E11
Conditions
Interventions
Group 1: Intervention group: 6-month use of Vitadio in addition to DMP standard diabetes care.
Group 2: Control group: Treatment according DMP standard diabetes care
Sponsors
Vitadio Health Technologies GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Type 2 diabetes patients benefitting from improved self-management • Patients not having used Vitadio in the past • Patients using/willing to use Vitadio as part of their diabetes management • HbA1c at baseline = 7.5 % and = 11.0 % • Patients with internet access and a computer and/or smartphone compatible with Vitadio • Digital literacy to use a smartphone adequately and willing to use it for their diabetes self-management • Sufficient understanding of user interface (UI) of Vitadio • Patients currently adjusting their diabetes management and lifestyle based on the self-testing of blood glucose at home • Participants willing and able to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures • Participants capable of giving personal signed informed consent
Exclusion criteria
Exclusion criteria: • Patients using other Apps for their diabetes management • Patients who have been using Vitadio in the past twelve months • Patients with impairments – including mental or psychic impairments – or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study • Patients under 18 years of age • Patients already using an insulin pump • Patients currently participating in a weight loss program • Steroid therapy within the last three months; topic or inhaled use is no exclusion criterion when not used regularly (more than five times a week) • Uncontrolled blood pressure = 200 mmHg at screening • Body mass index (BMI) > 40 kg/m² • Current pregnancy or pregnancy planned during the study, or breastfeeding women • Alcohol or drug abuse within the last three months • Patients with home health aides who assist with their BG testing and/or insulin adjustment • Current participation in another trial or study • Employees of Vitadio s. r. o., or any other institution carrying out the study or being involved in conducting/ organizing/ coordinating/ financing the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c during the use of Vitadio | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of patients reaching their HbA1c treatment goals < 7.0 % and < 6.5 % during the use of Vitadio • the number of non-severe hypoglycaemic episodes as determined by subjects’ recollection (i.e., requiring assistance from a HCP) • changes in motivation and patient self-management measured by the daily conducted blood glucose values and questionnaire PAID, PHQ-9, SDSCA, SF-12, WHO5 • changes in body weight, BMI and waist circumference • changes in blood pressure • changes in insulin dosing and medication • stereotypes of patients with either beneficial or not existing effect(s), i. e. patient groups, who achieve larger or smaller HbA1c changes associated with the use of Vitadio • the overall satisfaction of subjects and HCPs’ with Vitadio • the termination rate(s) (data from Vitadio • the usability and overall satisfaction and of patients with Vitadio (Patients Usability questionnaire and HCP questionnaire) | — |
Countries
Germany
Contacts
Public ContactPeter Schwarz
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Medizinische Klinik III, Abteilung Prävention und Versorgung des Diabetes
Outcome results
None listed