Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the efficacy of an Artificial Pancreas system which
      includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold
      Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical
      centres. After a 2 week run-in period, they will attend two investigational sessions of 65
      hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will
      be activated, depending on the randomization. The main endpoint is the time spent below
      70mg/dL between 22:00 and 07:00.
    

Detailed description: 
      The study is an open randomized control trial preceded by a run-in period and follows a
      cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy
      with a dedicated training to continuous glucose monitoring using study system (study CGM).
      During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM
      (run-in period). At the end of this period, the patient and the relative will be admitted in
      a parents'house or hotel/resort nearby the hospital for 65 hours to undergo the first
      interventional session. Admission will be at 17:00 Day 1. The investigator will connect
      wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be
      activated. Until 08:00 Day 2, insulin delivery will be managed in open-loop mode, i.e.
      insulin doses will be decided according to capillary glucose measurements. From 08:00 Day 2,
      one algorithm will be activated according to the randomization order, i.e. either the
      threshold low glucose suspend (TLGS) algorithm (threshold will be set at 70 mg/dl) or the
      closed-loop algorithm. Insulin delivery will then be managed in open-loop mode with activated
      TLGS or by the closed-loop algorithm until 08:00 Day 4. In both cases, meals will be of free
      content and taken around 09:00, 13:00, 17:00 and 20:00. Meal insulin doses will be managed
      according to pre-meal glucose level and CHO meal content in open-loop mode with TLGS, or
      according to DiAs bolus calculator suggestion in closed-loop mode. Patient and relative will
      be encouraged to move in parents'house or hotel/resort and surroundings between meals. The
      algorithm will be inactivated at 08:00 Day 4. The study pump will be removed and replaced by
      patient's usual pump. The patient and the relative will be released at 10:00 after breakfast.
      Study CGM will still be used at home for 2 to 4 weeks until the second interventional
      session. This session will be similar to the first one but the alternative algorithm will be
      activated. Patient will come back to pre-study insulin therapy from 08:00 Day 4 and be
      released at 10:00 when second session is completed.
    

Intervention name(s): Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm; Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend
Intervention type(s): Device; Device
Intervention description(s): The insuline used is usual patient insuline. There is no specific insulin for this protocol; The insuline used is usual patient insuline. There is no specific insulin for this protocol
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T1DM; Type 1 Diabetes; Artificial Pancreas; DiAs platform