Indications for the Postpartum Oral Glucose Tolerance Test­Data From the GestDiab Registry.

BACKGROUND: Gestational diabetes mellitus (GDM) affects more than 50 000 pregnant women in Germany every year. In postpartum diabetes screening, a 75 g oral glucose tolerance test (OGT) is recommended. This is time-consuming and can have side effects, and only 40% of mothers take it. The determination of pre-test probabilities might obviate the need for OGT except in women who are at particular risk. METHODS: We analyzed 5444 cases of GDM from the GestDiab registry over the period 2015-2019. The pretest probabilities of a postpartum diagnosis of diabetes mellitus (DM) or prediabetes were calculated on the basis of clinical variables including postpartum venous fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c). RESULTS: In 0.77% of mothers with a history of GDM in whom DM was not detected by FPG or HbA1c, postpartum DM was diagnosed on the basis of the 2-hour value in the OGT. Individual estimation of the pre-test probability of a diagnosis by OGT of postpartum DM or prediabetes was possible with the aid of the FPG and HbA1c values and clinical predictors including insulin treatment during pregnancy, obesity, GDM diagnosed before 24 weeks of gestation, age over 35, and a 1-hour value in the diagnostic OGT during pregnancy of 180 mg/dL (10.0 mmol/L) or above. The pretest probability of postpartum DM in the study group ranged from 0.11% to 4.17%, and that of postpartum prediabetes from 6.4% to 16.3%. CONCLUSION: The probability of a diagnosis of postpartum diabetes by OGT after GDM can be estimated in postpartum screening on the basis of various parameters. This enables risk-adapted counseling of the affected women along with a long-term strategy for diabetes prevention and follow-up. The findings of our study should be verified by further research.

Adverse perinatal outcomes in gestational diabetes mellitus with and without SARS-CoV-2 infection during pregnancy: results from two nationwide registries in Germany.

INTRODUCTION: Pregnancy is a known independent risk factor for a severe course of COVID-19. The relationship of SARS-CoV-2 infection and gestational diabetes mellitus (GDM) on neonatal outcomes is unclear. Our aim was to determine if SARS-CoV-2 infection represents an independent risk factor for adverse perinatal outcomes in pregnancy with GDM. RESEARCH DESIGN AND METHODS: We compared data from two German registries including pregnant women with GDM, established during the SARS-CoV-2 pandemic (COVID-19-Related Obstetric and Neonatal Outcome Study (CRONOS), a multicenter prospective observational study) and already existing before the pandemic (German registry of pregnant women with GDM; GestDiab). In total, 409 participants with GDM and SARS-CoV-2 infection and 4598 participants with GDM, registered 2018-2019, were eligible for analyses. The primary fetal and neonatal outcomes were defined as: (1) combined: admission to neonatal intensive care unit, stillbirth, and/or neonatal death, and (2) preterm birth before 37+0 weeks of gestation. Large and small for gestational age, maternal insulin therapy, birth weight >4500 g and cesarean delivery were considered as secondary outcomes. RESULTS: Women with SARS-CoV-2 infection were younger (32 vs 33 years) and had a higher median body mass index (28 vs 27 kg/m²). In CRONOS, more neonates developed the primary outcome (adjusted OR (aOR) 1.48, 95% CI 1.11 to 1.97) and were born preterm (aOR 1.50, 95% CI 1.07 to 2.10). Fasting glucose was higher in women in CRONOS versus GestDiab (5.4 vs 5.3 mmol/L) considering each 0.1 mmol/L increase was independently associated with a 5% higher risk of preterm birth among women in CRONOS only (aOR 1.05, 95% CI 1.01 to 1.09). CONCLUSIONS: GDM with SARS-CoV-2 infection in pregnancy is associated with an increased risk of adverse fetal and neonatal outcomes as compared with GDM without SARS-CoV-2 infection.

Gestational diabetes in Germany-prevalence, trend during the past decade and utilization of follow-up care: an observational study.

Gestational diabetes mellitus (GDM) is one of the most common medical complications in pregnancy. Information on key figures such as screening rates, prevalence of GDM or utilization of follow-up care and associated factors varies widely and is often lacking. The aim of our study is to provide information on screening rates for and prevalence of GDM as well as utilization of follow-up care in Germany. We used data (2010-2020) from a large, nationwide statutory health insurance containing information on inpatient and outpatient care, including diagnoses, medication and treatments. Descriptive analyses were performed to assess screening rates, prevalence of GDM and participation rates in follow-up care. A log-binomial regression model was calculated to analyze associated factors. Screening rates among pregnant women increased from 40.2% (2010) to 93.3% (2020) and prevalence from 9.4% (2010) to 15.1% (2020). The proportion of women attending follow-up care remained stable over time (around 42%). Age, educational level, insulin prescription, hypertension and obesity were positively associated with participation in follow-up care. Although over 90% of women in Germany are screened for GDM during pregnancy, follow-up care is used much less. Further research is needed to understand the trends in GDM healthcare (from screening to follow-up care) and the reasons for women's (non-)participation, as well as the attitudes and routines of the healthcare providers involved.

Postpartum screening of women with GDM in specialised practices: Data from 12,991 women in the GestDiab register.

BACKGROUND: Gestational diabetes (GDM) in the short term is associated with various complications during pregnancy; however, in the long run, women have an increased risk of type 2 diabetes mellitus (T2DM). Therefore, short- and long-term follow-up postpartum is recommended. METHODS: We assessed the proportion of postpartum diabetes screening among 12,991 women with their first GDM-diagnosed pregnancy in the study period in the nationwide German GestDiab register between 2015 and 2017. In addition to assessing prevalence, we assessed if the probability of postpartum screening was associated with maternal characteristics or pregnancy outcomes. RESULTS: In total, 38.2% (95% CI 32.8%-43.7%) of our sample underwent postpartum diabetes screening, irrespective of its timing. Around 50% of women (19.3% of the total sample) undertook the screening in the recommended time frame of 6-12 weeks postpartum. We found that age, native language, pre-pregnancy BMI, smoking status, number of previous pregnancies, fasting plasma glucose and HbA1c levels as well as previous pregnancies with GDM and treatment with insulin were associated with participation in the postpartum diabetes screening in our sample. CONCLUSION: In our study, more than 60% of the women with GDM did not participate in postpartum diabetes screening. This is a missed opportunity in a high-risk population to detect glucose intolerance. Consequently, appropriate interventions to prevent the progression to T2DM cannot be initiated. Further research should investigate barriers and enabling factors and allow developing a multilevel approach for GDM postpartum care.

Can Routine Data be used to Determine the Target Population of Patients with Type 2 Diabetes in Early Benefit Assessments in Germany?

OBJECTIVES: Since 2011, early benefit assessment of all new drugs launched in Germany is mandatory. The exact determination of the appropriate target population (i. e. patients eligible for a drug) plays an important role for subsequent price negotiations. In type 2 diabetes, the size of the target population varies considerably between company dossiers submitted for assessment. Our aim was to explore whether routine data from all persons insured in German statutory health insurance (SHI) funds can be used to derive information on the size of the target population with type 2 diabetes. METHODS: We explored how the data available at the German Institute of Medical Documentation and Information (DIMDI) can be used to obtain the information required. A data-based concept was chosen and the selection criteria were developed in a multidisciplinary project group. Before finalizing the database query, the criteria were evaluated in a test database and the database query was then repeatedly modified. RESULTS: At the time of the design of our analysis in 2017, the most recent data available at DIMDI were for 2013. The algorithm we developed for identifying patients with type 2 diabetes and classifying them according to their medication, based primarily on the combination of ICD and ATC codes, enabled us to determine the size of target populations for different indications in diabetes mellitus type 2. CONCLUSION: Our methodological approach seems to be suitable to determine target populations in type 2 diabetes.

Insulin Pump and CGM Usage in the United States and Germany: Results of a Real-World Survey With 985 Subjects.

BACKGROUND: This survey collected and evaluated user responses about routine tasks and preferences regarding insulin pumps and infusion sets (IIS) with comparison of intercountry differences between the United States (US) and Germany (GER), chosen for their large insulin pump populations. METHODS: A total of 985 subjects (534 US, 451 GER; 60% female) with type 1 diabetes on pump therapy anonymously answered 20 pump-related questions. US subjects also answered 11 questions about continuous glucose monitoring (CGM) usage. RESULTS: Length of use of insulin cartridges is shorter in US than in GER, mean (SD) 4.3 (5.0) versus 5.3 (3.2) days (P < .001), while the IIS is used longer: 3.3 (1.0) versus 2.7 (1.1) days (P < .001). Lower self-reported HbA1c levels were associated with longer use of insulin cartridges (7.3% for >3 days vs. 7.7% for <3 days; P < .01), and with use of an auto-insertion device (vs. manual IIS insertion) in the US (7.2% vs. 6.9%), but not in GER (7.7% vs. 7.9%). Only 47% of pump wearers stated that they were "very satisfied" with their pump (49% US vs. 45% GER, ns). However, 98% would recommend the pump to others (95% vs. 93%, ns). Analysis of CGM questions showed that 297 (60%) of 496 US responders currently wore one. Of these, 84% said they would recommend CGM to others. CGM wearers who stated they were "very satisfied" with their CGM had lower HbA1c than those who said they were "partly satisfied" (6.9% vs. 7.2%). CONCLUSIONS: This survey shows interesting differences in real-world use of insulin pumps in 2 large markets, and suggests areas where insulin pumps and CGMs might be improved.