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Inpatient Closed-loop Glucose Control

Primary Purpose

Diabetes Mellitus, Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Closed-loop blood glucose control
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Closed-loop blood glucose control, Continuous glucose monitoring, Bionic pancreas, Artificial pancreas

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MGH Diabetes Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed-loop blood glucose control

Arm Description

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

Outcomes

Primary Outcome Measures

Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2013
Last Updated
November 13, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT01819844
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hyperglycemia
Keywords
Closed-loop blood glucose control, Continuous glucose monitoring, Bionic pancreas, Artificial pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop blood glucose control
Arm Type
Experimental
Arm Description
Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg.
Intervention Type
Device
Intervention Name(s)
Closed-loop blood glucose control
Other Intervention Name(s)
InPatient Closed-Loop Blood Glucose Control Device.
Intervention Description
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 Outcome Measure Information:
Title
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol
Time Frame
12 hours
Title
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements
Time Frame
12 hours
Title
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
Title
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm
Time Frame
12 hours
Title
Number of BG Events < 70 mg/dl as Determined by the CGM
Time Frame
12 hours
Title
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
Title
Insulin Dosing (u/kg)
Time Frame
12 hours
Title
Dextrose Dosing (g/kg)
Time Frame
12 hours
Title
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.
Description
The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Russell, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Diabetes Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.bionicpancreas.org
Description
Related Info

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Inpatient Closed-loop Glucose Control

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