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Completed

NCT Number: NCT01819844

Inpatient Closed-loop Glucose Control

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH Diabetes Research Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: InPatient Closed-Loop Blood Glucose Control Device.

Primary outcomes

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

    Time frame: 12 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2013
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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