Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System - Full Text View

Purpose

The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin.

The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.

Condition	Intervention	Phase
Type 1 Diabetes	Device: Control-to-Range Automated Insulin Management System	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Medicines Diabetes Type 1 Exercise and Physical Fitness

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Juvenile Diabetes Research Foundation Artificial Pancreas Project Consortium:

Primary Outcome Measures:

Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit [ Time Frame: Admission Visit 1 ] [ Designated as safety issue: No ]
Group success criterion defined as a mean blood glucose >50%, lower end of one-sided 95% confidence interval >40% and individual criterion of no individual <30%.
Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus [ Time Frame: 4 hours following the breakfast with a missed meal bolus ] [ Designated as safety issue: No ]
Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.
Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount [ Time Frame: 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount ] [ Designated as safety issue: No ]
Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.
Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise [ Time Frame: Following exercise completion ] [ Designated as safety issue: Yes ]
Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.
Overall frequency of hypoglycemia [ Time Frame: Includes both admission visits ] [ Designated as safety issue: Yes ]
Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
Overall frequency of hyperglycemia [ Time Frame: Includes both admission visits ] [ Designated as safety issue: Yes ]
Success defined as no subjects with diabetic ketoacidosis (DKA).

Secondary Outcome Measures:

Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit [ Time Frame: Admission Visit Day 1 (9:00AM-11:00PM) ] [ Designated as safety issue: No ]
Group success criterion defined as a mean blood glucose >50%, lower end of one-sided 95% confidence interval >40% and individual criterion of no individual <30%.
Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit [ Time Frame: Admission Visit Night 1 (11:00PM-8:00AM) ] [ Designated as safety issue: No ]
Group success criterian defined as a mean blood glucose >60%, lower end of one-sided 95% confidence interval >50% and individual criterion of no individual <30%.
Percent of blood glucose values >400 mg/dL during the first admission visit [ Time Frame: Admission Visit 1 ] [ Designated as safety issue: Yes ]
Individual success is defined as no blood glucose values >400 mg/dL.
Percent of blood glucose values <=60 mg/dL during the first admission visit [ Time Frame: Admission Visit 1 ] [ Designated as safety issue: Yes ]
No more than 33% of visits with blood glucose <=60 mg/dL
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus [ Time Frame: 4 hours following the breakfast with a missed meal bolus ] [ Designated as safety issue: Yes ]
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus [ Time Frame: 4 hours following the breakfast with a missed meal bolus ] [ Designated as safety issue: Yes ]
Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount [ Time Frame: following the breakfast with a meal bolus 30% more than the recommended bolus amount ] [ Designated as safety issue: Yes ]
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount [ Time Frame: following the breakfast with a meal bolus 30% more than the recommended bolus amount ] [ Designated as safety issue: Yes ]
Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL

Enrollment:	57
Study Start Date:	March 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Closed-Loop Control The Control to Range algorithm will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.	Device: Control-to-Range Automated Insulin Management System The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.

Detailed Description:

Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)

Day 1 (24+ hours):

Admission at 7:00 AM
Standardized breakfast with normal bolus at 9:00 AM
Lunch with normal bolus at 1:00 PM
Dinner with normal bolus at 7:00 PM
Overnight sleep
Breakfast with missed meal bolus followed by user alert and correction bolus
Discharge

Day 2 (24+ hours):

Admission at 7:00 AM
Standardized breakfast with normal bolus at 9:00 AM
Lunch with normal bolus at 1:00 PM
Exercise
Dinner with normal bolus at 7:00 PM
Overnight sleep
Breakfast with overbolus at 7:00 AM
Discharge

Meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated; bolus confirmation by the physician/nurse will be requested by the closed-loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.

Eligibility

Ages Eligible for Study:	12 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
Age 12 to 65 years
Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
For females, not currently known to be pregnant
Demonstration of proper mental status and cognition for the study
An understanding of and willingness to follow the protocol and sign the informed consent or assent

Exclusion Criteria:

Diabetic ketoacidosis in the past 6 months
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
History of a seizure disorder (except hypoglycemic seizure). Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist treatment for a seizure disorder
Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
Cystic fibrosis
Active infection
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Presence of a known adrenal disorder
- Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine > 1.5 mg/dL)
- Active gastroparesis
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Uncontrolled thyroid disease
- Abuse of alcohol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
Current use of a beta blocker medication
Hematocrit <30% (labs drawn at screening visit or within one month prior to screening for other purposes will suffice for enrollment purposes related to hematocrit)
Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271023

Locations

United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Stanford University
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Health Sciences Center- Barbara Davis
Aurora, Colorado, United States, 80045
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
France
Montpellier University Hospital
Montpellier, France, 34295
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Italy
University of Padova
Padova, Italy, 93106

Sponsors and Collaborators

Juvenile Diabetes Research Foundation Artificial Pancreas Project Consortium

Investigators

Study Director:	Roy W Beck, MD, PhD	Jaeb Center for Health Research
Study Chair:	Howard Zisser, MD	Sansum Diabetes Research Institute

More Information

No publications provided

Responsible Party:	Roy W Beck, MD, PhD, Principal Investigator, Juvenile Diabetes Research Foundation Artificial Pancreas Project Consortium
ClinicalTrials.gov Identifier:	NCT01271023 History of Changes
Other Study ID Numbers:	CTR
Study First Received:	January 4, 2011
Last Updated:	August 8, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System (CTR)