Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)
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|ClinicalTrials.gov Identifier: NCT01727817|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Diabetes Assistant (DiAs)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 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 :||January 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 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. Subjects 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. Subjects 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. Subjects will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
- Effect size of Control-to-Range (CTR) vs. Continuous Glucose Monitor (CGM)-augmented insulin pump treatment in an outpatient setting. [ Time Frame: 40 hours ]The investigators expect that compared to CGM-augmented insulin pump treatment, CTR will result in moderate effect size of approximately 0.4, in terms of reduction of the overnight risk for hypoglycemia as measured by the Low Blood Glucose Index computed from retrofitted CGM data. This effect is not expected to be statistically significant with the anticipated sample size but will be used to inform power analysis for the subsequent multi-center trial of CTR at home.
- Time spent in target range [ Time Frame: 40 hours ]CTR will improve (non-significantly at the projected sample size of N=5 subjects/site) the time spent within the target range of 80-140 mg/dl overnight (computed from retrofitted CGM data) and will reduce the extent of postprandial glucose excursions during the day. These data will provide justification and design support for a subsequent larger multi-center trial of CTR at home.
- Patient comfort with the Diabetes Assistant (DiAs) user interface [ Time Frame: 40 hours ]Investigators want to ensure that subjects are comfortable using the cell phone to assess the current status of their diabetes management. Subjects will use the user guide as guidance on how to evaluate the DiAs' hypoglycemia and hyperglycemia warning lights, how to inform DiAs of carbohydrates consumed, and other important diabetes management issues.
- Reliability of DiAs remote monitoring [ Time Frame: 40 hours ]Assess the DiAs remote monitoring by medical personnel/technicians to confirm appropriate functioning outside of the hospital setting.
- Reliability of inter-device connections between DiAs and the CGM and between DiAs and the insulin pump. [ Time Frame: 40 hours ]Assess the functioning of the connections between DiAs, the continuous glucose sensor, and the insulin pump.
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): NCT01727817
|University of Padova|
|Padova, Italy, 35131|
|Principal Investigator:||Claudio Cobelli, Ph.D.||University of Padova|
|Study Director:||Boris P. Kovatchev, Ph.D.||University of Virginia|