Status:
COMPLETED
Inpatient Closed-loop Glucose Control
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Boston University
Conditions:
Diabetes Mellitus
Hyperglycemia
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hosp...
Detailed Description
The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects with type 1 diabetes
- Age 21 to 75 with clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Total daily dose (TDD) of insulin that is \< 1 u/kg
- Subjects with type 2 diabetes
- Age 21 to 75 with clinical type 2 diabetes for at least one year
- Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin
- Total daily dose (TDD) of insulin that is \> 1 u/kg/day but \< 2 u/kg/day or \> 2 u/kg/day
- Exclusion Criteria:
- Pregnancy
- Renal insufficiency
- Cancer
- Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- Acute illness or exacerbation of chronic illness at the time of the study procedure
- Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
- History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
- Known history of coronary artery disease, TIA or stroke
- History of seizures
- Transaminitis
- Stage 2 hypertension at the time of screening
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01819844
Start Date
March 1 2013
End Date
December 1 2014
Last Update
December 12 2017
Active Locations (1)
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1
MGH Diabetes Research Center
Boston, Massachusetts, United States, 02114