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

July 12, 2010
October 21, 2013
July 2010
December 2012   (final data collection date for primary outcome measure)
Mean blood glucose
Same as current
Complete list of historical versions of study NCT01161862 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management Of Type 1 Diabetes
Integration of Continuous Glucose Monitoring Into a Bi-Hormonal Closed-Loop Artificial Pancreas for Automated Management of Type 1 Diabetes

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01161862
H-29293, 1R01DK085633-01
Yes
Edward R. Damiano, Boston University
Boston University
  • 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
Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital
Boston University
October 2013

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