E11
Conditions
Interventions
Group 1: Oviva Direkt Diabetes Typ 2 (app-based digital lifestyle intervention) + care as usual for 24 weeks
Group 2: care as usual for 24 weeks
Sponsors
Oviva AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of Type 2 Diabetes Mellitus (ICD-10 code E11) - Age minimum 18 years old - HbA1c value = 7.0% (53 mmol/mol) and = 10.5% (91 mmol/mol) - Diabetes specific medication stable (no additional new agents) over the last 2 months. Dose adjustments of existing medications are permitted if stable = 1 month - Willing and able to comply with all scheduled visits, laboratory tests, and other study procedures - Physical and mental ability to independently carry out behavioural changes and physical activity - Ability to use a smartphone or tablet - Availability of a smartphone with a compatible operating system for the Oviva Direkt App - Ability to speak and write in German - Ability to give informed consent to the study - Motivation for Behavioural Change
Exclusion criteria
Exclusion criteria: - Diagnosis of Type 1 Diabetes Mellitus - Current and ongoing multiple daily insulin injections or use of rapid-acting insulin via a pump (once or twice daily injections of long-acting insulin are accepted) - Significant weight loss over the last 3 months (>5%) - History of bariatric surgery - Cardiovascular event (e.g. myocardial infarction, severe heart failure) within the last 6 months - Active oncological treatment - Pregnant or breastfeeding - Individuals with severe, active psychiatric disease (e.g. eating disorder, alcohol or drug abuse) - Significant weight-altering medication changes within 3 months prior to screening (i.e., initiation/discontinuation of GLP-1 RAs or SGLT2s; any uptitration of GLP-1RAs dose) - Current or planned treatment with high-potency systemic corticosteroids - Unstable dose of thyroxine and/or TSH values not in normal range within last 6 months - Participating in another clinical trial of an investigational drug or device. - Current use of another digital lifestyle intervention to treat diabetes or obesity - Dependence on the sponsor or investigator (e.g. employees of the sponsor or a trial site and their family members) - Longer term absence or hospitalisation planned during planned period of study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change of HbA1c (%) from baseline to week 24, compared between the intervention and control group | — |
Secondary
| Measure | Time frame |
|---|---|
| - Improvement in Diabetes Self-Management scores from baseline to weeks 12 and 24, compared between the intervention and control group, measured through the Summary of Diabetes Self-Care Activities Assessment Tool (SDSCA-G) - Improvement in the Mental Component Summary (MCS) of the quality of life scores from baseline to week 24, compared between the intervention and control group, measured through the Short-Form-12 (SF-12) questionnaire | — |
Countries
Germany
Contacts
Public ContactDirk Müller-Wieland
Futuremeds GmbH
Outcome results
None listed