Medtronic Treat to Range (TTR) Closed-Loop Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490151
Recruitment Status : Completed
First Posted : December 12, 2011
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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

Resource links provided by the National Library of Medicine

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.

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.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01490151

United States, California
Stanford University and Stanford Hospital & Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Bruce Buckingham, MD Stanford University

Responsible Party: Bruce A. Buckingham, Director, Pediatric Endocrinology, Stanford University Identifier: NCT01490151     History of Changes
Other Study ID Numbers: G110143
SPO 53117 ( Other Grant/Funding Number: Medtronic )
First Posted: December 12, 2011    Key Record Dates
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:
Type 1
Metabolic disorder

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Nutrition Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases