Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06346366
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Age ≥18 years
* Insulin dependent diabetes after total pancreatectomy (patients who previously participated in APPEL 5+ are allowed to be included)
* At least three months after total pancreatectomy
* Patients using flash or continuous glucose sensor (Free Style Libre, Guardian or Medtronic) ,willing to scan this sensor at least three times per day during the control period and to remove this sensor during BIHAP treatment
* Undergoing treatment with CSII or subcutaneous insulin injections.
Exclusion Criteria:
* Known or suspected allergy to trial product(s) or related products;
* Suboptimal clinical condition, for instance due to active postoperative surgical complications, including skin condition prohibiting needle insertion;
* Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment;
* Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening for other clinical trial related purposes;
* Current treatment with chemotherapy or when used less than 3 months prior to screening;
* BMI \> 35 kg/m2;
* HbA1c \> 97 mmol/ml (=11.0 %);
* Use of oral glucose-lowering medication;
* Limited ability to see, and to hear or feel alarms signals of the BIHAP;
* Use of acetaminophen (paracetamol) during the use of the BIHAP, as this may influence the sensor glucose measurements.
* Current pregnancy, breast feeding or planning to become pregnant during the trial or using ineffective birth control methods;
* Patients with a concomitant disease affecting metabolic control;
* Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06346366
Study Brief:
Protocol Section:
NCT06346366