Artificial Pancreas Control System in an Outpatient Setting

NCT01871870 | Completed Phase 2 Results

• 1 other identifier: 2013.001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this outpatient research study are (1) to assess the ability of this automated system to be operated by a subject with limited professional oversight; (2) to assess whether the new devices (Dexcom Gen 4 sensors, Motorola ES400 smart phone, iDex pump controller) will reduce the frequency of hardware and data communication lapses seen in the previous system; and (3) to measure the degree of glucose control achievable with this automated system. The system will adjust blood glucose by administering insulin and glucagon. Insulin is a hormone that lowers blood glucose and will be given nearly continuously during this study. Glucagon raises blood glucose and will be automatically administered during hypoglycemia. Both are natural hormones made by people without diabetes. Each subject will have four devices placed on his abdomen: two Omnipod insulin pumps, one for delivering insulin and one for delivering glucagon, and two Dexcom G4 glucose sensors for measuring glucose. The two sensors will feed glucose data into Motorola smart phone master controller, which will calculate the correct amount of insulin or glucagon to deliver. The system will then send the command to the correct Omnipod through the iDex pod controller. In this new system, the research subject will be able to monitor the progress of the study by use of the smart phone graphical user interface. The subject will have a companion with him/her during the entire study for safety purposes. Both the subject and companion will complete a training course on how to treat diabetic emergencies and how to operate the system. A study physician and technician will be in the hotel during each study and will be monitoring the study via a cloud-based data communication system. These studies will be carried out in a hotel setting.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Verification of the Automation and Telemetry Components

  This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.

  28 hours

Secondary Outcomes (1)

• Deviation From Target Blood Glucose

  28 hours

Study Arms (1)

Artificial Pancreas Control Software

EXPERIMENTAL

Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.

Device: Artificial Pancreas Control Software

Interventions

Artificial Pancreas Control Software DEVICE

This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.

Artificial Pancreas Control Software

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female subjects 21 to 60 years of age.
• Current use of an insulin pump.
• Willingness to follow all study procedures and to stay with a companion during the outpatient test of the artificial pancreas.
• Willingness to sign informed consent and HIPAA documents.
• Willingness for the subject and companion to attend a training course on the system including emergency management of extremes of glucose.

You may not qualify if:

• Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
• Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.3 g/dL; or serum bilirubin of over 2.
• Adrenal insufficiency
• Hematocrit of less than or equal to 34%.
• A history of cerebrovascular disease or coronary artery disease regardless of the time since occurrence.
• Congestive heart failure, NYHA class III or IV.
• Any active infection.
• Visual impairment preventing reading of glucose meter values or continuous glucose monitoring device.
• Physical impairment impeding the ability to use a glucose meter or continuous glucose monitoring device.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
• Active malignancy, except basal cell or squamous cell skin cancers.
• Major surgical operation within 30 days prior to screening.

Sponsors & Collaborators

• Legacy Health System: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Legacy Research Institute

Portland, Oregon, 97232, United States

Location

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

Results Point of Contact

• Title: Dr. Ken Ward
• Organization: Legacy Health System

kenward503@msn.com

971-570-2632

Study Officials

• William K Ward, MD

  Legacy Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 15, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-05

Locations

US (1)