Cross-sectional study examining factors impacting on uptake of postpartum type 2 diabetes screening among women diagnosed with hyperglycaemia in pregnancy.

AIMS: Early postpartum glucose screening of women with hyperglycaemia in pregnancy (HIP) can identify women who have the highest risk of developing impaired glucose tolerance and T2DM. This study examines the association between demographics, events during pregnancy, socioeconomic status and postpartum T2DM screening. METHODS: Using the French National Health Data System, this cross-sectional study included all deliveries where the mother had HIP in France in 2015, (n = 76,862). The odds ratio (OR) for attending postpartum screening was calculated via multi-level logistic regression. RESULTS: T2DM screening uptake at six months postpartum was 42·9% [95 % Confidence Interval: 42·6-43·3]. Several characteristics were associated with lower uptake: living in the most deprived area(OR = 0·78[0·74-0·83]); being < 25 years-old (reference age group 25-29;≤17: 0.53 [0·31-0·90];18-24: 0.73[0·69-0·78]); smoking (0·65[0·62-0·68]); obesity (0·93[0·89-0·97]); caesarean delivery (0·95[0·92-0·99]). Factors associated with higher uptake included primiparity (1·30[1·26-1·34]); having followed the French recommendations for HIP screening (1·24[1·20-1·28]); insulin prescription (1·75[1·69-1·81]) and pre-eclampsia (1·30[1·19-1·42]). p < 0.01 is justified due to sample size. CONCLUSION: Improving identification of factors affecting postpartum T2DM screening uptake, such as demographics, socioeconomic context and events during pregnancy, may lead to development of target interventions to aide adherence to screening regime and thereby diagnosis of women with prediabetes or diabetes, for whom secondary and tertiary prevention is crucial.

Maternal and neonatal outcomes according to the timing of diagnosis of hyperglycaemia in pregnancy: a nationwide cross-sectional study of 695,912 deliveries in France in 2018.

AIMS/HYPOTHESIS: We aimed to assess maternal-fetal outcomes according to various subtypes of hyperglycaemia in pregnancy. METHODS: We used data from the French National Health Data System (Système National des Données de Santé), which links individual data from the hospital discharge database and the French National Health Insurance information system. We included all deliveries after 22 gestational weeks (GW) in women without pre-existing diabetes recorded in 2018. Women with hyperglycaemia were classified as having overt diabetes in pregnancy or gestational diabetes mellitus (GDM), then categorised into three subgroups according to their gestational age at the time of GDM diagnosis: before 22 GW (GDM<22); between 22 and 30 GW (GDM22-30); and after 30 GW (GDM>30). Adjusted prevalence ratios (95% CI) for the outcomes were estimated after adjusting for maternal age, gestational age and socioeconomic status. Due to the multiple tests, we considered an association to be statistically significant according to the Holm-Bonferroni procedure. To take into account the potential immortal time bias, we performed analyses on deliveries at ≥31 GW and deliveries at ≥37 GW. RESULTS: The study population of 695,912 women who gave birth in 2018 included 84,705 women (12.2%) with hyperglycaemia in pregnancy: overt diabetes in pregnancy, 0.4%; GDM<22, 36.8%; GDM22-30, 52.4%; and GDM>30, 10.4%. The following outcomes were statistically significant after Holm-Bonferroni adjustment for deliveries at ≥31 GW using GDM22-30 as the reference. Caesarean sections (1.54 [1.39, 1.72]), large-for-gestational-age (LGA) infants (2.00 [1.72, 2.32]), Erb's palsy or clavicle fracture (6.38 [2.42, 16.8]), preterm birth (1.84 [1.41, 2.40]) and neonatal hypoglycaemia (1.98 [1.39, 2.83]) were more frequent in women with overt diabetes. Similarly, LGA infants (1.10 [1.06, 1.14]) and Erb's palsy or clavicle fracture (1.55 [1.22, 1.99]) were more frequent in GDM<22. LGA infants (1.44 [1.37, 1.52]) were more frequent in GDM>30. Finally, women without hyperglycaemia in pregnancy were less likely to have preeclampsia or eclampsia (0.74 [0.69, 0.79]), Caesarean section (0.80 [0.79, 0.82]), pregnancy and postpartum haemorrhage (0.93 [0.89, 0.96]), LGA neonate (0.67 [0.65, 0.69]), premature neonate (0.80 [0.77, 0.83]) and neonate with neonatal hypoglycaemia (0.73 [0.66, 0.82]). Overall, the results were similar for deliveries at ≥37 GW. Although the estimation of the adjusted prevalence ratio of perinatal death was five times higher (5.06 [1.87, 13.7]) for women with overt diabetes, this result was non-significant after Holm-Bonferroni adjustment. CONCLUSIONS/INTERPRETATION: Compared with GDM22-30, overt diabetes, GDM<22 and, to a lesser extent, GDM>30 were associated with poorer maternal-fetal outcomes.

Implementation of a clinical decision support system for the optimization of antidiabetic drug orders by pharmacists.

AIMS: The objective of the study was to describe the impact of a clinical decision support system (CDSS) on antidiabetic drug management by clinical pharmacists for hospitalized patients with T2DM. METHODS: We performed a retrospective, single-centre study in a teaching hospital, where clinical pharmacists analysed prescriptions and issued pharmacist interventions (PIs) through a computerized physician order entry (CPOE) system. A CDSS was integrated into the pharmacists' workflow in July 2019. We analysed PIs during 2 periods of interest: one before the introduction of the CDSS (from November 2018 to April 2019, PIs issued through the CPOE alone) and one afterwards (from November 2020 to April 2021, PIs issued through the CPOE and/or the CDSS). The study covered nondiabetology wards as endocrinology, diabetes and metabolism departments were not computerized at the time of the study. RESULTS: There were 203 PIs related to antidiabetic drugs in period 1 and 319 in period 2 (a 57.5% increase). Sixty-four of the 319 PIs were generated by the CDSS. Noncompliance/contraindication was the main problem identified by the CDSS (41 PIs, 68.4%), and 57.8% led to discontinuation of the drug. Most of the PIs issued through the CDSS corresponded to orders that had not been flagged up by clinical pharmacists using the CPOE. Conversely, most alerts about indications that were not being treated were detected by the clinical pharmacists using the CPOE and not by the CDSS. CONCLUSION: Use of CDSS by clinical pharmacists improved antidiabetic drug management for hospitalized patients with T2DM. The CDSS might add value to diabetes care in nondiabetology wards by decreasing the frequency of potentially inappropriate prescriptions and adverse drug reactions.

Pre-gestational diabetes and the risk of congenital heart defects in the offspring: A French nationwide study.

AIM: To compare the frequencies and types of congenital heart defects for infants of women without and with pre-gestational diabetes, type 1 and type 2 diabetes (T1DM, T2DM) and to identify risk factors. METHODS: All live births between 2012 and 2020 were screened for maternal diabetes and infant congenital heart defects using the French Medical Information System Program in Medicine, Surgery and Obstetrics database (PMSI-MCO). Incidences of these defects were estimated, and a logistic model evaluated maternal and fetal prognostic risk factors. RESULTS: Overall, 6,038,703 mothers did not have pre-gestational diabetes (no-diabetes), 23,147 had T1DM, and 14,401 had T2DM. The incidence of infant congenital disease was 6.2% for the no-diabetes group, 8.0%, for women with T1DM, and 8.4% for women with T2DM (P < 0.001); for congenital heart defects, incidences were respectively 0.8%, 3.0% and 2.7% (P < 0.001). In comparison with the no-diabetes group, the odds ratios (95%CI) of coronary heart defects were 2.07 (1.91;2.24) (P < 0.001) for women with T1DM and 2.20 (1.99;2.44) (P < 0.001) for women with T2DM, with no difference between T1DM and T2DM (P = 0.336). cesarian section, small and large for gestational age, and prematurity were also associated with an increased risk of congenital heart defects. CONCLUSION: In this study we observed higher incidences of congenital heart defects in infants of women with pre-gestational diabetes compared to women without pre-gestational diabetes, with no difference between women with T1DM or T2DM. These data call for intensifying preconception care and justify systematic cardiac echography in selected fetuses.

Risk factors for the development or progression of diabetic retinopathy in pregnancy: Meta-analysis and systematic review.

BACKGROUND: Diabetic retinopathy (DR) is the leading cause of blindness in the working-age population, and it increases in severity during pregnancy. METHODS: Systematic review of literature from PubMed, Cochrane Library and Web of Science using keywords 'diabetic retinopathy' and 'pregnancy' and 'progression' from inception to 2021 was completed. Included studies were (1) peer-reviewed observational studies addressing progression/development of DR in pregnancy, (2) provided the number of diabetic patients that developed/progressed in DR during pregnancy, and (3) included differential data on variables between progression and non-progression groups. This was applied by two independent researchers and referred to a third researcher as necessary. Twenty-seven of the original 138 studies met this criterion. Data were pooled and analysed using fixed-effects in meta-analysis. RESULTS: From 27 studies, 2537 patients were included. Pre-eclampsia [Risk Ratio (RR) 2.62 (95% CI = 1.72, 4.00)] and hypertension treatment during pregnancy [RR 2.74 (95% CI = 1.72, 4.00)] were significantly associated with the development/progression of DR. HbA1c at baseline [MD 0.82 (95% CI = 0.59, 1.06)], duration of diabetes [mean difference (MD) 5.97 (95% CI = 5.38, 6.57)], and diastolic blood pressure at baseline [MD 3.29 (95% CI = 0.46, 6.12)] were all significantly higher in the progression group while only mean birth weight [MD -0.17 (95% CI = -0.31, -0.03)] was significantly higher in the non-progression group. CONCLUSIONS: This study fills a gap in the literature and provide physicians with more information on the risk factors associated with the progression of DR in pregnancy and how to counsel this vulnerable patient population appropriately.

Diabetes is associated with high risk of severe adverse events during chemotherapy for cancer patients: A single-center study.

Diabetes mellitus (DM) is a common comorbidity among cancer patients, but its impact on chemotherapy tolerance has not been widely studied. We aimed to compare the occurrence of severe grade 3/4 adverse events (G3/4 AEs) within 90 days of starting chemotherapy between patients with and without diabetes. We conducted a retrospective single-center study in Lille University Hospital Oncology Department, France. Patients who received the first cycle of chemotherapy for gastrointestinal, gynecological or cancer of unknown primary source between 1 May 2013 and 1 May 2016, were included. Overall, 609 patients were enrolled: 490 patients without diabetes (80.5%) and 119 patients with diabetes (19.5%). Within 90 days of starting chemotherapy, patients with diabetes had a significantly higher occurrence of AEs G3/4 compared to those with no diabetes (multivariate odds ratio [OR]: 1.57 [1.02-2.42], P = .04). More frequent G3/4 AEs in patients with diabetes were infection (26%), hematological disorders (13%), endocrine disorders (13%) and deterioration of the general condition (13%). In the year following the beginning of chemotherapy, patients with diabetes were twice as likely to be hospitalized as those without diabetes (univariate OR: 2.1 [1.40-3.15], P = .0003). After multivariate adjustment, diabetes was no longer significantly associated with the risk of hospitalization (P = .051). There were no differences between patients with and without diabetes regarding dose reduction and chemotherapy treatment delays (P = .61 and P = .30, respectively). Our study suggests the need for better consideration of DM in the personalized care plan to improve chemotherapy tolerance and quality of life of patients with DM.

Intermittently scanned continuous glucose monitoring is associated with lower spontaneous abortion rate compared with conventional blood glucose monitoring in pregnant women with type 1 diabetes: An observational study.

AIM: The objective of the present real-life study in France was to assess and compare characteristics and outcomes in a cohort of pregnant women with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM) or conventional blood glucose monitoring (BGM). MATERIAL AND METHODS: We performed an observational study of a cohort of 153 women with T1D: 77 women were using isCGM, and 76 were using BGM. We compared the groups' maternal characteristics and maternal-fetal complications. The level of HbA1c was measured before pregnancy and then four times (after 8-12, 24-28, 30-33, and 35-37 weeks of gestation). RESULTS: The two groups were similar in terms of age, prepregnancy BMI, diabetes duration, and diabetic vascular complications. There were no significant intergroup differences in the obstetric history. The spontaneous abortion rate was lower in the isCGM group than in the blood glucose monitoring group (5.3% vs. 20%, respectively; p = .0129), while the prepregnancy and first-trimester HbA1c levels were similar. There were no significant intergroup differences in the incidence of other maternal-fetal complications. CONCLUSIONS: This observational study demonstrates that isCGM use is associated with lower spontaneous abortion compared with conventional BGM. Large prospective studies are needed to corroborate our findings and fully understand the relationship between glucose data at the time of conception/early pregnancy and foetal outcome.

Defining explicit definitions of potentially inappropriate prescriptions for antidiabetic drugs in patients with type 2 diabetes: A systematic review.

INTRODUCTION: Potentially inappropriate prescriptions (PIPs) of antidiabetic drugs (ADs) (PIPADs) to patients with type 2 diabetes mellitus (T2DM) have been reported in some studies. The detection of PIPs in electronic databases requires the development of explicit definitions. This approach is widely used in geriatrics but has not been extended to PIPADs in diabetes mellitus. The objective of the present literature review was to identify all explicit definitions of PIPADs in patients with T2DM. MATERIALS AND METHODS: We performed a systematic review of the literature listed on Medline (via PubMed), Scopus, Web of Science, and, Embase between 2010 and 2021. The query included a combination of three concepts ("T2DM" AND "PIPs" AND "ADs") and featured a total of 86 keywords. Two independent reviewers selected publications, extracted explicit definitions of PIPADs, and then classified the definitions by therapeutic class and organ class. RESULTS: Of the 4,093 screened publications, 39 were included. In all, 171 mentions of PIPADs (corresponding to 56 unique explicit definitions) were identified. More than 50% of the definitions were related to either metformin (34%) or sulfonylureas (29%). More than 75% of the definitions were related to either abnormal renal function (56%) or age (22%). In addition, 20% (n = 35) mentions stated that biguanides were inappropriate in patients with renal dysfunction and 17.5% (n = 30) stated that sulfonylureas were inappropriate above a certain age. The definitions of PIPADs were heterogeneous and had various degrees of precision. CONCLUSION: Our results showed that researchers focused primarily on the at-risk situations related to biguanide prescriptions in patients with renal dysfunction and the prescription of sulfonylureas to older people. Our systematic review of the literature revealed a lack of consensus on explicit definitions of PIPADs, which were heterogeneous and limited (in most cases) to a small number of drugs and clinical situations.

Impact of diabetes on COVID-19 prognosis beyond comorbidity burden: the CORONADO initiative.

AIMS/HYPOTHESIS: Diabetes has been recognised as a pejorative prognostic factor in coronavirus disease 2019 (COVID-19). Since diabetes is typically a disease of advanced age, it remains unclear whether diabetes remains a COVID-19 risk factor beyond advanced age and associated comorbidities. We designed a cohort study that considered age and comorbidities to address this question. METHODS: The Coronavirus SARS-CoV-2 and Diabetes Outcomes (CORONADO) initiative is a French, multicentric, cohort study of individuals with (exposed) and without diabetes (non-exposed) admitted to hospital with COVID-19, with a 1:1 matching on sex, age (±5 years), centre and admission date (10 March 2020 to 10 April 2020). Comorbidity burden was assessed by calculating the updated Charlson comorbidity index (uCCi). A predefined composite primary endpoint combining death and/or invasive mechanical ventilation (IMV), as well as these two components separately, was assessed within 7 and 28 days following hospital admission. We performed multivariable analyses to compare clinical outcomes between patients with and without diabetes. RESULTS: A total of 2210 pairs of participants (diabetes/no-diabetes) were matched on age (mean±SD 69.4±13.2/69.5±13.2 years) and sex (36.3% women). The uCCi was higher in individuals with diabetes. In unadjusted analysis, the primary composite endpoint occurred more frequently in the diabetes group by day 7 (29.0% vs 21.6% in the no-diabetes group; HR 1.43 [95% CI 1.19, 1.72], p<0.001). After multiple adjustments for age, BMI, uCCi, clinical (time between onset of COVID-19 symptoms and dyspnoea) and biological variables (eGFR, aspartate aminotransferase, white cell count, platelet count, C-reactive protein) on admission to hospital, diabetes remained associated with a higher risk of primary composite endpoint within 7 days (adjusted HR 1.42 [95% CI 1.17, 1.72], p<0.001) and 28 days (adjusted HR 1.30 [95% CI 1.09, 1.55], p=0.003), compared with individuals without diabetes. Using the same adjustment model, diabetes was associated with the risk of IMV, but not with risk of death, within 28 days of admission to hospital. CONCLUSIONS/INTERPRETATION: Our results demonstrate that diabetes status was associated with a deleterious COVID-19 prognosis irrespective of age and comorbidity status. TRIAL REGISTRATION: ClinicalTrials.gov NCT04324736.

An Unsafe/Safe Typology in People with Type 2 Diabetes: Bridging Patients' Expectations, Personality Traits, Medication Adherence, and Clinical Outcomes.

Background: Support programs are provided to people with diabetes to help them manage their disease. However, adherence to and persistence in support programs are often low, making it difficult to demonstrate their effectiveness. Aim: To identify the determinants of patients' perceived interest in diabetes support programs because it may be a powerful determinant of effective participation in such programs. Patients and Methods: An online study conducted in April 2021 in metropolitan France on 600 people with diabetes recruited from a consumer panel. A 64-item psychosocial questionnaire including a question asking to evaluate the helpfulness of a support program was used. Univariate, multivariate, and multiple correspondence analyses were performed. Results: The existence of a typology, known as Unsafe/Safe, was discovered, in which patients with type 2 diabetes respond in two distinct ways. Type U (unsafe) patients, who believe that a support program would be helpful, are more likely to be nonadherent to their treatment, have high hemoglobin A1c levels, have at least one diabetic complication, lack information regarding their disease and treatment, rate the burden of their disease and impairment of their quality of life as high, worry about their future, and are pessimistic. Type S (safe) patients have the opposite characteristics. Type U patients can be dichotomized into two broad classes: one in which they lack information regarding disease and treatment and the other in which alterations in the quality of life and burden of the disease predominate. Insulin-treated patients give more importance to the lack of information, whereas noninsulin-treated patients complain primarily about the burden of the disease and impairment of quality of life. Conclusion: This study describes this new U/S typology, proposes a simple method based on a nine-item questionnaire to identify type U patients by calculating a Program Helpfulness Score described herein, and clarifies the nature of the intervention to be provided to them. This novel approach could be applied to other chronic diseases.

Prognostic significance of reverse dipping status on lower limb event in type 2 diabetic patients without peripheral arterial disease.

AIMS: We assessed reverse dipping influence on the risk of lower limb events in type 2 diabetic patients without peripheral arterial disease. METHODS: Patients with type 2 diabetes addressed for cardiovascular risk stratification in our university hospital from 2008 to 2012 underwent 24 h blood pressure monitoring. Patients with a prior history of limb revascularization or with a stenosis > 50% of the legs were excluded. Reverse dipping was defined as a greater night-versus day-time systolic blood pressure. The endpoint was the first occurrence of lower limb revascularization or limb amputation. Hazard ratios (HRs) and 95% confidence intervals were calculated using the Cox model. RESULTS: Two hundred and eighty-one patients were included. During a median follow-up of 9.4 [7.7-10.6] years, 20 lower limb events and 45 all-cause deaths were observed. Thirty-five patients were reverse dippers. The reverse dipping status was associated with lower limb events when considering all-cause death as a competitive risk, (HR 3.61 [1.16-11.2], P = 0.026). Reverse dipping, HbA1C and proteinuria were independently associated with lower limb outcome in a multivariable analysis (respectively HR 4.09 [1.29-12.9], P = 0.017, HR 1.30 [1.04-1.63], P = 0.022 and HR 1.06 [1.02-1.11], P = 0.001). CONCLUSIONS: Reverse dipping status is independently associated with worse limb outcome in type 2 diabetic patients.

Association Between HbA1c Levels on Adverse Pregnancy Outcomes During Pregnancy in Patients With Type 1 Diabetes.

CONTEXT: Despite optimization of metabolic balance during pregnancy in type 1 diabetes (T1D), maternal-fetal complications remain higher than in the background population. OBJECTIVE: We examined whether there is an association between glycated hemoglobin (HbA1c) levels and these complications. METHODS: Retrospective study of pregnancies in 678 T1D subjects at Lille Hospital (1997-2019). The association between variations in HbA1c levels and complications was examined. The composite criterion (CC) was defined as having at least 1 of the following complications: prematurity, pre-eclampsia, large for gestational age (LGA), small for gestational age (SGA), or cesarean section. RESULTS: Among the 678 births, median preconception HbA1c was 7.2% (55 mmol/mol), 361 were LGA (56%), 29 were SGA (4.5%), and 504 were births without preterm delivery (76.1%). The CC occurred in 81.8%. Higher HbA1c during the first trimester was associated with the CC (OR 1.04; 95% CI 1.02-1.06 per 0.1% increase; P < .001). Higher HbA1c during the third trimester was associated with the CC (OR 1.07; 95% CI 1.03-1.10 per 0.1% increase; P < .001). The group defined by a first trimester Hba1c >6.5% (48 mmol/mol) and a third trimester HbA1c <6% was associated with an increased rate of the CC (OR 2.81; 95% CI 1.01-7.86) and an increased rate of LGA (OR 2.20; 95% CI 1.01- 4.78). CONCLUSION: Elevated HbA1c is associated with maternal-fetal complications. Despite optimization of metabolic balance during the third trimester, for patients with early glycemic imbalance the risk of LGA persists.

HbA1c at the time of testing for gestational diabetes identifies women at risk for pregnancy complications.

OBJECTIVE: It is unclear whether glycated haemoglobin (HbA1c) has utility in predicting adverse outcomes in gestational diabetes mellitus (GDM). The aims of the study were to examine the predictive value of HbA1c at GDM diagnosis with adverse pregnancy outcomes. RESEARCH DESIGN AND METHODS: This was a cohort study of 4,383 women with GDM between 2011 and 2018. We assessed the association of HbA1c with pregnancy outcomes using logistic regression models before and after adjustment for predefined risk factors of GDM. We examined these associations considering HbA1c as categorical variables using five pre-specified HbA1c classes: and as a continuous variable. RESULTS: An HbA1c ≥ 5.6% (38 mmol/mol) identified women with at greater risk for macrosomia: odds ratio (OR) [95% confidence interval] = 2.12 [1.29; 3.46] for HbA1c = 5.6-5.9% and 2.06 [1.14; 3.70] for HbA1c > 5.9% versus HbA1c ≤ 4.5% (26 mmol/mol). Similarly, HbA1c ≥ 5.6% (38 mmol/mol) was associated with greater risk for caesarean: 1.64 [1.06; 2.53] for HbA1c = 5.6-5.9% and 1.58 [0.93; 2.7] for HbA1c > 5.9% (41 mmol/mol) versus HbA1c ≤ 4.5% (26 mmol/mol). Using HbA1c ≤ 4.5% (26 mmol/mol) as reference category, HbA1c > 5.9% (41 mmol/mol) increased the OR of preterm delivery to 3.33 [1.27; 8.71]. HbA1c remained significant for Adverse Pregnancy Outcome Composite after adjustment (P < 0.0001). DISCUSSION: Our finding suggests that a single HbA1c reading may be a useful pragmatic tool to identify women at risk. Such identification may be a useful guide for identifying and applying preventative treatment for women at increased risk.

Defining Potentially Inappropriate Prescriptions for Hypoglycaemic Agents to Improve Computerised Decision Support: A Study Protocol.

In France, around 5% of the general population are taking drug treatments for diabetes mellitus (mainly type 2 diabetes mellitus, T2DM). Although the management of T2DM has become more complex, most of these patients are managed by their general practitioner and not a diabetologist for their antidiabetics treatments; this increases the risk of potentially inappropriate prescriptions (PIPs) of hypoglycaemic agents (HAs). Inappropriate prescribing can be assessed by approaches that are implicit (expert judgement based) or explicit (criterion based). In a mixed, multistep process, we first systematically reviewed the published definitions of PIPs for HAs in patients with T2DM. The results will be used to create the first list of explicit definitions. Next, we will complete the definitions identified in the systematic review by conducting a qualitative study with two focus groups of experts in the prescription of HAs. Lastly, a Delphi survey will then be used to build consensus among participants; the results will be validated in consensus meetings. We developed a method for determining explicit definitions of PIPs for HAs in patients with T2DM. The resulting explicit definitions could be easily integrated into computerised decision support tools for the automated detection of PIPs.