Total pancreatectomy after any indication
Conditions
Interventions
Sponsors
Amsterdam UMC (Academic Medical Center)
Eligibility
Inclusion criteria
Inclusion criteria: • Patients who underwent total pancreatectomy; • Diabetes treatment with continuous subcutaneous insulin infusion, sensor augmented pump therapy or subcutaneous insulin injections; • Age =18 years.
Exclusion criteria
Exclusion criteria: • Total pancreatectomy was performed within less than 3 months before start of the trial; • Impaired awareness of hypoglycemia (score = 4) according to Gold and/or Clarke questionnaire;11,12 • BMI > 35 kg/m2; • HbA1c > 90 mmol/mol; • Use of oral corticosteroids; • Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements; • Limited ability to see, and to hear or feel alarm signals of the closed loop system; • Refusal of disconnecting own glucose sensors during the closed loop system study period; • Pregnancy and/or breastfeeding; • Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily); • Any condition that the local investigator feels would interfere with study participation or the evaluation of the results. • Patients who are not motivated or not willing to comply with the artificial pancreas therapy; • Patients undergoing treatment with Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, X-ray or high frequency electrical heat (diathermy) treatment while wearing the AP system (must be removed); • Patients using the artificial pancreas system during sauna or swimming; • Known or suspected allergies or problems related to subcutaneous administration of insulin or glucagon; • Artificial pancreas therapy is not recommended for people who are unwilling or unable to maintain contact with their medical professional; • Alcohol and drug abusing patients; • Patients with insufficient general mental and physical abilities; • Known or suspected problems related to enzyme based glucose sensor usage; • Patients receiving dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of time spent in the target range (3.9-10 mmol/l), calculated the closed loop period (without the training period). | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety parameters are: The proportion of time spent in the following categories: • Hypoglycemia (10 mmol/l); • Hyperglycemia (>13.9 mmol/l). Secondary performance parameters are: • Median sensor glucose concentration; • Glycemic variability; • Day and night median sensor glucose concentration; • Day and night time spent in hypo-, hyper- and euglycemia. The day period is defined as the time between 6 AM and 12 PM, and the night period is defined as the time between 12 PM and 6 AM. Other secondary outcomes: • Percentage of time that the closed loop algorithm is active (closed loop period only). • Glucose measurement performance: absolute relative difference (ARD) for the paired SMBG-glucose sensor reading in the closed and open loop period. Only the 7-point glucose profile SMBGs will be used for this assessment. The mean (MARD) will be calculated with a MARD reliability index to assess the certainty of the MARD values. To compare the glucose sensors in the closed loop period the Precision Absolute Relative Difference (PARD) will be calculated. | — |
Contacts
Public ContactMarc Besselink
Amsterdam UMC, University of Amsterdam
Outcome results
None listed