Medtronic Treat to Range (TTR) Closed-Loop Control

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1 Diabetes, Metabolic and Nutritional Disorders

In brief

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 1 diabetes.

Key facts

Study ID

NCT01490151

Run by

Stanford University

People needed

22

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2017-09-29

Who can join

Age: 15 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University and Stanford Hospital & Clinics — Stanford, California, United States

Full record on ClinicalTrials.gov

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