Inpatient Closed-loop Glucose Control

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819844
• Other study ID #: 2011P000993
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: November 13, 2017
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperglycemia

Intervention

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).

Locations

Country	Name	City	State
United States	MGH Diabetes Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston University

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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