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Inpatient Closed-loop Glucose Control

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ClinicalTrials.gov Identifier: NCT01819844
Recruitment Status : Completed
First Posted : March 28, 2013
Results First Posted : July 21, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hyperglycemia Device: Closed-loop blood glucose control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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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 Name: InPatient Closed-Loop Blood Glucose Control Device.


Outcome Measures
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Primary Outcome Measures :
  1. Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol [ Time Frame: 12 hours ]
  2. Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements [ Time Frame: 12 hours ]
  3. 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 ]
  4. Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm [ Time Frame: 12 hours ]
  5. Number of BG Events < 70 mg/dl as Determined by the CGM [ Time Frame: 12 hours ]
  6. 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 ]
  7. Insulin Dosing (u/kg) [ Time Frame: 12 hours ]
  8. Dextrose Dosing (g/kg) [ Time Frame: 12 hours ]
  9. Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. [ Time Frame: 12 hours ]
    The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819844


Locations
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United States, Massachusetts
MGH Diabetes Research Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Boston University
Investigators
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Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital
More Information
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Additional Information:

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Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01819844    
Other Study ID Numbers: 2011P000993
First Posted: March 28, 2013    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Keywords provided by Steven J. Russell, MD, PhD, Massachusetts General Hospital:
Closed-loop blood glucose control
Continuous glucose monitoring
Bionic pancreas
Artificial pancreas
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases