A Feasibility Study of Automated Glucose Control With the Gen2 GlucoSTAT Bionic Pancreas in Volunteers With Type 1 and Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Massachusetts General Hospital
- Locations
- 1
- Primary Endpoint
- Average plasma glucose over the closed-loop control period
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
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).
Investigators
Steven J. Russell, MD, PhD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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:
Outcomes
Primary Outcomes
Average plasma glucose over the closed-loop control period
Time Frame: every 15 minutes for 8.5 hours
Average plasma glucose
Secondary Outcomes
- 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)