Glucose Counterregulation in Long Standing Type 1 Diabetes
We are in the final phase of this study and are searching for a Hypo-AWARE Type 1 diabetic control group (Group 2) The primary goal for Group 2 in this study is to show us how hormones of Type 1 diabetics should react during hypoglycemic and non-hypoglycemic events.
The present protocol is designed to determine whether strict hypoglycemia avoidance by real-time continuous glucose monitoring (RT-CGM), can restore endogenous glucose production in response to hypoglycemia in patients with long standing disease. Twelve subjects with long standing type 1 diabetes complicated by hypoglycemia unawareness underwent assessment of the endogenous glucose production response to insulin-induced hypoglycemia using paired hyper-insulinemic eu- and hypoglycemic clamps with stable glucose isotope infusions before and at 6 and 18 months following initiation of RT-CGM. The primary analysis will be change in the endogenous glucose production response from before to 6 months following initiation of RT-CGM, and a secondary analysis will consider the persistence of any change at 18 months. The clinical significance of any determined changes in the endogenous glucose production response to insulin-induced hypoglycemia will be determined by comparison to responses obtained using paired hyper-insulinemic eu- and hypoglycemic clamps on one occasion in a matched control group of 12 subjects with long-standing type 1 diabetes but no hypoglycemia unawareness, and in a matched control group of 12 non-diabetic subjects.
- Study Identifier: 814114