Assessment of an Automatic Closed-loop Insulin Delivery System

NCT02366767 | Completed Results DMC

• 1 other identifier: G140095
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

The overall aim of this research proposal is to determine the safety, feasibility and efficacy of an automatic closed-loop insulin delivery system.

Conditions

Diabetes Mellitus, Type 1

Keywords

Insulin Infusion Systems; Continuous Glucose Monitors

Outcome Measures

Primary Outcomes (1)

• Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes

  1. As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects 2. As measured by the number of events of system alerts of plasma glucose values \>300 mg/dL lasting for more than one hour in all subjects. 3. As measured by number of events of serum ketones \>3 mmol/L in all subjects 4. As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects

  6 days

Secondary Outcomes (2)

• Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes

  6 days

• Efficacy of Hybrid Closed-loop System in Comparison With Control

  6 days

Study Arms (2)

automatic closed-loop insulin delivery

EXPERIMENTAL

The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes

Device: Automatic closed-loop insulin delivery

Control

ACTIVE COMPARATOR

The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.

Device: Control

Interventions

Automatic closed-loop insulin delivery DEVICE

Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes.

automatic closed-loop insulin delivery

Control DEVICE

Threshold suspend

Also known as: 530G Pump

Control

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of type 1 diabetes
• The diagnosis of type 1 diabetes is based on the investigator's judgment
• C peptide levels and antibody determinations are not required
• Daily insulin therapy for ≥ 12 months
• Insulin pump therapy for ≥ 3 months
• Age 14.0 - 40.0 years
• Subject comprehends written English
• Female subjects who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD
• Female subjects past menarche must have a negative urine pregnancy test
• Informed consent form is signed by the subject and/or parent and assent assigned by the subject if under 18 years of age
• For subjects under 18 years, both the subject and parent/guardian understand the study protocol and agree to comply with it. Both parents must sign if possible.

You may not qualify if:

• Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol
• Diabetic ketoacidosis in the past month
• Hypoglycemic seizure or loss of consciousness or an event requiring glucagon or IV glucose in the past 3 months
• Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis
• Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
• Subject has a history of liver or kidney disease (other than microalbuminuria)
• Subject has active Graves' disease
• Subjects with inadequately treated thyroid disease or celiac disease
• Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
• Subject has a history of diagnosed medical eating disorder
• Subject has a history of known illicit drug abuse
• Subject has a history of known prescription drug abuse
• Subject has a history of current alcohol abuse
• Subject has a history of visual impairment which would not allow subject to participate
• Subject has an active skin condition that would affect sensor placement

Sponsors & Collaborators

• Stanford University: lead
• Medtronic: collaborator

Study Sites (3)

Camp Conrad-Chinnock

Angelus Oaks, California, 92305, United States

Location

Packard El Camino Hospital

Mountain View, California, 94040, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Ly TT, Roy A, Grosman B, Shin J, Campbell A, Monirabbasi S, Liang B, von Eyben R, Shanmugham S, Clinton P, Buckingham BA. Day and Night Closed-Loop Control Using the Integrated Medtronic Hybrid Closed-Loop System in Type 1 Diabetes at Diabetes Camp. Diabetes Care. 2015 Jul;38(7):1205-11. doi: 10.2337/dc14-3073. Epub 2015 Jun 6.

  PMID: 26049550 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was in a closely supervised diabetes camp setting. There was close supervision of fingerstick testing using the second drop of blood. Research staff did not assist subjects in carbohydrate counting and meal sizes were unrestricted.

Results Point of Contact

• Title: Bruce Buckingham
• Organization: Stanford School of Medicine

buckingham@stanford.edu

650-725-9549

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: February 19, 2015
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 17, 2017
• Results First Posted: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)