A Phase 2 interventional study of Closed-loop and Conventional insulin pump delivery in Type 1 Diabetes Mellitus, sponsored by University of Cambridge. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-29.
Sponsored by University of Cambridge · Phase 2, Interventional, and Treatment
The main study objective is to compare real-time continuous subcutaneous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone in the home setting.
Achievement of tight glycaemic control in type 1 diabetes mellitus (T1D) using intensive insulin regimens, which has been shown to be important for the prevention of long term diabetes-related complications, is limited by a significantly increased risk of hypoglycaemia. The average patient with T1D suffers two symptomatic episodes of hypoglycaemia per week, and one episode of severe hypoglycaemia, defined as an event requiring assistance of another person to administer rescue treatment in the form of carbohydrate and/or glucagon, per year.Despite the rapid advancements in insulin pump technology and the ongoing development of more physiological insulin preparations, the currently available therapeutic regimens are still unable to achieve optimal glycaemic control.The emergence of continuous glucose monitoring (CGM) over the last decade, which enables users to view in real-time estimates of plasma glucose and receive alarms for impending hypo- or hyperglycaemia, thus facilitating appropriate changes in insulin therapy, is a major step towards improved diabetes monitoring.
The desirable goal is the development of an insulin delivery that is glucose responsive and the development of effective real time glucose monitoring should allow this. Glucose responsive insulin delivery should allow achievement of ideal glucose targets with less risk of hypoglycaemia. Closed-loop systems may provide a realistic treatment option for people with T1D. The research we are conducting at the University of Cambridge has been focused on developing a closed-loop system for overnight glucose control in patients with T1D. The studies that have been performed so far employ model predictive control (MPC) - this algorithm estimates patient-specific parameters from CGM measurements taken every 1 to 15 minutes and makes predictions of glucose excursions, which are then used to calculate basal insulin infusion rates. We hypothesize that overnight automated closed-loop glucose control in the home setting will be efficacious and safe compared to CGM alone, in T1D subjects on insulin pump treatment.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Cambridge is the lead sponsor of 112 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Other: Closed-loop
Other: Conventional insulin pump delivery
Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings.
Also known as: Automated CL
Subcutaneous delivery of Novorapid insulin according to usual pump regime
Percentage of CGM (Continuous glucose monitoring) values in target (3.9 - 8.0 mmol/l).
Participants will be assessed overnight (00:00 to 07:00) for 4 weeks in each arm.
Time frame: 4 weeks
Percentage of CGM values below 3.9 mmol/l.
Participants will be assessed overnight (00:00 to 07:00) for 4 weeks in each arm.
Time frame: 4 weeks
Time spent with glucose levels below 3.9 mmol/l and above 8.0 mmol/l, as recorded by CGM and other CGM-based metrics
Participants will be assessed overnight (00:00 to 07:00) for 4 weeks in each arm.
Time frame: 4 weeks
Glycaemic control assessed by fructosamine and HbA1c
Participants will be assessed for 4 weeks in each arm.
Time frame: 4 weeks
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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University of Cambridge