Medtronic Treat to Range (TTR) Closed-Loop Control

NCT01490151 | Completed Results DMC

• 2 other identifiers: G110143SPO 53117
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Type 1 Diabetes; Metabolic and Nutritional Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

TTR controller

EXPERIMENTAL

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)

Interventions

TTR controller (Medtronic) DEVICE

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.

TTR controller

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Medtronic: collaborator

Study Sites (1)

Stanford University and Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Nutrition Disorders; Metabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Bruce Buckingham, MD
• Organization: Stanford University

buckingham@stanford.edu

408-356-0911

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Endocrinology

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 12, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)