Closing the Loop in Adults With Type 1 Diabetes in the Home Setting
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Closed-loop; Conventional insulin pump delivery
Intervention type(s): Other; Other
Intervention description(s): Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings.; Subcutaneous delivery of Novorapid insulin according to usual pump regime
Other intervention name(s): Automated CL
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment