diabetes
Conditions
Interventions
The intervention consists of the regulation of plasma glucose by means of the
artificial pancreas. The three treatment arms are: 1. closed loop with the
algorithm from Cambridge 2. closed loop with
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: aged 18 years or above diagnosed with Type 1 diabetes mellitus at least 6 months according to the WHO definition Body Mass Index (BMI)
Exclusion criteria
Exclusion criteria: Patient is pregnant, or breast feeding during the period of the study Symptomatic coronary artery disease Patient is using a medication that significantly impacts glucose metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent in target range; this is defined as plasma glucose values between 3.9 and 8.0 mmol/L in the basal or late postprandial state (more than 3 hours after breakfast, lunch and dinner) and plasma glucose values between 3.9 and 10.0 mmol/L in the early postprandial state (first 3 hours after breakfast, lunch and dinner). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Time spent in hypoglycaemia defined as plasma glucose value 8 mmol/l in the basal or late postprandial state and >10 mmol/l in the early postprandial state * Mean and standard deviation of plasma glucose * Time spent in target range defined as CGM glucose values between 3.9 and 8.0 mmol/L in the basal or late postprandial state and CGM glucose values between 3.9 and 10.0 mmol/L in the early postprandial state * Time spent in hypoglycaemia defined as CGM glucose value 8 mmol/l in the basal or late postprandial state and >10 mmol/l in the early postprandial state * Mean and standard deviation of CGM glucose values * Total number of insulin units infused * Median plasma insulin concentration * Total duration of treatment in minutes | — |
Countries
Netherlands
Outcome results
None listed