Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT01945060
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
Sponsor:
Marc Breton
Organization:
Study Overview
Official Title:
Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if the heart rate informed Control To Range (hrCTR) can improve the performance of the system during and immediately after exercise.
Detailed Description:
The artificial pancreas (AP), known as Closed-Loop Control of blood glucose in diabetes, is a system combining a continuous glucose monitor (glucose sensor), a control algorithm (complex mathematical formulas), and an insulin pump. The algorithms are intended to maintain your blood glucose level within a certain range. This is called Control-to-Range. The algorithms are intended to maintain your blood glucose level within a certain range. The algorithms run on a portable AP platform on an Android smart phone, called the Diabetes Assistant (DiAs) Medical Platform.
In this study, researchers hypothesize that the heart rate informed Control To Range (hrCTR) will limit the risk for hypo and hyperglycemia during and immediately after exercise in adolescents 12 - 17 years of age and assess if the hrCTR will improve additional measures of overall short term glycemic control in this population.
This trial will be performed at both Virginia Commonwealth University and the University of Virginia. IRB approvals have been obtained at both institutions.
In this study, researchers hypothesize that the heart rate informed Control To Range (hrCTR) will limit the risk for hypo and hyperglycemia during and immediately after exercise in adolescents 12 - 17 years of age and assess if the hrCTR will improve additional measures of overall short term glycemic control in this population.
This trial will be performed at both Virginia Commonwealth University and the University of Virginia. IRB approvals have been obtained at both institutions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 17-2013-498 | OTHER_GRANT | JDRF | View |