Medtronic Treat to Range (TTR) Closed-Loop Control

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Study & Design

Arm && Interventions

Group	Intervention	Description
TTR controller	TTR controller (Medtronic)	The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals

Primary Outcome Measures

Name	Time	Method
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions	Day of hospital admission (12 hours)	A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility