Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
|ClinicalTrials.gov Identifier: NCT01714505|
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Diabetes Assistant (DiAs)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: Experimental Involving Automated CTR
Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Device: Diabetes Assistant (DiAs)
A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work 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.
No Intervention: CGM-Augmented Insulin Pump Treatment
Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
- Safety, Low Blood Glucose Index (LBGI) [ Time Frame: 40 hours (x2 admissions) ]
The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in "risk space." Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes.
LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia.
- Safety, Frequency of Hypoglycemia [ Time Frame: 40 hours (x 2 admissions) ]Hypoglycemic episodes are defined as BG < 3.9mmol/L
- Efficacy, Time Spent in Target Range [ Time Frame: 40 hours (x2 admissions) ]Percentage of time in the target range of 3.9-10 mmol/L (70-180 mg/dL).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714505
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Boris P. Kovatchev, Ph.D.||University of Virginia|