Type 1 DiabetesNCT04227626
Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT
A study testing GlucoSTAT in people with Type 1 Diabetes and Type 2 Diabetes Treated With Insulin, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes Treated With Insulin
- What is being tested?
- GlucoSTAT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2021to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- History of TIA or stroke in the last 12 months
- Untreated or inadequately treated mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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).
- Being tested
- GlucoSTAT
- Keywords
- closed loop, insulin, dextrose
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoSTATDevice
Also called Closed-loop blood glucose control
Closed-loop blood glucose control using intravenous insulin and dextrose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: GlucoSTAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average plasma glucose over the closed-loop control period
Average plasma glucose
Measured: every 15 minutes for 8.5 hours
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: during 30 minute meal
Insulin dosing (u/kg)
Total amount of insulin delivered by the GlucoSTAT during the experiment
Measured: 8.5 hour experiment duration
Dextrose dosing (g/kg)
Total amount of dextrose delivered by the GlucoSTAT during the experiment
Measured: 8.5 hour experiment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startApr 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: The study has not started, the device is not ready so the study will be delayed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beta Bionics, Inc.
- Responsible party
- Principal investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227626
- Sponsor's protocol ID
- 2020P000079
- Status last verified
- Oct 2020
- First submitted
- 10 Jan 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Automated Glucose Control With the Gen2 GlucoSTAT Bionic Pancreas in Volunteers With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04227626
- Acronym / sponsor ID
- 2020P000079
- Keywords
- closed loop, insulin, dextrose
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has not started, the device is not ready so the study will be delayed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beta Bionics, Inc.
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlucoSTAT | Experimental | Device: GlucoSTATType 1 diabetes and Type 2 diabetes with a total daily dose (TDD) of insulin that is > 0.75 u/kg or ≥ 2 u/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoSTATAlso: Closed-loop blood glucose controlClosed-loop blood glucose control using intravenous insulin and dextrose | Device | GlucoSTAT |
Primary outcome
Average plasma glucose over the closed-loop control period
Time frame: every 15 minutes for 8.5 hours
Average plasma glucose
5 secondary outcomes
Number of carbohydrate interventions needed to treat hypoglycemia
Time frame: 8.5 hour experiment duration
Grams of carbohydrates needed to treat hypoglycemia
Time frame: 8.5 hour experiment duration
Carbohydrate content and total calories of consumed lunch meal
Time frame: during 30 minute meal
Insulin dosing (u/kg)
Time frame: 8.5 hour experiment duration
Dextrose dosing (g/kg)
Time frame: 8.5 hour experiment duration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Russell, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlucoSTAT in people with Type 1 Diabetes and Type 2 Diabetes Treated With Insulin, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average plasma glucose over the closed-loop control period (time frame: every 15 minutes for 8.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.