Preferences of people with diabetes for diabetes care in Germany: a discrete choice experiment.

OBJECTIVES: The objective of this study is to elicit health care preferences of people with diabetes and identify classes of people with different preferences. METHODS: A discrete choice experiment was conducted among people with diabetes in Germany comprising attributes of role division in daily diabetes care planning, type of lifestyle education, support for correct medication intake, consultation frequency, emotional support, and time spent on self-management. A conditional logit model and a latent class model were used to elicit preferences toward diabetes care and analyze preference heterogeneity. RESULTS: A total of 76 people with diabetes, recruited in two specialized diabetes care centers in Germany (mean age 51.9 years, 37.3% women, 49.1% type 2 diabetes mellitus, 50.9% type 1 diabetes mellitus), completed the discrete choice experiment. The most important attributes were consultation frequency, division in daily diabetes care planning, and correct medication intake. The latent class model detected preference heterogeneity by identifying two latent classes which differ mainly with respect to lifestyle education and medication intake. CONCLUSION: While the majority of people with diabetes showed preferences in line with current health care provision in Germany, a relevant subgroup wished to strengthen lifestyle education and medication intake support with an aid or website.

Indications for the Postpartum Oral Glucose Tolerance Test.

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.

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.

Pregnancy Complications in Women With Pregestational and Gestational Diabetes Mellitus.

BACKGROUND: Diabetes mellitus (DM) is a major risk factor for complications of pregnancy. Based on information for all inpatient births in Germany, we assessed the risks for selected pregnancy complications in women with pregestational diabetes mellitus (preDM) or gestational diabetes mellitus (GDM). METHODS: The underlying data comprised all singleton births contained in the inpatient perinatal medicine quality assurance statistics for the years 2013-2019. The frequencies of premature birth, elevated birth weight (large for gestational age, LGA), cesarean section, transfer of the newborn to the perinatal unit, and stillbirth were stratified by maternal age and diabetes status (preDM, GDM, no DM). Poisson regression was used to calculate the relative risks (RR) with 95% confidence intervals (95% CI) for the whole period and for each individual year in women with preDM or GDM relative to women without DM. RESULTS: Among the 4 991 275 singleton births included, GDM was documented in 283 210 (5.7%) and preDM in 46 605 (0.93%) cases. GDM was associated with higher RR for premature birth (1.13 [1.12; 1.15]), LGA (1.57 [1.55; 1.58]), cesarean section (1.26 [1.25; 1.27]), and transfer of the newborn (1.54 [1.52; 1.55]). These associations were even stronger in women with preDM: premature birth (2.13 [2.08; 2.18]), LGA (2.72 [2.67; 2.77]), cesarean section (1.62 [1.60; 1.64]), transfer of the newborn (2.61 [2.56; 2.66]). PreDM increased the risk of stillbirth (RR: 2.34 [2.11; 2.59]); GDM was associated with a lower risk (RR: 0.67 [0.62; 0.72]). For women with preDM, the risk of pregnancy complications increased over the study period. CONCLUSION: GDM and preDM are still associated with elevated risks of pregnancy complications. In the case of preDM, the risks may be attributable to the fact that the hyperglycemia is more severe and is already present before conception. Continuous monitoring should include risk factors in pregnant women and care-relevant aspects.

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.

Study protocol for a mixed methods exploratory investigation of aftercare services for gestational diabetes in women to develop a new patient-centred model in Germany: the GestDiNa_basic study.

INTRODUCTION: Women with gestational diabetes mellitus (GDM) have a higher risk of developing type 2 diabetes mellitus compared with women who never had GDM. Consequently, the question of structured aftercare for GDM has emerged. In all probability, many women do not receive care according to the guidelines. In particular, the process and interaction between obstetrical, diabetic, gynaecological, paediatric and general practitioner care lacks clear definitions. Thus, our first goal is to analyse the current aftercare situation for women with GDM in Germany, for example, the participation rate in aftercare diabetes screening, as well as reasons and attitudes stated by healthcare providers to offer these services and by patients to participate (or not). Second, we want to develop an appropriate, effective and patient-centred care model. METHODS AND ANALYSIS: This is a population-based mixed methods study using both quantitative and qualitative research approaches. In various working packages, we evaluate data of the GestDiab register, of the Association of Statutory Health Insurance Physicians of North Rhine and the participating insurance companies (AOK Rheinland/Hamburg, BARMER, DAK Gesundheit, IKK classic, pronova BKK). In addition, quantitative (postal surveys) and qualitative (interviews) surveys will be conducted with randomly selected healthcare providers (diabetologists, gynaecologists, paediatricians and midwives) and affected women, to be subsequently analysed. All results will then be jointly examined and evaluated. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (Ethics Committee No.: 2019-738). Participants of the postal surveys and interviews will be informed in detail about the study and the use of data as well as the underlying data protection regulations before voluntarily participating. The study results will be disseminated through peer-reviewed journals, conferences and public information. TRIAL REGISTRATION NUMBER: DRKS00020283.

Gestational diabetes in Germany: Development of screening participation and prevalence.

Gestational diabetes mellitus (GDM) is an important risk factor for pregnancy complications. Since 2012, the Federal Joint Committee's maternity directive recommends a two-step screening for GDM with a pre-test and subsequent diagnostic test if the pre-test is positive. This study analyses the implementation and development over time of GDM screening participation and prevalence in Germany. The data basis is the external inpatient obstetrics quality assurance documentation, which covers all births in hospital. Women with diabetes before pregnancy were excluded. The study defined women as GDM cases if the condition was documented in maternity records or if the ICD-10 diagnosis O24.4 was coded for inpatients at discharge and figures were determined for the years 2013 to 2018. As the documentation of screening tests has only been included in the data set since 2016, screening participation for the years 2016 to 2018 were estimated and evaluated based on the pre-test and/or diagnostic tests documented in maternity records. In 2018, the majority of all women who gave birth in hospitals had had a pre-test conducted (65.0%) or a pre-test and diagnostic test (18.2%) in line with the two-step procedure. A further 6.7% received a diagnostic test alone. GDM screening participation increased over time from 83.4% in 2016 to 89.9% in 2018. The prevalence of a documented GDM increased from 4.6% to 6.8% between 2013 and 2018. In 2018, this equates to 51,318 women with GDM. Reliably assessing the extent and causes of this development will require continuous analyses of screening implementation, documentation and changes in maternal risk factors.

New prescription of antihyperglycemic agents among patients with diabetes in Germany: Moderate concordance between health insurance data and self-reports.

PURPOSE: To analyze the concordance of new prescription of antihyperglycemic agents between two data sources: patients' self-reports and statutory health insurance (SHI) data among patients with diabetes. METHODS: Within a cross-sectional study, 494 patients with diabetes were interviewed if and which new prescriptions of diabetes medication they received within the last 3 or 6 months. SHI data for 12 months were linked to cover these periods. For the agreement measurement, SHI data was set as reference, and kappa, positive predictive value (PPV), and sensitivity were calculated for single Anatomical Therapeutic Chemical (ATC) codes and cumulated code groups. RESULTS: The number of new prescriptions within 3 or 6 months was low, with 5.5% (n = 27) for Metformin/self-report being the highest. Contingency tables were unbalanced and showed large numbers in the no/no-cells. Regarding non-agreement, we found new prescriptions slightly more often in SHI data only than in self-reports only, with insulin and metformin representing an exception. Agreement results were moderate with large confidence intervals (CI). The values for cumulated "all drugs in diabetes" were: kappa = 0.58 (95% CI: 0.51-0.65), PPV = 62.0 (53.4-70.2), sensitivity = 55.6 (47.3-63.6). CONCLUSIONS: Patients reported a low number of new prescriptions within the last 3 or 6 months. In general we found moderate agreement and in case of non-agreement that self-report no/SHI yes was slightly more frequent than vice versa. These results were based on small case numbers, but could nevertheless be considered when collecting self-reported information on the prescription of antihyperglycemic agents.

DiaDigital Apps: Evaluation of Smartphone Apps Using a Quality Rating Methodology for Use by Patients and Diabetologists in Germany.

There are several computer applications (apps) that can be installed on smartphones to assist patients with diabetes in treating their disease. Not only does the range of use of such apps vary greatly, their quality does as well. As part of the DiaDigital initiative of the German Working Group for Diabetes Technology (AGDT), apps are evaluated using a set of criteria and a seal of distinction is then awarded ( www.diadigital.de ). The information collected in this review process is made public on this website to ensure both the necessary transparency as well as to be able to rapidly adapt voting on further app development. Until now, no such approach on evaluating the quality of diabetes apps has existed in Germany. The hope is that this will also help improve the quality of apps.

Regional differences in type 2 diabetes treatment and outcomes in Germany-An analysis of the German DPV and DIVE registries.

AIMS: On the basis of the Diabetes Versorgungs-Evaluation (DIVE) and Diabetes-Patienten-Verlaufsdokumentation (DPV) datasets, we aimed to explore the impact of differences in treatment modalities on outcomes in Germany and put these into a global context. METHODS: The 2014 to 2016 DIVE and DPV databases were combined, and a total of 127 838 patients 18 years and older was analysed with respect to demographics, cardiovascular risk factors, comorbidities, treatments, and outcomes, separately for each German state. Estimates were expressed as adjusted least squares means together with 95% confidence intervals. RESULTS: Saarland dataset recorded the lowest mean HbA1c (6.7%; 6.6%-6.8%; 50 mmol/mol, 49-51 mmol/mol), Saxony-Anhalt showed the highest (8.3%; 8.2%-8.3%; 67 mmol/mol, 66-67 mmol/mol). The highest percentage of hypoglycaemic events was reported in Mecklenburg-West Pomerania (MWP) (4.7%; 3.9%-5.7%), the lowest in Thuringia (0.9%; 0.2%-3.4%). Metformin and sulfonylurea accounted for 36.4% to 53.3% of anti-diabetic treatments across states; other antihyperglycaemic drugs such as DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 analogues were used most often in MWP (40.0%; 37.8%-42.1%) and least in Rhineland-Palatinate (13.6%; 13.0%-14.2%). Treatment with insulin (alone or in combination) was reported most often in MWP (78.2%; 76.4%-80.0%) and least in Thuringia (26.0%; 20.1%-32.9%). CONCLUSIONS: Federal states in Germany are heterogeneous concerning diabetes treatment and associated outcomes. These data should stimulate further discussion about how optimal diabetes care can be implemented in all areas of Germany, to achieve good treatment outcomes in all federal states.

Lipohypertrophic Skin Changes in Patients With Diabetes: Visualization by Infrared Images.

BACKGROUND: Many patients with diabetes on insulin therapy develop lipohypertrophies (LHTs). So far, LHTs are diagnosed by conventional methods (CM; visual inspection, palpation and/or ultrasound). In everyday life, it would be advantageous to have a quick, simple and inexpensive alternative, for example, diagnosing them by obtaining infrared (IR) images. METHODS: We obtained IR images from 43 subjects (21 patients with type 1 diabetes, conventional subcutaneous insulin therapy and known LHTs, 8 patients with CSII and LHTs, 7 patients without LHTs, and 7 healthy people), all from one specialized diabetes practice. The IR images were taken under standardized conditions with a high-resolution infrared camera (VarioCam® HDx Jenoptic, IR pixel 640 × 480, thermal resolution 0.003K) and compared with LHT diagnoses with CM. RESULTS: In 14 of the 29 (48%) patients, CM diagnosed LHTs were "cold spots" in the IR images. The temperature difference to "healthy" skin (without LHTs) was up to 6°C. Of the 14 patients, 11 also showed such spots, without findings with CM. Four patients did not show clearly identifiable cold spots as LHT and 2 patients showed no changes in the IR images. The remaining 9 patients did not show clearly identifiable cold spots as LHT, but the diagnosis with CM was also ambiguous. CONCLUSIONS: The results of this small (pilot) study do not clearly support the value of IR images for the diagnosis of LHTs, but they do not refute this approach. Diagnosis of LHT might be hampered due to the existence of different types of LHTs. Usage of IR images can apparently detect LHTs before they can be diagnosed with CM. Further targeted investigations are required to make statements about the usability of this method.

How do patients with diabetes report their comorbidities? Comparison with administrative data.

AIMS: Patients with diabetes are probably often unaware of their comorbidities. We estimated agreement between self-reported comorbidities and administrative data. METHODS: In a random sample of 464 diabetes patients, data from a questionnaire asking about the presence of 14 comorbidities closely related to diabetes were individually linked with statutory health insurance data. RESULTS: Specificities were >97%, except cardiac insufficiency (94.5%), eye diseases (93.8%), peripheral arterial disease (92.6%), hypertension (90.9%), and peripheral neuropathy (85.8%). Sensitivities were <60%, except amputation (100%), hypertension (83.1%), and myocardial infarction (67.2%). A few positive predictive values were >90% (hypertension, myocardial infarction, and eye disease), and six were below 70%. Six negative predictive values were >90%, and two <70% (hypertension and eye disease). Total agreement was between 42.7% (eye disease) and 100% (dialysis and amputation). Overall, substantial agreement was observed for three morbidities (kappa 0.61-0.80: hypertension, myocardial infarction, and amputation). Moderate agreement (kappa 0.41-0.60) was estimated for angina pectoris, heart failure, stroke, peripheral neuropathy, and kidney disease. Factors associated with agreement were the number of comorbidities, diabetes duration, age, sex, and education. CONCLUSIONS: Myocardial infarction and amputation were well reported by patients as comorbidities; eye diseases and foot ulceration rather poorly, particularly in older, male, or less educated patients. Patient information needs improving.

Measurement of psychological adjustment to diabetes with the diabetes acceptance scale.

AIMS: To develop a psychometric measure of diabetes acceptance. METHODS: An item pool was developed and pilot-tested using a sample of 220 people with diabetes; item selection resulted in the 20-item 'Diabetes Acceptance Scale (DAS)'. 606 people with diabetes were then cross-sectionally assessed with the DAS to evaluate its reliability, validity and clinical utility; concurrent measurements included diabetes-related coping (FQCI), diabetes distress (PAID-5), depressive symptoms (PHQ-9), quality of life (EQ-5D), self-management (DSMQ), glycaemic control (HbA1c) and complications. RESULTS: Internal reliability was high (Cronbach's α = 0.96). Factorial and criterion-related results supported validity. Higher diabetes acceptance scores correlated with more functional coping styles, lower distress and depression levels, higher treatment adherence, better glycaemic control and better quality of life (all P < .001). Persons with low diabetes acceptance (22% of the sample) were four times more likely to have HbA1c values over 9.0% (75 mmol/mol), two times more likely to be diagnosed with long-term complications and each over two times more likely to have had episodes of severe hypoglycaemia and ketoacidosis in the past year; the prevalence of major depression in this group was fivefold increased (all P < .05). CONCLUSIONS: The DAS is a reliable and valid tool to measure diabetes acceptance. It may help identify patients with significant problems of accepting diabetes, a putative high-risk group in need of tailored care and support.

[Which patients from routine care use the new insulin analogue glargine U300 compared to patients with glargine U100 : A multicenter analysis of 14,123 patients with insulin glargine from die diabetes registries DPV and DIVE]. / Welche Patienten aus der Routinebetreuung verwenden das neue Insulin-Analogon Glargin U300 im Vergleich zu Patienten mit Glargin U100? : Eine multizentrische Analyse von 14.123 Patienten mit Insulin Glargin aus den Diabetesregistern DPV und DIVE.

BACKGROUND: Glargine U300 (Gla-300) is a further development of glargine U100 (Gla-100). Since 2015, Gla-300 has been available in Germany and Austria. We compared patients initiating therapy with Gla-300 with patients starting with Gla-100. Moreover, it was investigated whether patients from real-life diabetes care differ from patients participating in the EDITION clinical study program. METHODS: Data are based on the diabetes registries DPV and DIVE. Patients started/switched to Gla-100 or Gla-300 in 2015 were included. Linear regression was applied for bodyweight (BW), BMI, HbA1C, daily total and basal insulin dose/kgBW and negative binomial regression for severe hypoglycemia. Data were adjusted for age, sex, and diabetes duration. RESULTS: 14,123 patients were identified (Gla-100: 11,397; Gla-300: 2726). Gla-300 patients with T1D were older, T2D patients younger compared to subjects using Gla-100 (both p < 0.0001). In Gla-300 subjects, diabetes duration was longer (both p < 0.0001). Patients started/switched to Gla-300 had a higher BW, a higher BMI and a lower baseline HbA1C. The rate of severe hypoglycemia was comparable. Total and basal insulin doses/kgBW were higher in patients with Gla-300. DPV/DIVE subjects were older, had a lower BW, and were more frequently male compared to EDITION patients. HbA1C was higher in T1D patients from DPV/DIVE. CONCLUSION: Data from the diabetes registries DPV/DIVE indicate differences between Gla-300 and Gla-100 patients at the onset of insulin therapy. This analysis provides additional information to the EDITION clinical study program.

Selecting and defining indicators for diabetes surveillance in Germany.

Mainly because of the large number of people affected and associated significant health policy implications, the Robert Koch Institute (RKI) is developing a public health surveillance system using diabetes as an example. In a first step to ensure long-term and comparable data collection and establish efficient surveillance structures, the RKI has defined a set of relevant indicators for diabetes surveillance. An extensive review of the available literature followed by a structured process of consensus provided the basis for a harmonised set of 30 core and 10 supplementary indicators. They correspond to the following four fields of activity: (1) reducing diabetes risk, (2) improving diabetes early detection and treatment, (3) reducing diabetes complications, (4) reducing the disease burden and overall costs of the disease. In future, in addition to the primary data provided by RKI health monitoring diabetes surveillance needs to also consider the results from secondary data sources. Currently, barriers to accessing this data remain, which will have to be overcome, and gaps in the data closed. The RKI intentends to continuously update this set of indicators and at some point apply it also to further chronic diseases with high public health relevance.