Evaluation of the Digital Health Application glucura in the treatment of Diabetes mellitus Type 2.A randomized controlled trial over a period of 6 months - Metabolic III

Perfood GmbH0 个研究点目标入组 650 人开始时间: 2023年10月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients with T2DM (m/f/d) aged 18 years and older according to the ICD-10 code E11.-.
•- Participation in DMP T2DM, for at least 3 months before inclusion
•- HbA1c = 7.0 % (53 mmol/mol) and = 11,0 % (96,7 mmol/mol) at last routine clinical examination
•- Body mass index (BMI) = 25 kg/m²
•- Weight stable over the last 3 months (± 5 %)
•- Diabetes-specific medication stable over the last 3 months
•- Digital literacy to adequately use a smartphone and willingness to make lifestyle changes according to the given dietary recommendations

•- Current treatment with insulin
•- Bariatric surgery in the past
•- Existing or planned treatment with steroids during the intervention phase (topical, inhaled application and long-term use at low doses is not an exclusion criterion). The decisive factor is that the HbA1c value must not be influenced by this.
•- Pregnancy and breastfeeding (according to patient information)
•- Current or planned participation in another interventional clinical trial
•- Past use of the investigational product glucura
•- Current participation in a therapeutically effective program
•or use of a DiGA for weight reduction (does not apply to grade III obesity - see below for explanation) / use of another DiGA for diabetes management
•- Severe impairment (including mental or psychological impairment) that would hinder participation in the study according to the investigator's opinion and compromise the data integrity of the study
•- Lack of capacity to give informed consent
•In patients with grade III obesity (BMI = 40 kg/m2), adequate obesity therapy is permitted in parallel, but must have been stable for at least three months at the time of inclusion.

发起方

Perfood GmbH