Closed Loop System With Pramlintide Versus Exenatide (Closedloop)
Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting insulin therapy. Furthermore, this occurs even in the setting of the closed loop system. Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes, there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial hyperglycemia in diabetes. With this protocol, the investigators would like to optimize treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the process also optimize the insulin algorithm.
This is a paired, randomized, and controlled comparison of pramlintide and insulin versus exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin delivery.
The investigators will stratify the study subjects into the following sub-groups of 5 subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old. The investigators would also begin the study with the 21-25 year patient sub-group and then transition to the other sub-groups after evaluating all the safety issues. 22-30 year old ones would be considered as an adult subset, 18-21 year olds would be considered pediatric subset according to the guidelines of FDA's Center for Devices and Radiological Health (CDRH) and 16-18 year olds are considered typical pediatric population. At this time, Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not have any literature in Spanish that may used in explaining the study to this group of patients. When in the future Medtronic is able to provide us with the appropriate Spanish literature, the investigators will at that time amend the protocol to include this group of subjects.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CLOSED LOOP SYSTEM IN TYPE 1 DIABETES MANAGEMENT COMPARISON WITH PRAMLINTIDE Vs EXENATIDE|
- Better meal and post meal sugars on the closed loop device using the study medications. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]We will assess the preliminary data collected from the subjects enrolled by that time
|Study Start Date:||December 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Device: Medtronic ePID 2.0
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269008
|United States, New York|
|Albert Einstein College of Medicine CRC|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Rubina A Heptulla, MD||Albert Einstein College of Medicine of Yeshiva University|