Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation.
The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. The investigators think that if they take into account how quickly your blood sugar (glucose) is dropping we can stop your basal insulin from your pump for 2 hours and keep you from going low. The investigators hope that what they learn from this study can be used to set up communication between a continuous glucose monitor and an insulin pump. However, the investigators do not currently know the best way to do this.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Development of Algorithms for a Hypoglycemic Prevention Alarm|
- The prevention of nocturnal hypoglycemia defined as blood sugar less than 60 mg/dl. [ Time Frame: 7/2011 ] [ Designated as safety issue: Yes ]
- Blood sugar values above 180 mg/dl. [ Time Frame: 7/2011 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Predictive suspend
The intervention is using a predictive low glucose suspend algorithm to prevent nocturnal hypoglycemia using algorithm based on 'Medtronic Real Time Continuous Glucose monitor'
Device: Medtronic Real Time Continuous Glucose monitor
insulin pump delivery will be suspend when hypoglcyemia is predicted based on Medtronic real time continuous glucose monitor. Algorithym resides on a bedside computer
The study is expected to include a maximum of 80 people who have type 1 diabetes and are between the ages of 12 - 46 years old.
Your involvement in this research study is expected to take approximately 3-9 months depending on your decision to continue using the Navigator Continuous Glucose Monitor.
Each subject will have one enrollment visit of approximately 2 hours. You will then return for one or two 14 hour overnight hospital admissions in the Clinical Research Center (CRC). After the CRC visit(s) you will be given the option to continue using a Navigator CGM at home for an additional 13 weeks. If you decide to continue use of the Navigator you will be scheduled for an additional phone consult or visit to Stanford one week after your hospital admission. In addition, you will be required to return to Stanford for a final 13 week visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884611
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes, University of Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Bruce A. Buckingham||Stanford University|