Associations between continuous glucose monitoring (CGM) metrics and psycholinguistic measures: a correlational study.

AIM: Recently, the relationship between diabetes and mental health has been widely studied. With the advent of continuous glucose monitoring (CGM), some researchers have been interested in exploring the association between glucose-related metrics and psychological aspects. These studies have primarily relied on self-report questionnaires which present some limitations. Therefore, the present multicenter study aims at testing potential associations between CGM metrics and affective processes derived from narratives about using a CGM sensor. METHODS: An exploratory correlational design was used. Fifty-eight adults with type 1 diabetes using CGM were enrolled and invited to complete an online survey, where they replied to an open-ended question regarding their personal experience with the CGM sensor. Texts derived from the answers were analyzed through Linguistic Inquiry and Word Count, a widely used text analysis tool that can automatically identify and quantify linguistic patterns related to various psychological dimensions. Psycholinguistic measures were correlated with CGM metrics. RESULTS: Higher levels of sadness/depression correlated with lower %TIR (r = - 339; p < .01) and higher %TAR (r = .342; p < .01). CONCLUSIONS: The study highlights the relationship between CGM metrics and psychological variables derived from patients' narratives. In particular, it is possible to hypothesize a positive role of %TIR in reducing depressive feelings in individuals with diabetes, as well as a negative role of depressive feelings in achieving desirable CGM outcomes. Additionally, there is a potential role of glycemic variability, particularly hyperglycemia, in the expression of depressive and sad feelings, which has been less studied compared to the effects of hypoglycemia.

The Burden of Obesity in Type 1 Diabetic Subjects: A Sex-specific Analysis From the AMD Annals Initiative.

OBJECTIVE: Obesity is a growing emergency in type 1 diabetes (T1D). Sex differences in obesity prevalence and its clinical consequences in adult T1D subjects have been poorly investigated. The aim of this study was to investigate the prevalence of obesity and severe obesity, clinical correlates, and potential sex differences in a large cohort of T1D subjects participating to the AMD (Associazione Medici Diabetologi) Annals Initiative in Italy. RESEARCH DESIGN AND METHODS: The prevalence of obesity [body mass index(BMI) ≥30 kg/m2] and severe obesity (BMI ≥ 35 kg/m2) according to sex and age, as well as obesity-associated clinical variables, long-term diabetes complications, pharmacological treatment, process indicators and outcomes, and overall quality of care (Q-score) were evaluated in 37 436 T1D subjects (45.3% women) attending 282 Italian diabetes clinics during 2019. RESULTS: Overall, the prevalence of obesity was similar in the 2 sexes (13.0% in men and 13.9% in women; mean age 50 years), and it increased with age, affecting 1 out of 6 subjects ages >65 years. Only severe obesity (BMI >35 kg/m2) was more prevalent among women, who showed a 45% higher risk of severe obesity, compared with men at multivariate analysis. Cardiovascular disease risk factors (lipid profile, glucose, and blood pressure control), and the overall quality of diabetes care were worse in obese subjects, with no major sex-related differences. Also, micro- and macrovascular complications were more frequent among obese than nonobese T1D men and women. CONCLUSIONS: Obesity is a frequent finding in T1D adult subjects, and it is associated with a higher burden of cardiovascular disease risk factors, micro- and macrovascular complications, and a lower quality of care, with no major sex differences. T1D women are at higher risk of severe obesity.

Gestational Diabetes Mellitus pregnancy by pregnancy: early, late and nonrecurrent GDM.

AIMS: To assess the GDM recurrence rate in a cohort of pregnant women with prior GDM, to compare two consecutive pregnancies complicated by GDM, to compare women with nonrecurrent and recurrent GDM and to stratify the latter in women with early and late recurrent GDM. METHODS: Retrospective study including 113 women with GDM in an index pregnancy (G1), at least a postindex pregnancy (G2) and normal glucose tolerance in between. The GDM recurrence rate was assessed, and maternal and neonatal outcomes and pancreatic beta cell function of the index pregnancy were compared with those of the postindex pregnancy (G1 vs. G2). Women with nonrecurrent GDM were compared with those with recurrent GDM. RESULTS: The GDM recurrence rate was 83.2% and the minimum prevalence of early recurrent GDM was 43,4%. The pregravid BMI of women with recurrent GDM increased between the two pregnancies (27.3 ± 5.98 vs. 28.1 ± 6.19 kg/m2, p < 0.05). Women with recurrent GDM had a higher prepregnancy BMI than those with nonrecurrent GDM either at the index (27.3 ± 5.98 vs. 23.1 ± 4.78 kg/m2, p < 0.05) or the postindex pregnancy (27 ± 6vs.24 ± 4,4 kg/m2, p < 0.05). CONCLUSIONS: GDM shows a high recurrence rate in our cohort of slightly overweight women, with an early GDM minimum prevalence of 43.4%.

Understanding care relationships in diabetes practice: A psychodynamic interview-based exploratory study.

OBJECTIVE: To explore the subjective experience of physicians working in diabetic settings about their care relationships in order to find some unique clues contributing to physician professional health and capacity to manage patients' adherence. RESEARCH DESIGN AND METHODS: An interview-based exploratory study has been carried out involving 18 physicians (77.8% female) with at least 3 years of clinical practice in diabetes care. In-depth interviews about the emotional experience with patients with diabetes were conducted and audio recorded. Interviews transcripts were analyzed through a computer-based text analysis which allowed the identification of thematic domains (Cluster Analysis) and latent factors (Correspondence Analysis) viewed through a psychodynamic and constructivist lens. RESULTS: Six thematic domains emerged respectively referring to: Concern (8.43%), Control (14.42%), Ambivalence (22.08%), Devotion (22.49%), Guilt (19.29%) and Strive for Achievement (13.30%). Moreover, three latent dimensions were taken into account, which explained 69.20% of data variance: Affect Repression (28.50%), Tendency to Repair (22.70%) and Anxiety Pattern (18.00%). CONCLUSIONS: Overall, the results of the present study confirm the challenging nature of diabetes care. In particular, physicians ongoing effort to restore patients' psychological integrity in chronic condition constitute the most novel finding above all. In this regard, the need for emotional labor in physicians' education and training is suggested in order to both prevent burnout symptoms (e.g. depersonalization) and promote shared decision making in care relationships. However, findings should be treated as preliminary given the convenience nature of the sample and its reduced size.

Efficacy of flash glucose monitoring in pregnant women with poorly controlled pregestational diabetes (FlashMom): A randomized pilot study.

BACKGROUND AND AIMS: Good glycemic control is crucial to reduce the risk of adverse pregnancy outcomes. Our aim was to evaluate the efficacy of Flash Glucose Monitoring (FGM) on glucose control in women with pregestational diabetes. METHODS AND RESULTS: Forty women with inadequately controlled type 1 (T1D, n = 34) and type 2 (T2D, n = 6) diabetes at conception were randomly assigned to two arms: the Flash Glucose group (FG, n = 21) using FGM, and the control group (CG, n = 19) using self-monitoring of blood glucose (SMBG). Glycated hemoglobin (HbA1c, %), time in (TIR), below (TBR) and above (TAR) range, glucose variability as well as the occurrence of maternal and neonatal adverse outcomes, were evaluated. HbA1c decreased significantly (p < 0.01) and similarly (-0.65 ± 0.7 vs. -0.67 ± 0.8 for FG and CG, respectively; p = 0.89) in both groups during pregnancy. HbA1c reduction was positively associated with the number of daily FGM scans (p < 0.01). TBR (12.1 ± 2.0% vs. 19.6 ± 3.9%, p = 0.04) and the mean of the daily serum glucose difference (MODD) index (59.1 ± 5.4 vs. 77.7 ± 4.6, p = 0.02) were significantly lower in FG at second trimester. The rates of perinatal adverse outcomes were not different in the two studied groups. CONCLUSIONS: In women with pregestational diabetes, FGM and SMBG had similar efficacy on glucose control during pregnancy. FGM showed additional advantages in terms of TBR and glucose variability. Achievement of good metabolic results depended on the adequate use of glucose sensor. REGISTRATION: At ClinicalTrials.gov as NCT04666818 on December 14, 2020.

Screening of postpartum diabetes in women with gestational diabetes: high-risk subgroups and areas for improvements-the STRONG observational study.

AIMS: To assess the proportion of women with gestational diabetes (GDM) by performing postpartum Oral Glucose Tolerance Test (OGTT) and to identify GDM phenotypes at high-risk of postpartum dysglycemia (PPD). METHODS: Observational, retrospective, multicenter study involving consecutive GDM women. Recursive partitioning (RECPAM) analysis was used to identify distinct and homogeneous subgroups of women at different PPD risk. RESULTS: From a sample of 2,736 women, OGTT was performed in 941 (34.4%) women, of whom 217 (23.0%) developed PPD. Insulin-treated women having family history of diabetes represented the subgroup with the highest PPD risk (OR 5.57, 95% CI 3.60-8.63) compared to the reference class (women on diet with pre-pregnancy BMI < = 28.1 kg/m2). Insulin-treated women without family diabetes history and women on diet with pre-pregnancy BMI > 28.1 kg/m2 showed a two-fold PPD risk. Previous GDM and socioeconomic status represent additional predictors. Fasting more than post-prandial glycemia plays a predictive role, with values of 81-87 mg/dl (4.5-4.8 mmol/l) (lower than the current diagnostic GDM threshold) being associated with PPD risk. CONCLUSIONS: Increasing compliance to postpartum OGTT to prevent/delay PPD is a priority. Easily available characteristics identify subgroups of women more likely to benefit from preventive strategies. Fasting BG values during pregnancy lower than those usually considered deserve attention.

Insulin Requirements and Carbohydrate to Insulin Ratio in Normal Weight, Overweight, and Obese Women With Type 1 Diabetes Under Pump Treatment During Pregnancy: A Lesson From Old Technologies.

Aim: The primary aim of this study was to assess insulin requirements and carbohydrate to insulin ratio (CHO/IR) in normal weight, overweight, and obese pregnant women with type 1 diabetes across early, middle, and late pregnancy. Methods: In this multicenter, retrospective, observational study we evaluated 86 of 101 pregnant Caucasian women with type 1 diabetes under pump treatment. The women were trained to calculate CHO/IR daily by dividing CHO grams of every single meal by insulin units injected. Since the purpose of the study was to identify the CHO/IR able to reach the glycemic target, we only selected the CHO/IR obtained when glycemic values were at target. Statistics: SPSS 20. Results: We studied 45 normal weight, 31 overweight, and 10 obese women. Insulin requirements increased throughout pregnancy (p < 0.0001 and <0.001 respectively) in the normal and overweight women, while it remained unchanged in the obese women. Insulin requirements were different between groups when expressed as an absolute value, but not when adjusted for body weight. Breakfast CHO/IR decreased progressively throughout pregnancy in the normal weight women, from 13.3 (9.8-6.7) at the first stage of pregnancy to 6.2 (3.8-8.6) (p = 0.01) at the end stage, and in the overweight women from 8.5 (7.1-12.6) to 5.2 (4.0-8.1) (p = 0.001), while in the obese women it remained stable, moving from 6.0 (5.0-7.9) to 5.1 (4.1-7.4) (p = 0.7). Likewise, lunch and dinner CHO/IR decreased in the normal weight and overweight women (p < 0.03) and not in the obese women. The obese women gained less weight than the others, especially in early pregnancy when they even lost a median of 1.25 (-1 -1.1) kg (p = 0.005). In early pregnancy, we found a correlation between pregestational BMI and insulin requirements (IU/day) or CHO/IR at each meal (p < 0.001 and p = 0.001, respectively). In late pregnancy, a relationship between pre-gestational BMI and CHO/IR change was found (P = 0.004), as well as between weight gain and CHO/IR change (p=0.02). The significance was lost when both variables were included in the multiple regression analysis. There was no difference in pregnancy outcomes except for a higher pre-term delivery rate in the obese women. Conclusion: Pre-gestational BMI and weight gain may play a role in determining CHO/IR during pregnancy in women with type 1 diabetes under pump treatment.

Flash on gut microbiome in gestational diabetes: a pilot study.

Pregnancy induces a deep modification of women's gut microbiota composition. These changes may influence hormonal and metabolic factors, increasing insulin resistance and leading to hyperglycaemia in susceptible women. Data on 29 women in pregnancy showed insignificant reductions in the Bacteroidetes/ Firmicutes ratio in women with (n. 14) and without (n. 15) gestational diabetes (GDM). Gut microbiota compositions at the genera and species level were further analysed in ten pregnant women with and ten without GDM (9 samples were excluded due to low DNA quality/quantity), showing differences in functionally specific patterns affecting host energy dietary polysaccharide metabolism pathways. According to our results, gut microbiome alteration may play a role in GDM pathogenesis through an increase of gut permeability and higher intestinal energetic balance.

Recommendations and management of hyperglycaemia in pregnancy during COVID-19 pandemic in Italy.

Many specialists use the remote management of people with chronic disease as diabetes, but structured management protocols have not been developed yet. The COVID-19 pandemic has given a big boost to the use of telemedicine, as it allows to maintain the physical distance, essential to the containment of contagion having regular health contact. Encouraging results related to the use of telemedicine in women with hyperglycaemia in pregnancy, have been recently published. It is well known that hyperglycaemia alters the immune response to infections, that inflammation, in turn, worsens glycaemic control and that any form of hyperglycaemia in pregnancy (HIP) has effects not only on the mother but also on development of the foetus. Therefore, the Italian Diabetes and Pregnancy Study Group, together with a group of experts, developed these recommendations in order to guide physicians in the management of HIP, providing specific diagnostic, therapeutic and assistance pathways (PDTAs) for the COVID-19 emergency. Three detailed PDTAs were developed, for type 1, type 2 and gestational diabetes.

Breastfeeding during the COVID-19 pandemic: Suggestions on behalf of woman study group of AMD.

SARS-Cov2 infection has recently spread to Italy with important consequences on pregnancy management, mother and child health and mother-child contact. Breastfeeding improves the health of mother and child and reduces risk of neonatal infection with other pathogens that are likely to cause serious illness. To date no evidence confirmed COVID-19 vertical transmission from infected pregnant mother to their fetus. However it is well known that an infected mother can transmit the COVID-19 virus through respiratory droplets during breastfeeding or intimate contact. Thus, the mothers with known or suspected COVID-19 should adhere to standard and contact precautions during breastfeeding. Woman Study Group of AMD, after reviewing current knowledge about COVID-19 vertical transmission and the compatibility of breastfeeding in COVID-19 mother, the available recommendations from Health Care Organizations and main experts opinions, issued the following suggestions on breastfeeding during the COVID-19 pandemic, addressed both to mothers with and without diabetes. It should be considered that following suggestions may change in the future when more evidence is acquired regarding SARS-Cov2 infection.

Glucokinase Deficit Prevalence in Women With Diabetes in Pregnancy: A Matter of Screening Selection.

Introduction: The prevalence among pregnant women with diabetes of monogenic diabetes due to glucokinase deficit (GCK-MODY) varies from 0 to 80% in different studies, based on the chosen selection criteria for genetic test. New pregnancy-specific Screening Criteria (NSC), validated on an Anglo-Celtic pregnant cohort, have been proposed and include pre-pregnancy BMI <25 kg/m2 and fasting glycemia >99 mg/dl. Our aim was to estimate the prevalence of GCK-MODY and to evaluate the diagnostic performance of NSC in our population of women with diabetes in pregnancy. Patients and Methods: We retrospectively selected from our database of 468 diabetic pregnant patients in Sant'Andrea Hospital, in Rome, from 2010 to 2018, all the women who received a genetic test for GCK deficit because of specific clinical features. We estimated the prevalence of GCK-MODY among tested women and the minimum prevalence in our entire population with non-autoimmune diabetes. We evaluated diagnostic performance of NSC on the tested cohort and estimated the eligibility to genetic test based on NSC in the entire population. Results: A total of 409 patients had diabetes in pregnancy, excluding those with autoimmune diabetes; 21 patients have been tested for GCK-MODY, 8 have been positive and 13 have been negative (2 of them had HNF1-alfa mutations and 1 had HNF4-alfa mutation). We found no significant differences in clinical features between positive and negative groups except for fasting glycemia, which was higher in the positive group. The minimum prevalence of monogenic diabetes in our population was 2.4%. The minimum prevalence of GCK-MODY was 1.95%. In the tested cohort, the prevalence of GCK-MODY was 38%. In this group, NSC sensitivity is 87% and specificity is 30%, positive predictive value is 43%, and negative predictive value is 80%. Applying NSC on the entire population of women with non-autoimmune diabetes in pregnancy, 41 patients (10%) would be eligible for genetic test; considering a fasting glycemia >92 mg/dl, 85 patients (20.7%) would be eligible. Discussion: In our population, NSC have good sensitivity but low specificity, probably because there are many GDM with GCK-MODY like features. It is mandatory to define selective criteria with a good diagnostic performance on Italian population, to avoid unnecessary genetic tests.

Association between type 1 diabetes and female sexual dysfunction.

BACKGROUND: This study aims to evaluate: 1) the prevalence of Female Sexual Dysfunction (FSD) in women affected by type 1 Diabetes Mellitus (DM) and the control group; 2) the correlation between duration of DM, HbA1C levels and sexual life quality; 3) the relationship between different methods of insulin administration and sexual life quality; 4) the correlation between FSD and diabetes complications. METHODS: We selected 33 women with type 1 DM and 39 healthy women as controls. Each participant underwent a detailed medical history and physical examination and completed the 6-item Female Sexual Function Index questionnaire (FSFI-6). In patients affected by type 1 DM, the different methods of insulin administration (Multi Drug Injection - MDI or Continuous Subcutaneous Insulin Infusion - CSII) and the presence of DM complications were also investigated. RESULTS: The prevalence of FSD (total score ≤ 19) was significantly higher in the type 1 DM group than in the control group (12/33, 36.4% and 2/39, 5.2%, respectively; p = 0.010). No statistically significant differences were found regarding FSD according to the presence of complications, method of insulin administration or previous pregnancies. CONCLUSIONS: This study underlined that FSD is higher in women affected by type 1 DM than in healthy controls. This could be due to the diabetic neuropathy/angiopathy and the type of insulin administration. Therefore, it is important to investigate FSD in diabetic women, as well as erectile dysfunction in diabetic men.

A core outcome set for studies of gestational diabetes mellitus prevention and treatment.

AIMS/HYPOTHESIS: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.

Anxiety, Prenatal Attachment, and Depressive Symptoms in Women with Diabetes in Pregnancy.

The purpose of this study was to evaluate the relationship between anxiety, prenatal attachment, and depressive symptoms among women with diabetes in pregnancy. Participants were 131 consecutive pregnant women between the ages of 20 and 45 with a diagnosis of gestational or pregestational type 1 or type 2 diabetes. Data on previous psychiatric symptoms were obtained from the Anamnestic and Social Questionnaire and the Mini-International Neuropsychiatric Interview (MINI). Information on prenatal attachment was collected using The Prenatal Attachment Inventory (PAI), and The Edinburgh Postnatal Depression Scale (EPDS) assessed depressive symptoms in the third trimester of pregnancy (at a mean of 25 weeks). Results demonstrated that in women affected by diabetes in pregnancy, two facets of prenatal attachment (anticipation, interaction) were negatively correlated with depressive symptoms, and a history of anxiety, assessed with the MINI, moderated the relation between the prenatal attachment interaction factor and depressive symptoms during pregnancy.

Insulin Therapy and Diabetic Pregnancy.

BACKGROUND: A good metabolic control before conception and throughout pregnancy with diabetes decreases the risk of short- and long-term adverse outcomes of the mothers and their offsprings. Insulin treatment remains the gold standard treatment recommended for any type of diabetes. New technologies including new insulins and insulin analogues, continuous subcutaneous insulin infusion without and with sensors, the low-glucose predictive suspension function, and closed-loop systems that persistently and automatically self-adjust according to patients' continuous glucose monitoring readings have expanded the offer to clinicians for achieving tight glucose control. AREAS OF UNCERTAINTY: Unsafe effects of insulin and insulin analogues in pregnancy with diabetes could be linked with changes in insulin immunogenicity, teratogenicity, and mitogenicity. Second-generation insulin analogues need to be tested and proven. Effectiveness and safety of new insulin delivery systems in real life of diabetic women in pregnancy need further confirmations. SOURCES: MEDLINE, EMBASE, Web of Science, Cochrane Library, randomized controlled trials, systematic review and meta-analysis, observational prospective and retrospective studies, case series reports for the most recent insulin analogues, published in English impacted journals, and consensus statements from scientific societies I excluded 60 from 221 papers as not suitable for the purpose of the subject. RESULTS: Subcutaneous insulin infusion can be safely used during pregnancy and delivery of well-trained women. Sensors are increasingly accurate tools that improve the efficacy and safety of integrated systems' functioning. Continuous glucose monitoring provides metrics ("time in range" time in "hypoglycemia" and in "hyperglycemia," glucose variability, average glucose levels in different time intervals) used as a guide to diabetes management; these new metrics are object of discussion in special populations. Randomized controlled trials have shown that sensor-augmented pump therapy improves pregnancy outcomes in women with type 1 diabetes. Closed-loop insulin delivery provides better glycemic control than sensor-augmented pump therapy during pregnancy, before, and after delivery. CONCLUSION: Second-generation insulin analogues and newer insulin infusion systems that automatically self-adjust according to patients continuous glucose monitor readings are important tools improving the treatment and quality of life of these women. Multi-institutional and disciplinary teams are working to develop and evaluate a pregnancy-specific artificial pancreas.

"MySweetGestation": A novel smartphone application for women with or at risk of diabetes during pregnancy.

Mobile health (mHealth) applications (apps) have been recently introduced as an easily accessible tool for providing information to pregnant women with diabetes. Despite the growing number of apps on the topic "diabetes & pregnancy", a smartphone app offering comprehensive and individualized information to both women (before and during gestation) and their healthcare professionals was still missing. To overcome this lack, the Italian Diabetes and Pregnancy Study Group conceived and realized in 2016 a novel mobile app called "MySweetGestation". It is designed to be an interactive educational tool for both patients and physicians not expert in the field. Through an interactive way of learning, it provides validated information to the user, focusing on different area of interest: from prevention and risk factors for developing diabetes during pregnancy to treatment and follow-up strategies after gestation. Three years since its publication, MySweetGestation has been downloaded in different western and eastern countries worldwide, suggesting a widespread social impact. Easily accessible personalized information made available via mHealth technology may be of great importance to spread controlled information among the pregnant population. MySweetGestation, being an interactive educational device for both patients and healthcare professionals, may contribute to improve the management of pregnant women with diabetes.

Guidelines for the screening and diagnosis of gestational diabetes in Italy from 2010 to 2019: critical issues and the potential for improvement.

AIMS: In 2010, Italian health professionals rapidly implemented the one-step screening for gestational diabetes mellitus (GDM) based on a 75 g OGTT, to comply with the diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). The change was promoted by the two main Italian scientific societies of diabetology, Associazione Medici Diabetologi (AMD) and Società Italiana di Diabetologia (SID), and it took just a few months for the Istituto Superiore di Sanità, together with several scientific societies, to revise the criteria and include them in the National Guidelines System. Over the last 9 years, the implementation of these guidelines has shown some benefits and some drawbacks. METHODS: In order to evaluate the critical issues arisen from the implementation of the current Italian guidelines for the diagnosis of GDM, the studies published on this topic have been reviewed. The search was performed using the following keywords: "gestational diabetes" AND "diagnostic criteria" OR screening AND Ital*. The study is an expert opinion paper, based on the relevant scientific literature published between 2010 and 2019. The databases screened for the literature review included PubMed, MEDLINE, and Scopus. RESULTS: The implementation of the Guidelines for Screening and Diagnosis of GDM in Italy present some strengths and some weaknesses. One of the positive aspects is that high-risk women are required to perform an OGTT early in pregnancy. By contrast, there are several aspects in need of improvement: (1) In spite of the current indications, only a minority of high-risk women perform OGTT early in pregnancy; (2) several low-risk women are screened for GDM; (3) in some low-risk women affected by GDM, the diagnosis might be missed with the application of the current guidelines; (4) there is a lack of homogeneity in the risk assessment data from different regions. CONCLUSIONS: In order to improve the current Italian GDM guidelines, some practical solutions have been suggested.

Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey.

AIMS/HYPOTHESIS: Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The aim of this study is to develop a core outcome set (COS) for RCTs and other studies evaluating the long-term follow-up at 1 year and beyond of women with previous GDM treated with insulin and/oral glucose-lowering agents. METHODS: The study consisted of three work packages: (1) a systematic review of the outcomes reported in previous RCTs of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral glucose-lowering agents; (2) a three-round online Delphi survey with key stakeholders to prioritise these outcomes; and (3) a consensus meeting where the final COS was decided. RESULTS: Of 3344 abstracts identified and evaluated, 62 papers were retrieved and 25/62 papers were included in this review. A total of 121 outcomes were identified and included in the Delphi survey. Delphi round 1 was emailed to 835 participants and 288 (34.5%) responded. In round 2, 190 of 288 (65.9%) participants responded and in round 3, 165 of 190 (86.8%) participants responded. In total, nine outcomes were selected and agreed for inclusion in the final COS: assessment of glycaemic status; diagnosis of type 2 diabetes since the index pregnancy; number of pregnancies since the index pregnancy; number of pregnancies with a diagnosis of GDM since the index pregnancy; diagnosis of prediabetes since the index pregnancy; BMI; post-pregnancy weight retention; resting blood pressure; and breastfeeding. CONCLUSIONS/INTERPRETATION: This study identified a COS that will help bring consistency and uniformity to outcome selection and reporting in clinical trials and other studies involving the follow-up at 1 year and beyond of women diagnosed with GDM treated with insulin and/or oral glucose-lowering agents during pregnancy.