NCT01945060

Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Marc Breton · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	heart rate Control to Range System (hrCTR) using DiAs Platform	Diabetes Assistant (DiAs) Medical Platform System * A smart-phone medical platform (DiAs); * Continuous Glucose Monitor; * Insulin pump; * Bluetooth connection; * Remote Monitoring Server.
OTHER	DiAs Control-to-Range System not informed for heart rate	Not informing system of heart rate during exercise.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-09-18
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

2 sites across 1 country: United States