Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes Type 1 Diabetes Mellitus Type 1 Diabetes T1DM Continuous Subcutaneous Insulin Infusion (CSII) CSII Insulin pump Insulin rHuPH20 Hylenex recombinant human hyaluronidase (rHuPH20) Recombinant hyaluronidase
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 14
Healthy volunteers: no

Brief summary:
The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).

Detailed description:
There is a recognized need for more rapid insulin action than is available from current rapid-acting analog products. In addition, current products have inconstant absorption and action profiles over the course of infusion set life. Previous human studies of prandial insulin preparations have used co-mixtures of rHuPH20 (study drug) with insulin delivered to study participants by subcutaneous injection and have demonstrated acceleration of insulin absorption and action. CSII has been used clinically for the treatment of diabetes over the last three decades, and a previous study using a co-mixture of rHuPH20 during CSII showed that the combination resulted in a more consistent and ultrafast profile of insulin absorption and action across infusion set use as compared to rapid analog insulin alone.

Arms:
arm 1: Comparing the preadministration of Hylenex recombinant in the setting of continuous subcutaneous insulin infusion (CSII). arm 2: Comparing the preadministration of a sham injection in the setting of CSII.

Interventions: intervention 1: Rapid Acting insulin with pre-treatment of rHuPH20 intervention 2: Sham injection
Intervention descriptions: intervention 1: Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area. intervention 2: A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Protocol document: