Status:
COMPLETED
Medtronic Treat to Range (TTR) Closed-Loop Control
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Medtronic
Conditions:
Diabetes Mellitus
Type 1 Diabetes
Eligibility:
All Genders
15-30 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type ...
Detailed Description
The purpose of this study is to demonstrate the safety and efficacy of a closed-loop "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
- Age 15 years to less than 30 years old.
- HbA1c \< 10%.
- Subject has used a downloadable insulin pump for at least 3 months.
- Parent/guardian and subject understand the study protocol and agree to comply with it.
- Subject comprehends written English.
- Subject has a home computer with email access.
- For females, subject not intending to become pregnant during the study.
- No expectation that subject will be moving out of the area of the clinical center during the study.
- Informed Consent Form signed by the subject or guardian.
- Subjects cannot have had a severe hypoglycemic event described as a seizure, loss of consciousness requiring an emergency department visit or hospitalization within 6 months of enrollment.
Exclusion
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months; Subject has taken oral or injectable corticosteroids within the last 30 days; Current use of oral/inhaled Glucocorticoids
- Cystic fibrosis
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Use of non-insulin medications that may affect blood glucose (eg Symlin),
- Systolic blood pressure \>140 on screening; Diastolic blood pressure \>90 on screening
- History of seizure or loss of consciousness in the last 6 months.
- Adhesive allergies; Active skin condition that would affect sensor placement
- History of heart disease
- Active Graves disease;
- Currently on beta blocker medication;
- Unwilling or unable to follow the protocol;
- History of diagnosed medical eating disorder;
- History of known illicit drug abuse or prescription drug abuse;
- History of current alcohol abuse;
- History of visual impairment which would not allow subject to participate
- Currently participating in an investigational study (drug or device);
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01490151
Start Date
December 1 2011
End Date
December 1 2013
Last Update
September 29 2017
Active Locations (1)
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1
Stanford University and Stanford Hospital & Clinics
Stanford, California, United States, 94305