Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable Closed Loop format in patients after Total Pancreatectomy

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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

•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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of time spent in the target range (3.9-10 mmol/l), calculated the closed loop period (without the training period).

Secondary Outcome Measures

Name	Time	Method

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