Trial record 1 of 1 for: NCT01161862

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Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management Of Type 1 Diabetes (CL2)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Boston University.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Massachusetts General Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Juvenile Diabetes Research Foundation

Leona M. and Harry B. Helmsley Charitable Trust

Information provided by:

Boston University

ClinicalTrials.gov Identifier:

NCT01161862

First received: July 12, 2010

Last updated: March 29, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 12, 2010

Last Updated Date

March 29, 2011

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean blood glucose

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01161862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of carbohydrate interventions for hypoglycemia
Number of blood glucose events < 70 mg/dl and nadir blood glucose value for each
Fraction of time spent with blood glucose < 70 mg/dl
Fraction of time spent with blood glucose 70-120 mg/dl
Fraction of time spent with blood glucose 70-180 mg/dl
Fraction of time spent with blood glucose > 180 mg/dl

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management Of Type 1 Diabetes

Official Title ^ICMJE

Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes

Brief Summary

The investigators hypothesize that our closed-loop glucose-control system can provide BG control in subjects with type 1 diabetes using the estimated BG signal from a CGM as the input signal to the controller.

Detailed Description

The three specific aims of this study are:

Aim 1: To test the safety and efficacy of our control system in the bi-hormonal configuration in regulating BG in adults (18 years of age or older) and in children (12-17 years of age) with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM. Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods. In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.

Aim 2: To test the safety and efficacy of our control system in the insulin-only configuration in regulating BG in adults (18 years of age or older) and in children (12-17 years of age) with type 1 diabetes based on interstitial-fluid (ISF) glucose data from a CGM. Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods. In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.

Aim 3: To directly compare the performance of the bi-hormonal and insulin-only configurations of the controller in adults (18 years of age or older).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Device: Closed-loop blood glucose control with a bi-hormonal (insulin and glucagon) artificial pancreas
Device: Closed-loop blood glucose control with an insulin-only artificial pancreas

Study Arm (s)

Experimental: Bi-hormonal
Intervention: Device: Closed-loop blood glucose control with a bi-hormonal (insulin and glucagon) artificial pancreas
Experimental: Insulin-only
Intervention: Device: Closed-loop blood glucose control with an insulin-only artificial pancreas

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 12 years or older with clinical type 1 diabetes for at least one year
Weight > 41 kg
Otherwise healthy (mild chronic disease allowed if well controlled)
Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
Body mass index (BMI) between 20 and 35 for subjects >18 years of age or BMI between the 5th and 95th percentile for age for subjects < 18 years of age
Total daily dose (TDD) of insulin that is < 1 U/kg
Stimulated C-peptide < 0.1 nmol/L at 90 minutes after liquid mixed meal by DCCT protocol
Hemoglobin A1c <= 9%
Prescription medication regimen stable for 1 month

Exclusion Criteria:

Unable to provide informed consent for subjects > 18 years of age or unable to provide assent if < 18 years of age
Unable to comply with study procedures
Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Potential subjects enrolled in trials of passive monitoring equipment are not excluded.
Anemia (HCT less than normal for age and sex)
Alanine aminotransferase > 3 fold above upper limit of normal
Untreated or inadequately treated hyperthyroidism or hypothyroidism
Pregnancy
Renal insufficiency (creatinine clearance ≤ 50 ml/min)
Any known history of coronary artery disease
Abnormal EKG including, but not limited to evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), arrhythmia, tachycardia, and prolonged QT interval (> 440 ms)
Congestive heart failure
History of TIA or stroke
Acute illness or exacerbation of chronic illness
History of seizures
History of pheochromocytoma (fractionated metanephrines will be tested in patients with history suggestive of pheochromocytoma)
History of adrenal disease or tumor
History of pancreatic tumor, including insulinoma
History of impaired gastric motility or gastroparesis requiring pharmacological or surgical treatment
Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription)
Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year)
Impaired cognition or altered mental status.
Hypertension (blood pressure > 140/90 or > 95% for age, height and weight in subjects < 18 years of age) at the time of screening
Use of medications that reduce gastric motility (e.g. narcotics, anti-spasmodics, anticholinergics).
Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
Use non-insulin, injectable anti-diabetic medications
History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
Established history of latex, adhesive, or tape allergy
Inadequate venous access
History of allergy to aspirin or any history of aspirin intolerance, including Reye syndrome, or gastric ulcer or bleeding associated with salicylates
Blood dyscrasia or bleeding diathesis, such as hemophilia, Von Willebrands disorder, and idiopathic thrombocytopenic purpura (ITP)
Peptic ulcer
Unable to perform 30 minutes of moderate exercise on a treadmill or exercise bicycle
Unable or unwilling to discontinue dietary supplements for at least 2 weeks prior to each CRC admission
History of celiac disease

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kendra Magyar, RN, MSN, CPNP	617-724-6237	KLMAGYAR@PARTNERS.ORG
Contact: Kerry Grennan, R.N., M.S.N, C.P.N.P., C.D.E.	617-724-7700	KGRENNAN@PARTNERS.ORG

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01161862

Other Study ID Numbers ^ICMJE

H-29293, 1R01DK085633-01

Has Data Monitoring Committee

Yes

Responsible Party

Edward Damiano, Associate Professor of Biomedical Engineering, Boston University

Study Sponsor ^ICMJE

Boston University

Collaborators ^ICMJE

Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Leona M. and Harry B. Helmsley Charitable Trust

Investigators ^ICMJE

Principal Investigator:

Steven J Russell, MD, PhD

Massachusetts General Hospital

Information Provided By

Boston University

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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