In Clinic Evaluation of the PLGM Feature
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is a multi-center, single arm and in-clinic study to evaluate the safety of the
      PLGM System and its algorithm with the Enlite 3 Sensor.
    

Detailed description: 
      A total of up to 95 subjects with type 1 diabetes (age 14-75 years old) will be enrolled at
      up to 8 investigational centers in order to reach a minimum of 60 subjects who will complete
      the study (N=minimum 40 adult subjects, 22-75 years old) and N=minimum 15 pediatric subjects
      (14-21 years old). Subjects will be evaluated in an in-clinic setting with induction of
      hypoglycemia by increasing their basal rate using a standardized titration tool referred to
      in protocol as rate of change basal increase algorithm (Buckingham, Diabetes Care 5, 2010).
      Total duration of frequent sample testing (FST) using Yellow Springs Instrument (YSI) may be
      up to 19 hours.

      Subjects will undergo in-clinic testing on Sensor Day 1.

      All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using
      the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

      The In-Clinic part of the study consists of hypoglycemic induction and an observation period.

      Hypoglycemic induction ends when one of the following 3 criteria is met, whichever comes
      first:

        1. PLGM is activated

        2. YSI glucose is less than or equal to 65 mg/dL, followed by the next YSI sample less than
           or equal to 65 mg/dL (2 contiguous YSI samples).

        3. Neither condition for #1 or #2 has been met in 12 hours

      Observation with YSI ends when:

        1. If PLGM is activated, observation with YSI frequent sample testing will include the
           Suspend period (30 minutes minimum to 2 hours maximum) and insulin resumption period
           (approximately 4 hours from the time insulin delivery resumes). This may include insulin
           re-suspension during this period. Maximum observation with YSI frequent sample testing
           should be no longer than 19 hours.

        2. YSI glucose less than or equal to 65 mg/dL is followed by the next YSI sample less than
           or equal to 65 mg/dL (2 contiguous YSI samples). The subject will be rescued and YSI
           observation will end

        3. Twelve hours have passed since the start of hypoglycemic induction without PLGM
           activation

        4. See In-Clinic Stopping rules

      Enrollment for this study will proceed in phases.

      Phase 1 only allows enrollment of adult subjects (22-75 years). Subjects will wear pump
      system, as shown below:

        -  One Study Pump

        -  One GST-3C Transmitter

        -  One Enlite 3 Sensor

      Progression to Phase 2 may occur after 10 adult subjects have completed Phase 1 and a Data
      Safety Monitoring Board (DSMB) has approved that it is safe to continue on to Phase 2.

      Phase 2 enrollment involves a minimum of 15 pediatric subjects (14-21). Subjects will wear
      the same pump system as shown for Phase 1.

      A total of up to 95 subjects will be enrolled at up to 10 investigational centers in order to
      reach a minimum of 60 subjects (N=minimum 40 adult subjects and N=minimum 15 pediatric
      subjects) who will complete the study.

      Considering around 15% screen failure rate and approximately 15% drop-out rate, a total of up
      to 95 subjects will be enrolled in order to have 60 subjects complete the study.

        1. The investigational centers will be encouraged to include subjects of different
           ethnicities including Hispanic, Native American, and African-American

        2. Subjects will be grouped into cohorts by Age

      The study is anticipated to last no longer than 12 months from investigational center
      initiation to completion of all data entry and monitoring procedures including final report.
      Subjects can expect to participate for approximately 2-3 weeks.
    

Intervention name(s): Predictive Low Glucose Management Feature in Insulin pump
Intervention type(s): Device
Intervention description(s): All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
Other intervention name(s): Medtronic MiniMed 640G Insulin Pump, MMT-1512
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment