Outpatient Pump Shutoff Pilot Feasibility and Efficacy 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 a 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: 49.0
Sex: All
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Type 1 Diabetes; Hypoglycemia; Continuous Glucose Monitoring; Pump Suspension

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.
    

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 >/= 15.0 - 45 years

          -  HbA1c </= 8.0%

          -  Availability of internet access for periodic upload of study data

        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)

          -  History of any heart disease including coronary artery disease, heart failure, or
             arrhythmiasCoronary 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), or liver disease
             (Creatinine > 1.5 mg/dL (0.08 mmol/L))

          -  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

               -  Abuse of alcohol

          -  Pregnancy

          -  Liver disease as defined by an ALT greater than 3 times the upper limit of normal