Medtronic Treat to Range (TTR) Closed-Loop Control

• ClinicalTrials.gov Identifier: NCT01490151
• Recruitment Status: Completed
• First Posted: December 12, 2011
• Results First Posted: September 29, 2017
• Last Update Posted: September 29, 2017
• Sponsor: Stanford University
• Collaborator: Medtronic
• Information provided by (Responsible Party): Bruce A. Buckingham, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Type 1 Diabetes; Metabolic and Nutritional Disorders	Device: TTR controller (Medtronic)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Medtronic Treat to Range (TTR) Closed-Loop Control: Tuning a Treat-to-Range Controller for the Effects of High and Low Glycemic Index Meals
• Study Start Date: December 2011
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm

Intervention/treatment

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

Device: TTR controller (Medtronic); Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 30 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
2. Age 15 years to less than 30 years old.
3. HbA1c < 10%.
4. Subject has used a downloadable insulin pump for at least 3 months.
5. Parent/guardian and subject understand the study protocol and agree to comply with it.
6. Subject comprehends written English.
7. Subject has a home computer with email access.
8. For females, subject not intending to become pregnant during the study.
9. No expectation that subject will be moving out of the area of the clinical center during the study.
10. Informed Consent Form signed by the subject or guardian.
11. 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:

1. 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
2. Cystic fibrosis
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Use of non-insulin medications that may affect blood glucose (eg Symlin),
5. Systolic blood pressure >140 on screening; Diastolic blood pressure >90 on screening
6. History of seizure or loss of consciousness in the last 6 months.
7. Adhesive allergies; Active skin condition that would affect sensor placement
8. History of heart disease
9. Active Graves disease;
10. Currently on beta blocker medication;
11. Unwilling or unable to follow the protocol;
12. History of diagnosed medical eating disorder;
13. History of known illicit drug abuse or prescription drug abuse;
14. History of current alcohol abuse;
15. History of visual impairment which would not allow subject to participate
16. Currently participating in an investigational study (drug or device);
17. 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

Contacts and Locations

Locations

United States, California

Stanford University and Stanford Hospital & Clinics

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Medtronic

Investigators

• Principal Investigator: Bruce Buckingham, MD; Stanford University

More Information

• Responsible Party: Bruce A. Buckingham, Director, Pediatric Endocrinology, Stanford University
• ClinicalTrials.gov Identifier: NCT01490151
• Other Study ID Numbers: G110143; SPO 53117 ( Other Grant/Funding Number: Medtronic )
• First Posted: December 12, 2011
• Results First Posted: September 29, 2017
• Last Update Posted: September 29, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Bruce A. Buckingham, Stanford University:

Hormone; Diabetes; Mellitus; Type 1; Immune; Metabolic disorder

Additional relevant MeSH terms:

Diabetes Mellitus; Nutrition Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases