Status:
COMPLETED
Closed-loop Glucose Control for Automated Management of Type 1 Diabetes
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
Massachusetts General Hospital
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of clos...
Detailed Description
This study investigates the utility of an integrated closed-loop glucose-control system for regulating BG in type 1 diabetic subjects. The closed-loop system utilizes sub-cutaneous infusion or insulin...
Eligibility Criteria
Inclusion
- Inclusion Criteria (type 1 diabetic subjects):
- Age 18 years or older
- Clinical type 1 diabetes for at least five years
- Otherwise healthy (mild chronic disease allowed if well controlled)
- Diabetes managed using an insulin infusion pump
- Body mass index (BMI) between 20 and 31
- Total daily dose (TDD) of insulin ≤ 1 U/kg and ≤ 100 U/day
- Post-prandial C-peptide \< 0.1 nmol/L at 90 minutes in a mixed meal (Sustacal) tolerance test by the DCCT method
- Hemoglobin A1c less than or equal to 8.5%
- Prescription medication regimen stable for at least 1 month
- Inclusion Criteria (non-diabetic subjects):
- Age 18 years or older
- No personal history of diabetes, impaired fasting glucose, or impaired glucose tolerance
- No personal history of pancreatic disease
- Not taking medication that may affect glucose, insulin, or glucagon dynamics
- Otherwise healthy (mild chronic disease allowed if well controlled)
- Body mass index (BMI) between 20 and 31
- Normal 75 g oral glucose tolerance test (fasting, 1 hour, and 2 hour measurements)
- Exclusion Criteria (all subjects):
- Unable to provide informed consent or are unable to comply with study procedures
- Current participation in another clinical trial
- Anemia (HCT or hemoglobin less than normal for sex)
- Elevated alanine aminotransferase (ALT \> 3 fold above upper limit of normal)
- Untreated or inadequately treated hyperthyroidism or hypothyroidism (abnormal TSH or free T4)
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
- Progressive or proliferative diabetic retinopathy (subjects with mild, non-proliferative background retinopathy or stable disease previously treated with photocoagulation are not excluded).
- Renal insufficiency (creatinine clearance estimated by Cockcroft-Gault equation of ≤ 50 ml/min)
- Any known history or symptoms of coronary artery disease.
- Abnormal EKG
- Congestive heart failure
- History of TIA or stroke within preceding 6 months
- Acute illness or exacerbation of chronic illness at the time of the study procedure
- Change in medication regimen in the 30 days prior to enrollment
- History of seizures
- History of pheochromocytoma
- Abnormal plasma fractionated metanephrines
- 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 (\> 3 drinks daily) or substance abuse (any use within the last 6 months of illegal drugs)
- Severe mental illness (schizophrenia, bipolar disease, inadequately treated depression, or any psychiatric hospitalization in the last year)
- Impaired cognition or altered mental status.
- Hypertension (blood pressure \> 140/90) at the time of screening
- Use of medications that reduce gastric motility
- Electrically powered implants that might be susceptible to RF interference
- Use non-insulin injectable anti-diabetic medications, inhaled insulin, or oral anti-diabetic medications
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Established history of latex, adhesive, tape allergy, inadequate venous access, history of allergy to or intolerance of aspirin.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00811317
Start Date
May 1 2008
End Date
October 1 2009
Last Update
October 25 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114