CLIA 1988: impact on diabetes care.
Explore the source record for details and available documents.
Biomedical subjects
Publications and source records attributed to R E Ratner.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Current recommendations for appropriate weight gain in pregnancy suggest an optimum of 120% of ideal body weight (IBW) at delivery. This represents an increase of approximately 24 pounds in the normal weight woman and even the obese patient (more than 135% IBW) is told to gain 16 pounds. Information concerning gestational weight gain in the morbidly obese woman (more than 160% IBW) has not been reported. We evaluated 40 morbidly obese pregnant women for maternal morbidity relative to gestational weight gain. No correlation was found between maternal weight gain and the development of gestational diabetes, pregnancy-induced hypertension, preeclampsia, preterm labor, premature rupture of membranes, incompetent cervix, or intrauterine growth retardation. The incidence of primary cesarean delivery was statistically greater in those women gaining more than 24 pounds (p less than 0.05). It appears that current recommendations for gestational weight gain in the morbidly obese are excessive and may result in increased maternal risk.
Detection of an elevated prolactin level in the nonpregnant patient usually directs attention to the investigation of the pituitary gland. We describe a patient with secondary amenorrhea and galactorrhea in whom such an elevated prolactin level did initially lead to the discovery of a pituitary mass that was treated first unsuccessfully with surgery, and then successfully with medical therapy. After medical therapy normal menstruation continued, galactorrhea recurred intermittently, and the prolactin level rose again and remained in the approximately 36-micrograms/L range. However, 2 years later an ovarian teratoma was discovered incidentally and was removed surgically. On pathological evaluation the teratoma was noted to include prolactin-containing tissue, and immediately after surgery the patient's prolactin level and responsiveness to stimulatory testing returned to normal. To our knowledge this is the first case report of the association of clinically evident hyperprolactinemia with an ovarian cystic teratoma that contained prolactin-producing tissue.
Recommended gestational weight gain is based on supplying adequate nutrition to the conceptus, ensuring normal growth and development. Since morbidly obese women have an overabundance of nutrients for fetal transfer, we examined the effects of weight gain on fetal outcome in women greater than 160% of ideal body weight. Gestational weight gains varied from -18 to +64 pounds, allowing analysis of fetal outcome based on maternal weight gain. No correlation between maternal weight gain and ketonuria, birthweight or length, placental weight, or Apgar scores was noted. Gestational age at delivery was inversely related to weight gain. When grouped by maternal weight gain, fetal outcome was no different if mothers gained less than or greater than 10 pounds. We conclude that limited weight gain in the morbidly obese women does not adversely affect fetal outcome, and prospective trials of limited weight gain diets in morbidly obese women are warranted.
Cutaneous insulin allergy remains a clinical problem despite the use of highly purified human insulins. We used in vitro lymphocyte-transformation studies to examine the reactivity of various insulin formulations in diabetic patients with (n = 4) and without (n = 8) cutaneous allergies. Nonspecific response to concanavalin A demonstrated a greater than 40-fold response in both groups. Control patients did not respond to the addition of commercial insulin preparations (stimulation index [SI] less than 4), whereas allergic patients had an 11-fold response to beef (P less than 0.01), a 10-fold response to pork (P less than 0.01), and a 6-fold response to human (P less than 0.01) insulins. This response was limited to a single insulin manufacturer's preparations and was uniform in all three species tested. Efforts to identify the offending agent revealed no lymphoblast transformation when crystalline insulin was used or when commercial preparations were purified to a single peak by high-performance liquid chromatography (HPLC). Pure crystalline insulin dimers of beef, pork, and human species were tested; control subjects responded with mean SIs of 1.9, 1.9, and 1.8, respectively, whereas allergic patients showed greater reactivity to beef (SI 7.3) and pork (SI 14.8). The lymphoblast-transformation response to crystalline human dimer was dose dependent with mean SIs of 0.9 at low concentration (2.8 ng/ml) and 19.2 at a higher concentration (20.4 ng/ml). The commercial insulin preparations were run on size-exclusion HPLC to determine high-molecular-weight aggregate content. Independent of species, a single manufacturer had products demonstrating aggregate levels 3- to 6-fold higher than those found in other manufacturers' preparations.(ABSTRACT TRUNCATED AT 250 WORDS)
Individuals with diabetes are increasingly persuing employment in fields previously restricted as a result of the development of chronic complications. Improved glycemic control resulting from use of sophisticated insulin delivery and monitoring systems has also led to the recognition of recurrent hypoglycemia as a potential major clinical and occupational hazard. No data concerning the occupational safety of individuals with insulin-treated diabetes mellitus (ITDM) are available. We review the literature on diabetic drivers in an effort to examine the impact of certification of ITDMs as commercial drivers. In the absence of significant worldwide experience with ITDMs as commercial drivers, the discussion is necessarily based on projected accident rates derived from data on frequency of hypoglycemia. These studies are universally flawed by variable definitions of hypoglycemia, ascertainment bias, and patient selection. They do, however, provide a worst-case/best-case scenario for discussion. It is imperative that any expansion of employment opportunities for ITDMs be followed carefully with prospective studies to assess the impact on public safety.
Expansion of the team approach to diabetes care will most likely have significant ramifications in malpractice liability law as applied to diabetes educators, physicians, treatment teams, and supporting hospitals. This analysis focuses on the nature of the team approach to diabetes care, nationally promulgated standards for its practice, and predictions of the parameters of malpractice law. The establishment of a national certification procedure identifies specialists in diabetes education, allowing for the expanded roles of diabetes educators, and promotes a minimum standard of care to which practitioners may be held. Likewise, the criteria for recognition by the American Diabetes Association (ADA) serve as guidelines for diabetes education programs. Current legal decisions suggest that these standards may be applied nationally as measures of malpractice liability. Application of certification guidelines may minimize allegations of malpractice.