Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, hyperglycemia
Treatment closed-loop blood glucose control
Phase phase 1/phase 2
Sponsor Massachusetts General Hospital
Collaborator Boston University
Start date March 2013
End date June 2014
Trial size 30 participants
Trial identifier NCT01819844, 2011P000993

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
closed-loop blood glucose control InPatient Closed-Loop Blood Glucose Control Device.
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).

Primary Outcomes

Measure
Average blood glucose over the closed-loop control period, as determined from GlucoScout measurements.
time frame: 12 hours

Secondary Outcomes

Measure
Number of carbohydrate interventions (15 g) delivered according to study protocol
time frame: 12 hours
Number of BG events < 70 mg/dl and nadir BG for each as determined form GlucoScout measurements
time frame: 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
time frame: 12 hours
Average blood glucose over the closed-loop control period as determined from the CGM driving the control algorithm
time frame: 12 hours
Number of BG events < 70 mg/dl and nadir BG for each as determined from the CGM driving the control algorithm
time frame: 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
time frame: 12 hours
Insulin dosing (u/kg)
time frame: 12 hours
Dextrose dosing (g/kg)
time frame: 12 hours
Plasma insulin levels
time frame: 12 hours
Insulin clearance rate (t½)
time frame: 12 hours
Accuracy of the CGM device using the GlucoScout measurements as the standard.
time frame: 12 hours

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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

Additional Information

Official title Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting
Principal investigator Steven J Russell, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.