Status:
COMPLETED
Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
12+ years
Phase:
NA
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 co...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01161862
Start Date
July 1 2010
End Date
June 1 2013
Last Update
November 14 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114