Clinical trial NCT01819844: Inpatient Closed-loop Glucose Control
Official title: Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hyperglycemia
Keywords: Closed-loop blood glucose control
Continuous glucose monitoring
Bionic pancreas
Artificial pancreas
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2013-03-28
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 hospital, and others who may develop high blood sugar as a result of their medical problems.

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 type 2 diabetes (TTD \> 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (\<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.

Eligibility criteria: 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

Primary outcomes:
measure: Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
timeFrame: 12 hours
Secondary outcomes:
measure: Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol
timeFrame: 12 hours
measure: Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements
timeFrame: 12 hours
measure: Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl
timeFrame: 12 hours
measure: Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm
timeFrame: 12 hours
measure: Number of BG Events < 70 mg/dl as Determined by the CGM
timeFrame: 12 hours
measure: Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl
timeFrame: 12 hours
measure: Insulin Dosing (u/kg)
timeFrame: 12 hours
measure: Dextrose Dosing (g/kg)
timeFrame: 12 hours
measure: Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.
timeFrame: 12 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Diabetes Research Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Russell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: