Inpatient Closed-loop Glucose Control

Mass General Brigham

Status: Completed

Conditions: Hyperglycemia; Diabetes Mellitus

Treatments: Device: Closed-loop blood glucose control

Study type: Interventional

Funder types: Other

Identifiers

NCT01819844

2011P000993

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Closed-loop blood glucose control

Experimental group

Description:

Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is \> 1 u/kg or \> 2 u/kg.

Treatment:

Device: Closed-loop blood glucose control