Outpatient Pump Shutoff Pilot Feasibility and Efficacy Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see whether low blood sugar at night can be reduced by using
      a system that turns off the insulin pump automatically. The study system includes a
      combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and
      a regular laptop computer that runs a computer program that predicts low blood sugar. It
      works by (1) measuring the glucose levels under the skin with a continuous glucose monitor,
      (2) using a computer program on a laptop to predict what will happen to the glucose level
      over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program
      predicts that low blood sugar will occur.

      This study has several phases and will take about 3 months for a patient to complete.
      Patients will use the Medtronic CGM with the Enlite sensor at home for 10-15 days to be sure
      that they are able and willing to use this system and to determine if they meet the
      investigators study criteria to proceed with the next phase of the study. Patients will be
      provided teaching on how to use CGM data in real time. If a patient is not using a Medtronic
      CGM already, the patient will first use one at home for 10-15 days to be sure that he/she is
      able and willing to use it. If a patient is already using a Medtronic CGM, then his/her most
      recent 10-15 days of data will be used to find out if he/she is eligible. Those who need to
      complete the CGM run-in phase will have an extra office visit for training.

      If eligible to continue in the study, patients will need to use the study system for 5 nights
      at home so that the investigators can make sure they are able to use it correctly. After
      that, patients will be asked to use the study system each night for an additional 6 to 8
      weeks. If the system is active and predicts that a patient's blood sugar will become low, the
      insulin pump will shut off for up to 2 hours.

      The study will include about 45 individuals at 3 clinical centers in the United States and
      Canada.
    

Detailed description: 
      Patients who are eligible for the clinical trial initially will use a Medtronic Continuous
      Glucose Monitor (CGM) at home to verify that the subject is able to use the CGM and insert
      sensors. Subjects already using a Medtronic CGM will skip this phase, provided that the
      eligibility criteria for CGM use and the study are met.

      Patients who meet criteria for sensor use and the study will then use the closed-loop system
      at home for 5 days to demonstrate their ability to use the system and submit study data to
      the Coordinating Center.

      Patients who successfully demonstrate their ability to use the system at home as described
      above will be eligible for the randomized trial phase. This phase consists of use of the full
      system as an outpatient for approximately 42 nights:

        -  Each night the blood glucose level will be checked with the study home blood glucose
           (BG) meter and used to perform a calibration of the CGM. This calibration must occur no
           more than 90 minutes prior to activation of the system. NOTE: Patients will be
           instructed to calibrate the CGM per manufacturer guidelines.

        -  Then the system will be activated, linking the CGM and insulin pump to the computer at
           the bedside.

        -  A randomization schedule on the laptop will be used to determine whether the 'pump shut
           off' application will be active that night or not.

        -  Patients will be blinded as to whether the pump shut off is active when a session is
           initiated each night.

        -  There will not be an alarm if the pump shuts off. The CGM alarm will be set to 60 mg/dL
           (3.3 mmol/L). When a CGM alarm occurs, the patient will be asked to measure the blood
           glucose with a BG meter, if he/she is aware of the alarm.

        -  The time period for outcome assessment each night will be from the time the system is
           activated until it is turned off in the morning

        -  Pump shut off, when it occurs, will be for up to 2 hours. Multiple instances of pump
           suspension can occur if there are recurrent predictions of hypoglycemia during the
           night.

        -  Patients will be asked to check blood glucose with the study BG meter, blood ketones
           with the study ketone meter, and urine ketones with a ketone strip each morning prior to
           breakfast and enter the results on the study laptop. The patient will be instructed to
           contact the study physician if the blood glucose or ketone readings are out of an
           expected range. Patients will be contacted if these morning safety values are not
           reported as required or are out of range.

        -  Patients will be asked to record all overnight carbohydrate intake on the study laptop.

        -  Patients will be asked to perform periodic data uploads using the study laptop.
           Monitoring processes will ensure that the patient is contacted if these uploads do not
           occur as required, or if review of an upload reveals any extreme, prolonged episodes of
           low or high blood glucose readings, or elevated morning blood glucose, blood ketone, or
           urine ketone values.

      Upon completion of the study, patients as well as study clinicians will be asked to complete
      a questionnaire regarding use of the study system.

      There will be one follow-up visit after 21 days in the clinical trial and a second follow-up
      visit after the completion of 42 nights of successful study system use. A successful night of
      study system use is defined as use of the system for at least four hours. Phone contacts with
      the patients will be made once a week.
    

Intervention name(s): Pump suspension
Intervention type(s): Device
Intervention description(s): The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 1 Diabetes; Hypoglycemia; Continuous Glucose Monitoring; Pump Suspension