diabetes
Conditions
Interventions
Prior to the start of the intervention period, the patients must attend an
instruction day at a central location. This training will be given by trained
personnel from Inreda Diabetic BV, simultaneo
industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally
controlling plasma glucose levels. This BIHAP contains of two pumps for
subcutaneous infusion of either insulin or glucagon via a
Accu-Chek Instant, Roche) are needed for calibration of the glucose
sensors. The BIHAP-system has to be worn continuously, except while showering.
During the control period of the trial, patients wi
Sponsors
Amsterdam UMC
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 hypogycemia; Total pancreatectomy performed within less than 3 months before start of trial; BMI >35kg/m2; HbA1c > 97 mmol/mol; Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handling over diabetes control to a device or use of a medication that could comprise the results of the study or the safety of the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the percentage of time spent in the normal glucose range, defined as sensor glucose values within 70 to 180 mg/dl (3.9 to 10 mmol/l). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean sensor glucose concentrations; - Glycemic variability; coefficient of variation and standard deviation - Day and night time spent in hypo-, hyper- and euglycemia; - Day and night median glucose concentration; - Daily insulin and glucagon use; - Mean HbA1c and percentage of patients achieving HbA1c | — |
Countries
Netherlands
Outcome results
None listed