Trial Search Results

Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Jaeb Center for Health Research

Collaborator: Juvenile Diabetes Research Foundation

Stanford Investigator(s):

Intervention(s):

  • Device: Pump suspension algorithm

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

3 Years - 14 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting