Diabetes
Conditions
Interventions
The intervention is one week closed loop control of blood glucose with the
miniaturized prototype after a training period of 4-6 days. The prototype uses
two subcutaneous glucose sensors, two subcut
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients who underwent total pancreatectomy; Age *18 years.
Exclusion criteria
Exclusion criteria: Impaired awareness of hypoglycemia; Total pancreatectomy performed within less than 3 months before start of trial; BMI > 35 kg/m2; HbA1c > 90 mmol/mol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the percentage of time spent in the target range (3.9-10 mmol/L) which will be compared between open and closed loop. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are: - The proportion of time spent in hypoglycemia and hyperglycemia; - Median glucose concentration; - Glycemic variability; - Day and night median glucose concentration; - Day and night time spent in hypo-, hyper-, and euglycemia; - Percentage of time that the closed loop algorithm is active; - Mean absolute relative difference for the glucose sensor of the closed loop system. | — |
Countries
Netherlands
Outcome results
None listed