[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Pages 38844-38845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of NIH Consensus Development Conference: Diagnosing 
Gestational Diabetes Mellitus

SUMMARY: The National Institutes of Health (NIH) is holding a 
conference titled ``Consensus Development Conference: Diagnosing 
Gestational Diabetes Mellitus.'' The conference will be open to the 
public.

DATES: The conference will be held October 29-31, 2012, in the NIH 
Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892.

FOR FURTHER INFORMATION CONTACT: Advance information about the 
conference and conference registration materials may be obtained from 
the NIH Consensus Development Program Information Center by calling 
888-644-2667 or by sending an email to [email protected]. The 
Information Center's mailing address is P.O. Box 2577, Kensington, 
Maryland, 20891. Registration and conference information are also 
available on the NIH Consensus Development Program Web site at http://prevention.nih.gov/cdp.

SUPPLEMENTARY INFORMATION: Gestational diabetes mellitus (GDM) is a 
condition in which women without previously diagnosed diabetes exhibit 
high blood glucose levels during pregnancy (especially during the third 
trimester of pregnancy). It is defined as carbohydrate intolerance, 
which is the inability of the body to adequately process carbohydrates 
(sugars and starches) into energy for the body that develops or is 
first recognized during pregnancy. GDM is estimated to occur in 1-14 
percent of U.S. pregnancies, affecting more than 200,000 women 
annually. It is one of the most common disorders in pregnancy and is 
associated with an increased risk of complications for the mother and 
child. Potential complications during pregnancy and delivery include 
preeclampsia (high blood pressure and excess protein in the urine), 
caesarean delivery, macrosomia (large birth weight), shoulder dystocia 
(when a baby's shoulders become lodged during delivery), and birth 
injuries. For the neonate, complications include difficulty breathing 
at birth, hypoglycemia (low blood sugar), and jaundice. Up to one-half 
of women who have GDM during pregnancy will develop type 2 diabetes 
later in life.
    Although the U.S. Preventive Services Task Force found in 2008 that 
the evidence was insufficient to assess the balance between the 
benefits and harms of screening women for GDM, the American College of 
Obstetricians and Gynecologists recommends universal screening for 
gestational diabetes using patient history, risk factors, or laboratory 
testing, such as with a glucose challenge test (GCT). Different 
approaches are used internationally for screening and diagnosis of GDM. 
The standard method in the United States begins with a GCT, which 
involves drinking a sweetened liquid containing 50 grams of sugar 
(glucose). A blood sample is taken after 1 hour, which measures the 
glucose level. If high, a diagnostic test is administered using a 
larger dose of glucose, and several blood tests are performed over 3 
hours. Depending on the test used, and the chosen blood glucose levels 
that are used to diagnose GDM, the number of women who will receive the 
diagnosis will vary. Debate continues regarding the choice of tests and 
the effectiveness of treatment, especially in women with mild to 
moderate glucose intolerance. Potential harms of screening for GDM 
include anxiety for patients and the potentially adverse effects of a 
``high-risk'' label in pregnancy. In addition, women diagnosed with GDM 
face stressors including dietary constraints, a need to add or increase 
exercise, frequent self-monitoring of blood glucose levels, and for 
some, self-administration of insulin which will require adjustments of 
insulin doses.
    To better understand the benefits and risks of various GDM 
screening and diagnostic approaches, the NIH has engaged in a rigorous 
assessment of the available scientific evidence. This process is 
sponsored by the Eunice Kennedy Shriver National Institute of Child 
Health and Human Development and the Office of Disease Prevention. A 
multidisciplinary planning committee developed the following key 
questions:
    1. What are the current screening and diagnostic approaches for 
gestational diabetes mellitus, what are the glycemic thresholds for 
each approach, and how were these thresholds chosen?
    2. What are the effects of various gestational diabetes mellitus 
screening/diagnostic approaches for patients, providers, and U.S. 
health care systems?
    3. In the absence of treatment, how do health outcomes of mothers 
who meet various criteria for gestational diabetes

[[Page 38845]]

mellitus and their offspring compare with those who do not?
    4. Does treatment modify the health outcomes of mothers who meet 
various criteria for gestational diabetes mellitus and their offspring?
    5. What are the harms of treating gestational diabetes mellitus, 
and do they vary by diagnostic approach?
    6. Given all of the above, what diagnostic approach(es) for 
gestational diabetes mellitus should be recommended, if any?
    7. What are the key research gaps in the diagnostic approach of 
gestational diabetes mellitus?
    An evidence report on GDM will be prepared through the Agency for 
Healthcare Research and Quality's Evidence-based Practice Centers 
program, and a Consensus Development Conference will be held on October 
29-31, 2012.
    During the conference, invited experts, including the authors of 
the evidence report, will present scientific data. Attendees will have 
opportunities to ask questions and provide comments during open 
discussion periods. After weighing the evidence, an unbiased, 
independent panel will prepare and present a consensus statement 
addressing the key questions. The statement will be widely disseminated 
to practitioners, policymakers, patients, researchers, the general 
public, and the media.

    Please Note:  As part of measures to ensure the safety of NIH 
employees and property, all visitors must be prepared to show a 
photo ID upon request. Visitors may be required to pass through a 
metal detector and have bags, backpacks, or purses inspected or x-
rayed as they enter NIH buildings. For more information about the 
security measures at NIH, please visit the Web site at http://www.nih.gov/about/visitorsecurity.htm.


    Dated: June 21, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012-15992 Filed 6-28-12; 8:45 am]
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