An Outpatient Pump Shutoff Pilot Feasibility and Safety Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Pump suspension
Intervention description: The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes; Hypoglycemia; Continuous Glucose Monitoring; Pump Suspension

Summary:

      The purpose of this study is to evaluate an overnight system that will turn off the insulin
      pump automatically if the system predicts that a low blood sugar is likely. 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. We have tested this system
      overnight in the hospital and are ready to test the system in the home environment to learn
      more about how well it will work and to make sure that the blood sugar does not go too high
      when the pump shuts off.

      This study has several phases and will take about a month or a little more for a patient to
      complete. Patients will use the study system for about 5 days at home to show that the
      patient is able to use it correctly. After that, the patient will be asked to use the study
      system each night for an additional 3-4 weeks. During this time, the system will be active
      for two-thirds of the nights and not active for one-third of the nights. When the system is
      active and predicts that your blood sugar will become low, the insulin pump will shut off for
      up to 2 hours.

      The study will include 2 clinical centers in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one
             year and an insulin infusion pump for at least 6 months

          -  Age >=18.0 years

          -  HbA1c <=8.0%

          -  Availability of internet access for periodic upload of study data

          -  Experience using the Medtronic pump and CGM and investigator is confident that subject
             will use CGM on a near-daily basis during the study

          -  Nocturnal hypoglycemia meeting the following criterion based on CGM download: during
             the most recent 15 nights with CGM glucose data (must be within the past 42 days), one
             or more nights with a sensor glucose value <=70 mg/dL.

        Exclusion Criteria:

          -  Diabetic ketoacidosis in the past 3 months

          -  Hypoglycemic seizure or loss of consciousness in the past 6 months

          -  History of seizure disorder (except for hypoglycemic seizure)

          -  Coronary artery disease or heart failure

          -  Cystic fibrosis

          -  Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which
             in the judgment of the investigator would be a contraindication to participation in
             the study.

          -  History of ongoing renal disease (other than microalbuminuria). Creatinine level to
             have been obtained within the last year if subject has diabetes of >10 years duration
             or is over 50 years of age. If creatinine is > 1.5 mg/dL, the subject is excluded.

          -  History of liver disease

          -  Medical or psychiatric condition that in the judgment of the investigator might
             interfere with the completion of the protocol such as: inpatient psychiatric treatment
             in the past 6 months, uncontrolled adrenal disorder, and/or abuse of alcohol

          -  Pregnancy: A negative urine pregnancy test will be required for all premenopausal
             women who are not surgically sterile. Subjects who become pregnant will be
             discontinued from the study.