type 1 diabetes type 1 diabetes
Conditions
Interventions
Interventie Cloudcare applicatie  
vs Groundcare (standaard behandeling) 
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Diagnosed with Type 1 Diabetes more than 12 months ago- age stratification: children (0-8 years , 8-12 years and 12-18 years) and adults > 18 years- starting Hba1c <8% / GMI <8% achieved by either Multiple Day Injections or MDI or insulin pump on stable CGM (FSL, Dexcom or Guardian/Simplera) use (at least 50% per group) .
Exclusion criteria
Exclusion criteria: hypo-unawareness / severe hypo (i.e. any hypo requiring third party assistance) < 6 monthsDKA (diabetes ketoacidosis) proneprevious cloudcare usePregnancy - Inability or unwillingness to work with online eHealth application. - Inability to read Dutch or unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Compare patient burden (clinic visit frequency and duration, hospitalizations) and HCP workload (time spent per patient) while maintaining good glycemic control (TIR >70%, HbA1c <7%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes:Wellbeing (WHO-5), diabetes distress (PAID-5), treatment satisfaction, perceived effectiveness.User-friendliness (Net Promoter Score, app logins, nurse vs doctor contact time).HCP satisfaction and costs effectiveness time spent on patients (QUALYs).Cost-effectiveness (number/duration of contacts, initiator, purpose).Lifestyle improvements (movement/sleep via Fitbit; diet logs every 1 week per every 3 months). | — |
Countries
Netherlands
Contacts
Public ContactD van Raalte
Amsterdam UMC
Outcome results
None listed