Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT

A Feasibility Study of Automated Glucose Control With the Gen2 GlucoSTAT Bionic Pancreas in Volunteers With Type 1 and Type 2 Diabetes

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.

Study Overview

• Status: Withdrawn
• Conditions: Type 1 Diabetes; Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: GlucoSTAT

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, this study will test the ability of the new integrated configuration of the system (the GlucoSTAT) to control PG in subjects with extremes of insulin sensitivity. The 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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Closed-loop blood glucose control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average plasma glucose over the closed-loop control period	Average plasma glucose	every 15 minutes for 8.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of carbohydrate interventions needed to treat hypoglycemia	The number of times that carbohydrates were consumed in response to hypoglycemia throughout the 8.5 hour experiment	8.5 hour experiment duration
Grams of carbohydrates needed to treat hypoglycemia	The amount of carbohydrates consumed in response to hypoglycemia throughout the 8.5 hour experiment	8.5 hour experiment duration
Carbohydrate content and total calories of consumed lunch meal	The amount of carbohydrates and total calories the subject consumed during their provided lunch	during 30 minute meal
Insulin dosing (u/kg)	Total amount of insulin delivered by the GlucoSTAT during the experiment	8.5 hour experiment duration
Dextrose dosing (g/kg)	Total amount of dextrose delivered by the GlucoSTAT during the experiment	8.5 hour experiment duration

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Beta Bionics, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: insulin; closed loop; dextrose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2020P000079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes