Glucose Counterregulation in Long Standing Type 1 Diabetes

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Study Overview

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. 

Study Description

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.

Additional Information:

In a "nutshell" we are comparing type 1 diabetics who experience severe unawareness (group 1) to two other groups: 1. Hypo AWARE Type 1 diabetics (group 2) 2. Non-diabetics. (group 3) Currently we are in the final phase of this study and are recruiting group 2. Enrollment is complete for group 1 and group 3. Participation requires a total of 3 visits within approximately 6 weeks. Visit 1 is a Screening visit. Visits 2 and 3 are Hyperinsulinemic clamps and require an overnight stay with an arrival time in the early evening prior to the testing day. 

Reimbursement for participation is $350.00 via check from the University of Pennsylvania. We will also give you cash at each visit to cover your parking or regional rail ticket.


  • Study Identifier: 814114

Recruitment Status

Open

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If you need assistance finding a non-cancer study or if you have any questions, please email psom-ocr@pobox.upenn.edu