Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT

NCT04227626 | Withdrawn DMC FDA Device

• 1 other identifier: 2020P000079
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes Treated With Insulin

Keywords

closed loop; insulin; dextrose

Outcome Measures

Primary Outcomes (1)

• Average plasma glucose over the closed-loop control period

  Average plasma glucose

  every 15 minutes for 8.5 hours

Secondary Outcomes (5)

• Number of carbohydrate interventions needed to treat hypoglycemia

  8.5 hour experiment duration

• Grams of carbohydrates needed to treat hypoglycemia

  8.5 hour experiment duration

• Carbohydrate content and total calories of consumed lunch meal

  during 30 minute meal

• Insulin dosing (u/kg)

  8.5 hour experiment duration

• Dextrose dosing (g/kg)

  8.5 hour experiment duration

Study Arms (1)

GlucoSTAT

EXPERIMENTAL

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

Interventions

GlucoSTAT DEVICE

Closed-loop blood glucose control using intravenous insulin and dextrose

Also known as: Closed-loop blood glucose control

GlucoSTAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes:
• Age 18 years or older with clinical type 1 diabetes for at least one year.
• 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).
• Total daily dose (TDD) of insulin that is ≤ 1 U/kg
• Prescription medication regimen stable for at least 1 month.
• Informed consent obtained before any trial-related activities.
• Type 2 diabetes:
• Age 18 years or older with clinical type 2 diabetes for at least 1 year.
• 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.
• 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
• Prescription medication regimen stable for at least 1 month.
• Informed consent obtained before any trial-related activities.

You may not qualify if:

• Unable to provide informed consent.
• Unable to comply with study procedures.
• 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
• 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.
• Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
• Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
• Established history of latex, adhesive, or tape allergy that must be used in the study
• Inadequate venous access as determined by study nurse or physician at time of screening.
• 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.
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beta Bionics, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 13, 2020
• Study Start: April 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)