Glucose Counterregulation in Long Standing Type 1 Diabetes (PRIME)

Brief Description Of Study

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. Participants can be (on a pump or injections) and... 1. Are between the age of 25 and 65. 2. Have had T1D for at least of 10 years (and been on insulin for 10 years) 3. Are in a diabetes management program with an endocrinologist or diabetes specialist which includes approximately 3 visits per year. 4. Has some hypoglycemia but is always aware when blood glucoses occasionally go low. 5. Does not currently wear a CGM. 6. Has an HbA1c that is not greater than 10. 7. Has a BMI less than 30

Clinical Study Identifier: TBD

Detailed 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 About The Study

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.

Contact research investigator to learn more about this study by filling out the form below.


To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: Glucose Counterregulation in Long Standing Type 1 Diabetes (PRIME)
I am hoping to hear back from you and discuss details of the study

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