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)

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Juvenile Diabetes Research Foundation
Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Edward R. Damiano, Boston University
ClinicalTrials.gov Identifier:
NCT01161862
First received: July 12, 2010
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Mean blood glucose

Secondary Outcome Measures:
  • 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

Enrollment: 100
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-hormonal Device: Closed-loop blood glucose control with a bi-hormonal (insulin and glucagon) artificial pancreas
Experimental: Insulin-only Device: Closed-loop blood glucose control with an insulin-only artificial pancreas

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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161862

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Boston University
Massachusetts General Hospital
Juvenile Diabetes Research Foundation
Leona M. and Harry B. Helmsley Charitable Trust
Investigators
Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edward R. Damiano, Associate Professor of Biomedical Engineering, Boston University
ClinicalTrials.gov Identifier: NCT01161862     History of Changes
Other Study ID Numbers: H-29293, 1R01DK085633-01
Study First Received: July 12, 2010
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston University:
Closed-loop
Artificial pancreas
Bi-hormonal
Insulin
Glucagon
Diabetes mellitus type 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glucagon
Insulin
Insulin, Globin Zinc
Pancreatin
Pancrelipase
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014