Status:
COMPLETED
Medtronic Minimed Overnight Closed-Loop System
Lead Sponsor:
Bruce A. Buckingham
Conditions:
Type 1 Diabetes Mellitus
Autoimmune Diabetes
Eligibility:
All Genders
10-35 years
Phase:
NA
Brief Summary
To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will m...
Detailed Description
The steps are the same for the inpatient and camp studies, except that during the inpatient study subjects will have an IV inserted and blood samples will be obtained every 1/2 hour overnight. They wi...
Eligibility Criteria
Inclusion
- To be eligible for the study, a subject must meet the following criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic insulin infusion pump for at least 3 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- Age 10.0 - 35 years
Exclusion
- The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past month
- Hypoglycemic seizure or loss of consciousness in the past 3 months
- History of seizure disorder (except for hypoglycemic seizure)
- History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- 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).
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01881009
Start Date
June 1 2013
End Date
August 3 2013
Last Update
November 14 2019
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305-5208