Medtronic Treat to Range (TTR) Closed-Loop Control: Tuning a Treat-to-Range Controller for the Effects of High and Low Glycemic Index Meals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Stanford University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 1 diabetes.
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 delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a "hybrid" system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.
Investigators
Bruce A. Buckingham
Director, Pediatric Endocrinology
Stanford University
Eligibility Criteria
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.
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;
Outcomes
Primary Outcomes
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
Time Frame: 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.