Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: Pump suspension algorithm
Intervention description: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 3 Years
Maximum age: 14 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
      continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular
      laptop computer. A The system works by (1) measuring the glucose levels under the skin with
      the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is
      likely to occur, and (3) turning off the insulin pump when the computer program predicts that
      a low blood sugar will occur.

      We have tested the system in the home environment in individuals with type 1 diabetes age 15
      years and older. We have found an indication that the system can decrease the frequency of
      hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We
      are now ready to further test the system in the home environment in a younger age group to
      learn more about its ability to reduce overnight low blood sugar risk.

      This study has several phases and will take about 3 months for a patient to complete.

        -  First, the patient will use the CGM and pump at home for up to 15 days with the help of
           a parent/guardian. This is done to determine if the patient meets our study criteria to
           proceed with the next phase of the study.

        -  If the patient is eligible to continue in the study, the patient will need to use the
           full study system for at least 5 nights at home with the help of a parent/guardian. This
           is done to make sure the patient and parent/guardian are able to use the system
           correctly. The patient may participate in starting and stopping the system at home, but
           the parent/guardian is responsible for making sure it is used as instructed.

        -  After that, the patient will be asked to use the study system each night for an
           additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the
           system is used as instructed.

      The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the
      United States and Canada. First a study of children 8 to less than 15 years old will be done.
      Then, a study of children 3 to less than 8 years old will be conducted.
    

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 3 to <15 years

          -  HbA1c <=8.5%

          -  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 past 6 months

          -  History of seizure disorder (except for hypoglycemic seizures)

          -  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 is > 1.5 mg/dL (132 µmol/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 Alanine Aminotransferase Test (ALT) greater than 3
             times the upper limit of normal