Rosa Corcoy

Gestational diabetes mellitus in Europe: prevalence, current screening practice and barriers to screening. A review

Diabet. Med. 29, 844–854 (2012)

Assessment of insulin sensitivity and beta-cell function from measurements in the fasting state and during an oral glucose tolerance test.

Aims/hypothesis. We aimed to find if the relation between insulin sensitivity and beta-cell function assessed from fasting and OGTT measurements has a physiological shape (hyperbolic with the reference methods). Methods. Healthy women without diabetic first-degree relatives underwent a 75 g OGTT with plasma glucose and insulin (n = 35) concentrations being measured at 0, 30, 60 and 120 min. Beta-cell function and insulin sensitivity were estimated using previously described indices from fasting (1 for beta-cell function, 6 for insulin sensitivity) and OGTT measurements (3 for beta-cell function and 5 for insulin sensitivity). A hyperbolic relation was tested for the 21 beta-cell function-insulin sensitivity pairs using a non-lineal regression method. Results. The assessment of beta-cell function from OGTT was impossible in seven women and one had outlier indices. For the remaining 27 women, only 8 combinations adjusted to a hyperbolic relation. The best adjustment was achieved using the fasting glucose to insulin ratio as the estimation of insulin sensitivity and the homeostasis model assessment (HOMA) index (single fasting sample) as the estimation of beta-cell function (r2 0.802, k 869.71, p < 0.001). Conclusion/interpretation. In this group of healthy women, the estimation of insulin sensitivity and beta-cell function by most methods using OGTT-derived glucose and insulin measurements did not adjust to a hyperbolic relation but all fasting indices combinations did. Beta-cell function estimated with the HOMA index and insulin sensitivity with fasting glucose to insulin ratio had the best adjustment. [Diabetologia (2000) 43: 1507–1511]

Maternal and Fetal Outcome in Women with Type 2 Versus Type 1 Diabetes Mellitus: A Systematic Review and Metaanalysis

CONTEXT Glycemic disturbance is usually less severe in pregnant women with type 2 than in those with type 1 diabetes mellitus (DM). Nevertheless, a worse perinatal outcome in women with type 2 DM has been reported in some studies. OBJECTIVE Our objective was to review maternal and fetal outcomes in pregnant women with type 2 vs. type 1 DM. STUDY SELECTION We conducted a systematic review of papers providing original data on pregnancy outcomes in both type 2 and type 1 DM (Medline search of the period January 1, 1987, to June 30, 2008). Two independent investigators considered papers for eligibility, and a third one solved discrepancies. DATA EXTRACTION Metaanalysis tools were used to compare four main outcomes (major congenital malformations, stillbirth, and neonatal and perinatal mortality) and 15 secondary ones (five maternal, 10 fetal). Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were used to assess quality. DATA SYNTHESIS Thirty-three studies qualified for inclusion of 3743 citations retrieved. Women with type 2 DM had lower glycated hemoglobin (HbA1c) at booking and throughout pregnancy but a higher risk of perinatal mortality [odds ratio (OR) 1.50, 95% confidence interval (CI) 1.15-1.96] without significant differences in the rates of major congenital malformations, stillbirth, and neonatal mortality. As to secondary outcomes, women with type 2 DM had less diabetic ketoacidosis (OR 0.09, 95% CI 0.02-0.34) and cesarean section (OR 0.80, 95% CI 0.59-0.94) without differences in other outcomes. CONCLUSIONS Despite a milder glycemic disturbance, women with type 2 DM had no better perinatal outcomes than those with type 1, indicating that type 2 DM in pregnancy is a serious condition.

Telemedicine as a tool for intensive management of diabetes: the DIABTel experience

This paper presents the current features of the DIABTel telemedicine system and the evaluation outcomes of its use in clinical routine. This telemedicine system is designed to complement the daily care and intensive management of diabetic patients through telemonitoring and telecare services. The system comprises a patient unit (PU) used by patients in their day-to-day activities and a Medical Workstation used by physicians and nurses at hospitals. Both applications offer tools to collect, manage, view and interpret data and to exchange data and messages. The system was evaluated for usability, telemedical protocols, metabolic control and quality of life. This evaluation consisted in a 6-month cross-over pilot study with ten Type I diabetic patients. The results of the evaluation allowed assessment of the telemedicine protocols in terms of the number of communications/patient (21.6+/-7.7); days between communications (5.4+/-2.66); messages sent by physicians (118 text messages); and data and messages transmitted by patients (3524 blood glucose readings, 1649 day-to-day insulin adjustments, 24 exercise reports, ten diet modifications and 63 text messages). Physicians performed more therapeutic changes during the DIABTel period than in the control period. There was a trend towards HbA1c improvement during DIABTel use with no incidence in the number of hypoglycaemias. This pilot study demonstrates the feasibility of the DIABTel system in clinical routine use and its potential benefits for diabetes care: improving the availability of information necessary for therapy adjustments; offering new physician-patient communication tools; increasing patient empowerment and education; and showing a positive trend towards improving the metabolic control of patients. Further studies are needed to validate these findings and to promote telemedicine as an opportunity to better diabetes care.

Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis

Objective To summarize short term outcomes in randomized controlled trials comparing glibenclamide or metformin versus insulin or versus each other in women with gestational diabetes requiring drug treatment. Design Systematic review and meta-analysis. Eligibility criteria for selecting studies Randomized controlled trials that fulfilled all the following: (1) published as full text; (2) addressed women with gestational diabetes requiring drug treatment; (3) compared glibenclamide v insulin, metformin v insulin, or metformin v glibenclamide; and (4) provided information on maternal or fetal outcomes. Data sources Medline, CENTRAL, and Embase were searched up to 20 May 2014. Outcomes measures We considered 14 primary outcomes (6 maternal, 8 fetal) and 16 secondary (5 maternal, 11 fetal) outcomes. Results We analyzed 15 articles, including 2509 subjects. Significant differences for primary outcomes in glibenclamide v insulin were obtained in birth weight (mean difference 109 g (95% confidence interval 35.9 to 181)), macrosomia (risk ratio 2.62 (1.35 to 5.08)), and neonatal hypoglycaemia (risk ratio 2.04 (1.30 to 3.20)). In metformin v insulin, significance was reached for maternal weight gain (mean difference −1.14 kg (−2.22 to −0.06)), gestational age at delivery (mean difference −0.16 weeks (−0.30 to −0.02)), and preterm birth (risk ratio 1.50 (1.04 to 2.16)), with a trend for neonatal hypoglycaemia (risk ratio 0.78 (0.60 to 1.01)). In metformin v glibenclamide, significance was reached for maternal weight gain (mean difference −2.06 kg (−3.98 to −0.14)), birth weight (mean difference −209 g (−314 to −104)), macrosomia (risk ratio 0.33 (0.13 to 0.81)), and large for gestational age newborn (risk ratio 0.44 (0.21 to 0.92)). Four secondary outcomes were better for metformin in metformin v insulin, and one was worse for metformin in metformin v glibenclamide. Treatment failure was higher with metformin than with glibenclamide. Conclusions At short term, in women with gestational diabetes requiring drug treatment, glibenclamide is clearly inferior to both insulin and metformin, while metformin (plus insulin when required) performs slightly better than insulin. According to these results, glibenclamide should not be used for the treatment of women with gestational diabetes if insulin or metformin is available. Systematic review registration NCT01998113

A telemedicine support for diabetes management: the T-IDDM project

In the context of the EU funded Telematic Management of Insulin-Dependent Diabetes Mellitus (T-IDDM) project, we have designed, developed and evaluated a telemedicine system for insulin dependent diabetic patients management. The system relies on the integration of two modules, a Patient Unit (PU) and a Medical Unit (MU), able to communicate over the Internet and the Public Switched Telephone Network. Using the PU, patients are allowed to automatically download their monitoring data from the blood glucose monitoring device, and to send them to the hospital data-base; moreover, they are supported in their every day self monitoring activity. The MU provides physicians with a set of tools for data visualization, data analysis and decision support, and allows them to send messages and/or therapeutic advice to the patients. The T-IDDM service has been evaluated through the application of a formal methodology, and has been used by European patients and physicians for about 18 months. The results obtained during the project demonstration, even if obtained on a pilot study of 12 subjects, show the feasibility of the T-IDDM telemedicine service, and seem to substantiate the hypothesis that the use of the system could present an advantage in the management of insulin dependent diabetic patients, by improving communications and, potentially, clinical outcomes.

In human gestational diabetes mellitus congenital malformations are related to pre-pregnancy body mass index and to severity of diabetes

AbstractAims/hypothesisThis study analysed the relationship between congenital malformations (CM) and severity of gestational diabetes mellitus.MethodsA cohort of 2060 infants of mothers with gestational diabetes was studied. Universal screening and 3rd Workshop-Conference criteria were used to diagnose gestational diabetes. The severity of diabetes was assessed on the basis of previous hyperglycaemia, blood glucose values in diagnostic OGTT, area under the glucose curve, gestational age and HbA1c at diagnosis, insulin requirements during pregnancy, and OGTT after delivery. Potentially confounding variables (age, pre-pregnancy BMI, smoking) were considered. The relationship of potential predictors with CM was analysed with several multivariate logistic regression analyses.ResultsThe rate of CM was 6% for minor and 3.8% for major malformations (1.4% heart, 0.8% renal/urinary, 0.7% skeletal, 0.3% hypospadias, 0.2% central nervous system, 0.2% cleft lip/palate, 0.1% digestive tract, 0.3% other). In the final models, forward logistic regression analysis identified pre-pregnancy BMI as the predictor of CM (area under receiver operating characteristic curve 0.616); in the backward analysis additional predictors were 1-h blood glucose in diagnostic OGTT and gestational age at diagnosis (area under receiver operating characteristic curve 0.646). Both BMI and severity of gestational diabetes were predictors of heart and minor CM, whereas BMI predicted renal/urinary CM and severity of diabetes predicted skeletal CM.Conclusions/interpretationIn these infants of mothers with gestational diabetes, severity of diabetes and pre-pregnancy BMI were predictors of CM, in accordance with the well-documented pathogenic role of BMI (in the general population) and hyperglycaemia (in diabetic pregnancy). BMI was the main predictor of more prevalent CM.

DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol

BackgroundGestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women.Methods/designPregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose<5.1mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5 mmol) and randomized to one of the 8 intervention arms using a 2×(2×2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5kg and either 7 healthy eating ‘messages’ and/or 5 physical activity ‘messages’ depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24–28 weeks, 35–37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight.DiscussionDALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women.Trial registrationISRCTN70595832

Insulin Antibody Response to a Short Course of Human Insulin Therapy in Women With Gestational Diabetes

OBJECTIVE To assess the insulin antibody (IA) response to human insulin (HI) therapy in women with gestational diabetes. RESEARCH DESIGN AND METHODS IAs were measured by a competitive radiobinding assay in 50 women with gestational diabetes before and during treatment with HI and after delivery. At delivery, 15 maternal-cord blood sample pairs were analyzed for IA. As a reference, we searched for IA in 25 new-onset type I diabetic patients, before and at 3, 6, and 12 months after insulin therapy. RESULTS Insulin autoantibodies (IAAs) were detected in 1 of 50 women with gestational diabetes and 4 of 16 type I diabetic patients (P < 0.05). At the end of pregnancy after 9.3 ± 6.8 weeks on insulin therapy, 22 of 50 (44%) women with gestational diabetes became IA+ and 4 additional women were found to be positive 2 months postpartum. After 3 months on insulin, type I diabetic patients showed a higher rate of IA positivity (92%, P < 0.001). IA titers at the end of pregnancy were associated with the cumulative insulin dose (r = 0.29, P < 0.05). Postpartum, IA disappeared slowly in most IA+ women, but two women still showed IA 2 years after delivery Titers in cord blood were strongly related to those in maternal blood (r = 0.74, P < 0.01). The rate of adverse fetal outcome did not differ in IA− and IA+ mothers (27 vs. 40%, NS). CONCLUSIONS HI is immunogenic, and a short course of HI therapy induces IA in ∼ 50% of women with gestational diabetes and 92% of type I diabetic patients. In women with gestational diabetes, insulin dose is slightly associated with IA titers. These IAs apparently cross the placenta. Fetal outcome does not differ according to the maternal IA status, and IAs disappear gradually after delivery but may remain positive for 2 years after delivery.

Major congenital malformations in women with gestational diabetes mellitus: a systematic review and meta-analysis.

The risk of major congenital malformations (MCM) is increased in women with pregestational diabetes mellitus (PGDM). Whether this risk is increased in gestational diabetes mellitus (GDM) is still debated. The aim of this study was to perform a systematic review (and meta‐analysis) of major congenital malformations in women with gestational diabetes versus a reference population.