MD Logic Pump Advisor -Pediatric Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The objective of this feasibility study is to evaluate the efficacy and safety of automated
      determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration
      and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1
      diabetes.

      Study design:

      Prospective study with two segments: (i) Pilot study, 30 days trial evaluating the MD-Logic
      pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing MD-Logic
      pump advisor to the standard of care of patients with type 1 diabetes. The RCT will be
      initiated after the pilot segment (including data analysis). The pilot segment will include
      15-30 pediatric patients. In the RCT, up to 105 (50 minors under this protocol and 55 adults
      under a separate protocol)eligible subjects will be enrolled to allow for 92 valuable
      subjects at the end of the study. The subject population will be randomly assigned 1:1 to
      either the intervention group or control group. At this pediatric sub study approximately 50
      patients will participate and at the separate Adults study additional 55 adult patients will
      participate.
    

Detailed description: 
      the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of
      Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's
      Medical Center of Israel. The MD-Logic Pump Advisor learns and adapts the patient's insulin
      pump settings in order to optimize glucose control. The MD-Logic Pump Advisor needs, as
      input, sensor readings, insulin delivery and recording of the meals during home care. During
      collection of the data, the patients are asked to continue their daily routine (no need for
      special consideration).

      The present study was designed to test the automatic algorithm that will evaluate and change,
      when necessary, the patient's insulin pump settings based on prior sensor reading, insulin
      delivery, and meals data that was collected while the patient is under his regular treatment
      at home.

      The objective of this feasibility study is to evaluate the efficacy and safety of automated
      determined Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration
      and insulin activity time) using the MD-Logic Pump Advisor in individuals with type 1
      diabetes.

      Study design:

      Prospective study with two segments: (i) Pilot study, 30-78 days trial evaluating the
      MD-Logic pump advisor and (ii), randomized controlled trial (RCT), 30-78 days trial comparing
      MD-Logic pump advisor to the standard of care of patients with type 1 diabetes. The RCT will
      be initiated after the pilot segment (including data analysis). The pilot segment will
      include 15-30 pediatric patients. In the RCT segment, up to 105(50 minors under this protocol
      and 55 adults under a separate protocol) eligible subjects will be enrolled to allow for 92
      valuable subjects at the end of the study. The subject population will be randomly assigned
      1:1 to either the intervention group or control group. At this pediatric sub study
      approximately 50 patients will participate and at the separate Adults study additional 55
      adult patients will participate.
    

Intervention name(s): MD Logic Pump Advisor
Intervention type(s): Device
Intervention description(s): Insulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Insulin Pump Therapy