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Medtronic Treat to Range (TTR) Closed-Loop Control

Primary Purpose

Diabetes Mellitus, Type 1 Diabetes, Metabolic and Nutritional Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TTR controller (Medtronic)

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Hormone, Diabetes, Mellitus, Type 1, Immune, Metabolic disorder

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.
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:

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;
Unwilling or unable to follow the protocol;
History of diagnosed medical eating disorder;
History of known illicit drug abuse or prescription drug abuse;
History of current alcohol abuse;
History of visual impairment which would not allow subject to participate
Currently participating in an investigational study (drug or device);
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

Sites / Locations

Stanford University and Stanford Hospital & Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TTR controller

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01490151

First Posted

December 8, 2011

Last Updated

August 31, 2017

Sponsor

Stanford University

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01490151

Brief Title

Medtronic Treat to Range (TTR) Closed-Loop Control

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1 Diabetes, Metabolic and Nutritional Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TTR controller

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

TTR controller (Medtronic)

Intervention Description

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 Measure Information:

Title

Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions

Description

Time Frame

Day of hospital admission (12 hours)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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. 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: 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; Unwilling or unable to follow the protocol; History of diagnosed medical eating disorder; History of known illicit drug abuse or prescription drug abuse; History of current alcohol abuse; History of visual impairment which would not allow subject to participate Currently participating in an investigational study (drug or device); 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Buckingham, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University and Stanford Hospital & Clinics

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Medtronic Treat to Range (TTR) Closed-Loop Control

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