Medtronic Treat to Range (TTR) Closed-Loop Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Stanford University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University
ClinicalTrials.gov Identifier:
NCT01490151
First received: December 8, 2011
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention
Diabetes Mellitus
Type 1 Diabetes
Metabolic and Nutritional Disorders
Device: TTR controller (Medtronic)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Safety and efficacy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Outcome Measure: 75% of admissions successful with our nominal tuning parameters, and for all subjects to be successful in meeting our safety criteria with no more than 2 adjustments of algorithm tuning parameters.


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TTR controller
Treatment with treat-to-range closed-loop controller
Device: TTR controller (Medtronic)
Subjects will arrive in the morning and the TTR controller 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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490151

Contacts
Contact: Kari Benassi, RN, FNP 650-736-8948 karis@stanford.edu
Contact: Satya Shanmugham, BS 650-736-8142 satyas1@stanford.edu

Locations
United States, California
Stanford University and Stanford Hospital & Clinics Recruiting
Stanford, California, United States, 94305
Contact: Kari Benassi, RN, FNP    650-736-8948    karis@stanford.edu   
Sponsors and Collaborators
Stanford University
Medtronic
Investigators
Principal Investigator: Bruce Buckingham, MD Stanford University
  More Information

No publications provided

Responsible Party: Bruce A. Buckingham, Director, Pediatric Endocrinology, Stanford University
ClinicalTrials.gov Identifier: NCT01490151     History of Changes
Other Study ID Numbers: G110143, SPO 53117
Study First Received: December 8, 2011
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Hormone
Diabetes
Mellitus
Type 1
Immune
Metabolic disorder

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

ClinicalTrials.gov processed this record on August 27, 2014