Conditions: Type 2 Diabetes Insulin Resistance
Keywords: Type 2 diabetes Insulin Resistance Continuous Subcutaneous Insulin Infusion U-500 Insulin Omnipod
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Detailed description:
Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.

Arms:
arm 1: All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.

Interventions: intervention 1: U-500 Insulin delivered by Omnipod (disposable insulin pump)
Intervention descriptions: intervention 1: U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs

Protocol document: