Diabetes MellitusNCT01819844
Inpatient Closed-loop Glucose Control
A study of Diabetes Mellitus and Hyperglycemia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device 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 more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 1 diabetes
- Age 21 to 75 with clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Total daily dose (TDD) of insulin that is < 1 u/kg
- Subjects with type 2 diabetes
- Age 21 to 75 with clinical type 2 diabetes for at least one year
- Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin
- Total daily dose (TDD) of insulin that is > 1 u/kg/day but < 2 u/kg/day or > 2 u/kg/day
Who cannot join
- Pregnancy
- Renal insufficiency
- Cancer
- Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- Acute illness or exacerbation of chronic illness at the time of the study procedure
- Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
Show all 11Show fewer
- History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
- Known history of coronary artery disease, TIA or stroke
- History of seizures
- Transaminitis
- Stage 2 hypertension at the time of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Diabetes Research Center
Boston, Massachusetts, 02114
About this study
Official title: Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device 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
The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD > 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.
- Conditions
- Diabetes Mellitus, Hyperglycemia
- Being tested
- Closed-loop blood glucose control
- Keywords
- Closed-loop blood glucose control, Continuous glucose monitoring, Bionic pancreas, Artificial pancreas
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop blood glucose controlDevice
Also called InPatient Closed-Loop Blood Glucose Control Device.
The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg).
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop blood glucose control | Experimental | Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg. Receives: Device: Closed-loop blood glucose control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
Measured: 12 hours
Secondary outcomes (9)
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol
Measured: 12 hours
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements
Measured: 12 hours
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl
Measured: 12 hours
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm
Measured: 12 hours
Number of BG Events < 70 mg/dl as Determined by the CGM
Measured: 12 hours
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl
Measured: 12 hours
Insulin Dosing (u/kg)
Measured: 12 hours
Dextrose Dosing (g/kg)
Measured: 12 hours
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.
The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- 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
- NCT01819844
- Sponsor's protocol ID
- 2011P000993
- Status last verified
- Nov 2017
- First submitted
- 28 Feb 2013
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting
- ClinicalTrials.gov ID
- NCT01819844
- Acronym / sponsor ID
- 2011P000993
- Conditions
- Diabetes Mellitus, Hyperglycemia
- Keywords
- Closed-loop blood glucose control, Continuous glucose monitoring, Bionic pancreas, Artificial pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Posted 21 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device 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
The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD > 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-loop blood glucose control | Experimental | Device: Closed-loop blood glucose controlType 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with type 1 diabetes
- Age 21 to 75 with clinical type 1 diabetes for at least one year
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
- Total daily dose (TDD) of insulin that is < 1 u/kg
- Subjects with type 2 diabetes
Key exclusion criteria (11 listed)
- Pregnancy
- Renal insufficiency
- Cancer
- Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
- Acute illness or exacerbation of chronic illness at the time of the study procedure
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 |
|---|---|---|
| Closed-loop blood glucose controlAlso: InPatient Closed-Loop Blood Glucose Control Device.The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg). | Device | Closed-loop blood glucose control |
Primary outcome
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.
Time frame: 12 hours
9 secondary outcomes
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol
Time frame: 12 hours
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements
Time frame: 12 hours
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl
Time frame: 12 hours
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm
Time frame: 12 hours
Number of BG Events < 70 mg/dl as Determined by the CGM
Time frame: 12 hours
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl
Time frame: 12 hours
Insulin Dosing (u/kg)
Time frame: 12 hours
Dextrose Dosing (g/kg)
Time frame: 12 hours
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.
Time frame: 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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 of Diabetes Mellitus and Hyperglycemia, 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 12 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. (time frame: 12 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 12 Dec 2017.