Inpatient Closed-loop Glucose Control

Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Diabetes Mellitus
• Intervention / Treatment: Device: Closed-loop blood glucose control

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Closed-loop blood glucose control; Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.

Device: Closed-loop blood glucose control; The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg).; Other Names: InPatient Closed-Loop Blood Glucose Control Device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol		12 hours
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements		12 hours
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		12 hours
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm		12 hours
Number of BG Events < 70 mg/dl as Determined by the CGM		12 hours
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		12 hours
Insulin Dosing (u/kg)		12 hours
Dextrose Dosing (g/kg)		12 hours
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.	The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout	12 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Boston University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Artificial pancreas; Bionic pancreas; Closed-loop blood glucose control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 2011P000993