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Clinical Islet Transplantation Study (CIT)

          Inclusion Criteria
    Patients who meet all of the following criteria are eligible for participation in the study:

    1. Male and female patients age 18 to 65 years of age.
    2. Ability to provide written informed consent.
    3. Mentally stable and able to comply with the procedures of the study protocol.
    4. Clinical history compatible with T1D with onset of disease at < 40 years of age, insulin-dependence for ≥ 5 years at the time of enrollment, and a sum of patient age and insulin dependent diabetes duration of ≥ 28.
    5. Absent stimulated c-peptide (<0.3ng/mL) in response to a mixed meal tolerance test (MMTT; BoostŪ 6 mL/kg body weight to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be substituted for BoostŪ) measured at 60 and 90 min after the start of consumption.
    6. Involvement in intensive diabetes management defined as self monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or insulin pump therapy. Such management must be under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least 3 clinical evaluations during the 12 months prior to study enrollment.

    7. At least one episode of severe hypoglycemia in the 12 months prior to study enrollment.
    8. Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR a HYPO score greater than or equal to the 90th percentile (1047) during the screening period and within the last 6 months prior to randomization;

      OR

      Marked glycemic lability characterized by wide swings in blood glucose despite optimal diabetes therapy and defined by an LI score greater than or equal to the 90th percentile (433 mmol/L2/h•wk-1) during the screening period and within the last 6 months prior to randomization;

      OR

      A composite of a Clarke score of 4 or more and a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than or equal to the 75th percentile (329) during the screening period and within the last 6 months prior to randomization.
          Exclusion Criteria
    Patients who meet any of these criteria are not eligible for participation in the study:

    1. Body mass index (BMI) >30 kg/m2 or patient weight ?50kg.

    2. Insulin requirement of >1.0 IU/kg/day or <15 U/day.

    3. HbA1c >10%.

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