adult-onset diabetes type 2 diabetes
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Type 2 diabetes; • Stable chronic disease three months prior to inclusion; • Treated with diet and lifestyle, oral anti-diabetic medication, and/or subcutaneous anti-diabetic medication, including insulin; • Owns a smartphone (Android 7 or newer; IOS 11 or newer) and o is able to use apps in Dutch; o is able to receive push notifications; o is able to use Bluetooth Low Energy; o has access to a Wi-Fi connection at home. • Able to understand and decide on written informed consent in Dutch; • Able to perform activities of daily living (ADL) independently.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Treatment with subcutaneous insulin pump; • Female subject who is pregnant or breastfeeding or planning to become pregnant or breastfeed during the study; • Other types of diabetes mellitus; • Major health conditions: o liver, heart or lung transplant; o untreated cancer, current chemotherapy or radiotherapy; o acute infections, sepsis, or acute organ failure; o cystic fibrosis; o life expectancy less than one year; • Alcohol or other drug abuse or psychosis in the year prior to the study; • History of bariatric surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary and secondary study parameters/outcome of the study are: • To provide a reliable and easy-to-use platform for remote care, including the use of a medical service center with high accessibility, usability, acceptance and satisfaction of users. • To maintain stable regulation: HbA1c, blood pressure, and body weight. • To maintain adequate: health-related quality of life (PAID-5), patient activation (PAM-6), patient satisfaction. | — |
Secondary
| Measure | Time frame |
|---|---|
| see above | — |
Countries
Netherlands