Closed Loop System With Pramlintide Versus Exenatide
Public ClinicalTrials.gov record NCT01269008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CLOSED LOOP SYSTEM IN TYPE 1 DIABETES MANAGEMENT COMPARISON WITH PRAMLINTIDE Vs EXENATIDE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01269008
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 13 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 30 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- Dec 31, 2012
- Completion
- Dec 31, 2012
- Last update posted
- Feb 19, 2018
2010 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Albert Einstein College of Medicine CRC | The Bronx | New York | 10461 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01269008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01269008 live on ClinicalTrials.gov.