Angie01
An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Treatment in Adults With Type 2 Diabetes on Non-insulin Glucose-lowering Agents
Sponsor study identifier
interventional
16
1 country
1
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)The main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied as it is representative of patients with glucose dysregulation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 19, 2011
Actual (reported)May 24, 2011
Actual (reported)November 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 2012
Actual (reported)July 2012
Actual (reported)Percent of plasma glucose values within target range 3.9-8.0 mmol/l
24 hrs
Percent of sensor glucose values within target range 3.9-8.0 mmol/l
24 hrs
Percent of plasma and sensor glucose values below 3.9 mmol/l
24 hrs
Percent of plasma and sensor glucose values above 8.0 mmol/l
24 hrs
Mean plasma and sensor glucose
24 hrs
Mean plasma insulin concentration
24 hrs
Subcutaneous insulin delivery adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
Usual non-insulin glucose-lowering medications
Insulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
Usual non-insulin glucose lowering medications
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, CB20QQ, United Kingdom
Roman Hovorka, PhD
University of Cambridge
16 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2011
First Posted
May 24, 2011
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
November 12, 2012
Record last verified: 2012-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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