Evaluation of the impact of ESYSTA® on HbA1c in patients with type 1 and type 2 diabetes mellitus in daily practice - DAVOS

Emperra GmbH E-Health Technologies0 个研究点目标入组 154 人开始时间: 2022年4月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Diabetes mellitus type 1 or type 2
•- Treated with insulin
•- HbA1c at baseline = 7.5% and = 11.0%.
•- No use of ESYSTA® in the past 12 months.
•- Willingness to use a smart glucometer and/or smart insulin pen
•- Internet access, smartphone/computer compatible with ESYSTA®.
•- Digital literacy for sufficient understanding of the user interface (ESYSTA®).

•- Use of other apps connected to a blood glucose meter or use of an insulin pump or continuous glucose monitoring
•- Use of ESYSTA® in the past 12 months
•- Impairments (including mental impairments)
•- Current participation in a weight loss program
•- Current participation in another study
•- Steroid therapy within the last three months (not an exclusion criterion if used topically or inhaled less than five times per week)
•- Blood pressure = 200 mmHg at screening
•- Body mass index (BMI) = 40 kg/m²
•- Anemia (as defined by WHO)
•- Glomerular filtration rate (GFR) = 40 ml/min
•- Current or planned pregnancy, breastfeeding women
•- Alcohol or drug abuse (within the last three months)
•- Patients with home care (assistance with BG measurement)
•- Employees of Emperra GmbH E-Health Technologies (or other institutions involved in the study in any way)

发起方

Emperra GmbH E-Health Technologies