NCT01582139

Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) 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 information about heart rate can help the AP Platform reduce hypoglycemia related to exercise.

Detailed description

The combination of the Control to Range system and the cell phone is called the "Artificial Pancreas (AP) Platform". The purpose of this study is to see if this investigational technology can help control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy can be successfully used and supervised in a hospital setting. This study is also being done to see if giving information about heart rate to the Closed-to-Range System can reduce hypoglycemia as it relates to exercise. Subjects will exercise on an exercise bike in the clinical research unit. During one exercise testing session, the Closed-to-Range System will receive information about your heart rate (Experimental Condition). During the other exercise testing session, the Control to Range System will not receive information about your heart rate (Control Condition). This part of the study is being done to see whether heart rate information helps the Closed-to-Range System reduce the occurrences of exercise-related hypoglycemia. The Closed-to-Range system has two parts (modules) that can work together or separately. A. The Safety Supervision Module (SSM) helps to prevent low blood sugars. It can reduce the amount of basal insulin that the pump is delivering and alert you if carbohydrates are needed to help prevent a low blood sugar. This module will be active at all times during the operation of the Closed-to-Range System. B. The Hyperglycemia Mitigation Module (HMM) helps to prevent high blood sugars. It can instruct the insulin pump to deliver small boluses to help prevent high blood sugar. It can also help warn you of a possible pump problem if the blood sugar level is not responding to the insulin as it should. The Closed-to-Range System works with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL) during the day and help avoid hypoglycemia during the night.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Heart rate informed SSM+HMM	The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-04-20
• Last updated: 2014-08-15
• Results posted: 2014-08-15

Locations

1 site across 1 country: United States