Portable Artificial Pancreas Applied for Youth and Adolescents
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine the performance of a bi-hormonal reactive
      closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent
      in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the
      bi-hormonal closed-loop system and the current treatment of the patients. Also, safety
      parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment
      satisfaction scores) are compared.

      This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will
      be randomized to receive either the open-loop therapy or the closed-loop therapy for the
      first two-week study period and switch to the alternate treatment with at least two weeks in
      between.
    

Detailed description: 
      Background of the study:

      Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop
      system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes
      mellitus type 1. In previous studies, we tested the performance and safety of this
      bi-hormonal closed-loop system in an outpatient setting in patients with type 1 diabetes
      mellitus (T1DM) for a duration up to 2 weeks, leading to CE-marking of the system. The device
      is currently intended for insulin-dependent adult patients with diabetes. However, there is
      great need to improve glycaemic control in youth and adolescents with diabetes.

      Objective of the study:

      The main objective of this study is to determine the performance of the closed-loop system in
      adolescents with T1DM. Secondary objectives include: to assess the safety of the closed-loop
      system; to determine the time that the closed-loop algorithm is active; and to assess
      expectations and treatment satisfaction of the closed-loop system.

      Study design:

      This study is a monocenter randomized cross-over trial.

      Study population:

      The study population will comprise 20 patients with T1DM, between 12 and 18 years old, not
      having impaired awareness of hypoglycaemia, and who are treated with insulin therapy for at
      least 6 months. Patients receiving treatment with multiple daily injections (MDI) or
      continuous subcutaneous insulin injections (CSII), and in addition glucose monitoring using
      self-monitored blood glucose (SMBG), flash glucose monitoring (FGM) or continuous glucose
      monitoring (CGM) are included into the study.

      Intervention:

      The intervention includes 2 weeks of closed-loop control with the artificial pancreas (AP) of
      Inreda Diabetic. The device uses 2 subcutaneous glucose sensors, 2 subcutaneous infusion
      sets, and incorporates 2 pumps and a reactive closed-loop algorithm. During 4-6 days before
      the intervention the patients receive training on the use of the closed-loop system and will
      start using the device under close supervision. The control arm (open loop treatment)
      consists of the patient's standard therapy at home for 2 weeks.

      Main study parameters/endpoints:

      Main study parameter is the percentage of time spent in the target range (3.9-10.0 mmol/L),
      which will be compared between the open and closed-loop periods for each patient.
    

Intervention name(s): Bi-hormonal closed-loop control; Open-loop control
Intervention type(s): Device; Device
Intervention description(s): During bi-hormonal closed-loop control insulin and glucagon are administered to the developed closed-loop algorithm. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the closed loop period.; During open-loop control the patients will use their usual diabetes therapy. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the open loop period.
Other intervention name(s): Artificial Pancreas (AP); bi-hormonal AP system; AP5
Intervention MeSH terms: Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a monocenter, randomized cross-over trial. The total duration of the study will be three months: two weeks open loop control and 4-6 training days followed by a two-week closed-loop period, or vice versa, with at least 2 weeks in between.
Masking: None (Open Label)
Primary purpose: Treatment