEd, RD, CDE; Robert A. Gabbay, MD, PhD, FACP; and the members of the Joslin Clinical Oversight Committee
From the Editors: Bringing the Joslin Clinical Guidelines to the Diabetes Care Community
Om P. Ganda, MD; and Robert A. Gabbay, MD, PhD, FACP
Clinical Oversight Committee, Joslin Diabetes Center
Om P. Ganda, MD; and Robert A. Gabbay, MD, PhD, FACP
CHAPTER 1. Clinical Guideline for Adults With Diabetes
Samar Hafida, MD; Om P. Ganda, MD, Chair, Clinical Oversight Committee; Robert A. Gabbay, MD, PhD, FACP; and the members of the Joslin Clinical Oversight Committee
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CHAPTER 3. Guideline for Detection and Management of Diabetes in Pregnancy
Florence M. Brown, MD; Sue-Ellen Anderson-Haynes, RD, CDE; Elizabeth Blair, MSN, ANP-BC, CDE, CDTC; Shanti Serdy, MD; Elizabeth Halprin, MD; Anna Feldman, MD; Karen E. O'Brien, MD; Sue Ghiloni, RN, CDE; Emmy Suhl, MEd, RD, CDE; Jo-Anne Rizzotto, MEd, RD, CDE; Om P. Ganda, MD, Chair, Clinical Oversight Committee; Robert A. Gabbay, MD, PhD, FACP; and members of the Joslin Clinical Oversight Committee, with administrative support from Breda Curran
CHAPTER 5. Clinical Guideline for Pharmacological Management of Adults With Type 2 Diabetes
Om P. Ganda, MD, Chair, Clinical Oversight Committee; Alissa Segal, PharmD, CDE, CDTC; Elizabeth Blair, MS, ANP-BC, CDE, CDTC; Richard Beaser, MD; Jason Gaglia, MD; Elizabeth Halprin, MD; Robert A. Gabbay, MD, PhD, FACP; and the members of the Joslin Clinical Oversight Committee

CHAPTER 3. Guideline for Detection and Management of Diabetes in Pregnancy

Florence M. Brown, MD; Sue-Ellen Anderson-Haynes, RD, CDE; Elizabeth Blair, MSN, ANP-BC, CDE, CDTC; Shanti Serdy, MD; Elizabeth Halprin, MD; Anna Feldman, MD; Karen E. O'Brien, MD; Sue Ghiloni, RN, CDE; Emmy Suhl, MEd, RD, CDE; Jo-Anne Rizzotto, MEd, RD, CDE; Om P. Ganda, MD, Chair, Clinical Oversight Committee; Robert A. Gabbay, MD, PhD, FACP; and members of the Joslin Clinical Oversight Committee, with administrative support from Breda Curran
From the Adult Diabetes and Clinical Research sections, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts
Objective: The Joslin Guideline for Detection and Management of Diabetes in Pregnancy is designed to assist internal medicine specialists, endocrinologists, and obstetricians in individualizing the care of and setting goals for women with preexisting diabetes who are pregnant or planning pregnancy. It is also a guide for managing women who are at risk for or who develop gestational diabetes mellitus (GDM). This guideline is not intended to replace sound medical judgment or clinical decision making. Clinical judgment determines the need for adaptation in all patient care situations; more or less stringent interventions may be necessary.

The objective of the Joslin Guideline for Detection and Management of Diabetes in Pregnancy is to support clinical practice and to influence clinical behaviors in order to improve clinical outcomes and assure that patient expecta- tions are reasonable and informed. This guideline was approved November 13, 2016, and updated February 12, 2018.

3.1.0 SCREENING FOR GESTATIONAL DIABETES MELLITUS

FIGURE. See at end of Chapter 3 (download PDF at end of chapter).

3.2.0 PRECONCEPTION CARE. For preexisting type 1 diabetes (T1D) or type 2 diabetes (T2D)

3.2.1 Glucose goals prior to conception:
  • Fasting and pre-meal glucose: plasma 80 to 110 mg/dL [1C]
  • 1-hour postprandial blood glucose: plasma 100 to 155 mg/dL [1C]
  • Glycated hemoglobin (A1C): <7% and as close to 6% as possible, without severe hypoglycemia [1B]
  • Avoid severe hypoglycemia [1B]
3.2.2 Counseling:
  • Educate women of childbearing age about the importance of near-normal blood glucose control prior to conception.
  • Refer to a specialist in maternal–fetal medicine and/ or endocrinology/diabetes for counseling, assessment of maternal and fetal risk, and guidance in achieving management goals. This includes all women who are planning pregnancy and women who are not planning pregnancy but are using inadequate contraception and have A1C greater than 7%.
  • Assess diabetes self-management, including meal planning, insulin care and use, activity program, medication schedule, self-monitoring of blood glucose (SMBG), treatment for hypoglycemia and hyperglycemia, and sick day management, utilizing diabetes educators (DEs) as appropriate. Review maternal and fetal health issues.
  • Begin a multivitamin with 400 mcg of folic acid to supplement average daily intake of 400 mcg for a total daily intake of 800 mcg to 1 mg of folic acid to decrease the risk of neural tube defects. Patients with a prior pregnancy affected with a neural tube defect should take folic acid 4 mg daily.
  • Strongly advise smoking and alcohol cessation.
  • Refer overweight and obese women with and without known diabetes or polycystic ovary syndrome (PCOS) for medical nutrition therapy with a goal of 5% to 10% weight loss based on 2009 Institute of Medicine recommendation
3.2.3 Medical assessment:
  • Take thorough medical and obstetrical history, including comprehensive review of diabetes history and management.
  • Eye evaluation: dilated comprehensive eye exam and pregnancy clearance by an ophthalmologist; should also include a discussion about the risk of developing and/or the progression of diabetic retinopathy during pregnancy.
  • Kidney function assessment: random urine albumin/ creatinine ratio and serum creatinine. Refer to nephrology if urine protein >1 gram.
  • Thyroid evaluation: Check thyroid stimulating hormone level.
  • Gynecology evaluation: Make sure pelvic exam and Pap smear are up to date.
  • Cardiac evaluation: If asymptomatic and ≥ 35 years of age with 1 or more additional risk factors (hypertension, smoking, family history of coronary artery disease, hypercholesterolemia, albuminuria, or nephropathy), recommend 1 or more of the following: electrocardio- gram (ECG), echocardiogram, or exercise tolerance test (ETT). If symptomatic, recommend ECG and echocar- diogram or ETT and consider referral to cardiologist.
  • Check vitamin B12 level in patients consuming more than 1 mg folic acid daily, as high-dose folic acid may mask a B12 deficiency.
3.2.4 Diabetes medications:
  • Discontinue oral antihyperglycemic therapy; start insulin. An exception is metformin, which may be continued during anovulatory infertility and in the first trimester in patients with PCOS or T2D. Prior

    to the first prenatal visit, the patient should begin increasing doses of insulin as necessary to control blood glucose while metformin is tapered off or discontinued. Metformin should not be used beyond the first trimester or in lieu of insulin based on safety and efficacy data available at this time. 
    • Metformin crosses the placenta and achieves therapeutic levels in the fetus. Presently, there are no long term randomized controlled trials (RCT) regarding outcomes in offspring of mothers with preexisting diabetes treated with metformin during pregnancy. (See 3.3.3b regarding outcomes in infants exposed to metformin in utero in PCOS and GDM.).
    • Other oral medications have not been adequately studied for the treatment of preexisting T2D in pregnancy.
  • The rapid-acting insulin analogs lispro and aspart lower postprandial blood glucose and decrease the risk of nocturnal hypoglycemia. Patients on lispro and aspart prior to conception may continue them during pregnancy. Patients on regular insulin may be switched to lispro or aspart if 1-hour postprandial blood glucose levels are above target and/or the patient is also experiencing pre-meal or nocturnal hypoglycemia.
  • No information exists on the safety of using the insulin analogs glulisine and degludec in pregnancy. We cannot recommend their use at this time.
  • A rapid-acting insulin, lispro or aspart, may be delivered either through multiple daily injections or an insulin pump.
  • Detemir is a long-acting insulin analog that has been studied in T1D and is noninferior to isophane insulin in terms of safety, efficacy, and outcomes.
  • Glargine, a long-acting insulin analog, is not recom- mended in women who are planning a pregnancy or who are currently pregnant. There is no RCT data comparing it to detemir or isophane insulins. A specific concern

    in the pregnant population is related to the 6- to 8-fold increased insulin-like growth factor receptor affinity and mitogenic potency compared with human insulin.
  • There is inadequate safety information about the use of glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, and sodium glucose co-transporter-2 inhibitors in pregnancy. Therefore, they should not be used in pregnancy.
3.2.5 Other medications:

3.2.5a Hypertension and/or albuminuria management:
  • Angiotensin-converting-enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) should be stopped preconception except as cited in 3.2.5b below, due to the increased risk of fetal injury or demise

    with second or third trimester use and inconsistent teratogenicity data.
    • The nondihydropyridine calcium channel blocker diltiazem in extended release forms may be a useful substitute for ACE inhibitors and ARBs.
    • Switch to antihypertensive agents that are safe in pregnancy (see section 3.5.0 below).
3.2.5b Diabetic nephropathy/chronic kidney disease management:
  • Data on teratogenicity of ACE inhibitors and ARBs are inconsistent; therefore, risks and benefits of continuing them during preconception should be weighed. [1B] The benefits of preconception use of ACE inhibitors for renal protection may outweigh the uncertain risk of birth defects. In this case, ACE inhibitors should be stopped as soon as pregnancy is diagnosed in the first trimester.
3.2.5c Lipid management:
  • Stop all cholesterol-lowering agents before conception, including statins. [1B]
  • Hypertriglyceridemia: Omega-3 fatty acids may be started or continued in pregnancy. [2B]

3.3.0 DIABETES MANAGEMENT DURING PREGNANCY

3.3.1 Self-monitoring of blood glucose and urine ketones: preexisting diabetes and GDM:

  • For gestational diabetes, check glucose levels 4 times/ day: once before breakfast and 1 hour after each meal.
  • For preexisting diabetes, check glucose levels before every meal and 1 hour after each meal.
  • Nocturnal monitoring (around 3 am) may be necessary on an intermittent basis.
  • Check fasting urine ketones daily.
3.3.2 Treatment goals:

3.3.2a Preexisting diabetes:
  • Fasting and pre-meal plasma glucose: 60 to 99 mg/dL. [1C]
  • 1-hour post meal or peak postprandial plasma glucose: 100 to 129 mg/dL. [1C]
  • Urine ketones: negative.
  • Normalization of A1C to <6% if possible without resulting in severe hypoglycemia. [2B]
  • Use standard hypoglycemia treatment for blood glucose less than 60 mg/dL: Consume 15 grams of carbohydrate, and recheck glucose in 15 minutes. If blood glucose remains less than 60 mg/dL, consume an additional 15 grams of carbohydrate.
  • Avoid severe hypoglycemia (an episode in which the patient experiences coma, seizure, or suspected seizure, or impairment sufficient to require the assis- tance of another person). Blood glucose goals must be relaxed for patients with hypoglycemia unawareness or recurrent hypoglycemia.
3.3.2b Gestational diabetes mellitus (GDM):

TABLE 1. Diagnosing GDM
  • Urine ketones: negative.
  • Initiate insulin therapy if above levels are not maintained.
  • Use standard hypoglycemia treatment for blood glucose less than 60 mg/dL: Consume 15 grams of carbohydrate, and recheck glucose in 15 minutes. If blood glucose remains less than 60 mg/dL, consume an additional 15 grams of carbohydrate.
3.3.3 Diabetes monitoring and visits:

 
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