An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro… (NCT02064309) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
An Open Label, Pilot Investigation, to Assess the Safety and Efficacy of Transplantation of Macro-encapsulated Human Islets Within the Bioartificial Pancreas Beta-Air in Patients With Type 1 Diabetes Mellitus
Sweden4 participantsStarted 2014-02
Plain-language summary
The primary objective of this clinical investigation is to investigate the safety of implantation of the human islet containing device Beta-Air in type 1 diabetic subjects.
The secondary objective of this clinical investigation is to investigate if the transplantation of macro-encapsulated human islets within the Beta-Air device can provide improved glycaemic control in type 1 diabetes patients with reduced incidences of hypoglycaemic episodes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Informed consent obtained before any investigation-related activities. Investigation-related activities are any procedure that would not have been performed during normal management of the subject.
✓. Diagnosis of type 1 diabetes mellitus for \> 5 years
✓. Men or women \> 18 years of age at the time of enrolment
✓. Involvement in intensive diabetes management defined as self-monitoring of blood glucose level no less than a mean of three times per day averaged over each week and by the administration of three or more insulin injections per day or insulin pump therapy. This management must be under the direction of a diabetologist or diabetes specialist during the 12 months prior to study enrolment.
Exclusion criteria
✕. Body mass index (BMI) \> 30 kg/m²
✕. Insulin requirement of \> 1.0 Units/kg/day
✕. HbA1c \> 10 % (DCCT)
✕. Random C-peptide \> 0.003 nmol/l
✕
What they're measuring
1
Safety of device, as evaluated by incidence of adverse events or serious adverse events judged probable or highly probable related to the device
✕. Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or unwilling to use adequate contraceptive methods for the duration of the trial (implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner).
✕. Active infection including hepatitis B, hepatitis C, HIV, Tbc