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.

U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod

Type 2 Diabetes

Insulin Resistance

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.

U-500 Insulin delivered by Omnipod (disposable insulin pump)

A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens

HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.

Director of Research, Principal Investigator

For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.

Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.

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

Mountain Diabetes and Endocrine Center

Subjects will be assessed for adverse events at each study visit and will report serious adverse events via the 24 hour contact number.

All Subjects Active

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Small sample size. Also an uncontrolled pilot study.

Dr. Wendy Lane, Director of Clinical Research

All Subjects Using U-500 Regular Insulin Via Omnipod

Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)

All Subjects

Percentage of Time Spent in Hypoglycemia

All subjects will receive the IDRSQ at baseline and at Week 52

U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?