Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of FGM

The incidence of gestational diabetes mellitus (GDM), defined as a glucose tolerance disorder diagnosed for the first time during pregnancy, is steadily increasing, reaching 8.58 % in Germany in 2019, according to figures from the Institute for Quality Assurance and Transparency in Health Care (IQTIG). Standardized guideline-compliant treatment has significantly reduced the rate of perinatal complications for both mother and child. A central component of management is the adjustment of blood glucose levels to the specified target values. To date, patients' glucose levels have been determined by blood self-measurement (SMBG) in accordance with guidelines. The diagnosis of GDM and the subsequent management is perceived by the patients as an enormous burden, especially because of the self-measurement, which is perceived as time-consuming, painful and stigmatizing. Since 2017, the Flash Glucose Monitoring (FGM) has been approved for use in the care of pregnant diabetic women. Its use by gestational diabetics is critically discussed. To date, there is a lack of systematically collected data on the use of FGM in the care of GDM patients that would justify its routine use. The aim of the pilot project planned here is to investigate the influence of FGM on patient satisfaction and adherence to therapy. The investigators hypothesize that the use of the FGM relieves the affected women decisively and mediated by biofeedback leads to more therapy adherence. These data will be used to plan a multicenter study. At the Competence Center for Diabetes and Pregnancy of the University Hospital Jena, 100 women diagnosed with GDM will be included in a randomized controlled trial and will be treated with either FGM (n = 50) or SMBG (n = 50) and followed up according to the guidelines. The primary endpoint is the assessment of treatment satisfaction and adherence using the following measures: step count, physical activity (IPAQ), food error count and weight gain. In order to meet the principle "In the sense of a patient-centered individual therapy, the affected persons should be involved in the decision for or against a glucose monitoring system" of the Association of Diabetes Counseling and Training Professions in Germany (VDBD), the aim of our project is to create a data basis for this.