MD Logic Pump Advisor- Adults Study
Condition: Type 1 Diabetes; Insulin Pump Therapy
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to
      the standard of care of patients with type 1 diabetes.

      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.The study will be consisted from two segments:(I)pilot study, 30-78 days trial
      evaluating the MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing
      MD-Logic pump algorithm to the standard of care.In segment 1, the pilot study, the aim is to
      enroll 15-30 subjects without control group. In segment 2, the randomized controlled segment,
      the aim is to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for
      dropouts.

      The randomized controled study segment will be initiated after the pilot segment.Each segment
      of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of
      30-78 days study duration for each segment. Before each clinic visit, subjects will wear
      continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations
      (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period
      according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin
      pump settings will not be changed during the study period (patient's usual standard of care).
    

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.

      The study will be consisted from two segments:(I)pilot study, 30-78 days trial evaluating the
      MD-Logic pump advisor and (II)randomized controlled 30-78 days trial comparing MD-Logic pump
      algorithm to the standard of care.In segment 1, the pilot study, the aim is to enroll 15-30
      subjects without control group. In segment 2, the randomized controlled segment, the aim is
      to enroll 92 subjects, but enrolling up to 105 eligible subjects to allow for dropouts.

      The randomized controled study segment will be initiated after the pilot segment.Each segment
      of the study will consist of 6 clinic visits taking place at intervals of 1-3 weeks, sum of
      30-78 days study duration for each segment. Before each clinic visit, subjects will wear
      continuous glucose sensors for 6 days; the intervention group will have up to 4 iterations
      (e.g the pump setting will be reviewed and adjusted up to 4 times during the study period
      according to the MD-Logic Pump Advisor).For the control group (at segment 2 only), insulin
      pump settings will not be changed during the study period (patient's usual standard of care).

      Endpoints:

        -  Primary endpoint Increase in time spent in the normal range, defined as sensor glucose
           level within 70 to 180 mg/dl

        -  Secondary endpoints Reduced time spent above 180 mg/dl, reduced time spent below 70
           mg/dl, reduced number of hypoglycemic events below 63 mg/dl, reduced glucose
           variability, quality of life measurements and subject treatment satisfaction.

      Inclusion Criteria:

        -  Subject with Type 1 diabetes (>1yr since diagnosis)

        -  Medtronic ( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII
           (continuous subcutaneous insulin infusion) therapy for at least 3 months

        -  Age ≥ 18 years

        -  HbA1c at inclusion ≥ 6.0%

        -  No concomitant diseases that influence metabolic control

        -  No current use of CGM

        -  Subjects do not participate in any other interventional study
    

Intervention name(s): MD Logic Pump Advisor
Intervention type(s): Device
Intervention description(s): Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration 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