SummaryBackgroundPregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes.MethodsIn this multicentre, open-label, randomised controlled trial, we recruited women aged 18–40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527.FindingsBetween March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference −0·19%; 95% CI −0·34 to −0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most...
OBJECTIVEWomen with diabetes in pregnancy have high rates of pregnancy complications. Our aims were to explore trends in the incidence of diabetes in pregnancy and examine whether the risk of serious perinatal outcomes has changed. RESEARCH DESIGN AND METHODSWe performed a population-based cohort study of 1,109,605 women who delivered in Ontario, Canada, between 1 April 1996 and 31 March 2010. We categorized women as gestational diabetes (GDM) (n = 45,384), pregestational diabetes (pre-GDM) (n = 13,278), or no diabetes (n = 1,050,943). The annual age-adjusted rates of diabetes in pregnancy were calculated, and rates of serious perinatal outcomes were compared between groups and by year using Poisson regression. RESULTSThe age-adjusted rate of both GDM (2.7-5.6%, P < 0.001) and pre-GDM (0.7-1.5%, P < 0.001) doubled from 1996 to 2010. The rate of congenital anomalies declined by 23%, whereas the rate of perinatal mortality did not change significantly. However, compared with women with no diabetes, women with pre-GDM and GDM faced an increased risk of congenital anomalies (relative risk 1.86 [95% CI 1.49-2.33] and 1.26 [1.09-1.45], respectively), and perinatal mortality remained elevated in women with pre-GDM (2.33 [1.59-3.43]). CONCLUSIONSThe incidence of both GDM and pre-GDM in pregnancy has doubled over the last 14 years, and the overall burden of diabetes in pregnancy on society is growing. Although congenital anomaly rates have declined in women with diabetes, perinatal mortality rates remain unchanged, and the risk of both remains significantly elevated compared with nondiabetic women. Increased efforts are needed to reduce these adverse outcomes.Diabetes in pregnancy is becoming an increasingly growing concern as the prevalence of diabetes continues to rise (1). Women with diabetes who become pregnant have an increased risk of pregnancy complications (2-7), including serious perinatal outcomes such as stillbirth, perinatal mortality, and major congenital malformations. Hyperglycemia in the period around conception and the first weeks
Abstract-Lowering blood pressure reduces cardiovascular risk, yet hypertension is poorly controlled in diabetic patients.In a pilot study we demonstrated that a home blood pressure telemonitoring system, which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading, improved blood pressure control. Messages were based on care paths defined by running averages of transmitted readings. The present study tests the system's effectiveness in a randomized, controlled trial in diabetic patients with uncontrolled systolic hypertension. Of 244 subjects screened for eligibility, 110 (45%) were randomly allocated to the intervention (nϭ55) or control (nϭ55) group, and 105 (95.5%) completed the 1-year outcome visit. In the intention-to-treat analysis, mean daytime ambulatory systolic blood pressure, the primary end point, decreased significantly only in the intervention group by 9.1Ϯ15.6 mmHg (SD; PϽ0.0001), and the mean between-group difference was 7.1Ϯ2.3 mmHg (SE; PϽ0.005). Furthermore, 51% of intervention subjects achieved the guideline recommended target of Ͻ130/80 mmHg compared with 31% of control subjects (PϽ0.05). These improvements were obtained without the use of more or different antihypertensive medications or additional clinic visits to physicians. Providing self-care support did not affect anxiety but worsened depression on the Hospital Anxiety and Depression Scale (baseline, 4.1Ϯ3.76; exit, 5.2Ϯ4.30; Pϭ0.014). This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control. Home blood pressure monitoring alone had no effect on blood pressure. 3 Such results spurred development of chronic care models that engage patients in their own care. 4 Home BP monitoring promotes self-care, improves BP control, and is endorsed by several prominent organizations as an adjunct to hypertension treatment. 5 A recent meta-analysis suggested that adding telemonitoring to self-measurement of BP is even more effective in reducing BP. 6 In the telemonitoring studies, however, a physician or member of the healthcare team reviewed the transmitted data and contacted the patients to adjust antihypertensive treatment.7-13 Thus, it is unclear whether the better outcome was related to the use of a telemonitoring system or the increased involvement of healthcare providers in the treatment process.Previously we reported the development of a home BP telemonitoring system that provided self-care messages on the smartphone of patients immediately after each reading. A.G.L. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. None of the other authors has real or perceived conflicts of interest related to the study.This trial has been registered at www.clinicaltrials.gov (identifier NCT00717665 eliminate the need for a health provider to re...
The encouraging results of this study provide a strong rationale for a long-term, randomized, clinical trial to determine whether this home BP tele-management system improves BP control in the community among patients with uncontrolled hypertension.
All women with pre-existing type 1 or type 2 diabetes should receive preconception care to optimize glycemic control, assess for complications, review medications and begin folic acid supplementation.• All pregnant women without known pre-existing diabetes should be screened for gestational diabetes between 24 to 28 weeks of pregnancy • If you were diagnosed with gestational diabetes during your pregnancy, it is important to:• Breastfeed immediately after birth and for a minimum of 4 months in order to prevent hypoglycemia in your newborn, obesity in childhood, and diabetes for both you and your childConflict of interest statements can be found on page S274.Can J Diabetes 42 (2018) S255-S282
All women with pre-existing type 1 or type 2 diabetes should receive preconception care to optimize glycemic control, assess complications, review medications and begin folate supplementation. Care by an interdisciplinary diabetes healthcare team composed of diabetes nurse educators, dietitians, obstetricians and diabetologists, both prior to conception and during pregnancy, has been shown to minimize maternal and fetal risks in women with pre-existing type 1 or type 2 diabetes. Gestational Diabetes MellitusThe diagnostic criteria for gestational diabetes mellitus (GDM) remain controversial; however, the committee has chosen a preferred approach and an alternate approach. The preferred approach is to begin with a 50 g glucose challenge test and, if appropriate, proceed with a 75 g oral glucose tolerance test, making the diagnosis of GDM if !1 value is abnormal (fasting !5.3 mmol/L, 1 hour !10.6 mmol/L, 2 hours !9.0 mmol/L). The alternate approach is a 1-step approach of a 75 g oral glucose tolerance test, making the diagnosis of GDM if !1 value is abnormal (fasting !5.1 mmol/L, 1 hour !10.0 mmol/L, 2 hours !8.5 mmol/L). Untreated GDM leads to increased maternal and perinatal morbidity, while treatment is associated with outcomes similar to control populations. Preconception carePreconception care for women with pregestational diabetes is associated with better outcomes (10,11). Although multidisciplinary clinics improve outcomes, <50% of women receive such care. Women who are heavier, younger and smokers, and who have a lower socioeconomic status, lower health literacy and a poor relationship with their healthcare provider, are less likely to receive preconception care (11e14). Some, but not all, have shown that women with type 2 diabetes are also less likely to receive preconception care (7,15). Higher glycated hemoglobin (A1C) levels are associated with poorer outcomes, but even women who achieve tight glycemic control (A1C <7.0%) have an increased risk of complications, which may be caused, in part, by maternal obesity (16,17). By discussing pregnancy prior to conception, healthcare providers may be able to improve outcomes by educating women Contents lists available at SciVerse ScienceDirect Canadian Journal of Diabetes j o u r n a l h o m e p a g e : w w w . c a n a d ia n j o u r n a l o f d i a b e t e s . c o m
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