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Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227626
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Beta Bionics, Inc.
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Brief Summary:
The goal of this study is to perform a first-in-humans trial of a fully integrated, automated, closed-loop blood glucose control system designed for inpatient use. The GlucoSTAT 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
Type 1 Diabetes Type 2 Diabetes Treated With Insulin Device: GlucoSTAT Not Applicable

Detailed Description:
Our envisioned end product is an in-patient automated closed-loop control system for PG regulation in the ICU as well as on the general hospital wards. In order to qualify the system for the broad spectrum of challenges it will face in the inpatient setting, we intend to test the ability of the new integrated configuration GlucoSTAT of the system to control PG in subjects with extremes of insulin sensitivity. Our first goal of this study is to test the safety and efficacy of the control system in insulin sensitive subjects with type 1 diabetes. The second goal of this study is to test the safety and efficacy of the control system in subjects with type 2 diabetes and substantial insulin resistance (TDD > 0.75 u/kg/day, with up to 3 subjects with a TDD > 2 u/kg/day).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of Automated Glucose Control With the Gen2 GlucoSTAT Bionic Pancreas in Volunteers With Type 1 and Type 2 Diabetes
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: GlucoSTAT
Type 1 diabetes and Type 2 diabetes with a total daily dose (TDD) of insulin that is > 0.75 u/kg or ≥ 2 u/kg.
Device: GlucoSTAT
Closed-loop blood glucose control using intravenous insulin and dextrose
Other Name: Closed-loop blood glucose control




Primary Outcome Measures :
  1. Average plasma glucose over the closed-loop control period [ Time Frame: t=0 min to t=510 min ]
    Average plasma glucose measured every 15 minutes over the course of the experiment


Secondary Outcome Measures :
  1. Number of carbohydrate interventions and grams of carbohydrates needed to treat hypoglycemia [ Time Frame: t=0 min to t=510 min ]
    The number of times that carbohydrates were consumed and the amount of carbohydrates consumed in response to hypoglycemia

  2. Carbohydrate content and total calories of consumed lunch meal [ Time Frame: t=0 min to t=510 min ]
    The amount of carbohydrates and total calories the subject consumed during their provided lunch

  3. Insulin dosing (u/kg) [ Time Frame: t=0 min to t=510 min ]
    Total amount of insulin delivered by the GlucoSTAT during the experiment

  4. Dextrose dosing (g/kg) [ Time Frame: t=0 min to t=510 min ]
    Total amount of dextrose delivered by the GlucoSTAT during the experiment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Type 1 diabetes:

  1. Age 18 years or older with clinical type 1 diabetes for at least one year.
  2. Diabetes currently managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog or Fiasp), insulin lispro (Humalog), and insulin glulisine (Apidra).
  3. Total daily dose (TDD) of insulin that is ≤ 1 U/kg
  4. Prescription medication regimen stable for at least 1 month.
  5. Informed consent obtained before any trial-related activities.

Type 2 diabetes:

  1. Age 18 years or older with clinical type 2 diabetes for at least 1 year.
  2. Diabetes currently managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin and/or other anti-diabetic drugs.
  3. Total daily dose (TDD) of insulin that is > 0.75 u/kg

    • Our goal is to have up to 3 T2D subjects with a TDD > 2 u/kg
  4. Prescription medication regimen stable for at least 1 month.
  5. Informed consent obtained before any trial-related activities.

Exclusion Criteria:

  1. Unable to provide informed consent.
  2. Unable to comply with study procedures.
  3. Current participation in another diabetes-related clinical trial that, in the judgement of the principal investigator, will compromise the results of this study or the safety of the participant
  4. Use of a long-acting insulin (in type 1 diabetes subjects) or a long-acting insulin other than NPH (in type 2 diabetes subjects), including insulin glargine (Lantus), insulin detemir (Levemir), insulin degludec (Tresiba), or ultra-lente.
  5. Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
  6. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
  7. Established history of latex, adhesive, or tape allergy that must be used in the study
  8. Inadequate venous access as determined by study nurse or physician at time of screening.
  9. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
  10. A condition that in the opinion of the investigator could interfere with the safe completion of the study. Conditions to be considered by the investigator may include the following:

    • Alcohol or drug abuse
    • Use of prescription drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study
    • Renal failure
    • Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. climbing a flight of stairs) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
    • Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
    • History of TIA or stroke in the last 12 months
    • Untreated or inadequately treated mental illness

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): NCT04227626


Contacts
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Contact: Courtney Balliro, BS, RN, CDE 617-726-1242 cballiro@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Courtney Balliro, BS, RN, CDE    617-726-1242    cballiro@partners.org   
Principal Investigator: Steven J Russell, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Beta Bionics, Inc.
Investigators
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Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital

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Responsible Party: Steven J. Russell, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04227626    
Other Study ID Numbers: 2020P000079
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Steven J. Russell, MD, PhD, Massachusetts General Hospital:
closed loop
insulin
dextrose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs