Assessment of adherence to aspirin for preeclampsia prophylaxis and reasons for nonadherence.

BACKGROUND: Preeclampsia is a hypertensive disease unique to pregnancy and has a significant impact on maternal and neonatal morbidity and mortality. Daily aspirin has been demonstrated to reduce the risk of preeclampsia. The American College of Obstetricians and Gynecologists recommends daily low-dose aspirin, ideally before 16 weeks' gestation, in at-risk patients for preeclampsia risk reduction. This study examined whether patients at-risk for preeclampsia by the American College of Obstetricians and Gynecologists criteria recalled aspirin recommendation and factors associated with treatment adherence. OBJECTIVE: This study examined whether patients at-risk for preeclampsia by the American College of Obstetricians and Gynecologists criteria recalled aspirin recommendation and factors associated with treatment adherence. STUDY DESIGN: This study used an anonymous written survey. Pregnant patients were asked to record self-reported risk factors and to recall recommendation to take aspirin for preeclampsia prophylaxis. Participants were then determined to be high-, moderate-, or low-risk on the basis of the American College of Obstetricians and Gynecologists guidelines. Self-reported adherence to recommendations and factors contributing to the patients' decisions to take or decline aspirin were assessed. Secondary outcomes included demographic characteristics of adherent patients and patients who did not recall aspirin recommendation. RESULTS: A total of 544 surveys were distributed and 500 were returned (91.9% response rate). Of the 104 high-risk pregnancies identified, aspirin was recommended in 60 (57.7%; 95% confidence interval, 0.48-0.67). Of the 269 patients with 2 or more moderate-risk factors, aspirin was recommended for 13 (4.8%; 95% confidence interval, 0.03-0.08). Among the participants who recalled aspirin recommendation, adherence was similar between high-risk (81.7%) and moderate-risk (76.9%) groups (P=.69). Patients with chronic hypertension, a history of preeclampsia or gestational hypertension in a previous pregnancy, and pregestational diabetes mellitus were most likely to report receiving aspirin recommendation (78.8%, 76.5%, 63.8%, and 53.3%, respectively). No high-risk factor was associated with a decreased likelihood of adherence. Nonadherent patients rarely discussed their decision with their medical provider (5.9%). In the 42.3% of high-risk participants who did not recall aspirin recommendation, autoimmune disease, multiple gestation, and kidney disease were the most prevalent risk factors (42.9%, 35.7%, and 25.0%, respectively). CONCLUSION: In the population studied, many at-risk patients, as defined by the American College of Obstetricians and Gynecologists criteria, did not recall recommendations to take aspirin for preeclampsia prophylaxis. This raises concerns for absent or ineffective counseling. Of the patients who recalled aspirin recommendation, most reported adherence, and a history of hypertensive disorders or preeclampsia, autoimmune disease, and pregestational diabetes mellitus were most often associated with adherence. There was no single factor most strongly associated with intentional nonadherence.

Health care resource utilization and cost of severe hypoglycemia treatment in insulin-treated patients with diabetes in the United States.

BACKGROUND: Hypoglycemia is a major limiting factor in achieving glycemic control in persons with diabetes. In some instances, recovery from a severe hypoglycemia event may require health care resource utilization (HCRU), including the use of emergency medical services (EMS), visits to the emergency department (ED), and inpatient hospitalization. OBJECTIVES: To (a) describe the profiles of patients who experience severe hypoglycemic events and (b) characterize HCRU and the associated cost related to severe hypoglycemia treatment. METHODS: This retrospective, observational cohort study used administrative claims data from IBM MarketScan Research Databases. The study examined a cohort of subjects who experienced severe hypoglycemic events that involved HCRU during the 1-year index period. Baseline patient demographic data were collected according to patient profiles, such as payer type, type of diabetes, age, and type of insulin. HCRU and the associated cost data categorized by the patient profiles and care progression scenarios were described. RESULTS: 9,563 patients from the IBM MarketScan Research Databases experienced a severe hypoglycemic event during the index period and were included in the study; approximately 75% of those patients did not experience a severe hypoglycemic event in the previous year. Of the 9,563 patients in the cohort, the largest patient profile (n = 1,767, 18.5%) consisted of those who were on Medicaid, had type 2 diabetes, and used basal/bolus or premixed-only insulins. Overall, more than 90% of the index severe hypoglycemic events involved visits to the ED. EMS claims in the 24 hours before the ED visit were found for half of the severe hypoglycemic events (51.5%). CONCLUSIONS: Differences in HCRU and the associated costs for the treatment of severe hypoglycemia were observed among patients based on insurance, diabetes, and insulin types. Clinicians need to be aware of these differences. Optimizing treatment of severe hypoglycemia, specifically EMS care, and examining patient profiles to develop targeted interventions could potentially provide benefits to patients and reduce cost and resource utilization. DISCLOSURES: This study was funded by Eli Lilly and Company. All authors are employees and shareholders of Eli Lilly and Company. The data presented here have been presented in poster form at AMCP Nexus 2020 Virtual, October 19-23, 2020; ADCES Virtual Conference 2020, August 13-16, 2020; and Virtual ISPOR 2020, May 18-20, 2020.

Diabetes Technology Use in Adults with Type 1 and Type 2 Diabetes.

In the last 2 decades, diabetes technology has emerged as a branch of diabetes management thanks to the advent of continuous glucose monitoring (CGM) and increased availability of continuous subcutaneous insulin infusion systems, or insulin pumps. These tools have progressed from rudimentary instruments to sophisticated therapeutic options for advanced diabetes management. This article discusses the available CGM and insulin pump systems and the clinical benefits of their use in adults with type 1 diabetes, intensively insulin-treated type 2 diabetes, and pregnant patients with preexisting diabetes.

Use of Antidiabetic drugs during pregnancy among U.S. women with Livebirth deliveries in the Mini-Sentinel system.

BACKGROUND: As the prevalence of diabetes mellitus increases in the population, the exposure to antidiabetic drugs (ADDs) during pregnancies is expected to grow, as has been seen over the last decade. The objective of this study was to estimate the prevalence of ADD use during pregnancy among women in the Mini-Sentinel Distributed Database (MSDD) who delivered a liveborn infant. METHODS: We identified qualifying livebirth pregnancies among women aged 10 to 54 years in the MSDD from 2001 to 2013. ADD use was estimated using outpatient pharmacy dispensing claims and days-supplied among three cohorts: all livebirth pregnancies, pregnancies among women with pre-existing diabetes, and pregnancies among women without prior ADD use. RESULTS: Among the 1.9 million pregnancies in the MSDD that resulted in a livebirth from 2001 to 2013, 4.4% were exposed to an ADD. Of the 15,606 pregnancies (0.8%) with pre-existing diabetes, 92.8% were also exposed during the pregnancy period. The most commonly used product in these pregnancies was insulin (75.6% of pregnancies). In contrast, in pregnancies of women without prior ADD use, the most commonly used products were glyburide and insulin, and most of these users were diagnosed with gestational diabetes. CONCLUSIONS: Patterns of ADD use during pregnancy described here, along with changes in disease incidence and management, highlight the importance of continuing surveillance of ADD utilization patterns and examining the safety and effectiveness of these products in pregnancy.

Glycemic profile assessment during betamethasone administration in women with gestational diabetes mellitus.

AIM: Betamethasone's effect on glucose homeostasis in the presence of gestational diabetes has not been adequately investigated. MATERIALS-METHODS: We assessed the glycemic profile of 99 women with gestational diabetes (52 on insulin, 47 on medical nutrition therapy) who were given betamethasone during hospitalization for at risk pregnancies. RESULTS: In insulin-treated women the increase in total daily insulin dose significantly linked to betamethasone dose (p = 0.014). In women on diet, the need for insulin was positively related to betamethasone dose, age and gestational age >34th week (all p < 0.05). CONCLUSION: Parsimonious betamethasone use might still be beneficial with a milder effect on glycemia.

Women's Experiences of Day-and-Night Closed-Loop Insulin Delivery During Type 1 Diabetes Pregnancy.

AIMS: Closed-loop insulin delivery has the potential to improve day-to-day glucose control in type 1 diabetes pregnancy. However, the psychosocial impact of day-and-night usage of automated closed-loop systems during pregnancy is unknown. Our aim was to explore women's experiences and relationships between technology experience and levels of trust in closed-loop therapy. METHODS: We recruited 16 pregnant women with type 1 diabetes to a randomized crossover trial of sensor-augmented pump therapy compared to automated closed-loop therapy. We conducted semistructured qualitative interviews at baseline and follow-up. Findings from follow-up interviews are reported here. RESULTS: Women described benefits and burdens of closed-loop systems during pregnancy. Feelings of improved glucose control, excitement and peace of mind were counterbalanced by concerns about technical glitches, CGM inaccuracy, and the burden of maintenance requirements. Women expressed varied but mostly high levels of trust in closed-loop therapy. CONCLUSIONS: Women displayed complex psychosocial responses to day-and-night closed-loop therapy in pregnancy. Clinicians should consider closed-loop therapy not just in terms of its potential impact on biomedical outcomes but also in terms of its impact on users' lives.

The need for appropriate registration of pregnancy outcomes under newer oral glucose-lowering therapies.

Because of the increase in type 2 diabetes (T2DM) in young adults, women of childbearing age are frequently treated with newer glucose-lowering therapies, and an increase in unintentional exposure to therapies unapproved for use during pregnancy is expected. The clinician is left with the dilemma of deciding between discontinuation of a novel agent that is providing excellent glycaemic control, while switching to other agents may cause deterioration of glycaemia, and continued use of novel agents that may have uncertain effects on the unborn child. For T2DM, pregnancy data are collected only via spontaneous reporting systems. Therefore, we evaluated the available data on pregnancy outcomes under newer glucose-lowering agents in pharmaceutical safety databases. We found that data on pregnancy outcomes with new glucose-lowering agents in T2DM are scarce, with a high risk of bias towards negative outcomes, limiting their usefulness in robustly assessing safety. Because of the lack of information at present, these agents are not recommended for use during pregnancy or when planning pregnancy. To better guide clinical practice, structured systems of assessing pregnancy outcomes in women receiving these novel agents are urgently needed.

Anti-diabetic drug utilization of pregnant diabetic women in us managed care.

BACKGROUND: With the increasing prevalence of type 2 diabetes in young adulthood, treatment of diabetes in pregnancy faces new challenges. Anti-diabetic drug utilization patterns of pregnant women with pre-existing diabetes are poorly described. We aim to describe anti-diabetic (AD) agent utilization among diabetic pregnant women. METHODS: We utilized IMS LifeLink, including administrative claims data of patients in US managed care plans, to establish a retrospective cohort of women, age 18-46 years (N = 96,740) with billed procedures for a live birth, and a 12 month eligibility period before and 3 month after delivery. Diabetes mellitus was identified from ≥2 in- or outpatient claims with diagnoses (ICD-9-CM 250.XX) before pregnancy. We estimated the prevalence of AD drugs before, during and after pregnancy, and secular trends across the study period (1999-2009), using linear regression. A sensitivity analysis was conducted to identify the extent of misclassification of trimesters. RESULTS: Almost six percent (n = 5,581) of the live birth cohort had diabetes mellitus. Throughout the study, 48% (1999) and 78% (2009) (p < 0.0001) of diabetic women received AD drugs during pregnancy. The most common AD drugs during pregnancy were insulin, metformin, sulfonylureas, thiazolidinediones (TZD), and combination AD. The annual prevalence of insulin use increased by only 1% from 39% (1999) to 40% (2009) (p = 0.589) during pregnancy, while use of sulfonylureas and metformin increased from 2.5% and 4.2% (1999) to 17.3% and 15.3% (2009) (p < 0.0001), respectively. Insulin and sulfonylurea use steadily increased in prevalence from the 1st to 3rd trimester (16.5% and 3.3% to 33.0% and 7.5%), while metformin and TZD use decreased (11.4% and 1.6% to 3.8% and 0.2%). CONCLUSIONS: AD use during pregnancy demonstrates the need for additional investigation regarding safety and efficacy of AD drugs on maternal outcomes.

Growth assessment of diabetic rat fetuses under the influence of insulin and melatonin: a morphologic study.

Hyperglycemia-induced oxidative stress makes an important contribution to the etiology of diabetic teratogenicity namely fetal growth and congenital dysmorphogenesis. The aim of this study is to evaluate the protective roles of melatonin and insulin against diabetic's embryolethality and teratogenicity. Diabetes was induced to virgin Sprague Dawley albino rats by a single peritoneal injection of alloxan. Thirty pregnant rats were divided equally into 5 groups: 1) Control 2) Diabetic 3) Diabetic insulin 4) Diabetic melatonin 5) Diabetic melatonin-insulin. Insulin and melatonin were administered daily throughout the whole gestational period. Fetuses were collected on day 20 of gestation and were examined for malformations and growth disorders. A significant increase in fetal growth parameters (Macrosomia) were noticed in the diabetic group compared to the control. Melatonin prevents the appearance of soft tissue anomalies, but it leads to fetal growth restriction of diabetic rats (Microsomia). No significant changes were noticed in fetal growth parameters in diabetic insulin or in diabetic melatonin-insulin groups compared to the control. Congenital anomalies were not seen in diabetic insulin and in diabetic melatonin-insulin groups while the rate of resorption was reduced in both groups when compared to the diabetic group. In conclusion, co-administration of melatonin with insulin leads to a slight non significant improvement of the protective role of insulin against diabetic embryolethality, teratogenicity and fetal growth changes.

Insulin Glargine: a review 8 years after its introduction.

Insulin Glargine was the first long-acting insulin analog produced by recombinant DNA technology, approved for use by the US FDA in April 2000 and by the European Agency for the Evaluation of Medicinal Products in June, 2000. It has become the most widely used insulin in the USA owing to its long duration of action without a pronounced peak. The principal advantage of insulin Glargine over neutral protamine Hagedorn (NPH) insulin is in a lower frequency of hypoglycemic reactions, thus affording improved safety. It is used in both type 1 and type 2 diabetes, usually as a single daily dose. In type 2 patients, it is often the first insulin introduced as a single daily dose. Although insulin Glargine is typically administered as a single nighttime dose, it can be given in the morning or at any other time convenient for the patient. In labile type 1 diabetes, it is often most effective given as two daily injections. In obese, insulin-resistant patients, it may be best to administer insulin Glargine in two separate doses, owing to the high volumes of injected insulin required. Insulin Glargine does not treat postprandial hyperglycemia. It is necessary to supplement with short-acting insulin at mealtimes to control glucose surges after meals. Insulin Glargine is effective in hospitalized and postsurgical patients on account of its lack of pronounced insulin peaks and long duration of action. Although there is considerable use of Glargine in pregnant diabetic women, there is no definitive study to confirm its benefits. Insulin Glargine is thought to coprecipitate supplementary short-acting insulins when co-administered in the same syringe. Therefore, more injections are typically needed in the usual treatment regimen for insulin requiring diabetes. In many cases, constant basal insulin levels may be achieved with multiple overlapping doses of NPH insulin given together with short-acting insulin at mealtimes. Such a therapy may be less costly, but the major advantage of insulin Glargine remains the greater safety of a lower frequency of hypoglycemic reactions.

Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness.

Portable insulin infusion devices are effective and safe insulin delivery systems for managing diabetes mellitus, especially type 1 diabetes. Rapidly absorbed insulin analogues, such as insulin lispro or insulin aspart, may offer an advantage over regular human insulin for insulin pumps. Several open-label randomised crossover trials demonstrated that continuous subcutaneous insulin infusion (CSII) with insulin lispro provided a better control of postprandial hyperglycaemia and a slightly but significantly lower glycated haemoglobin level, with lower daily insulin requirement and similar or even less hypoglycaemic episodes. A CSII study comparing insulin lispro and insulin aspart demonstrated similar results with the two analogues, and better results than those with regular insulin. Because these analogues have a quicker onset and a shorter duration of action than regular insulin, one might expect an earlier and greater metabolic deterioration in case of CSII interruption, but a more rapid correction of metabolic abnormalities after insulin boluses when reactivating the pump. These expectations were confirmed in randomised protocols comparing the metabolic changes occurring during and after CSII interruption of various durations when the pump infused either insulin lispro or regular insulin. The extra cost resulting from the use of CSII and insulin analogues in diabetes management should be compensated for by better metabolic control and quality of life. In conclusion, CSII delivering fast-acting insulin analogues may be considered as one of the best methods to replace insulin in a physiological manner by mimicking meal and basal insulin requirements, without higher risk of hypoglycaemia or ketoacidosis in well-educated diabetic patients.

Teletransmission system supporting intensive insulin treatment of out-clinic type 1 diabetic pregnant women. Technical assessment during 3 years' application.

A telematic system supporting intensive insulin treatment of pregnant type 1 diabetic out-clinic patients was implemented and technical efficiency of the system was evaluated over long-term ambulatory application. The system consists of a patient teletransmission module (PTM) and a central clinical control unit (CCU). The PTM contains a one-box blood glucose meter and electronic logbook, a modem and a dial-up or cellular phone set. The CCU consists of a PC computer with a modem and DIAPRET - an original program designed to monitor the intensive insulin treatment. The system was installed in the Clinic of Gastroenterology and Metabolic Disease, MA Warsaw and was tested for 166 +/- 24 days on 15 pregnant type 1 diabetic women. Telemonitoring of the patient data was done automatically. No major technical problems with proper operation or handling of the system was noted. Total effectiveness was 69.3 +/- 13.0% and technical effectiveness 91.5 +/- 6.1%. The efficacy of the system was not significantly influenced by patient intelligence level, education level or place of residence (p < 0.05). Significant improvement of metabolic control was noted during application of the system. In conclusion, the telematic system we developed and implemented should have a positive influence on the quality of diabetes treatment during pregnancy.

Benefits, risks, costs, and patient satisfaction associated with insulin pump therapy for the pregnancy complicated by type 1 diabetes mellitus.

OBJECTIVE: Glycemic control, perinatal outcome, and health care costs were evaluated among women with type 1 diabetes mellitus who began insulin pump therapy during pregnancy (group 1, n = 24), were treated with multiple insulin injections (group 2, n = 24), or were already using an insulin pump before pregnancy (group 3, n = 12). Patient satisfaction and continuation of pump therapy post partum were assessed. STUDY DESIGN: A retrospective review of maternal and neonatal medical records was performed, and a questionnaire was sent to patients after delivery. Patients in groups 1 and 2 were matched for age, age at onset and duration of diabetes mellitus, White class, and date of delivery. RESULTS: No differences in glycosylated hemoglobin A levels were observed among groups 1, 2 or 3 in the first, second, or third trimester. Patients in group 1 started pump therapy at a mean of 16.8 weeks' gestation, and 17 (70.8%) began therapy as outpatients. No deterioration in glycemic control was noted during the 2- to 4-week period after the start of pump treatment. Among the women in group 1 eight had at least one episode of severe hypoglycemia before starting pump therapy, but only one had such an episode after this treatment was begun. Two episodes of ketoacidosis occurred in group 1, and no episodes occurred in groups 2 and 3. No significant differences in perinatal outcomes or health care costs were observed among groups 1, 2, and 3. After delivery 94. 7% of the women in group 1 continued to use the pump because it provided better glycemic control and a more flexible lifestyle. Postpartum glycosylated hemoglobin A values were 7.2% in group 1 and 9.1% in group 2, a significant difference. CONCLUSIONS: Insulin pump therapy was initiated during pregnancy without a deterioration of glycemic control and was associated with maternal and perinatal outcomes and health care costs comparable to those among women who were already using the pump before pregnancy or who received multiple-dose insulin therapy. Women who began pump therapy in pregnancy were highly likely to continue pump use after delivery and preferred the flexible lifestyle that this treatment allowed.

New concepts and applications in the use of the insulin pump during pregnancy.

Subcutaneous insulin infusion or insulin pump therapy has been advocated as an alternative to multiple dose insulin injections for nearly two decades. These devices provide insulin administration in a pattern which more closely resembles that of physiologic insulin release, a basal insulin infusion during the day and throughout the night with boluses given prior to meals. Because the number of patients using an insulin pump is increasing, it is likely the perinatologist will encounter women who are being treated with an insulin infusion pump or are considering this therapy. Insulin pump therapy requires that the patient be highly motivated and compliant. One of the most important criteria in selecting patients for this treatment is their willingness to test their capillary glucose levels 6 to 8 times each day. Interruption of the insulin infusion can produce hyperglycemia in any pump user. Should this occur in the pregnant patient, the likelihood of ketoacidosis developing is significantly greater. Ideally, insulin pump therapy should be initiated prior to pregnancy so that glucose control can be normalized, thereby reducing the risk for spontaneous abortion and fetal malformations. Gradually improving glucose control prior to pregnancy can reduce the likelihood of deterioration of retinopathy, which has been observed when poorly controlled pregnant patients rapidly become euglycemic. The published experience with the insulin pump has demonstrated that this therapy can achieve glucose control and perinatal outcomes comparable to that obtained with multiple-dose insulin injection therapy.

Hypoglycemia: the price of intensive insulin therapy for pregnant women with insulin-dependent diabetes mellitus.

OBJECTIVE: To evaluate the risk of hypoglycemia associated with intensive insulin therapy of type I diabetes during pregnancy. METHODS: Eighty-four women with type I diabetes were recruited before 9 weeks' gestation and received intensive insulin therapy throughout pregnancy. Patients monitored glucose concentrations with memory glucometers, and insulin dosages were adjusted weekly accordingly. A detailed history of clinical hypoglycemic events was obtained at each weekly clinic visit. RESULTS: Clinically significant hypoglycemia requiring assistance from another person occurred in 71% of pregnant patients, with a peak incidence between 10-15 weeks. Severe hypoglycemia during the early weeks of embryogenesis was not associated with an increase in embryopathy. Glycemic control was similar in women with or without recurrent hypoglycemia, but glucose fluctuations were significantly greater in hypoglycemic women. CONCLUSION: Severe hypoglycemia is a significant maternal risk associated with intensive insulin therapy of pregnant women with type I diabetes. In women with recurrent episodes of hypoglycemia, the clear benefits of strict glycemic control must be weighed against the hazards of hypoglycemia.

[Evaluation of the insulin requirements with an artificial pancreas in the pregnant woman with gestational insulin-dependent diabetes (type I)]. / Valoración de los requerimientos insulínicos con páncreas artificial en la embarazada con diabetes pregestacional insulinodependiente (tipo I).

The evolution of insulin requirements in 9 pregnant women with insulin-dependent diabetes mellitus (type I) was evaluated. Requirements were increased between weeks 11 and 24 and remained stable between weeks 24 and 35. Those corresponding to breakfast in the two initial connections were significantly higher, while those corresponding to breakfast, lunch and dinner became equal in the last connection (35 gestational weeks). We found a significant lineal correlation between the intravenous and the subcutaneous requirements. We conclude that the artificial pancreas is a useful instrument, which permits a detailed analysis of the time course of intravenous insulin requirements during pregnancy in the insulin-dependent pregnant woman and facilitates the adjustment of insulin therapy.

[Evaluation of the insulin requirements with an artificial pancreas in gestational diabetes]. / Valoración de los requerimientos insulínicos con páncreas artificial en la diabetes gestacional.

The evolution of insulin requirements in 10 patients with gestational diabetes mellitus was evaluated with the use of an artificial pancreas. We found that intravenous insulin requirements showed a definite tendency to decline, the greatest reduction being found between gestational weeks 27 and 37. Postprandial requirements after lunch were significantly higher in the weeks 15 and 27, with a tendency to become equal to those corresponding to breakfast and dinner in week 37. We found a lack of lineal correlation between the intravenous and subcutaneous requirements. We conclude that the artificial pancreas is a useful instrument to examine in detail the temporal evolution of insulin requirements in gestational diabetes. The artificial pancreas facilitates the adjustment of insulin therapy and plays a major role in the understanding of the pathophysiological abnormalities in these patients.

Ultrasonographic assessment of early fetal growth in insulin-treated diabetic pregnancies.

Early fetal growth aberrations have been suggested in diabetic gestations. To characterize such aberrations sonographically, longitudinal crown-rump length measurements were made in a group of 20 control and 20 diabetic pregnancies. The study evaluated growth between 40 and 100 days of amenorrhea. The best-fit curve of growth as a function of gestational age was that of a nonlinear polynomial regression curve for both the control and the diabetic groups. The correlation coefficients were 0.997 and 0.887 for the control and diabetic groups, respectively; the standard error of the estimate was 0.054 and 0.19, respectively. A log10 linear transformation was performed successfully on each curve. Comparison of the slopes and the intercepts of the transformed control and diabetic curves revealed no significant differences. To evaluate the possibility of a transient fetal growth delay, interval growths and interval growth velocities were compared between groups. No significant differences were observed. The control and diabetic groups' mean (+/- SD) growth velocities were 0.043 +/- 0.023 and 0.040 +/- 0.022 mm/day/mm total, respectively (p = NS). The growth of two anomalous fetuses in the diabetic group was studied individually. Their growth characteristics could not be distinguished from the control fetuses' growth profiles. The present study fails to confirm the presence of early fetal growth delay in diabetic pregnancies. Moreover, the data suggest that the fetuses' early growth in the mother with poorly controlled diabetes is similar to that of control fetuses.

[Assessment of self monitoring of blood glucose (SMBG) and continuous subcutaneous insulin infusion (CSII) in diabetic pregnant women].

We instructed pregnant women with insulin dependent diabetes mellitus (IDDM) or noninsulin dependent diabetes mellitus (NIDDM) how to monitor their own blood glucose concentrations and evaluated the efficiency and feasibility of continuous subcutaneous insulin infusion (CSII) therapy. Self-monitored glucose concentrations with a reflectance meter correlated with those of hospital laboratory measurements (hexokinase method) with a coefficient of more than 0.9. Glycosylated hemoglobin (HbA1) levels of the patients were normalized with insulin treatment based on the self-monitored glucose concentrations. In pregnant women with NIDDM who monitored their blood glucose concentrations before breakfast, the fasting glucose concentrations could be lowered by insulin administration and the duration of hospitalization could be shortened compared to non-monitored patients. Although diurnal variations were prominent in pregnant women with IDDM and precise control of their blood glucose concentrations was difficult with conventional insulin administration, even if the patients had monitored their glucose concentrations 7 times a day, the mean glucose concentrations and M values could be kept in the optimum range in patients treated with CSII. These methods have contributed to the improvement in maternal and infant complications.