diabetes
Conditions
Interventions
This pilot study entails a hotel design targeting adults with T1D that are
experienced insulin pump users. Subjects will spend two nights in a local
hotel, during which the phone-based system will b
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: aged 21 years or older Diagnosed with type 1 diabetes mellitus use of an insulin pump for at least 1 year HbA1c between 6.0% and 9.0%
Exclusion criteria
Exclusion criteria: Diabetic Ketoacidosis within the last 6 months Severe hypoglycaemia within the last 12 months Pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the failure rates of system components, frequency of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/missing data records from our past in-clinic studies. | — |
Primary
| Measure | Time frame |
|---|---|
| The main endpoint will be the percent time the system is operative with all expected data from CGM, pump and patient manual inputs available on the Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation. | — |
Countries
Netherlands
Outcome results
None listed