E11
Conditions
Interventions
Group 1: Digital intervention "glykio" (therapy accompaniment) and standard care according to guidelines of the German Diabetes Society and disease management programme (DMP) guidelines
Group 2: Exclu
Sponsors
mementor DE GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -medically diagnosed T2DM according to ICD-10 (E11) -historical HbA1c value =7.0% - =11.0%, not older than 3 months -stable diabetes medication in the last three months -Internet access and computer/smartphone which are compatible with glykio -Ability to speak and read the German language -patients are able to participate fully in the clinical trial and comply with the requirements for participation
Exclusion criteria
Exclusion criteria: -Patient with home health care assisting with blood glucose monitoring or insulin administration -current or planned pregnancy during the study; breastfeeding women -steroid therapy within the last three months (not an exclusion criterion if used topically or inhaled less than five times per week) -cognitive impairment -alcohol and/or drug abuse (within the last six months) -uncontrolled hypertension (=200 mmHg at baseline) -participation in another clinical trial -current or recent (within the last six months) use of glycio -current or recent (within the last six months) participation in a lifestyle intervention programme (e.g. exercise or diet programme) -Patients using an insulin pump -Staff of mementor or other institution involved in the conduct/organisation/coordination/funding of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the average long-term blood glucose (HbA1c), which is measured by taking a blood sample at study inclusion (t0) and 12 weeks after the start of the intervention (t1). | — |
Secondary
| Measure | Time frame |
|---|---|
| A total of eight secondary endpoints are recorded: - The number of non-severe self-reported hypoglycaemic episodes, i.e. those that the test persons remember and for which the support of a healthcare professional was required, is recorded. The recording of self-reported hypoglycaemic episodes at time t0 and time t1 refers to the past 12 weeks (3 months). - The patients' blood pressure is recorded with the help of a blood pressure monitor at time t1 and t0. - The patients' body mass index (BMI) will be calculated from the patients' self-reported height and body weight at time t0 and t1. - Patients' waist-to-hip ratio (WHR) will be calculated from patients' self-reported hip and waist circumference data at time t0 and t1. - The patients' diabetes self-management at time t0 and t1 will be recorded. The endpoint is operationalised by the Diabetes Self-Management Questionnaire (DSMQ). - The patients' diabetes self-management behaviour at time t0 and t1 will be recorded. The endpoint will be operationalised by the Summary of Diabetes Self-Care Activities Measure (SDSCA) questionnaire. - The patients' problems related to diabetes at time t0 and t1 will be recorded. The endpoint will be operationalised by the Problem Areas in Diabetes (PAID) questionnaire. - The patients' health-related quality of life at time t0 and t1 will be recorded. The endpoint is operationalised by the Short Form-12 (SF-12) questionnaire. | — |
Countries
Germany
Contacts
Public ContactTobias; Wiesner;
MVZ Stoffwechselmedizin Leipzig;GREENBAY research GmbH
Outcome results
None listed