Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a
      good range is a difficult task. A primary source for poor glucose control in adolescents is
      skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the
      research towards closed-loop delivery systems to automatically regulate glucose levels.
      Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous
      glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on
      sensor readings. The performance of a closed-loop delivery after a missed bolus may be
      improved if the computer program that calculates the insulin is enhanced with a meal
      detection module. The meal detection module will automatically detect the meal (which had no
      bolus delivered), and signal the delivery of more insulin.

      The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and
      without meal detection module compared to conventional pump therapy in regulating
      post-prandial glycemic levels after omission of a meal bolus.

      The primary hypothesis is that closed-loop delivery with no meal detection module will reduce
      the mean increase in postprandial glucose levels after a missed bolus compared to
      conventional pump therapy.
    

Detailed description: 
      Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a
      good range is a difficult task. A primary source for poor glucose control in adolescents is
      skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the
      research towards closed-loop delivery systems to automatically regulate glucose levels.
      Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous
      glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on
      sensor readings. The performance of a closed-loop delivery after a missed bolus may be
      improved if the computer program that calculates the insulin is enhanced with a meal
      detection module. The meal detection module will automatically detect the meal (which had no
      bolus delivered), and signal the delivery of more insulin.

      The aim of this study is to conduct a randomized, three-way, cross-over trial to compare the
      efficacy of closed-loop delivery, closed-loop delivery with a meal detection module, and
      conventional pump therapy. The study aims to compare these three interventions for 9 hours in
      adolescents with poorly controlled type 1 diabetes.

      Each 9 hours will include two meals of different carbohydrate content, of which one will not
      have a carbohydrate-matched prandial bolus. This study will allow for the assessment of the
      safety and efficacy of closed-loop delivery with and without a meal detection module compared
      to conventional pump therapy in regulating post-prandial glycaemia.

      The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and
      without meal detection module compared to conventional pump therapy in regulating
      post-prandial glycemic levels after omission of a meal bolus.

      The primary hypothesis is that closed-loop delivery with no meal detection module will reduce
      the mean increase in postprandial glucose levels after a missed bolus compared to
      conventional pump therapy.

      The secondary hypotheses are:

        1. Closed-loop delivery with meal detection module will reduce the mean increase in
           postprandial glucose levels after a missed bolus compared to conventional pump therapy.

        2. Closed-loop delivery with meal detection module will reduce the mean increase in
           postprandial glucose levels after a missed bolus compared to closed-loop delivery with
           no meal detection module.
    

Intervention name(s): Closed Loop Delivery; Closed Loop Delivery with Meal Detection Module; Conventional Pump Therapy
Intervention type(s): Device; Device; Device
Intervention description(s): Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm.; Closed Loop Delivery with Meal Detection Module Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm; Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Artificial Pancreas; Closed-Loop Delivery; Insulin; Adolescent; Missed Bolus