Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)

NCT00977808 | Completed Results

• 2 other identifiers: 12998BPK004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This will be done using two continuous glucose monitors (CGMs), a computer containing an investigational control algorithm that uses glucose information from the CGM to recommend insulin dosing, and an insulin pump. The purpose of this study is to test the ability of continuous glucose monitors together with an insulin pump and a mathematical formula to control blood sugar levels of people with type 1 diabetes. The Closed-Loop control algorithm will:

1. 1.Suggest adequate insulin delivery for blood glucose control in steady state (overnight);
2. 2.Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast.

Conditions

Type 1 Diabetes

Keywords

Artificial pancreas; Closed-Loop control

Outcome Measures

Primary Outcomes (1)

• Occurrence of Hypoglycemic Episodes

  Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).

  Overnight (21:30 until 08:00)

Study Arms (2)

Closed-Loop Model Predictive Control (MPC)

EXPERIMENTAL

Insulin dosing was performed by a model-predictive control (MPC) algorithm.

Device: Closed-Loop, Model Predictive Control (MPC)

Open-Loop

PLACEBO COMPARATOR

Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.

Device: Open-Loop

Interventions

Closed-Loop, Model Predictive Control (MPC) DEVICE

Subjects used the OmniPod Insulin Management System (Insulet Corp.) and Insulin lispro (Eli Lilly, Indianapolis, IN). MPC algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician. Otherwise, the admission remained the same as in the open-loop admission (i.e. meals, sleep, etc...).

Closed-Loop Model Predictive Control (MPC)

Open-Loop DEVICE

This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects used their own insulin pumps and Insulin lispro (Eli Lilly, Indianapolis, IN). Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, sleep, etc...).

Open-Loop

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 2 years (including those who may also be treated with metformin, thiazolidinedione, exenatide, or pramlintide).
• Use of an insulin pump
• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 1 month prior to enrollment in the study
• Willingness to use lispro (Humalog) insulin for the duration of the inpatient study
• Demonstration of proper mental status and cognition for the study

You may not qualify if:

• Age \<21
• Pregnancy
• Hematocrit \<36% (females); \<38% (males)
• Symptomatic coronary artery disease (e.g. history of myocardial infarction, history of acute coronary syndrome, history of therapeutic coronary intervention, history of coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, positive stress test or catheterization with coronary blockages \>50%).
• Congestive heart failure
• History of a cerebrovascular event
• Use of a medication that significantly impacts glucose metabolism (oral steroids)
• Atrial fibrillation
• Uncontrolled hypertension (resting blood pressure \>140/90)
• History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
• Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the FreeStyle NavigatorTM CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
• Active enrollment in another clinical trial
• Allergy or adverse reaction to lispro insulin
• Known adrenal gland problem, pancreatic tumor, or insulinoma
• Current alcohol abuse, substance abuse, or severe mental illness

Sponsors & Collaborators

• University of Virginia: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• Kovatchev B, Cobelli C, Renard E, Anderson S, Breton M, Patek S, Clarke W, Bruttomesso D, Maran A, Costa S, Avogaro A, Dalla Man C, Facchinetti A, Magni L, De Nicolao G, Place J, Farret A. Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results. J Diabetes Sci Technol. 2010 Nov 1;4(6):1374-81. doi: 10.1177/193229681000400611.

  PMID: 21129332 BACKGROUND

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: Boris Kovatchev, Ph.D./Principal Investigator
• Organization: University of Virginia

pcm9b@virginia.edu

434-982-6479

Study Officials

• Boris P Kovatchev, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: September 4, 2014
• Results First Posted: August 25, 2014

Record last verified: 2014-08

Locations

US (1)