Medtronic Treat to Range (TTR) Closed-Loop Control

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490151
• Other study ID #: G110143
• Secondary ID: SPO 53117
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: August 31, 2017
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic and Nutritional Disorders
• Nutrition Disorders
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University and Stanford Hospital & Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions	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.	Day of hospital admission (12 hours)