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New SkyCare - Type 2 Diabetes part: improvement and implementation study of virtual health care for patients with type 2 diabetes.

New SkyCare - Type 2 Diabetes part: improvement and implementation study of virtual health care for patients with type 2 diabetes. - SkyCare-T2D-imp

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57252
Enrollment
75
Registered
2021-11-18
Start date
2022-01-06
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult-onset diabetes type 2 diabetes

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime frame
see above

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)