Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT01939834|
Recruitment Status : Terminated (Subjects preferred the 5 night overnight system in terms of ease of use.)
First Posted : September 11, 2013
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: AAA control Other: CGM + insulin pump at home||Not Applicable|
The primary goal of this study is to test an Advisory/Automated Adaptive (AAA) Control system, which includes three interacting control modules:
- Module 1 - Automated Safety Supervision (SSM) responsible for prevention of hypoglycemia, which can be adapted (individualized) with prior data for each subject;
- Module 2 - Advisory Module (AM) responsible for pre-meal boluses and postprandial corrections, which can be adapted (individualized) with prior data for each subject;
- Module 3 -- Automated Basal Rate Module (BRM) responsible for augmentation of basal rate to compensate for changes in insulin sensitivity, particularly overnight (e.g. dawn phenomenon), which can be adapted with prior data for each subject.
Daytime control (40hour studies) includes all 3 modules (n=36). Overnight only closed loop control (5 consecutive overnights) includes Module 1 and 3 (n=5-7).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: AAA Control
Subjects will use their home insulin pump along with a continuous glucose monitor (CGM) receiver. A CGM will be worn for 7 days prior to the study admission. Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal.
Subjects will be asked to provide the study team their insulin pump data on Day 2 or 3 to ensure accuracy of data collection. Subjects will be asked to submit insulin pump, glucometer, and CGM data 1-2 days prior to their admission and again the evening prior to the study admission at a Research House.
During the Experimental Admission, the AAA system will be tested using the DiAs platform. Subjects will participate in 45 minutes of exercise during the 40 hour admission (n=36). A subset (n=5-7) will continue with 5 nights of consecutive closed loop control (23:00-07:00).
Device: AAA control
AAA control is a method to determine insulin dosing to keep glucose in range. AAA control is run on the DiAs which is a medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump. The cell phone runs the AAA control and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range.
AAA control will be tested in 40 hours sessions and 5 consecutive overnight sessions.
Active Comparator: CGM + insulin pump at home
The experimental and control admissions (40hr admissions) are exactly the same except for the study admission. During the Control Admission, subjects will use their home insulin pump along with a continuous glucose monitor receiver without running any specialized mathematical equations.
The active comparator for subjects participating in 5 consecutive nights of closed loop control will be the sensor-augmented pump therapy at home.
Other: CGM + insulin pump at home
The subject will be on their home insulin pump and using a CGM per their usual care.
- Evaluating the risk for hypoglycemia as measured by the Low Blood Glucose Index [ Time Frame: 40 hours ]Primary goal is to evaluate the ability of the AAA Control to prevent hypoglycemia with the outcome measure of Low Blood Glucose Index.
- Time in range overnight [ Time Frame: 5 consecutive nights ]For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.
- Time within target range [ Time Frame: 40 hours ]Closed loop control will improve the time spent within the target range of 70-180 mg/dl (computed from retrofitted CGM data).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939834
|United States, Virginia|
|University of Virginia Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Sue Brown, MD||University of Virginia Center for Diabetes Technology|